Conference Coverage

A low-level light therapy cap may be a safe, convenient treatment for some patients with central centrifugal cicatricial alopecia, though the treatment effects from a small prospective trial appear to be subtle.

Central centrifugal cicatricial alopecia (CCCA) is a form of scarring hair loss with unknown etiology and no known cure that affects mainly women of African descent.

“The low-level light therapy (LLLT) cap does indeed seem to help with symptoms and mild regrowth in CCCA,” senior study author Amy J. McMichael, MD, told this news organization. “The dual-wavelength cap we used appears to have anti-inflammatory properties, and that makes sense for a primarily inflammatory scarring from of alopecia.

“Quality of life improved with the treatment and there were no reported side effects,” added Dr. McMichael, professor of dermatology at Wake Forest University, Winston-Salem, N.C.

The results of the study were presented in a poster at the annual meeting of the Society for Investigative Dermatology.

The REVIAN RED cap (REVIAN Inc.) used in the study contains 119 light-emitting diodes (LEDs) arrayed on the cap’s interior surface that emit orange (620 nm) and red (660 nm) light.

The hypothesis for how the dual-wavelength lights work is that light is absorbed by the chromophore cytochrome c oxidase in the mitochondrial membrane. This induces the release of nitric oxide and the production of adenosine triphosphate (ATP), which leads to vasodilation, cytokine regulation, and increased transcription and release of growth factors.

LLLT is approved to treat androgenetic alopecia, the authors wrote, but has not been studied as a treatment for CCCA.

To assess the effects of LLLT on CCCA, Dr. McMichael and her colleagues at Wake Forest followed the condition’s progress in five Black women over their 6-month course of treatment. Four participants completed the study.

At baseline, all participants had been on individual stable CCCA treatment regimens for at least 3 months. They continued those treatments along with LLLT therapy throughout the study. The women ranged in age from 38 to 69 years, had had CCCA for an average of 12 years, and their disease severity ranged from stage IIB to IVA.

They were instructed to wear the REVIAN RED cap with the LEDs activated for 10 minutes each day.

At 2, 4, and 6 months, participants self-assessed their symptoms, a clinician evaluated the condition’s severity, and digital photographs were taken.

At 6 months:

• Three patients showed improved Dermatology Life Quality Index (DLQI).
• Three patients showed decreased loss of follicular openings and breakage.
• A dermoscopic image of the scalp of one patient revealed short, regrowing vellus hairs and minimal interfollicular and perifollicular scale.
• No patients reported side effects.

Small study raises big questions

“I hope this study will lead to a larger study that will look at the long-term outcomes of CCCA,” Dr. McMichael said. “This is a nice treatment that does not require application of something to the scalp that may affect hair styling, and it has no systemic side effects.”

Dr. McMichael acknowledges that the small sample size, participants continuing with their individual stable treatments while also undergoing light therapy, and the lack of patients with stage I disease, are weaknesses in the study.

“However, the strength is that none of the patients had side effects or stopped using the treatment due to difficulty with the system,” she added.

Dr. McMichael said she would like to investigate the effects of longer use of the cap and whether the cap can be used to prevent CCCA.

Chesahna Kindred, MD, assistant professor of dermatology at Howard University, Washington, D.C., and founder of Kindred Hair & Skin Center in Columbia, Md., told this news organization that she uses LLLT in her practice.

“I find that LLLT is mildly helpful, or at least does not worsen, androgenetic alopecia,” she said.

“Interestingly, while all four patients had stable disease upon initiating the study, it appears as though two of the four worsened after the use of LLLT, one improved, and one remained relatively stable,” noted Dr. Kindred, who was not involved in the study. “This is important because once there is complete destruction of the follicle, CCCA is difficult to improve.

“Given that there are several options to address inflammation and follicular damage in CCCA, more studies are needed before I would incorporate LLLT into my regular treatment algorithms,” she added.

“Studies like this are important and remind us to not lump all forms of hair loss together,” she said.

REVIAN Inc. provided the caps, but the study received no additional funding. Dr. McMichael and Dr. Kindred report relevant financial relationships with the pharmaceutical industry. Study coauthors have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

A low-level light therapy cap may be a safe, convenient treatment for some patients with central centrifugal cicatricial alopecia, though the treatment effects from a small prospective trial appear to be subtle.

Central centrifugal cicatricial alopecia (CCCA) is a form of scarring hair loss with unknown etiology and no known cure that affects mainly women of African descent.

“The low-level light therapy (LLLT) cap does indeed seem to help with symptoms and mild regrowth in CCCA,” senior study author Amy J. McMichael, MD, told this news organization. “The dual-wavelength cap we used appears to have anti-inflammatory properties, and that makes sense for a primarily inflammatory scarring from of alopecia.

“Quality of life improved with the treatment and there were no reported side effects,” added Dr. McMichael, professor of dermatology at Wake Forest University, Winston-Salem, N.C.

The results of the study were presented in a poster at the annual meeting of the Society for Investigative Dermatology.

The REVIAN RED cap (REVIAN Inc.) used in the study contains 119 light-emitting diodes (LEDs) arrayed on the cap’s interior surface that emit orange (620 nm) and red (660 nm) light.

The hypothesis for how the dual-wavelength lights work is that light is absorbed by the chromophore cytochrome c oxidase in the mitochondrial membrane. This induces the release of nitric oxide and the production of adenosine triphosphate (ATP), which leads to vasodilation, cytokine regulation, and increased transcription and release of growth factors.

LLLT is approved to treat androgenetic alopecia, the authors wrote, but has not been studied as a treatment for CCCA.

To assess the effects of LLLT on CCCA, Dr. McMichael and her colleagues at Wake Forest followed the condition’s progress in five Black women over their 6-month course of treatment. Four participants completed the study.

At baseline, all participants had been on individual stable CCCA treatment regimens for at least 3 months. They continued those treatments along with LLLT therapy throughout the study. The women ranged in age from 38 to 69 years, had had CCCA for an average of 12 years, and their disease severity ranged from stage IIB to IVA.

They were instructed to wear the REVIAN RED cap with the LEDs activated for 10 minutes each day.

At 2, 4, and 6 months, participants self-assessed their symptoms, a clinician evaluated the condition’s severity, and digital photographs were taken.

At 6 months:

• Three patients showed improved Dermatology Life Quality Index (DLQI).
• Three patients showed decreased loss of follicular openings and breakage.
• A dermoscopic image of the scalp of one patient revealed short, regrowing vellus hairs and minimal interfollicular and perifollicular scale.
• No patients reported side effects.

Small study raises big questions

“I hope this study will lead to a larger study that will look at the long-term outcomes of CCCA,” Dr. McMichael said. “This is a nice treatment that does not require application of something to the scalp that may affect hair styling, and it has no systemic side effects.”

Dr. McMichael acknowledges that the small sample size, participants continuing with their individual stable treatments while also undergoing light therapy, and the lack of patients with stage I disease, are weaknesses in the study.

“However, the strength is that none of the patients had side effects or stopped using the treatment due to difficulty with the system,” she added.

Dr. McMichael said she would like to investigate the effects of longer use of the cap and whether the cap can be used to prevent CCCA.

Chesahna Kindred, MD, assistant professor of dermatology at Howard University, Washington, D.C., and founder of Kindred Hair & Skin Center in Columbia, Md., told this news organization that she uses LLLT in her practice.

“I find that LLLT is mildly helpful, or at least does not worsen, androgenetic alopecia,” she said.

“Interestingly, while all four patients had stable disease upon initiating the study, it appears as though two of the four worsened after the use of LLLT, one improved, and one remained relatively stable,” noted Dr. Kindred, who was not involved in the study. “This is important because once there is complete destruction of the follicle, CCCA is difficult to improve.

“Given that there are several options to address inflammation and follicular damage in CCCA, more studies are needed before I would incorporate LLLT into my regular treatment algorithms,” she added.

“Studies like this are important and remind us to not lump all forms of hair loss together,” she said.

REVIAN Inc. provided the caps, but the study received no additional funding. Dr. McMichael and Dr. Kindred report relevant financial relationships with the pharmaceutical industry. Study coauthors have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

A low-level light therapy cap may be a safe, convenient treatment for some patients with central centrifugal cicatricial alopecia, though the treatment effects from a small prospective trial appear to be subtle.

Central centrifugal cicatricial alopecia (CCCA) is a form of scarring hair loss with unknown etiology and no known cure that affects mainly women of African descent.

“The low-level light therapy (LLLT) cap does indeed seem to help with symptoms and mild regrowth in CCCA,” senior study author Amy J. McMichael, MD, told this news organization. “The dual-wavelength cap we used appears to have anti-inflammatory properties, and that makes sense for a primarily inflammatory scarring from of alopecia.

“Quality of life improved with the treatment and there were no reported side effects,” added Dr. McMichael, professor of dermatology at Wake Forest University, Winston-Salem, N.C.

The results of the study were presented in a poster at the annual meeting of the Society for Investigative Dermatology.

The REVIAN RED cap (REVIAN Inc.) used in the study contains 119 light-emitting diodes (LEDs) arrayed on the cap’s interior surface that emit orange (620 nm) and red (660 nm) light.

The hypothesis for how the dual-wavelength lights work is that light is absorbed by the chromophore cytochrome c oxidase in the mitochondrial membrane. This induces the release of nitric oxide and the production of adenosine triphosphate (ATP), which leads to vasodilation, cytokine regulation, and increased transcription and release of growth factors.

LLLT is approved to treat androgenetic alopecia, the authors wrote, but has not been studied as a treatment for CCCA.

To assess the effects of LLLT on CCCA, Dr. McMichael and her colleagues at Wake Forest followed the condition’s progress in five Black women over their 6-month course of treatment. Four participants completed the study.

At baseline, all participants had been on individual stable CCCA treatment regimens for at least 3 months. They continued those treatments along with LLLT therapy throughout the study. The women ranged in age from 38 to 69 years, had had CCCA for an average of 12 years, and their disease severity ranged from stage IIB to IVA.

They were instructed to wear the REVIAN RED cap with the LEDs activated for 10 minutes each day.

At 2, 4, and 6 months, participants self-assessed their symptoms, a clinician evaluated the condition’s severity, and digital photographs were taken.

At 6 months:

• Three patients showed improved Dermatology Life Quality Index (DLQI).
• Three patients showed decreased loss of follicular openings and breakage.
• A dermoscopic image of the scalp of one patient revealed short, regrowing vellus hairs and minimal interfollicular and perifollicular scale.
• No patients reported side effects.

Small study raises big questions

“I hope this study will lead to a larger study that will look at the long-term outcomes of CCCA,” Dr. McMichael said. “This is a nice treatment that does not require application of something to the scalp that may affect hair styling, and it has no systemic side effects.”

Dr. McMichael acknowledges that the small sample size, participants continuing with their individual stable treatments while also undergoing light therapy, and the lack of patients with stage I disease, are weaknesses in the study.

“However, the strength is that none of the patients had side effects or stopped using the treatment due to difficulty with the system,” she added.

Dr. McMichael said she would like to investigate the effects of longer use of the cap and whether the cap can be used to prevent CCCA.

Chesahna Kindred, MD, assistant professor of dermatology at Howard University, Washington, D.C., and founder of Kindred Hair & Skin Center in Columbia, Md., told this news organization that she uses LLLT in her practice.

“I find that LLLT is mildly helpful, or at least does not worsen, androgenetic alopecia,” she said.

“Interestingly, while all four patients had stable disease upon initiating the study, it appears as though two of the four worsened after the use of LLLT, one improved, and one remained relatively stable,” noted Dr. Kindred, who was not involved in the study. “This is important because once there is complete destruction of the follicle, CCCA is difficult to improve.

“Given that there are several options to address inflammation and follicular damage in CCCA, more studies are needed before I would incorporate LLLT into my regular treatment algorithms,” she added.

“Studies like this are important and remind us to not lump all forms of hair loss together,” she said.

REVIAN Inc. provided the caps, but the study received no additional funding. Dr. McMichael and Dr. Kindred report relevant financial relationships with the pharmaceutical industry. Study coauthors have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Advances have been made in earlier diagnosis and better overall survival among older patients with lung cancer, but younger adults have not experienced the same benefit, according to a new study.

The improvements in patients aged 55-80 are likely associated with the introduction in 2013 of low dose computed tomography lung cancer screening.

“It was unknown whether young adults diagnosed with lung cancer, who are ineligible for screening, have experienced a similar shift to earlier stages of lung cancer. While previous studies have shown that young adults diagnosed with lung cancer have distinct tumor characteristics and survival compared to older adults diagnosed with lung cancer, no study has examined whether recent improvements in early diagnosis and survival among older adults with lung cancer extend to younger adults diagnosed with lung cancer,” study coauthor Alexandra Potter told this news organization.

The study was presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.

The difference might be explained by difference in tumor biology, as younger adults are often diagnosed with more aggressive cancers. Other factors include delayed diagnosis and a lack of early detection strategies for this population. Older patients likely benefited from the onset of lung cancer screening, as well as an increase in non-screening chest CT use in hospital settings, which may lead to more incidental diagnoses, according to Ms. Potter, a research assistant Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.

Investigators found that about three in four lung cancer diagnoses among adults aged 20-29 were stage IV disease, and only 8% in that group were stage I. “I was surprised” by the high frequency of stage IV cancer, said Ms. Potter. “I would also highlight that there has been no improvement in early diagnosis among patients aged 20-49 during the study period,” she added.

And although it is often assumed that patients diagnosed at a younger age have better survival, the study painted a grim picture: Five-year survival was 10%-15% among patients diagnosed at age 20-49 with stage IV cancer. “More research is needed to better understand the risk factors, diagnosis, treatment, and survival of lung cancer in young adults,” Ms. Potter said.

There are strategies in development, including biomarkers, machine learning analysis of CT scans, and risk prediction models, but none have yet borne fruit. “Once we are able to [identify high-risk young adults], this will allow us to offer lung cancer screening to these young adults who are at high risk for developing lung cancer,” Ms. Potter said.
 

Study methodology

The researchers analyzed data from the United States Cancer Statistics (USCS) database and the National Cancer Database (NCDB). They included patients aged 20-79 diagnosed with non–small cell lung cancer (NSCLC) between 2010 and 2018. The study included 1,328 individuals aged 20-29, 5,682 men and women aged 30-39, 39,323 individuals aged 40-49, 202,709 aged 50-59, 410,482 aged 60-69, and 447,366 aged 70-79.

Stage IV diagnoses were most common in the youngest group (76% versus 8% stage I), and steadily declined with age 30-39 (70% versus 10%), age 40-49 (60% versus 14%), 50-59 (52%versus 19%), 60-69 (45% versus 25%), and 70-79 (40% versus 25%; P < .001). The trend reversed among patients aged 80-89, with 45% of patients diagnosed with stage IV cancer, though the rising trend of stage I diagnoses continued at 29%. Between 2010 and 2018, there was a statistically significant increase in stage IV diagnoses among those aged 40-49, and a decrease among those aged 50-59, 60-69, and 70-79.

Five-year overall survival was lowest among patients aged 20-29 at 20%. It was 27%-28% among each 10-year age group up to age 69, then dropped to 24% among those aged 70-79 (P < .001).

The study was limited by a lack of data on disease-free or recurrence-free survival, as well as use of biomarkers or targeted therapy. Ms. Potter has no relevant financial disclosures. The conference was sponsored by the International Association for the Study of Lung Cancer.

Advances have been made in earlier diagnosis and better overall survival among older patients with lung cancer, but younger adults have not experienced the same benefit, according to a new study.

The improvements in patients aged 55-80 are likely associated with the introduction in 2013 of low dose computed tomography lung cancer screening.

“It was unknown whether young adults diagnosed with lung cancer, who are ineligible for screening, have experienced a similar shift to earlier stages of lung cancer. While previous studies have shown that young adults diagnosed with lung cancer have distinct tumor characteristics and survival compared to older adults diagnosed with lung cancer, no study has examined whether recent improvements in early diagnosis and survival among older adults with lung cancer extend to younger adults diagnosed with lung cancer,” study coauthor Alexandra Potter told this news organization.

The study was presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.

The difference might be explained by difference in tumor biology, as younger adults are often diagnosed with more aggressive cancers. Other factors include delayed diagnosis and a lack of early detection strategies for this population. Older patients likely benefited from the onset of lung cancer screening, as well as an increase in non-screening chest CT use in hospital settings, which may lead to more incidental diagnoses, according to Ms. Potter, a research assistant Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.

Investigators found that about three in four lung cancer diagnoses among adults aged 20-29 were stage IV disease, and only 8% in that group were stage I. “I was surprised” by the high frequency of stage IV cancer, said Ms. Potter. “I would also highlight that there has been no improvement in early diagnosis among patients aged 20-49 during the study period,” she added.

And although it is often assumed that patients diagnosed at a younger age have better survival, the study painted a grim picture: Five-year survival was 10%-15% among patients diagnosed at age 20-49 with stage IV cancer. “More research is needed to better understand the risk factors, diagnosis, treatment, and survival of lung cancer in young adults,” Ms. Potter said.

There are strategies in development, including biomarkers, machine learning analysis of CT scans, and risk prediction models, but none have yet borne fruit. “Once we are able to [identify high-risk young adults], this will allow us to offer lung cancer screening to these young adults who are at high risk for developing lung cancer,” Ms. Potter said.
 

Study methodology

The researchers analyzed data from the United States Cancer Statistics (USCS) database and the National Cancer Database (NCDB). They included patients aged 20-79 diagnosed with non–small cell lung cancer (NSCLC) between 2010 and 2018. The study included 1,328 individuals aged 20-29, 5,682 men and women aged 30-39, 39,323 individuals aged 40-49, 202,709 aged 50-59, 410,482 aged 60-69, and 447,366 aged 70-79.

Stage IV diagnoses were most common in the youngest group (76% versus 8% stage I), and steadily declined with age 30-39 (70% versus 10%), age 40-49 (60% versus 14%), 50-59 (52%versus 19%), 60-69 (45% versus 25%), and 70-79 (40% versus 25%; P < .001). The trend reversed among patients aged 80-89, with 45% of patients diagnosed with stage IV cancer, though the rising trend of stage I diagnoses continued at 29%. Between 2010 and 2018, there was a statistically significant increase in stage IV diagnoses among those aged 40-49, and a decrease among those aged 50-59, 60-69, and 70-79.

Five-year overall survival was lowest among patients aged 20-29 at 20%. It was 27%-28% among each 10-year age group up to age 69, then dropped to 24% among those aged 70-79 (P < .001).

The study was limited by a lack of data on disease-free or recurrence-free survival, as well as use of biomarkers or targeted therapy. Ms. Potter has no relevant financial disclosures. The conference was sponsored by the International Association for the Study of Lung Cancer.

Advances have been made in earlier diagnosis and better overall survival among older patients with lung cancer, but younger adults have not experienced the same benefit, according to a new study.

The improvements in patients aged 55-80 are likely associated with the introduction in 2013 of low dose computed tomography lung cancer screening.

“It was unknown whether young adults diagnosed with lung cancer, who are ineligible for screening, have experienced a similar shift to earlier stages of lung cancer. While previous studies have shown that young adults diagnosed with lung cancer have distinct tumor characteristics and survival compared to older adults diagnosed with lung cancer, no study has examined whether recent improvements in early diagnosis and survival among older adults with lung cancer extend to younger adults diagnosed with lung cancer,” study coauthor Alexandra Potter told this news organization.

The study was presented by Chi-Fu Jeffrey Yang, MD, at a press conference held at the World Conference on Lung Cancer. Dr. Yang is a thoracic surgeon at Massachusetts General Hospital, Boston.

The difference might be explained by difference in tumor biology, as younger adults are often diagnosed with more aggressive cancers. Other factors include delayed diagnosis and a lack of early detection strategies for this population. Older patients likely benefited from the onset of lung cancer screening, as well as an increase in non-screening chest CT use in hospital settings, which may lead to more incidental diagnoses, according to Ms. Potter, a research assistant Massachusetts General Hospital and president of the American Lung Cancer Screening Initiative.

Investigators found that about three in four lung cancer diagnoses among adults aged 20-29 were stage IV disease, and only 8% in that group were stage I. “I was surprised” by the high frequency of stage IV cancer, said Ms. Potter. “I would also highlight that there has been no improvement in early diagnosis among patients aged 20-49 during the study period,” she added.

And although it is often assumed that patients diagnosed at a younger age have better survival, the study painted a grim picture: Five-year survival was 10%-15% among patients diagnosed at age 20-49 with stage IV cancer. “More research is needed to better understand the risk factors, diagnosis, treatment, and survival of lung cancer in young adults,” Ms. Potter said.

There are strategies in development, including biomarkers, machine learning analysis of CT scans, and risk prediction models, but none have yet borne fruit. “Once we are able to [identify high-risk young adults], this will allow us to offer lung cancer screening to these young adults who are at high risk for developing lung cancer,” Ms. Potter said.
 

Study methodology

The researchers analyzed data from the United States Cancer Statistics (USCS) database and the National Cancer Database (NCDB). They included patients aged 20-79 diagnosed with non–small cell lung cancer (NSCLC) between 2010 and 2018. The study included 1,328 individuals aged 20-29, 5,682 men and women aged 30-39, 39,323 individuals aged 40-49, 202,709 aged 50-59, 410,482 aged 60-69, and 447,366 aged 70-79.

Stage IV diagnoses were most common in the youngest group (76% versus 8% stage I), and steadily declined with age 30-39 (70% versus 10%), age 40-49 (60% versus 14%), 50-59 (52%versus 19%), 60-69 (45% versus 25%), and 70-79 (40% versus 25%; P < .001). The trend reversed among patients aged 80-89, with 45% of patients diagnosed with stage IV cancer, though the rising trend of stage I diagnoses continued at 29%. Between 2010 and 2018, there was a statistically significant increase in stage IV diagnoses among those aged 40-49, and a decrease among those aged 50-59, 60-69, and 70-79.

Five-year overall survival was lowest among patients aged 20-29 at 20%. It was 27%-28% among each 10-year age group up to age 69, then dropped to 24% among those aged 70-79 (P < .001).

The study was limited by a lack of data on disease-free or recurrence-free survival, as well as use of biomarkers or targeted therapy. Ms. Potter has no relevant financial disclosures. The conference was sponsored by the International Association for the Study of Lung Cancer.

Among women who took vitamin D supplements during pregnancy and who breastfed for more than 1 month, the likelihood of atopic eczema in the baby’s first year was reduced, according to results of a clinical trial.

“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.

“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.

The study also was published in the British Journal of Dermatology.

Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.

The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.

Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.

The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.

The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.

Infants appear to be protected up to 1 year of age

Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.

After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).

The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.

The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.

At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).

The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.

Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.

“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.

The results are mixed, though, she noted.

“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.

“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.

“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”

The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among women who took vitamin D supplements during pregnancy and who breastfed for more than 1 month, the likelihood of atopic eczema in the baby’s first year was reduced, according to results of a clinical trial.

“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.

“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.

The study also was published in the British Journal of Dermatology.

Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.

The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.

Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.

The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.

The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.

Infants appear to be protected up to 1 year of age

Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.

After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).

The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.

The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.

At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).

The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.

Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.

“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.

The results are mixed, though, she noted.

“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.

“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.

“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”

The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among women who took vitamin D supplements during pregnancy and who breastfed for more than 1 month, the likelihood of atopic eczema in the baby’s first year was reduced, according to results of a clinical trial.

“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.

“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.

The study also was published in the British Journal of Dermatology.

Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.

The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.

Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.

The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.

The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.

Infants appear to be protected up to 1 year of age

Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.

After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).

The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.

The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.

At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).

The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.

Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.

“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.

The results are mixed, though, she noted.

“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.

“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.

“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”

The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

There is a growing body of evidence to show that air pollution is a major risk factor for lung cancer among never-smokers, although there is less certainty about the duration of exposure to fine particulate matter in ambient air as it relates to risk for lung cancer.

But as Canadian researchers now report, even 20 years of data on cumulative exposure to air pollution may underestimate the magnitude of the effect, especially among people diagnosed with lung cancer who have migrated from regions where heavy air pollution is the norm.

In a study of Canadian women with newly diagnosed lung cancer who never smoked, Renelle Myers, MD, FRCPC, from the University of British Columbia in Vancouver and colleagues found that shorter-term assessment of cumulative exposure to ambient air particles smaller than 2.5 microns (PM2.5) may underestimate the health effects of chronic exposure to pollution, especially among those patients who had migrated to Canada after living in areas of high PM2.5 exposure for long periods of time.

“Our study points to the importance of incorporating this long-term cumulative exposure to air pollutants in the assessment of individual lung cancer risk, of course in combination with traditional risk factors, and depending on the country of residence, I think that even a 20-year cumulative exposure may underestimate the effects of PM2.5, as we’re not capturing childhood or adolescent exposure when the lung is developing, and what effect that will have,” she said in an oral abstract presented at the World Conference on Lung Cancer.
 

Satellite data on local pollution

With the objective of comparing cumulative 3-year vs. 20-year exposure to PM2.5 in women who had never smoked and had a new diagnosis of lung cancer, Dr. Myers and colleagues conducted a cross-sectional study.

They recruited a total of 236 women and had them fill out a detailed residential history questionnaire, and demographic details including age, race, country of birth, arrival in Canada for those born out of the country, occupations, family history of lung cancer, and exposure to second-hand smoke.

The investigators linked local addresses or postal to satellite-derived data on local PM2.5 levels, which first became available in 1996.

The median age of participants was 66.1 years. Of the 236 participants, 190 (80.5%) were born outside of Canada, and came to the country at the median age of 45. About half of all participants came from mainland China or Hong Kong, and another one-third came from elsewhere in Asia.

Tumor histologies included adenocarcinomas in 219 patients, squamous cell carcinoma in 1, and other types in 16 patients. Slightly more than half of the patients (55.%) had stage III or IV disease at diagnosis. In all, 106 of 227 evaluable patients had EGFR mutations.

3 years not enough

Among the foreign-born patients, only 4 (2%) had 3-year cumulative PM2.5 exposure greater than 10 mcg/m³, but 38 (20%) had 20-year cumulative exposure greater than 10 mcg/m³ (P < .0001).

All of the patients had cumulative PM2.5 exposures greater than 5 mcg/m³.

Comparing patients with and without EGFR mutations, the investigators found that higher 3-year cumulative PM2.5 exposure was significantly associated with EGFR mutations compared with nonmutated cancers (P = .049), but there was no significant association with higher 20-year cumulative exposures.

“The significance of this study really captures that short term or at least less than 3-year cumulative exposure risk for PM2.5 will probably underestimate the adverse effects that chronic exposure to air pollution has, especially among patients who lived elsewhere that may have had higher exposure throughout their lifetime than where you actually meet them,” Dr. Myers said in a media briefing held prior to her presentation.
 

Lung cancer in female nonsmokers

During the oral abstract session, invited discussant Chang-Chuan Chan, ScD, National Taiwan University, Taipei, said that the study’s focus on female patients with lung cancer is important. He pointed to a 2019 study examining the relationship between air pollution and lung cancer among nonsmokers in Taiwan, in which the authors found that, although smoking levels among women remained low over time (about 5%), the incidence of lung adenocarcinomas among women increased from 7.05 per 100,000 in 1995, to 24.22 per 100,000 in 2015.

The authors of that study also found that changes in PM2.5 levels in Taiwan were predictive of fluctuations in lung cancer prevalence in never-smokers.

“We’re moving from 50-year studies of smoking to these new issues of air pollution, asbestos, and radon, and I think it’s better that these three factors can be combined together,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

The study was supported by the BC Cancer Foundation, Terry Fox Research Institute, and VGH-UBC Hospital Foundation. Dr. Myers and Dr. Chan reported having no financial conflicts of interest to disclose.

There is a growing body of evidence to show that air pollution is a major risk factor for lung cancer among never-smokers, although there is less certainty about the duration of exposure to fine particulate matter in ambient air as it relates to risk for lung cancer.

But as Canadian researchers now report, even 20 years of data on cumulative exposure to air pollution may underestimate the magnitude of the effect, especially among people diagnosed with lung cancer who have migrated from regions where heavy air pollution is the norm.

In a study of Canadian women with newly diagnosed lung cancer who never smoked, Renelle Myers, MD, FRCPC, from the University of British Columbia in Vancouver and colleagues found that shorter-term assessment of cumulative exposure to ambient air particles smaller than 2.5 microns (PM2.5) may underestimate the health effects of chronic exposure to pollution, especially among those patients who had migrated to Canada after living in areas of high PM2.5 exposure for long periods of time.

“Our study points to the importance of incorporating this long-term cumulative exposure to air pollutants in the assessment of individual lung cancer risk, of course in combination with traditional risk factors, and depending on the country of residence, I think that even a 20-year cumulative exposure may underestimate the effects of PM2.5, as we’re not capturing childhood or adolescent exposure when the lung is developing, and what effect that will have,” she said in an oral abstract presented at the World Conference on Lung Cancer.
 

Satellite data on local pollution

With the objective of comparing cumulative 3-year vs. 20-year exposure to PM2.5 in women who had never smoked and had a new diagnosis of lung cancer, Dr. Myers and colleagues conducted a cross-sectional study.

They recruited a total of 236 women and had them fill out a detailed residential history questionnaire, and demographic details including age, race, country of birth, arrival in Canada for those born out of the country, occupations, family history of lung cancer, and exposure to second-hand smoke.

The investigators linked local addresses or postal to satellite-derived data on local PM2.5 levels, which first became available in 1996.

The median age of participants was 66.1 years. Of the 236 participants, 190 (80.5%) were born outside of Canada, and came to the country at the median age of 45. About half of all participants came from mainland China or Hong Kong, and another one-third came from elsewhere in Asia.

Tumor histologies included adenocarcinomas in 219 patients, squamous cell carcinoma in 1, and other types in 16 patients. Slightly more than half of the patients (55.%) had stage III or IV disease at diagnosis. In all, 106 of 227 evaluable patients had EGFR mutations.

3 years not enough

Among the foreign-born patients, only 4 (2%) had 3-year cumulative PM2.5 exposure greater than 10 mcg/m³, but 38 (20%) had 20-year cumulative exposure greater than 10 mcg/m³ (P < .0001).

All of the patients had cumulative PM2.5 exposures greater than 5 mcg/m³.

Comparing patients with and without EGFR mutations, the investigators found that higher 3-year cumulative PM2.5 exposure was significantly associated with EGFR mutations compared with nonmutated cancers (P = .049), but there was no significant association with higher 20-year cumulative exposures.

“The significance of this study really captures that short term or at least less than 3-year cumulative exposure risk for PM2.5 will probably underestimate the adverse effects that chronic exposure to air pollution has, especially among patients who lived elsewhere that may have had higher exposure throughout their lifetime than where you actually meet them,” Dr. Myers said in a media briefing held prior to her presentation.
 

Lung cancer in female nonsmokers

During the oral abstract session, invited discussant Chang-Chuan Chan, ScD, National Taiwan University, Taipei, said that the study’s focus on female patients with lung cancer is important. He pointed to a 2019 study examining the relationship between air pollution and lung cancer among nonsmokers in Taiwan, in which the authors found that, although smoking levels among women remained low over time (about 5%), the incidence of lung adenocarcinomas among women increased from 7.05 per 100,000 in 1995, to 24.22 per 100,000 in 2015.

The authors of that study also found that changes in PM2.5 levels in Taiwan were predictive of fluctuations in lung cancer prevalence in never-smokers.

“We’re moving from 50-year studies of smoking to these new issues of air pollution, asbestos, and radon, and I think it’s better that these three factors can be combined together,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

The study was supported by the BC Cancer Foundation, Terry Fox Research Institute, and VGH-UBC Hospital Foundation. Dr. Myers and Dr. Chan reported having no financial conflicts of interest to disclose.

There is a growing body of evidence to show that air pollution is a major risk factor for lung cancer among never-smokers, although there is less certainty about the duration of exposure to fine particulate matter in ambient air as it relates to risk for lung cancer.

But as Canadian researchers now report, even 20 years of data on cumulative exposure to air pollution may underestimate the magnitude of the effect, especially among people diagnosed with lung cancer who have migrated from regions where heavy air pollution is the norm.

In a study of Canadian women with newly diagnosed lung cancer who never smoked, Renelle Myers, MD, FRCPC, from the University of British Columbia in Vancouver and colleagues found that shorter-term assessment of cumulative exposure to ambient air particles smaller than 2.5 microns (PM2.5) may underestimate the health effects of chronic exposure to pollution, especially among those patients who had migrated to Canada after living in areas of high PM2.5 exposure for long periods of time.

“Our study points to the importance of incorporating this long-term cumulative exposure to air pollutants in the assessment of individual lung cancer risk, of course in combination with traditional risk factors, and depending on the country of residence, I think that even a 20-year cumulative exposure may underestimate the effects of PM2.5, as we’re not capturing childhood or adolescent exposure when the lung is developing, and what effect that will have,” she said in an oral abstract presented at the World Conference on Lung Cancer.
 

Satellite data on local pollution

With the objective of comparing cumulative 3-year vs. 20-year exposure to PM2.5 in women who had never smoked and had a new diagnosis of lung cancer, Dr. Myers and colleagues conducted a cross-sectional study.

They recruited a total of 236 women and had them fill out a detailed residential history questionnaire, and demographic details including age, race, country of birth, arrival in Canada for those born out of the country, occupations, family history of lung cancer, and exposure to second-hand smoke.

The investigators linked local addresses or postal to satellite-derived data on local PM2.5 levels, which first became available in 1996.

The median age of participants was 66.1 years. Of the 236 participants, 190 (80.5%) were born outside of Canada, and came to the country at the median age of 45. About half of all participants came from mainland China or Hong Kong, and another one-third came from elsewhere in Asia.

Tumor histologies included adenocarcinomas in 219 patients, squamous cell carcinoma in 1, and other types in 16 patients. Slightly more than half of the patients (55.%) had stage III or IV disease at diagnosis. In all, 106 of 227 evaluable patients had EGFR mutations.

3 years not enough

Among the foreign-born patients, only 4 (2%) had 3-year cumulative PM2.5 exposure greater than 10 mcg/m³, but 38 (20%) had 20-year cumulative exposure greater than 10 mcg/m³ (P < .0001).

All of the patients had cumulative PM2.5 exposures greater than 5 mcg/m³.

Comparing patients with and without EGFR mutations, the investigators found that higher 3-year cumulative PM2.5 exposure was significantly associated with EGFR mutations compared with nonmutated cancers (P = .049), but there was no significant association with higher 20-year cumulative exposures.

“The significance of this study really captures that short term or at least less than 3-year cumulative exposure risk for PM2.5 will probably underestimate the adverse effects that chronic exposure to air pollution has, especially among patients who lived elsewhere that may have had higher exposure throughout their lifetime than where you actually meet them,” Dr. Myers said in a media briefing held prior to her presentation.
 

Lung cancer in female nonsmokers

During the oral abstract session, invited discussant Chang-Chuan Chan, ScD, National Taiwan University, Taipei, said that the study’s focus on female patients with lung cancer is important. He pointed to a 2019 study examining the relationship between air pollution and lung cancer among nonsmokers in Taiwan, in which the authors found that, although smoking levels among women remained low over time (about 5%), the incidence of lung adenocarcinomas among women increased from 7.05 per 100,000 in 1995, to 24.22 per 100,000 in 2015.

The authors of that study also found that changes in PM2.5 levels in Taiwan were predictive of fluctuations in lung cancer prevalence in never-smokers.

“We’re moving from 50-year studies of smoking to these new issues of air pollution, asbestos, and radon, and I think it’s better that these three factors can be combined together,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

The study was supported by the BC Cancer Foundation, Terry Fox Research Institute, and VGH-UBC Hospital Foundation. Dr. Myers and Dr. Chan reported having no financial conflicts of interest to disclose.

Nearly one-third of smokers who were offered smoking cessation support on the spot when they showed up for lung cancer screening remained off cigarettes 1 year later, a quit-smoking rate considerably higher than that reported in clinical studies, investigators from the United Kingdom found.

When they added a stop-smoking component to the Yorkshire Lung Screening Trial, Rachael Murray, PhD, and colleagues at the University of Nottingham (England), found that immediately offering a combination of behavioral support and pharmacotherapy to help smokers kick the habit resulted in a 7-day validated point prevalent abstinence rate at 3 months of 30% among smokers randomized to a standard smoking cessation program, and 33.6% among patients randomized to also receive a personalized intervention that included images of their heart and lungs to demonstrate the harmful effects of tobacco.

In contrast, smoking cessation rates reported in trials of lung cancer screening have ranged from approximately 10% to 20%.

Although there was no overall statistical difference in quit-smoking rates between the standard and enhanced intervention arms of the study, the investigators found that women, but not men, were significantly more likely to quit when shown the heart and lung images, compared with those who received the standard smoking cessation support, Dr. Murray said at the World Conference on Lung Cancer held this week in Vienna.

“I think having smoking cessation as an integrated part of the lung cancer track was really positively received by our participants, particularly through having a physical presence and being conveniently located within the setting,” she said in a presidential symposium highlighting the best abstracts presented at the meeting.

“We’ve offered a high-intensity intervention, which is not going to be cheap to offer but I think is really important for these individuals with complex smoking histories and multiple comorbidities,” she added.
 

No judgment

In an interview, Dr. Murray noted that colocating stop-smoking services with lung screening is important for capturing smokers who may have the will but not the means to quit, and that participants especially appreciated the offer of help without the usual condescending attitude.

“We’re not an add-on: We’re there and physically present at the time of the lung health check,” she said. “It’s a standard of care that our smoking cessation advisers are able to provide. It’s very nonjudgmental and very holistic, providing social support that these people need. They’ve got long smoking histories, and they’re often made to feel guilty for that, and just being able to approach them in a nonjudgmental way makes a big difference.”

Smoking cessation is known to be the most effective way to reduce lung cancer deaths, Dr. Murray said in her presentation, pointing to a 2020 study by University of Michigan researchers showing that adding tobacco treatment to lung cancer screening can reduce deaths by 14% and increase the overall number of life-years gained by 81%.
 

Reduce smoking?

To see whether adding a personalized on-site smoking cessation program to lung cancer screening could improve quit-smoking rates, Dr. Murray and colleagues enrolled 1,003 smokers who attended the lung cancer screening program and randomly assigned them to either the intervention arm with personalized feedback, supportive communications, ongoing behavioral support and pharmacotherapy, or to a control arm consisting of ongoing behavioral support and pharmacotherapy.

Participants in the intervention arm were shown CT scans of the heart and lungs plus drawings highlighting coronary artery calcification and areas of their lungs damaged by smoking, and information on how quitting smoking can help to improve their health. The smoking cessation advisers followed a tightly controlled script to ensure that the messages were delivered in a uniform fashion to all participants.

As noted before, rates of 7-day validated point prevalent abstinence, measured by exhaled carbon dioxide, were 33.8% in the intervention arm, and 30% in the control arm. The respective costs per quitter were £521.30 ($630.77) and £412.80 ($499.48).

The validated 12-month smoking-free rates were 29.% in the intervention arm, and 28.6% in the control arm. None of the differences were statistically significant.

However, when they looked at between-arm differences by sex, the investigators found that significantly more women assigned to the intervention arm remained abstinent at 3 months, with rates of 33.9% compared with 23.1% of controls, a difference that translated into an unadjusted odds ratio of 1.70 favoring the intervention among women (P = .008).
 

Effective and durable

“My interpretation of this study is that the abstinence rates were very high, and this in fact was durable because this effect was maintained after 12 months,” commented invited discussant and smoking cessation expert Jacek Jassem, MD, from the University of Gdansk (Poland).

He said that the lack of a difference between the intervention and control arms might be attributable to lower levels of concern about heart disease or emphysema among participants, or possibly to the efficacy of the on-site support program itself.

The differences in efficacy of the intervention between men and women suggest that there may be a need for a sex- or gender-adapted approach, he said at the conference sponsored by the International Association for the Study of Lung Cancer.

“Lung cancer screening is a unique opportunity to motivate smoking cessation. All cancer screening programs should included best available and ongoing cessation support, and please, don’t blame smoking persons: Be compassionate, and helpful, and smile like our British colleagues did,” he concluded.

The study was supported by Yorkshire Cancer Research. Dr. Murray and Dr. Jassem reported no financial conflicts of interest.

Nearly one-third of smokers who were offered smoking cessation support on the spot when they showed up for lung cancer screening remained off cigarettes 1 year later, a quit-smoking rate considerably higher than that reported in clinical studies, investigators from the United Kingdom found.

When they added a stop-smoking component to the Yorkshire Lung Screening Trial, Rachael Murray, PhD, and colleagues at the University of Nottingham (England), found that immediately offering a combination of behavioral support and pharmacotherapy to help smokers kick the habit resulted in a 7-day validated point prevalent abstinence rate at 3 months of 30% among smokers randomized to a standard smoking cessation program, and 33.6% among patients randomized to also receive a personalized intervention that included images of their heart and lungs to demonstrate the harmful effects of tobacco.

In contrast, smoking cessation rates reported in trials of lung cancer screening have ranged from approximately 10% to 20%.

Although there was no overall statistical difference in quit-smoking rates between the standard and enhanced intervention arms of the study, the investigators found that women, but not men, were significantly more likely to quit when shown the heart and lung images, compared with those who received the standard smoking cessation support, Dr. Murray said at the World Conference on Lung Cancer held this week in Vienna.

“I think having smoking cessation as an integrated part of the lung cancer track was really positively received by our participants, particularly through having a physical presence and being conveniently located within the setting,” she said in a presidential symposium highlighting the best abstracts presented at the meeting.

“We’ve offered a high-intensity intervention, which is not going to be cheap to offer but I think is really important for these individuals with complex smoking histories and multiple comorbidities,” she added.
 

No judgment

In an interview, Dr. Murray noted that colocating stop-smoking services with lung screening is important for capturing smokers who may have the will but not the means to quit, and that participants especially appreciated the offer of help without the usual condescending attitude.

“We’re not an add-on: We’re there and physically present at the time of the lung health check,” she said. “It’s a standard of care that our smoking cessation advisers are able to provide. It’s very nonjudgmental and very holistic, providing social support that these people need. They’ve got long smoking histories, and they’re often made to feel guilty for that, and just being able to approach them in a nonjudgmental way makes a big difference.”

Smoking cessation is known to be the most effective way to reduce lung cancer deaths, Dr. Murray said in her presentation, pointing to a 2020 study by University of Michigan researchers showing that adding tobacco treatment to lung cancer screening can reduce deaths by 14% and increase the overall number of life-years gained by 81%.
 

Reduce smoking?

To see whether adding a personalized on-site smoking cessation program to lung cancer screening could improve quit-smoking rates, Dr. Murray and colleagues enrolled 1,003 smokers who attended the lung cancer screening program and randomly assigned them to either the intervention arm with personalized feedback, supportive communications, ongoing behavioral support and pharmacotherapy, or to a control arm consisting of ongoing behavioral support and pharmacotherapy.

Participants in the intervention arm were shown CT scans of the heart and lungs plus drawings highlighting coronary artery calcification and areas of their lungs damaged by smoking, and information on how quitting smoking can help to improve their health. The smoking cessation advisers followed a tightly controlled script to ensure that the messages were delivered in a uniform fashion to all participants.

As noted before, rates of 7-day validated point prevalent abstinence, measured by exhaled carbon dioxide, were 33.8% in the intervention arm, and 30% in the control arm. The respective costs per quitter were £521.30 ($630.77) and £412.80 ($499.48).

The validated 12-month smoking-free rates were 29.% in the intervention arm, and 28.6% in the control arm. None of the differences were statistically significant.

However, when they looked at between-arm differences by sex, the investigators found that significantly more women assigned to the intervention arm remained abstinent at 3 months, with rates of 33.9% compared with 23.1% of controls, a difference that translated into an unadjusted odds ratio of 1.70 favoring the intervention among women (P = .008).
 

Effective and durable

“My interpretation of this study is that the abstinence rates were very high, and this in fact was durable because this effect was maintained after 12 months,” commented invited discussant and smoking cessation expert Jacek Jassem, MD, from the University of Gdansk (Poland).

He said that the lack of a difference between the intervention and control arms might be attributable to lower levels of concern about heart disease or emphysema among participants, or possibly to the efficacy of the on-site support program itself.

The differences in efficacy of the intervention between men and women suggest that there may be a need for a sex- or gender-adapted approach, he said at the conference sponsored by the International Association for the Study of Lung Cancer.

“Lung cancer screening is a unique opportunity to motivate smoking cessation. All cancer screening programs should included best available and ongoing cessation support, and please, don’t blame smoking persons: Be compassionate, and helpful, and smile like our British colleagues did,” he concluded.

The study was supported by Yorkshire Cancer Research. Dr. Murray and Dr. Jassem reported no financial conflicts of interest.

Nearly one-third of smokers who were offered smoking cessation support on the spot when they showed up for lung cancer screening remained off cigarettes 1 year later, a quit-smoking rate considerably higher than that reported in clinical studies, investigators from the United Kingdom found.

When they added a stop-smoking component to the Yorkshire Lung Screening Trial, Rachael Murray, PhD, and colleagues at the University of Nottingham (England), found that immediately offering a combination of behavioral support and pharmacotherapy to help smokers kick the habit resulted in a 7-day validated point prevalent abstinence rate at 3 months of 30% among smokers randomized to a standard smoking cessation program, and 33.6% among patients randomized to also receive a personalized intervention that included images of their heart and lungs to demonstrate the harmful effects of tobacco.

In contrast, smoking cessation rates reported in trials of lung cancer screening have ranged from approximately 10% to 20%.

Although there was no overall statistical difference in quit-smoking rates between the standard and enhanced intervention arms of the study, the investigators found that women, but not men, were significantly more likely to quit when shown the heart and lung images, compared with those who received the standard smoking cessation support, Dr. Murray said at the World Conference on Lung Cancer held this week in Vienna.

“I think having smoking cessation as an integrated part of the lung cancer track was really positively received by our participants, particularly through having a physical presence and being conveniently located within the setting,” she said in a presidential symposium highlighting the best abstracts presented at the meeting.

“We’ve offered a high-intensity intervention, which is not going to be cheap to offer but I think is really important for these individuals with complex smoking histories and multiple comorbidities,” she added.
 

No judgment

In an interview, Dr. Murray noted that colocating stop-smoking services with lung screening is important for capturing smokers who may have the will but not the means to quit, and that participants especially appreciated the offer of help without the usual condescending attitude.

“We’re not an add-on: We’re there and physically present at the time of the lung health check,” she said. “It’s a standard of care that our smoking cessation advisers are able to provide. It’s very nonjudgmental and very holistic, providing social support that these people need. They’ve got long smoking histories, and they’re often made to feel guilty for that, and just being able to approach them in a nonjudgmental way makes a big difference.”

Smoking cessation is known to be the most effective way to reduce lung cancer deaths, Dr. Murray said in her presentation, pointing to a 2020 study by University of Michigan researchers showing that adding tobacco treatment to lung cancer screening can reduce deaths by 14% and increase the overall number of life-years gained by 81%.
 

Reduce smoking?

To see whether adding a personalized on-site smoking cessation program to lung cancer screening could improve quit-smoking rates, Dr. Murray and colleagues enrolled 1,003 smokers who attended the lung cancer screening program and randomly assigned them to either the intervention arm with personalized feedback, supportive communications, ongoing behavioral support and pharmacotherapy, or to a control arm consisting of ongoing behavioral support and pharmacotherapy.

Participants in the intervention arm were shown CT scans of the heart and lungs plus drawings highlighting coronary artery calcification and areas of their lungs damaged by smoking, and information on how quitting smoking can help to improve their health. The smoking cessation advisers followed a tightly controlled script to ensure that the messages were delivered in a uniform fashion to all participants.

As noted before, rates of 7-day validated point prevalent abstinence, measured by exhaled carbon dioxide, were 33.8% in the intervention arm, and 30% in the control arm. The respective costs per quitter were £521.30 ($630.77) and £412.80 ($499.48).

The validated 12-month smoking-free rates were 29.% in the intervention arm, and 28.6% in the control arm. None of the differences were statistically significant.

However, when they looked at between-arm differences by sex, the investigators found that significantly more women assigned to the intervention arm remained abstinent at 3 months, with rates of 33.9% compared with 23.1% of controls, a difference that translated into an unadjusted odds ratio of 1.70 favoring the intervention among women (P = .008).
 

Effective and durable

“My interpretation of this study is that the abstinence rates were very high, and this in fact was durable because this effect was maintained after 12 months,” commented invited discussant and smoking cessation expert Jacek Jassem, MD, from the University of Gdansk (Poland).

He said that the lack of a difference between the intervention and control arms might be attributable to lower levels of concern about heart disease or emphysema among participants, or possibly to the efficacy of the on-site support program itself.

The differences in efficacy of the intervention between men and women suggest that there may be a need for a sex- or gender-adapted approach, he said at the conference sponsored by the International Association for the Study of Lung Cancer.

“Lung cancer screening is a unique opportunity to motivate smoking cessation. All cancer screening programs should included best available and ongoing cessation support, and please, don’t blame smoking persons: Be compassionate, and helpful, and smile like our British colleagues did,” he concluded.

The study was supported by Yorkshire Cancer Research. Dr. Murray and Dr. Jassem reported no financial conflicts of interest.

PORTLAND, ORE. – The recurrent boils, abscesses, and nodules of the chronic inflammatory skin condition hidradenitis suppurativa (HS) may improve during pregnancy for a subset of women, but for many, pregnancy does not change the disease course and may worsen symptoms.

In addition, HS appears to be a risk factor for adverse pregnancy and maternal outcomes.

“This is relevant, because in the United States, HS disproportionately impacts women compared with men by a ratio of about 3:1,” Jennifer Hsiao, MD, said at the annual meeting of the Pacific Dermatologic Association.

“It’s at the beginning of the third trimester that the placental transfer of antibodies picks up,” she said. “At that point in time, you can have a discussion with the patient: do you want to stay on treatment and treat through, or do you want to consider being taken off the medication? I think this is a discussion that needs to be had, because let’s say you peel off adalimumab or infliximab and they have severe HS flares. I’m not sure that leads to a better outcome. I usually treat through for my pregnant patients.”

To better understand clinician practice patterns on the management of HS in pregnancy, Dr. Hsiao and Erin Collier, MD, MPH, of University of California, Los Angeles, and colleagues distributed an online survey to HS specialists in North America. They reported the findings in the International Journal of Women’s Dermatology.

Of the 49 respondents, 36 (73%) directed an HS specialty clinic and 29 (59%) reported having prescribed or continued a biologic agent in a pregnant HS patient. The top three biologics prescribed were adalimumab (90%), infliximab (41%), and certolizumab pegol (34%). Dr. Hsiao noted that certolizumab pegol is a pegylated anti-TNF, so it lacks an Fc region on the medication.

“This means that it cannot be actively transported by the neonatal Fc receptor on the placenta, thus resulting in minimal placental transmission,” she said. “The main issue is that there is little data on its efficacy in HS, but it’s a reasonable option to consider in a pregnant patient, especially in a patient with severe HS who asks, ‘what’s the safest biologic that I can go on?’ But you’d have to discuss with the patient that in terms of efficacy data, there is much less in the literature compared to adalimumab or infliximab.”

Breastfeeding while on anti–TNF-alpha biologics is considered safe. “There are minimal amounts of medication in breast milk,” she said. “If any gets through, infant gastric digestion is thought to take care of the rest. Of note, babies born to mothers who are continually treated with biologic agents should not be given live vaccinations for 6 months after birth.”

In a single-center study, Dr. Hsiao and colleagues retrospectively examined pregnancy complications, pregnancy outcomes, and neonatal outcomes in patients with HS. The study population included 202 pregnancies in 127 HS patients. Of 134 babies born to mothers with HS, 74% were breastfed and 24% were bottle-fed, and presence of HS lesions on the breast was significantly associated with not breastfeeding.

“So, when we see these patients, if moms decide to breastfeed and they have lesions on the breast, it would be helpful to discuss expectations and perhaps treat HS breast lesions early, so the breastfeeding process may go more smoothly for them after they deliver,” said Dr. Hsiao, who is one of the editors of the textbook “A Comprehensive Guide to Hidradenitis Suppurativa” (Elsevier, 2021). Safety-related resources that she recommends for clinicians include Mother to Baby and the Drugs and Lactation Database (LactMed).

Dr. Hsiao concluded her presentation by spotlighting the influence of pregnancy on HS comorbidities. Patients with HS already have a higher prevalence of depression and anxiety compared to controls. “Pregnancy can exacerbate underlying mood disorders in patients,” she said. “That’s why monitoring the patient’s mood and coordinating mental health care with the patient’s primary care physician and ob.gyn. is important.”

In addition, pregnancy-related changes in body mass index, blood pressure, lipid metabolism, and glucose tolerance trend toward changes seen in metabolic syndrome, she said, and HS patients are already at higher risk of metabolic syndrome compared with the general population.

HS may also compromise a patient’s ability to have a healthy pregnancy. Dr. Hsiao worked with Amit Garg, MD, and colleagues on a study that drew from the IBM MarketScan Commercial Claims Database to evaluate adverse pregnancy and maternal outcomes in women with HS between Jan. 1, 2011, and Sept. 30, 2015.

After the researchers adjusted for age, race, smoking status, and other comorbidities, they found that HS pregnancies were independently associated with spontaneous abortion (odds ratio, 1.20), gestational diabetes (OR, 1.26), and cesarean section (OR, 1.09). The findings were published in the Journal of the American Academy of Dermatology.

A separate study that used the same database found comparable results, also published in the Journal of the American Academy of Dermatology. “What I say to patients right now is, ‘there are many women with HS who have healthy pregnancies and deliver healthy babies, but HS could be a risk factor for a higher-risk pregnancy.’ It’s important that these patients are established with an ob.gyn. and are closely monitored to make sure that we optimize their care and give them the best outcome possible for mom and baby.”

Dr. Hsiao disclosed that she is on the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as an advisor for Novartis, UCB, and Boehringer Ingelheim and as a speaker and advisor for AbbVie.

PORTLAND, ORE. – The recurrent boils, abscesses, and nodules of the chronic inflammatory skin condition hidradenitis suppurativa (HS) may improve during pregnancy for a subset of women, but for many, pregnancy does not change the disease course and may worsen symptoms.

In addition, HS appears to be a risk factor for adverse pregnancy and maternal outcomes.

“This is relevant, because in the United States, HS disproportionately impacts women compared with men by a ratio of about 3:1,” Jennifer Hsiao, MD, said at the annual meeting of the Pacific Dermatologic Association.

“It’s at the beginning of the third trimester that the placental transfer of antibodies picks up,” she said. “At that point in time, you can have a discussion with the patient: do you want to stay on treatment and treat through, or do you want to consider being taken off the medication? I think this is a discussion that needs to be had, because let’s say you peel off adalimumab or infliximab and they have severe HS flares. I’m not sure that leads to a better outcome. I usually treat through for my pregnant patients.”

To better understand clinician practice patterns on the management of HS in pregnancy, Dr. Hsiao and Erin Collier, MD, MPH, of University of California, Los Angeles, and colleagues distributed an online survey to HS specialists in North America. They reported the findings in the International Journal of Women’s Dermatology.

Of the 49 respondents, 36 (73%) directed an HS specialty clinic and 29 (59%) reported having prescribed or continued a biologic agent in a pregnant HS patient. The top three biologics prescribed were adalimumab (90%), infliximab (41%), and certolizumab pegol (34%). Dr. Hsiao noted that certolizumab pegol is a pegylated anti-TNF, so it lacks an Fc region on the medication.

“This means that it cannot be actively transported by the neonatal Fc receptor on the placenta, thus resulting in minimal placental transmission,” she said. “The main issue is that there is little data on its efficacy in HS, but it’s a reasonable option to consider in a pregnant patient, especially in a patient with severe HS who asks, ‘what’s the safest biologic that I can go on?’ But you’d have to discuss with the patient that in terms of efficacy data, there is much less in the literature compared to adalimumab or infliximab.”

Breastfeeding while on anti–TNF-alpha biologics is considered safe. “There are minimal amounts of medication in breast milk,” she said. “If any gets through, infant gastric digestion is thought to take care of the rest. Of note, babies born to mothers who are continually treated with biologic agents should not be given live vaccinations for 6 months after birth.”

In a single-center study, Dr. Hsiao and colleagues retrospectively examined pregnancy complications, pregnancy outcomes, and neonatal outcomes in patients with HS. The study population included 202 pregnancies in 127 HS patients. Of 134 babies born to mothers with HS, 74% were breastfed and 24% were bottle-fed, and presence of HS lesions on the breast was significantly associated with not breastfeeding.

“So, when we see these patients, if moms decide to breastfeed and they have lesions on the breast, it would be helpful to discuss expectations and perhaps treat HS breast lesions early, so the breastfeeding process may go more smoothly for them after they deliver,” said Dr. Hsiao, who is one of the editors of the textbook “A Comprehensive Guide to Hidradenitis Suppurativa” (Elsevier, 2021). Safety-related resources that she recommends for clinicians include Mother to Baby and the Drugs and Lactation Database (LactMed).

Dr. Hsiao concluded her presentation by spotlighting the influence of pregnancy on HS comorbidities. Patients with HS already have a higher prevalence of depression and anxiety compared to controls. “Pregnancy can exacerbate underlying mood disorders in patients,” she said. “That’s why monitoring the patient’s mood and coordinating mental health care with the patient’s primary care physician and ob.gyn. is important.”

In addition, pregnancy-related changes in body mass index, blood pressure, lipid metabolism, and glucose tolerance trend toward changes seen in metabolic syndrome, she said, and HS patients are already at higher risk of metabolic syndrome compared with the general population.

HS may also compromise a patient’s ability to have a healthy pregnancy. Dr. Hsiao worked with Amit Garg, MD, and colleagues on a study that drew from the IBM MarketScan Commercial Claims Database to evaluate adverse pregnancy and maternal outcomes in women with HS between Jan. 1, 2011, and Sept. 30, 2015.

After the researchers adjusted for age, race, smoking status, and other comorbidities, they found that HS pregnancies were independently associated with spontaneous abortion (odds ratio, 1.20), gestational diabetes (OR, 1.26), and cesarean section (OR, 1.09). The findings were published in the Journal of the American Academy of Dermatology.

A separate study that used the same database found comparable results, also published in the Journal of the American Academy of Dermatology. “What I say to patients right now is, ‘there are many women with HS who have healthy pregnancies and deliver healthy babies, but HS could be a risk factor for a higher-risk pregnancy.’ It’s important that these patients are established with an ob.gyn. and are closely monitored to make sure that we optimize their care and give them the best outcome possible for mom and baby.”

Dr. Hsiao disclosed that she is on the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as an advisor for Novartis, UCB, and Boehringer Ingelheim and as a speaker and advisor for AbbVie.

PORTLAND, ORE. – The recurrent boils, abscesses, and nodules of the chronic inflammatory skin condition hidradenitis suppurativa (HS) may improve during pregnancy for a subset of women, but for many, pregnancy does not change the disease course and may worsen symptoms.

In addition, HS appears to be a risk factor for adverse pregnancy and maternal outcomes.

“This is relevant, because in the United States, HS disproportionately impacts women compared with men by a ratio of about 3:1,” Jennifer Hsiao, MD, said at the annual meeting of the Pacific Dermatologic Association.

“It’s at the beginning of the third trimester that the placental transfer of antibodies picks up,” she said. “At that point in time, you can have a discussion with the patient: do you want to stay on treatment and treat through, or do you want to consider being taken off the medication? I think this is a discussion that needs to be had, because let’s say you peel off adalimumab or infliximab and they have severe HS flares. I’m not sure that leads to a better outcome. I usually treat through for my pregnant patients.”

To better understand clinician practice patterns on the management of HS in pregnancy, Dr. Hsiao and Erin Collier, MD, MPH, of University of California, Los Angeles, and colleagues distributed an online survey to HS specialists in North America. They reported the findings in the International Journal of Women’s Dermatology.

Of the 49 respondents, 36 (73%) directed an HS specialty clinic and 29 (59%) reported having prescribed or continued a biologic agent in a pregnant HS patient. The top three biologics prescribed were adalimumab (90%), infliximab (41%), and certolizumab pegol (34%). Dr. Hsiao noted that certolizumab pegol is a pegylated anti-TNF, so it lacks an Fc region on the medication.

“This means that it cannot be actively transported by the neonatal Fc receptor on the placenta, thus resulting in minimal placental transmission,” she said. “The main issue is that there is little data on its efficacy in HS, but it’s a reasonable option to consider in a pregnant patient, especially in a patient with severe HS who asks, ‘what’s the safest biologic that I can go on?’ But you’d have to discuss with the patient that in terms of efficacy data, there is much less in the literature compared to adalimumab or infliximab.”

Breastfeeding while on anti–TNF-alpha biologics is considered safe. “There are minimal amounts of medication in breast milk,” she said. “If any gets through, infant gastric digestion is thought to take care of the rest. Of note, babies born to mothers who are continually treated with biologic agents should not be given live vaccinations for 6 months after birth.”

In a single-center study, Dr. Hsiao and colleagues retrospectively examined pregnancy complications, pregnancy outcomes, and neonatal outcomes in patients with HS. The study population included 202 pregnancies in 127 HS patients. Of 134 babies born to mothers with HS, 74% were breastfed and 24% were bottle-fed, and presence of HS lesions on the breast was significantly associated with not breastfeeding.

“So, when we see these patients, if moms decide to breastfeed and they have lesions on the breast, it would be helpful to discuss expectations and perhaps treat HS breast lesions early, so the breastfeeding process may go more smoothly for them after they deliver,” said Dr. Hsiao, who is one of the editors of the textbook “A Comprehensive Guide to Hidradenitis Suppurativa” (Elsevier, 2021). Safety-related resources that she recommends for clinicians include Mother to Baby and the Drugs and Lactation Database (LactMed).

Dr. Hsiao concluded her presentation by spotlighting the influence of pregnancy on HS comorbidities. Patients with HS already have a higher prevalence of depression and anxiety compared to controls. “Pregnancy can exacerbate underlying mood disorders in patients,” she said. “That’s why monitoring the patient’s mood and coordinating mental health care with the patient’s primary care physician and ob.gyn. is important.”

In addition, pregnancy-related changes in body mass index, blood pressure, lipid metabolism, and glucose tolerance trend toward changes seen in metabolic syndrome, she said, and HS patients are already at higher risk of metabolic syndrome compared with the general population.

HS may also compromise a patient’s ability to have a healthy pregnancy. Dr. Hsiao worked with Amit Garg, MD, and colleagues on a study that drew from the IBM MarketScan Commercial Claims Database to evaluate adverse pregnancy and maternal outcomes in women with HS between Jan. 1, 2011, and Sept. 30, 2015.

After the researchers adjusted for age, race, smoking status, and other comorbidities, they found that HS pregnancies were independently associated with spontaneous abortion (odds ratio, 1.20), gestational diabetes (OR, 1.26), and cesarean section (OR, 1.09). The findings were published in the Journal of the American Academy of Dermatology.

A separate study that used the same database found comparable results, also published in the Journal of the American Academy of Dermatology. “What I say to patients right now is, ‘there are many women with HS who have healthy pregnancies and deliver healthy babies, but HS could be a risk factor for a higher-risk pregnancy.’ It’s important that these patients are established with an ob.gyn. and are closely monitored to make sure that we optimize their care and give them the best outcome possible for mom and baby.”

Dr. Hsiao disclosed that she is on the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as an advisor for Novartis, UCB, and Boehringer Ingelheim and as a speaker and advisor for AbbVie.

SAN DIEGO – Even after recovery of an acute COVID-19 infection, some patients experience extended or even long-term symptoms that can range from mild to debilitating. Some of these symptoms are neurological: headaches, brain fog, cognitive impairment, loss of taste or smell, and even cerebrovascular complications such stroke. There are even hints that COVID-19 infection could lead to future neurodegeneration.

Those issues have prompted efforts to identify biomarkers that can help track and monitor neurological complications of COVID-19. “Throughout the course of the pandemic, it has become apparent that COVID-19 can cause various neurological symptoms. Because of this, it’s really important for us to find a way to monitor and understand neurological complications occurring in patients with COVID 19,” Jennifer Cooper said during a lecture at the Alzheimer’s Association International Conference. She presented new research suggesting that neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) may prove useful.

Ms. Cooper is a master’s degree student at the University of British Columbia and Canada.
 

Looking for sensitivity and specificity in plasma biomarkers

The researchers turned to plasma-based markers because they can reflect underlying pathology in the central nervous system. They focused on NfL, which reflects axonal damage, and GFAP, which is a marker of astrocyte activation.

The researchers analyzed data from 209 patients with COVID-19 who were admitted to the Vancouver (B.C.) General Hospital intensive care unit. Sixty-four percent were male, and the median age was 61 years. Sixty percent were ventilated, and 17% died.

The researchers determined if an individual patient’s biomarker level at hospital admission fell within a normal biomarker reference interval. A total of 53% had NfL levels outside the normal range, and 42% had GFAP levels outside the normal range. In addition, 31% of patients had both GFAP and NfL levels outside of the normal range.

Among all patients, 12% experienced ischemia, 4% hemorrhage, 2% seizures, and 10% degeneration.

At admission, NfL predicted a neurological complication with an area under the curve (AUC) of 0.702. GFAP had an AUC of 0.722. In combination, they had an AUC of 0.743. At 1 week, NfL had an AUC of 0.802, GFAP an AUC of 0.733, and the combination an AUC of 0.812.

Using age-specific cutoff values, the researchers found increased risks for neurological complications at admission (NfL odds ratio [OR], 2.9; GFAP OR, 1.6; combined OR, 2.1) and at 1 week (NfL OR, not significant; GFAP OR, 4.8; combined OR, 6.6). “We can see that both NFL and GFAP have utility in detecting neurological complications. And combining both of our markers improves detection at both time points. NfL is a marker that provides more sensitivity, where in this cohort GFAP is a marker that provides a little bit more specificity,” said Ms. Cooper.
 

Will additional biomarkers help?

The researchers are continuing to follow up patients at 6 months and 18 months post diagnosis, using neuropsychiatric tests and additional biomarker analysis, as well as PET and MRI scans. The patient sample is being expanded to those in the general hospital ward and some who were not hospitalized.

During the Q&A session, Ms. Cooper was asked if the group had collected reference data from patients who were admitted to the ICU with non-COVID disease. She responded that the group has some of that data, but as the pandemic went on they had difficulty finding patients who had never been infected with COVID to serve as reliable controls. To date, they have identified 33 controls who had a respiratory condition when admitted to the ICU. “What we see is the neurological biomarker levels in COVID are slightly lower than those with another respiratory condition in the ICU. But the data has a massive spread and the significance is very small between the two groups,” said Ms. Cooper.
 

Unanswered questions

The study is interesting, but leaves a lot of unanswered questions, according to Wiesje van der Flier, PhD, who moderated the session where the study was presented. “There are a lot of unknowns still: Will [the biomarkers] become normal again, once the COVID is over? Also, there was an increased risk, but it was not a one-to-one correspondence, so you can also have the increased markers but not have the neurological signs or symptoms. So I thought there were lots of questions as well,” said Dr. van der Flier, professor of neurology at Amsterdam University Medical Center.

She noted that researchers at her institution in Amsterdam have observed similar relationships, and that the associations between neurological complications and plasma biomarkers over time will be an important topic of study.

The work could provide more information on neurological manifestations of long COVID, such as long-haul fatigue. “You might also think that’s some response in their brain. It would be great if we could actually capture that [using biomarkers],” said Dr. van der Flier.

Ms. Cooper and Dr. van der Flier have no relevant financial disclosures.

SAN DIEGO – Even after recovery of an acute COVID-19 infection, some patients experience extended or even long-term symptoms that can range from mild to debilitating. Some of these symptoms are neurological: headaches, brain fog, cognitive impairment, loss of taste or smell, and even cerebrovascular complications such stroke. There are even hints that COVID-19 infection could lead to future neurodegeneration.

Those issues have prompted efforts to identify biomarkers that can help track and monitor neurological complications of COVID-19. “Throughout the course of the pandemic, it has become apparent that COVID-19 can cause various neurological symptoms. Because of this, it’s really important for us to find a way to monitor and understand neurological complications occurring in patients with COVID 19,” Jennifer Cooper said during a lecture at the Alzheimer’s Association International Conference. She presented new research suggesting that neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) may prove useful.

Ms. Cooper is a master’s degree student at the University of British Columbia and Canada.
 

Looking for sensitivity and specificity in plasma biomarkers

The researchers turned to plasma-based markers because they can reflect underlying pathology in the central nervous system. They focused on NfL, which reflects axonal damage, and GFAP, which is a marker of astrocyte activation.

The researchers analyzed data from 209 patients with COVID-19 who were admitted to the Vancouver (B.C.) General Hospital intensive care unit. Sixty-four percent were male, and the median age was 61 years. Sixty percent were ventilated, and 17% died.

The researchers determined if an individual patient’s biomarker level at hospital admission fell within a normal biomarker reference interval. A total of 53% had NfL levels outside the normal range, and 42% had GFAP levels outside the normal range. In addition, 31% of patients had both GFAP and NfL levels outside of the normal range.

Among all patients, 12% experienced ischemia, 4% hemorrhage, 2% seizures, and 10% degeneration.

At admission, NfL predicted a neurological complication with an area under the curve (AUC) of 0.702. GFAP had an AUC of 0.722. In combination, they had an AUC of 0.743. At 1 week, NfL had an AUC of 0.802, GFAP an AUC of 0.733, and the combination an AUC of 0.812.

Using age-specific cutoff values, the researchers found increased risks for neurological complications at admission (NfL odds ratio [OR], 2.9; GFAP OR, 1.6; combined OR, 2.1) and at 1 week (NfL OR, not significant; GFAP OR, 4.8; combined OR, 6.6). “We can see that both NFL and GFAP have utility in detecting neurological complications. And combining both of our markers improves detection at both time points. NfL is a marker that provides more sensitivity, where in this cohort GFAP is a marker that provides a little bit more specificity,” said Ms. Cooper.
 

Will additional biomarkers help?

The researchers are continuing to follow up patients at 6 months and 18 months post diagnosis, using neuropsychiatric tests and additional biomarker analysis, as well as PET and MRI scans. The patient sample is being expanded to those in the general hospital ward and some who were not hospitalized.

During the Q&A session, Ms. Cooper was asked if the group had collected reference data from patients who were admitted to the ICU with non-COVID disease. She responded that the group has some of that data, but as the pandemic went on they had difficulty finding patients who had never been infected with COVID to serve as reliable controls. To date, they have identified 33 controls who had a respiratory condition when admitted to the ICU. “What we see is the neurological biomarker levels in COVID are slightly lower than those with another respiratory condition in the ICU. But the data has a massive spread and the significance is very small between the two groups,” said Ms. Cooper.
 

Unanswered questions

The study is interesting, but leaves a lot of unanswered questions, according to Wiesje van der Flier, PhD, who moderated the session where the study was presented. “There are a lot of unknowns still: Will [the biomarkers] become normal again, once the COVID is over? Also, there was an increased risk, but it was not a one-to-one correspondence, so you can also have the increased markers but not have the neurological signs or symptoms. So I thought there were lots of questions as well,” said Dr. van der Flier, professor of neurology at Amsterdam University Medical Center.

She noted that researchers at her institution in Amsterdam have observed similar relationships, and that the associations between neurological complications and plasma biomarkers over time will be an important topic of study.

The work could provide more information on neurological manifestations of long COVID, such as long-haul fatigue. “You might also think that’s some response in their brain. It would be great if we could actually capture that [using biomarkers],” said Dr. van der Flier.

Ms. Cooper and Dr. van der Flier have no relevant financial disclosures.

SAN DIEGO – Even after recovery of an acute COVID-19 infection, some patients experience extended or even long-term symptoms that can range from mild to debilitating. Some of these symptoms are neurological: headaches, brain fog, cognitive impairment, loss of taste or smell, and even cerebrovascular complications such stroke. There are even hints that COVID-19 infection could lead to future neurodegeneration.

Those issues have prompted efforts to identify biomarkers that can help track and monitor neurological complications of COVID-19. “Throughout the course of the pandemic, it has become apparent that COVID-19 can cause various neurological symptoms. Because of this, it’s really important for us to find a way to monitor and understand neurological complications occurring in patients with COVID 19,” Jennifer Cooper said during a lecture at the Alzheimer’s Association International Conference. She presented new research suggesting that neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) may prove useful.

Ms. Cooper is a master’s degree student at the University of British Columbia and Canada.
 

Looking for sensitivity and specificity in plasma biomarkers

The researchers turned to plasma-based markers because they can reflect underlying pathology in the central nervous system. They focused on NfL, which reflects axonal damage, and GFAP, which is a marker of astrocyte activation.

The researchers analyzed data from 209 patients with COVID-19 who were admitted to the Vancouver (B.C.) General Hospital intensive care unit. Sixty-four percent were male, and the median age was 61 years. Sixty percent were ventilated, and 17% died.

The researchers determined if an individual patient’s biomarker level at hospital admission fell within a normal biomarker reference interval. A total of 53% had NfL levels outside the normal range, and 42% had GFAP levels outside the normal range. In addition, 31% of patients had both GFAP and NfL levels outside of the normal range.

Among all patients, 12% experienced ischemia, 4% hemorrhage, 2% seizures, and 10% degeneration.

At admission, NfL predicted a neurological complication with an area under the curve (AUC) of 0.702. GFAP had an AUC of 0.722. In combination, they had an AUC of 0.743. At 1 week, NfL had an AUC of 0.802, GFAP an AUC of 0.733, and the combination an AUC of 0.812.

Using age-specific cutoff values, the researchers found increased risks for neurological complications at admission (NfL odds ratio [OR], 2.9; GFAP OR, 1.6; combined OR, 2.1) and at 1 week (NfL OR, not significant; GFAP OR, 4.8; combined OR, 6.6). “We can see that both NFL and GFAP have utility in detecting neurological complications. And combining both of our markers improves detection at both time points. NfL is a marker that provides more sensitivity, where in this cohort GFAP is a marker that provides a little bit more specificity,” said Ms. Cooper.
 

Will additional biomarkers help?

The researchers are continuing to follow up patients at 6 months and 18 months post diagnosis, using neuropsychiatric tests and additional biomarker analysis, as well as PET and MRI scans. The patient sample is being expanded to those in the general hospital ward and some who were not hospitalized.

During the Q&A session, Ms. Cooper was asked if the group had collected reference data from patients who were admitted to the ICU with non-COVID disease. She responded that the group has some of that data, but as the pandemic went on they had difficulty finding patients who had never been infected with COVID to serve as reliable controls. To date, they have identified 33 controls who had a respiratory condition when admitted to the ICU. “What we see is the neurological biomarker levels in COVID are slightly lower than those with another respiratory condition in the ICU. But the data has a massive spread and the significance is very small between the two groups,” said Ms. Cooper.
 

Unanswered questions

The study is interesting, but leaves a lot of unanswered questions, according to Wiesje van der Flier, PhD, who moderated the session where the study was presented. “There are a lot of unknowns still: Will [the biomarkers] become normal again, once the COVID is over? Also, there was an increased risk, but it was not a one-to-one correspondence, so you can also have the increased markers but not have the neurological signs or symptoms. So I thought there were lots of questions as well,” said Dr. van der Flier, professor of neurology at Amsterdam University Medical Center.

She noted that researchers at her institution in Amsterdam have observed similar relationships, and that the associations between neurological complications and plasma biomarkers over time will be an important topic of study.

The work could provide more information on neurological manifestations of long COVID, such as long-haul fatigue. “You might also think that’s some response in their brain. It would be great if we could actually capture that [using biomarkers],” said Dr. van der Flier.

Ms. Cooper and Dr. van der Flier have no relevant financial disclosures.

SAN DIEGO – Among older patients with mild cognitive impairment (MCI), the combination of vitamin D and physical exercise plus cognitive training led to greater improvements than exercise alone. The findings were drawn from an unusual study design that split patients into five groups, one of which included both interventions.

After the study was completed, researchers collapsed the groups into a single analysis to compare the different regimens, according to Manuel Montero-Odasso, MD, PhD, who presented the work at the Alzheimer’s Association International Conference. He is a geriatrician at Parkwood Institute, London, Ont.

Two previous trials looked at whether the combination of exercise plus cognitive training could outperform either intervention alone. In both, the combination improved cognition but not as much as either intervention alone. “So it seemed that when they combine it, they didn’t do as well,” said Dr. Montero-Odasso. Those findings left doubt about whether or not there is synergism between the two approaches.
 

Sequential, not simultaneous

A possible explanation for the finding is that patients who are doing both cognitive training and physical exercise simultaneously might not be able to focus enough on either task to do get the maximum benefit. “When we try to combine concurrently, participants or patients cannot focus and do enough progression in both at the same time. That’s the reason we designed the trial in a way that the interventions were sequential. You got a very good quality (cognitive) training, and later you got the exercise,” said Dr. Montero-Odasso.

In the new study, patients receiving both interventions conducted the cognitive training first, then did physical exercises 30 minutes later. “The practical message is that you should follow a program. Something I see in my patients, when they do the two things at the same time, they don’t pay enough attention,” said Dr. Montero-Odasso.

The researchers added vitamin D to the regimen as there have been small studies reporting that vitamin D supplementation can lead to greater muscle mass resulting from exercise.

The study included 176 patients aged 60-85 with MCI. The researchers excluded patients already participating in an active exercise program with a personal trainer, as well as those taking vitamin D at doses higher than 1,000 IU/day.

Over 20 weeks, the randomized groups included combination exercise and cognitive training with vitamin D (10,000 IU three times per week), exercise and cognitive training with placebo, exercise with a cognitive control and vitamin D, exercise with a cognitive control and placebo, and an exercise control (balance and toning) with cognitive control and placebo.

The interventions were completed three times per week. Cognitive training employed a tablet with multifunctional tasks and memory components. It was adaptive, becoming more difficult as patients improved or simplifying the task if a patient struggled. The exercise component included 40 minutes of progressive, supervised resistance training, followed by 20 minutes of aerobic exercise.

Compared with the double-placebo group, the double-intervention group had significant improvement in cognitive performance. “Exercise alone without cognitive training shows an effect, but that effect was lower than a combination with cognitive training,” said Dr. Montero-Odasso.

The combined groups had medium effect sizes on cognition when combined with vitamin D (Cohen’s d, 0.65; P = .003) and with vitamin D placebo (Cohen’s d, 0.58; P = .013). There were nonsignificant improvements in the exercise and vitamin D group (Cohen’s d, 0.30; P = .241) and the exercise plus placebo group (Cohen’s d, 0.42; P = .139)

After collapsing the arms, the researchers found that the exercise plus cognitive training regimen had an effect size of 0.62 (P = .002), while exercise alone only trended toward improvement and with a small effect size (Cohen’s d, 0.36; P = .13). There was no apparent effect of vitamin D supplementation, though Dr. Montero-Odasso pointed out that most participants were taking vitamin D supplements before study entry and had normal to high serum levels of vitamin D.
 

‘Optimistic’ results

The study was limited by an inability to retain patients due to the COVID-19 pandemic, leading to a dropout rate of 17%.

“I think the idea of combining risk reduction strategies together in a population and individuals with MCI is really exciting. These are optimistic results. You certainly need to look into a larger and more diverse population as it goes forward,” said Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, who was asked to comment on the study.

She noted that the study looked at all-cause cognitive impairment. It would be interesting, Dr. Snyder said, to see how individuals with different underlying conditions handle the combination intervention.

The researchers are now in the planning stage of the Synergic 2 trial, which will incorporate exercise and cognitive training, plus diet and sleep counseling. It will be conducted virtually, involving one-to-one interactions with coaches.

Dr. Montero-Odasso and Dr. Snyder have no relevant financial disclosures.

SAN DIEGO – Among older patients with mild cognitive impairment (MCI), the combination of vitamin D and physical exercise plus cognitive training led to greater improvements than exercise alone. The findings were drawn from an unusual study design that split patients into five groups, one of which included both interventions.

After the study was completed, researchers collapsed the groups into a single analysis to compare the different regimens, according to Manuel Montero-Odasso, MD, PhD, who presented the work at the Alzheimer’s Association International Conference. He is a geriatrician at Parkwood Institute, London, Ont.

Two previous trials looked at whether the combination of exercise plus cognitive training could outperform either intervention alone. In both, the combination improved cognition but not as much as either intervention alone. “So it seemed that when they combine it, they didn’t do as well,” said Dr. Montero-Odasso. Those findings left doubt about whether or not there is synergism between the two approaches.
 

Sequential, not simultaneous

A possible explanation for the finding is that patients who are doing both cognitive training and physical exercise simultaneously might not be able to focus enough on either task to do get the maximum benefit. “When we try to combine concurrently, participants or patients cannot focus and do enough progression in both at the same time. That’s the reason we designed the trial in a way that the interventions were sequential. You got a very good quality (cognitive) training, and later you got the exercise,” said Dr. Montero-Odasso.

In the new study, patients receiving both interventions conducted the cognitive training first, then did physical exercises 30 minutes later. “The practical message is that you should follow a program. Something I see in my patients, when they do the two things at the same time, they don’t pay enough attention,” said Dr. Montero-Odasso.

The researchers added vitamin D to the regimen as there have been small studies reporting that vitamin D supplementation can lead to greater muscle mass resulting from exercise.

The study included 176 patients aged 60-85 with MCI. The researchers excluded patients already participating in an active exercise program with a personal trainer, as well as those taking vitamin D at doses higher than 1,000 IU/day.

Over 20 weeks, the randomized groups included combination exercise and cognitive training with vitamin D (10,000 IU three times per week), exercise and cognitive training with placebo, exercise with a cognitive control and vitamin D, exercise with a cognitive control and placebo, and an exercise control (balance and toning) with cognitive control and placebo.

The interventions were completed three times per week. Cognitive training employed a tablet with multifunctional tasks and memory components. It was adaptive, becoming more difficult as patients improved or simplifying the task if a patient struggled. The exercise component included 40 minutes of progressive, supervised resistance training, followed by 20 minutes of aerobic exercise.

Compared with the double-placebo group, the double-intervention group had significant improvement in cognitive performance. “Exercise alone without cognitive training shows an effect, but that effect was lower than a combination with cognitive training,” said Dr. Montero-Odasso.

The combined groups had medium effect sizes on cognition when combined with vitamin D (Cohen’s d, 0.65; P = .003) and with vitamin D placebo (Cohen’s d, 0.58; P = .013). There were nonsignificant improvements in the exercise and vitamin D group (Cohen’s d, 0.30; P = .241) and the exercise plus placebo group (Cohen’s d, 0.42; P = .139)

After collapsing the arms, the researchers found that the exercise plus cognitive training regimen had an effect size of 0.62 (P = .002), while exercise alone only trended toward improvement and with a small effect size (Cohen’s d, 0.36; P = .13). There was no apparent effect of vitamin D supplementation, though Dr. Montero-Odasso pointed out that most participants were taking vitamin D supplements before study entry and had normal to high serum levels of vitamin D.
 

‘Optimistic’ results

The study was limited by an inability to retain patients due to the COVID-19 pandemic, leading to a dropout rate of 17%.

“I think the idea of combining risk reduction strategies together in a population and individuals with MCI is really exciting. These are optimistic results. You certainly need to look into a larger and more diverse population as it goes forward,” said Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, who was asked to comment on the study.

She noted that the study looked at all-cause cognitive impairment. It would be interesting, Dr. Snyder said, to see how individuals with different underlying conditions handle the combination intervention.

The researchers are now in the planning stage of the Synergic 2 trial, which will incorporate exercise and cognitive training, plus diet and sleep counseling. It will be conducted virtually, involving one-to-one interactions with coaches.

Dr. Montero-Odasso and Dr. Snyder have no relevant financial disclosures.

SAN DIEGO – Among older patients with mild cognitive impairment (MCI), the combination of vitamin D and physical exercise plus cognitive training led to greater improvements than exercise alone. The findings were drawn from an unusual study design that split patients into five groups, one of which included both interventions.

After the study was completed, researchers collapsed the groups into a single analysis to compare the different regimens, according to Manuel Montero-Odasso, MD, PhD, who presented the work at the Alzheimer’s Association International Conference. He is a geriatrician at Parkwood Institute, London, Ont.

Two previous trials looked at whether the combination of exercise plus cognitive training could outperform either intervention alone. In both, the combination improved cognition but not as much as either intervention alone. “So it seemed that when they combine it, they didn’t do as well,” said Dr. Montero-Odasso. Those findings left doubt about whether or not there is synergism between the two approaches.
 

Sequential, not simultaneous

A possible explanation for the finding is that patients who are doing both cognitive training and physical exercise simultaneously might not be able to focus enough on either task to do get the maximum benefit. “When we try to combine concurrently, participants or patients cannot focus and do enough progression in both at the same time. That’s the reason we designed the trial in a way that the interventions were sequential. You got a very good quality (cognitive) training, and later you got the exercise,” said Dr. Montero-Odasso.

In the new study, patients receiving both interventions conducted the cognitive training first, then did physical exercises 30 minutes later. “The practical message is that you should follow a program. Something I see in my patients, when they do the two things at the same time, they don’t pay enough attention,” said Dr. Montero-Odasso.

The researchers added vitamin D to the regimen as there have been small studies reporting that vitamin D supplementation can lead to greater muscle mass resulting from exercise.

The study included 176 patients aged 60-85 with MCI. The researchers excluded patients already participating in an active exercise program with a personal trainer, as well as those taking vitamin D at doses higher than 1,000 IU/day.

Over 20 weeks, the randomized groups included combination exercise and cognitive training with vitamin D (10,000 IU three times per week), exercise and cognitive training with placebo, exercise with a cognitive control and vitamin D, exercise with a cognitive control and placebo, and an exercise control (balance and toning) with cognitive control and placebo.

The interventions were completed three times per week. Cognitive training employed a tablet with multifunctional tasks and memory components. It was adaptive, becoming more difficult as patients improved or simplifying the task if a patient struggled. The exercise component included 40 minutes of progressive, supervised resistance training, followed by 20 minutes of aerobic exercise.

Compared with the double-placebo group, the double-intervention group had significant improvement in cognitive performance. “Exercise alone without cognitive training shows an effect, but that effect was lower than a combination with cognitive training,” said Dr. Montero-Odasso.

The combined groups had medium effect sizes on cognition when combined with vitamin D (Cohen’s d, 0.65; P = .003) and with vitamin D placebo (Cohen’s d, 0.58; P = .013). There were nonsignificant improvements in the exercise and vitamin D group (Cohen’s d, 0.30; P = .241) and the exercise plus placebo group (Cohen’s d, 0.42; P = .139)

After collapsing the arms, the researchers found that the exercise plus cognitive training regimen had an effect size of 0.62 (P = .002), while exercise alone only trended toward improvement and with a small effect size (Cohen’s d, 0.36; P = .13). There was no apparent effect of vitamin D supplementation, though Dr. Montero-Odasso pointed out that most participants were taking vitamin D supplements before study entry and had normal to high serum levels of vitamin D.
 

‘Optimistic’ results

The study was limited by an inability to retain patients due to the COVID-19 pandemic, leading to a dropout rate of 17%.

“I think the idea of combining risk reduction strategies together in a population and individuals with MCI is really exciting. These are optimistic results. You certainly need to look into a larger and more diverse population as it goes forward,” said Heather Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, who was asked to comment on the study.

She noted that the study looked at all-cause cognitive impairment. It would be interesting, Dr. Snyder said, to see how individuals with different underlying conditions handle the combination intervention.

The researchers are now in the planning stage of the Synergic 2 trial, which will incorporate exercise and cognitive training, plus diet and sleep counseling. It will be conducted virtually, involving one-to-one interactions with coaches.

Dr. Montero-Odasso and Dr. Snyder have no relevant financial disclosures.

People who are severely ill with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are often too sick to leave home, but clinicians can still support them in many ways, experts say.

Approximately 250,000 people in the United Kingdom (0.2%-0.4%) have ME/CFS – where it’s called “ME.” As many as 2.5 million in the United States have it. Those numbers are expected to dramatically increase with the addition of people with long COVID. An estimated 25% of patients with the condition are so severely impaired that they are housebound or bedbound to the point where they’re unable to attend medical office visits. There are very few data about them because they’re typically unable to participate in studies.

Speaking at the annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME), patient advocate Helen Baxter, of the U.K. charity 25% ME Group, presented a case series of five patients bedbound with ME/CFS who became severely malnourished because of delays in the placement of feeding tubes. The delays occurred because it was not recognized that the patients were unable to eat. The inability to eat may be due to a variety of factors, including gastrointestinal dysfunction, dysphagia, nausea, or lack of sufficient energy to eat or drink.

A report of those cases was included in a special issue of Healthcare, devoted to the topic of severe and very severe ME/CFS. The issue, which was published in April 2021, included 25 articles on the pathophysiology of severe ME/CFS, ways that clinicians can support patients who are too sick to make office visits, and psychosocial aspects of the condition that result from physical debilitation.

Two additional articles by specialist physicians aim to counter the skepticism about ME/CFS that has long persisted among some in the medical community.

“ME/CFS is under-researched and has historically received insufficient funding for research, particularly when compared to other chronic conditions, such as multiple sclerosis. And most of the research that has been done about it has focused on patients who are able to attend clinics. Patients with severe ME/CFS have largely been excluded from research due to the severity of their illness and are often described as ‘hard to reach.’ Consequently, research into severe ME is very limited,” Ms. Baxter said.

Asked to comment, Lucinda Bateman, MD, founder and director of the Bateman Horne Center, Salt Lake City, told this news organization, “It’s a big gap, even in the knowledgeable community. The research is totally skewed towards people who can get up and go participate in research. ... I don’t think most clinicians have any idea how sick people can get with ME/CFS.”

Cardiopulmonary exercise testing (CPET), which is commonly used in research, is intended to elicit objective biomarker responses. Such testing, which is considered the gold standard for determining disability, is impossible for the most severely ill patients with ME/CFS and is potentially harmful to these patients because of the hallmark postexertional malaise (PEM) phenomenon, Dr. Bateman noted.

“If we want to use CPET for research, we have to remember that it harms people to some degree and that we’re only studying the people who aren’t as sick. ... It’s one of the reasons I’ve been aggressively pursuing medical education about orthostatic testing, because it’s a clear objective marker, not as deleterious, and potentially leads to treatment options,” she said.

Misdiagnosis, treatment delays led to life-threatening malnutrition

The five patients that Ms. Baxter presented had become severely malnourished and dehydrated. There was evidence of clinical inertia for each of them.

“All were judged to have anorexia nervosa, and psychiatrists were involved, which was an added delay to starting tube feeding. ... In each case, the doctors resorted to making inappropriate psychological diagnoses without positive evidence of psychopathology, failing to recognize the significance of the malnutrition,” Ms. Baxter said. (Urgent tube feeding would have been warranted even had anorexia nervosa been the correct diagnosis, she pointed out.)

Once the problem was finally recognized, “all participants saw an improvement in their situation following the allocation of a home enteral nutrition dietician.”

At the IACFS/ME conference, Ms. Baxter described the painstaking methods used for gathering information, which were described in the same journal. These involved a combination of online, telephone, and text communications with patients or their caregivers. Efforts were made to avoid overtaxing the patients and triggering PEM.

“An early warning system needs to be put in place for patients with severe ME so that when they or their representatives become aware of the development of problems with oral intake, prompt action is taken, and tube feeding started, thereby avoiding undernutrition in patients with very severe ME,” Ms. Baxter and colleagues write.

Indeed, coauthor and semiretired pediatric ME/CFS specialist physician Nigel Speight, of Durham, United Kingdom, said in an interview, “In most of my patients, I used tube feeding early simply to avoid using unnecessary energy and causing stress to the patient.”

Dr. Speight added, “Patients can also die from sheer weakness leading to lack of respiratory drive. Also, and very understandably, some commit suicide.”
 

Caring for the patient with severe or very severe ME/CFS

Appearing in the special issue is an article entitled, “Caring for the Patient with Severe or Very Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”. It was authored by a multidisciplinary group led by Jose G. Montoya, MD, of the Jack S. Remington Laboratory for Specialty Diagnostics, Palo Alto Medical Foundation, Calif.

In that article, four levels of severity are defined: mild, moderate, severe, and very severe. Included in the “severe” category are patients who are mostly homebound and whose activities of daily living are limited. They may have severe cognitive difficulties. Patients in the “very severe” caregory are bedbound and are unable to care for themselves.

Clinical features include more extreme versions of the core ME/CFS criteria: profound fatigue/weakness, PEM, unrefreshing sleep, orthostatic intolerance, and cognitive impairment. Additional symptoms in those with severe/very severe ME can include extreme hypersensitivity to light, sound, touch, and/or odors. Even small amounts of physical, mental, emotional, and orthostatic stressors can trigger PEM and increased weakness.

The authors recommend a “patient-centered, collaborative approach that is grounded in compassion and respect for the patient in all interactions,” and they provide lists of steps providers can take. These include seeing patients at home if possible and considerations regarding that care, such as partnering with the patient’s caregivers and other health care providers, who may include physical and occupational therapists, home health nurses, and social workers who understand the condition. Home visits by optometrists or ophthalmologists and dentists may be required.

Documenting limitations in activities of daily living is particularly important for helping patients to obtain homecare and disability benefits, Dr. Montoya and colleagues say.

Clinicians should investigate any medical problems that may be amenable to treatment, including orthostatic intolerance, pain, sleep difficulties, comorbidities, or gastrointestinal problems. For patients with pain, bloating, and diarrhea who are found on assessment to have mast cell activation disorder (MCAD), a trial of sodium cromoglicate may be tried, Ms. Baxter told this news organization.

Nonmedical problems that may be contributing to the patient’s morbidity should also be assessed, including a lack of caretaking, social services, transportation, food, and/or supportive devices, such as wheelchairs, bedpans, feeding tubes, and catheters.

The article provides additional detailed recommendations regarding pharmacologic treatments, follow-up visits – in-person or virtual – and hospitalization, as well as recommendations for energy conservation and management.

A section titled Practical Considerations for Busy Providers includes advice to be aware of any regulatory or insurance requirements for providing home visits and to maximize reimbursement by diagnosing any comorbidities, such as postural orthostatic tachycardia syndrome, Ehlers-Danlos syndrome, or MCAD.

Dr. Speight, who authored an article in the special issue on the management of ME in children, called the article by Dr. Montoya and colleagues “absolutely excellent,” and added his own advice, which included not “overinvestigating to cover your back but at the expense of causing stress to the patient” and considering a trial of immunoglobulin.

Importantly, Dr. Speight stressed, “avoid referral to psychiatrists unless specifically indicated for additional psychiatric morbidity; in which case, make clear that the psychiatrist accepts [that the] basic illness is medical.”

He also advised that clinicians stop using the term “chronic fatigue syndrome” because it suggests the illness is mild and/or psychosomatic. “Maybe the United States should embrace the term ME once and for all,” he said.

Dr. Baxter, Dr. Speight, and Dr. Montoya have disclosed no relevant financial relationships. Dr. Bateman is conducting research for Terra Biological.

A version of this article first appeared on Medscape.com.

People who are severely ill with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are often too sick to leave home, but clinicians can still support them in many ways, experts say.

Approximately 250,000 people in the United Kingdom (0.2%-0.4%) have ME/CFS – where it’s called “ME.” As many as 2.5 million in the United States have it. Those numbers are expected to dramatically increase with the addition of people with long COVID. An estimated 25% of patients with the condition are so severely impaired that they are housebound or bedbound to the point where they’re unable to attend medical office visits. There are very few data about them because they’re typically unable to participate in studies.

Speaking at the annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME), patient advocate Helen Baxter, of the U.K. charity 25% ME Group, presented a case series of five patients bedbound with ME/CFS who became severely malnourished because of delays in the placement of feeding tubes. The delays occurred because it was not recognized that the patients were unable to eat. The inability to eat may be due to a variety of factors, including gastrointestinal dysfunction, dysphagia, nausea, or lack of sufficient energy to eat or drink.

A report of those cases was included in a special issue of Healthcare, devoted to the topic of severe and very severe ME/CFS. The issue, which was published in April 2021, included 25 articles on the pathophysiology of severe ME/CFS, ways that clinicians can support patients who are too sick to make office visits, and psychosocial aspects of the condition that result from physical debilitation.

Two additional articles by specialist physicians aim to counter the skepticism about ME/CFS that has long persisted among some in the medical community.

“ME/CFS is under-researched and has historically received insufficient funding for research, particularly when compared to other chronic conditions, such as multiple sclerosis. And most of the research that has been done about it has focused on patients who are able to attend clinics. Patients with severe ME/CFS have largely been excluded from research due to the severity of their illness and are often described as ‘hard to reach.’ Consequently, research into severe ME is very limited,” Ms. Baxter said.

Asked to comment, Lucinda Bateman, MD, founder and director of the Bateman Horne Center, Salt Lake City, told this news organization, “It’s a big gap, even in the knowledgeable community. The research is totally skewed towards people who can get up and go participate in research. ... I don’t think most clinicians have any idea how sick people can get with ME/CFS.”

Cardiopulmonary exercise testing (CPET), which is commonly used in research, is intended to elicit objective biomarker responses. Such testing, which is considered the gold standard for determining disability, is impossible for the most severely ill patients with ME/CFS and is potentially harmful to these patients because of the hallmark postexertional malaise (PEM) phenomenon, Dr. Bateman noted.

“If we want to use CPET for research, we have to remember that it harms people to some degree and that we’re only studying the people who aren’t as sick. ... It’s one of the reasons I’ve been aggressively pursuing medical education about orthostatic testing, because it’s a clear objective marker, not as deleterious, and potentially leads to treatment options,” she said.

Misdiagnosis, treatment delays led to life-threatening malnutrition

The five patients that Ms. Baxter presented had become severely malnourished and dehydrated. There was evidence of clinical inertia for each of them.

“All were judged to have anorexia nervosa, and psychiatrists were involved, which was an added delay to starting tube feeding. ... In each case, the doctors resorted to making inappropriate psychological diagnoses without positive evidence of psychopathology, failing to recognize the significance of the malnutrition,” Ms. Baxter said. (Urgent tube feeding would have been warranted even had anorexia nervosa been the correct diagnosis, she pointed out.)

Once the problem was finally recognized, “all participants saw an improvement in their situation following the allocation of a home enteral nutrition dietician.”

At the IACFS/ME conference, Ms. Baxter described the painstaking methods used for gathering information, which were described in the same journal. These involved a combination of online, telephone, and text communications with patients or their caregivers. Efforts were made to avoid overtaxing the patients and triggering PEM.

“An early warning system needs to be put in place for patients with severe ME so that when they or their representatives become aware of the development of problems with oral intake, prompt action is taken, and tube feeding started, thereby avoiding undernutrition in patients with very severe ME,” Ms. Baxter and colleagues write.

Indeed, coauthor and semiretired pediatric ME/CFS specialist physician Nigel Speight, of Durham, United Kingdom, said in an interview, “In most of my patients, I used tube feeding early simply to avoid using unnecessary energy and causing stress to the patient.”

Dr. Speight added, “Patients can also die from sheer weakness leading to lack of respiratory drive. Also, and very understandably, some commit suicide.”
 

Caring for the patient with severe or very severe ME/CFS

Appearing in the special issue is an article entitled, “Caring for the Patient with Severe or Very Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”. It was authored by a multidisciplinary group led by Jose G. Montoya, MD, of the Jack S. Remington Laboratory for Specialty Diagnostics, Palo Alto Medical Foundation, Calif.

In that article, four levels of severity are defined: mild, moderate, severe, and very severe. Included in the “severe” category are patients who are mostly homebound and whose activities of daily living are limited. They may have severe cognitive difficulties. Patients in the “very severe” caregory are bedbound and are unable to care for themselves.

Clinical features include more extreme versions of the core ME/CFS criteria: profound fatigue/weakness, PEM, unrefreshing sleep, orthostatic intolerance, and cognitive impairment. Additional symptoms in those with severe/very severe ME can include extreme hypersensitivity to light, sound, touch, and/or odors. Even small amounts of physical, mental, emotional, and orthostatic stressors can trigger PEM and increased weakness.

The authors recommend a “patient-centered, collaborative approach that is grounded in compassion and respect for the patient in all interactions,” and they provide lists of steps providers can take. These include seeing patients at home if possible and considerations regarding that care, such as partnering with the patient’s caregivers and other health care providers, who may include physical and occupational therapists, home health nurses, and social workers who understand the condition. Home visits by optometrists or ophthalmologists and dentists may be required.

Documenting limitations in activities of daily living is particularly important for helping patients to obtain homecare and disability benefits, Dr. Montoya and colleagues say.

Clinicians should investigate any medical problems that may be amenable to treatment, including orthostatic intolerance, pain, sleep difficulties, comorbidities, or gastrointestinal problems. For patients with pain, bloating, and diarrhea who are found on assessment to have mast cell activation disorder (MCAD), a trial of sodium cromoglicate may be tried, Ms. Baxter told this news organization.

Nonmedical problems that may be contributing to the patient’s morbidity should also be assessed, including a lack of caretaking, social services, transportation, food, and/or supportive devices, such as wheelchairs, bedpans, feeding tubes, and catheters.

The article provides additional detailed recommendations regarding pharmacologic treatments, follow-up visits – in-person or virtual – and hospitalization, as well as recommendations for energy conservation and management.

A section titled Practical Considerations for Busy Providers includes advice to be aware of any regulatory or insurance requirements for providing home visits and to maximize reimbursement by diagnosing any comorbidities, such as postural orthostatic tachycardia syndrome, Ehlers-Danlos syndrome, or MCAD.

Dr. Speight, who authored an article in the special issue on the management of ME in children, called the article by Dr. Montoya and colleagues “absolutely excellent,” and added his own advice, which included not “overinvestigating to cover your back but at the expense of causing stress to the patient” and considering a trial of immunoglobulin.

Importantly, Dr. Speight stressed, “avoid referral to psychiatrists unless specifically indicated for additional psychiatric morbidity; in which case, make clear that the psychiatrist accepts [that the] basic illness is medical.”

He also advised that clinicians stop using the term “chronic fatigue syndrome” because it suggests the illness is mild and/or psychosomatic. “Maybe the United States should embrace the term ME once and for all,” he said.

Dr. Baxter, Dr. Speight, and Dr. Montoya have disclosed no relevant financial relationships. Dr. Bateman is conducting research for Terra Biological.

A version of this article first appeared on Medscape.com.

People who are severely ill with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are often too sick to leave home, but clinicians can still support them in many ways, experts say.

Approximately 250,000 people in the United Kingdom (0.2%-0.4%) have ME/CFS – where it’s called “ME.” As many as 2.5 million in the United States have it. Those numbers are expected to dramatically increase with the addition of people with long COVID. An estimated 25% of patients with the condition are so severely impaired that they are housebound or bedbound to the point where they’re unable to attend medical office visits. There are very few data about them because they’re typically unable to participate in studies.

Speaking at the annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME), patient advocate Helen Baxter, of the U.K. charity 25% ME Group, presented a case series of five patients bedbound with ME/CFS who became severely malnourished because of delays in the placement of feeding tubes. The delays occurred because it was not recognized that the patients were unable to eat. The inability to eat may be due to a variety of factors, including gastrointestinal dysfunction, dysphagia, nausea, or lack of sufficient energy to eat or drink.

A report of those cases was included in a special issue of Healthcare, devoted to the topic of severe and very severe ME/CFS. The issue, which was published in April 2021, included 25 articles on the pathophysiology of severe ME/CFS, ways that clinicians can support patients who are too sick to make office visits, and psychosocial aspects of the condition that result from physical debilitation.

Two additional articles by specialist physicians aim to counter the skepticism about ME/CFS that has long persisted among some in the medical community.

“ME/CFS is under-researched and has historically received insufficient funding for research, particularly when compared to other chronic conditions, such as multiple sclerosis. And most of the research that has been done about it has focused on patients who are able to attend clinics. Patients with severe ME/CFS have largely been excluded from research due to the severity of their illness and are often described as ‘hard to reach.’ Consequently, research into severe ME is very limited,” Ms. Baxter said.

Asked to comment, Lucinda Bateman, MD, founder and director of the Bateman Horne Center, Salt Lake City, told this news organization, “It’s a big gap, even in the knowledgeable community. The research is totally skewed towards people who can get up and go participate in research. ... I don’t think most clinicians have any idea how sick people can get with ME/CFS.”

Cardiopulmonary exercise testing (CPET), which is commonly used in research, is intended to elicit objective biomarker responses. Such testing, which is considered the gold standard for determining disability, is impossible for the most severely ill patients with ME/CFS and is potentially harmful to these patients because of the hallmark postexertional malaise (PEM) phenomenon, Dr. Bateman noted.

“If we want to use CPET for research, we have to remember that it harms people to some degree and that we’re only studying the people who aren’t as sick. ... It’s one of the reasons I’ve been aggressively pursuing medical education about orthostatic testing, because it’s a clear objective marker, not as deleterious, and potentially leads to treatment options,” she said.

Misdiagnosis, treatment delays led to life-threatening malnutrition

The five patients that Ms. Baxter presented had become severely malnourished and dehydrated. There was evidence of clinical inertia for each of them.

“All were judged to have anorexia nervosa, and psychiatrists were involved, which was an added delay to starting tube feeding. ... In each case, the doctors resorted to making inappropriate psychological diagnoses without positive evidence of psychopathology, failing to recognize the significance of the malnutrition,” Ms. Baxter said. (Urgent tube feeding would have been warranted even had anorexia nervosa been the correct diagnosis, she pointed out.)

Once the problem was finally recognized, “all participants saw an improvement in their situation following the allocation of a home enteral nutrition dietician.”

At the IACFS/ME conference, Ms. Baxter described the painstaking methods used for gathering information, which were described in the same journal. These involved a combination of online, telephone, and text communications with patients or their caregivers. Efforts were made to avoid overtaxing the patients and triggering PEM.

“An early warning system needs to be put in place for patients with severe ME so that when they or their representatives become aware of the development of problems with oral intake, prompt action is taken, and tube feeding started, thereby avoiding undernutrition in patients with very severe ME,” Ms. Baxter and colleagues write.

Indeed, coauthor and semiretired pediatric ME/CFS specialist physician Nigel Speight, of Durham, United Kingdom, said in an interview, “In most of my patients, I used tube feeding early simply to avoid using unnecessary energy and causing stress to the patient.”

Dr. Speight added, “Patients can also die from sheer weakness leading to lack of respiratory drive. Also, and very understandably, some commit suicide.”
 

Caring for the patient with severe or very severe ME/CFS

Appearing in the special issue is an article entitled, “Caring for the Patient with Severe or Very Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”. It was authored by a multidisciplinary group led by Jose G. Montoya, MD, of the Jack S. Remington Laboratory for Specialty Diagnostics, Palo Alto Medical Foundation, Calif.

In that article, four levels of severity are defined: mild, moderate, severe, and very severe. Included in the “severe” category are patients who are mostly homebound and whose activities of daily living are limited. They may have severe cognitive difficulties. Patients in the “very severe” caregory are bedbound and are unable to care for themselves.

Clinical features include more extreme versions of the core ME/CFS criteria: profound fatigue/weakness, PEM, unrefreshing sleep, orthostatic intolerance, and cognitive impairment. Additional symptoms in those with severe/very severe ME can include extreme hypersensitivity to light, sound, touch, and/or odors. Even small amounts of physical, mental, emotional, and orthostatic stressors can trigger PEM and increased weakness.

The authors recommend a “patient-centered, collaborative approach that is grounded in compassion and respect for the patient in all interactions,” and they provide lists of steps providers can take. These include seeing patients at home if possible and considerations regarding that care, such as partnering with the patient’s caregivers and other health care providers, who may include physical and occupational therapists, home health nurses, and social workers who understand the condition. Home visits by optometrists or ophthalmologists and dentists may be required.

Documenting limitations in activities of daily living is particularly important for helping patients to obtain homecare and disability benefits, Dr. Montoya and colleagues say.

Clinicians should investigate any medical problems that may be amenable to treatment, including orthostatic intolerance, pain, sleep difficulties, comorbidities, or gastrointestinal problems. For patients with pain, bloating, and diarrhea who are found on assessment to have mast cell activation disorder (MCAD), a trial of sodium cromoglicate may be tried, Ms. Baxter told this news organization.

Nonmedical problems that may be contributing to the patient’s morbidity should also be assessed, including a lack of caretaking, social services, transportation, food, and/or supportive devices, such as wheelchairs, bedpans, feeding tubes, and catheters.

The article provides additional detailed recommendations regarding pharmacologic treatments, follow-up visits – in-person or virtual – and hospitalization, as well as recommendations for energy conservation and management.

A section titled Practical Considerations for Busy Providers includes advice to be aware of any regulatory or insurance requirements for providing home visits and to maximize reimbursement by diagnosing any comorbidities, such as postural orthostatic tachycardia syndrome, Ehlers-Danlos syndrome, or MCAD.

Dr. Speight, who authored an article in the special issue on the management of ME in children, called the article by Dr. Montoya and colleagues “absolutely excellent,” and added his own advice, which included not “overinvestigating to cover your back but at the expense of causing stress to the patient” and considering a trial of immunoglobulin.

Importantly, Dr. Speight stressed, “avoid referral to psychiatrists unless specifically indicated for additional psychiatric morbidity; in which case, make clear that the psychiatrist accepts [that the] basic illness is medical.”

He also advised that clinicians stop using the term “chronic fatigue syndrome” because it suggests the illness is mild and/or psychosomatic. “Maybe the United States should embrace the term ME once and for all,” he said.

Dr. Baxter, Dr. Speight, and Dr. Montoya have disclosed no relevant financial relationships. Dr. Bateman is conducting research for Terra Biological.

A version of this article first appeared on Medscape.com.

Emerging evidence is shedding light on the common underlying mechanisms contributing to the overlapping clinical phenomena of “long COVID,” myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and dysautonomia.

At the virtual annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFSME), speakers presented data showing similar pathophysiologic abnormalities in people with systemic symptoms associated with ME/CFS who had a prior SARS-CoV-2 infection and those who did not, including individuals whose illness preceded the COVID-19 pandemic.

Core clinical diagnostic criteria for ME/CFS established by the Institute of Medicine in 2015 include substantial decrement in functioning for 6 months or longer, postexertional malaise, or a worsening of symptoms following even minor exertion (often described by patients as “crashes”), unrefreshing sleep, and cognitive dysfunction and/or orthostatic intolerance that are frequent and severe.

Long COVID has been defined in several different ways using different terminology. The U.S. Centers for Disease Control and Prevention, for example, defines “post-COVID conditions” as those continuing four or more weeks beyond first symptoms. The World Health Organization’s clinical case definition of “post COVID-19 condition” includes otherwise unexplained symptoms 3 months from COVID-19 onset and lasting longer than 2 months.

Both ME/CFS and long COVID commonly involve numerous symptoms beyond the defining ones, affecting nearly every organ system in the body, including systemic, neurocognitive, endocrine, cardiovascular, pulmonary, musculoskeletal, and gastrointestinal, with wide variation among individuals. Autonomic dysfunction is common to both conditions, particularly postural orthostatic tachycardia syndrome (POTS).

“My way of understanding these illnesses is that they’re not just multisystem illnesses, but all these interactive systems that lean on each other are dysregulated. … I would say that a very common underlying mediator of both ME/CFS and long COVID is autonomic dysfunction, and it presents as POTS,” Nancy Klimas, MD, director of the Institute for Neuro-Immune Medicine at Nova Southeastern University, Fort Lauderdale, Fla., told this news organization.

Dr. Klimas, who is also director of Clinical Immunology Research at the Miami Veterans Affairs Medical Center, added that “if basic bioenergetics are disrupted and in an oxidative-stress state [then] they have downregulated energy production at the cellular level, which seems to be the case in ME/CFS and now in long COVID.”
 

New ICD-10 codes better characterize the syndromes

New ICD-10 codes for 2023, being implemented on Oct. 1, will enable clinicians to better document all of these interrelated conditions.

Under the existing G93.3, Postviral and related fatigue syndromes, there will now be:

• G93.31 – Postviral fatigue syndrome.
• G93.32 – Myalgic encephalomyelitis/chronic fatigue syndrome (and the separate terms).
• G93.39 – Other postinfection and related fatigue syndromes.

The old R53.82, “Chronic fatigue, unspecified” code now excludes all of the above conditions.

The additional code U09.9 for “post COVID-19 condition, unspecified,” may also be used if applicable.

In addition, a new code for POTS, G90.A, which wasn’t previously mentioned in ICD-10, may also be used starting Oct. 1.

Lucinda Bateman, MD, founder and director of the Bateman Horne Center, Salt Lake City, advises using all applicable codes for a given patient. “If a patient came into my office with long COVID and met criteria for ME/CFS, we would code both, and also any other syndrome criteria that they may meet, such as POTS or fibromyalgia.

“If people use the codes appropriately, then you can understand the overlap better. It increases the likelihood of reimbursement, creates a more accurate medical record for the patient, and provides them with a better tool should they require disability benefits.”

Dr. Bateman advises in-office orthostatic evaluation for all patients with this symptom constellation, using a passive standing evaluation such as the 10-minute NASA Lean test.

“Clinicians should take the time to do orthostatic testing in these patients because it provides objective markers and will help lead us to potential interventions to help improve people’s function.”

The Bateman Horne center offers clinician resources on management of ME/CFS and related conditions.
 

How common is ME/CFS after COVID-19?

According to one published meta-analysis, the global prevalence of “post-acute sequelae of SARS-CoV-2,” defined by any symptom, is about 43% of patients overall following infection, and 49% at 120 days. Fatigue was the most commonly reported symptom, followed by memory problems. As of March 22, the World Health Organization estimated that there have been more than 470 million COVID-19 cases, which would give a figure of about 200 million people who are experiencing a wide range of long-COVID symptoms. 

On the final day of the IACFSME conference, Luis Nacul, MD, of the University of British Columbia, Vancouver, presented several sets of data from his group and others aiming to determine the proportion of individuals who develop symptoms suggestive of ME/CFS following a COVID-19 infection.   

Among a cohort of 88 adults hospitalized with confirmed SARS-CoV-2 infections during the first pandemic wave in 2020 and followed up in the respiratory clinic, rates of reported generalized fatigue were 67% at 3 months and 59.5% at 6 months. Substantial fatigue (that is, present most days and affecting activity levels) were reported by 16% at 3 months and 7% at 6 months. “This should represent in principle the maximum prevalence of cases who would meet the criteria for ME/CFS,” Dr. Nacul said.

Baseline age was indirectly associated with fatigue at 3 and 6 months, while the number of comorbidities a patient had was directly associated. Comorbidities also predicted severe fatigue at 3 months, but the numbers were too small for assessment at 6 months.

Studies involving nonhospitalized patients suggested lower rates. One meta-analysis showed 1-year rates of fatigue in 32% and cognitive impairment in 22%. Another showed very similar rates, reporting fatigue in 28% and memory/concentration difficulties in 18%-19%.   

Dr. Nacul cautioned that these figures are likely overestimates since many of the study populations are taken from respiratory or long-COVID clinics. “The evidence on ‘post-COVID fatigue syndrome’ or ME/CFS following COVID is still evolving. There is a huge need for studies looking more closely at cases meeting well-defined ME/CFS criteria. This unfortunately hasn’t been done for most studies.”
 

Immune system dysfunction appears to underlie many cases

In a keynote address during the conference, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., pointed out that long COVID and ME/CFS are among many unexplained postacute infection syndromes associated with a long list of viral pathogens, including Ebola, the prior SARS viruses, Epstein-Barr virus, and Dengue, as well as nonviral pathogens such as Coxiella burnetii (Q fever syndrome) and Borrelia (posttreatment Lyme disease syndrome).

Dr. Iwasaki cited a recent Nature Medicine review article that she coauthored on this topic with an ME/CFS patient, noting: “We really need to understand why some people are failing to recover from these types of diseases.”

Emerging evidence supports four different hypotheses regarding pathogenesis: viral reservoir/viral pathogen-associated molecular pattern molecules, autoimmunity, dysbiosis/viral reactivation, and tissue damage

“Right now, it’s too early to exclude or make any conclusions about these. We need to have an open mind to dissect these various possibilities,” she said.

Two speakers reported findings of immune dysregulation in both ME/CFS and long COVID. Wakiro Sato, MD, PhD, of the National Center of Neurology and Psychiatry, Tokyo, reported that anti–G-protein coupled receptor antibodies were found in 33 (55%) of 60 patients with long COVID, and more than 40% had peripheral immune cell profile abnormalities. These findings were similar to those found in patients with ME/CFS, published by Sato’s team (Brain Behav Immun. 2021 Mar 29. doi: 10.1016/j.bbi.2021.03.023) and other researchers in Germany.  

Liisa K. Selin, MD, PhD, professor of pathology at the University of Massachusetts, Worcester, presented data for an analysis of peripheral blood mononuclear cells from 26 donors with ME/CFS (8 with long COVID) and 24 healthy controls. In both patient groups, they found altered expression of inflammatory markers and decreases in CD8 T-cell number and function. The patients with long COVID showed evidence of sustained activation of both T-cell populations with increased CD38 and HLA-DR, associated with a compensatory increased frequency of activated CD4+CD8+ T cells.

“These results are consistent with immune dysregulation associated with overactivation and exhaustion of CD8 T cells, as observed in chronic viral infections and tumor environments,” Dr. Selin said.
 

ME/CFS and long COVID ‘frighteningly similar, if not identical’

Data for a different system derangement in long COVID and ME/CFS, the pathophysiology of exercise intolerance, were presented in another keynote talk by David M. Systrom, MD, a pulmonary and critical care medicine specialist at Brigham and Women’s Hospital and director of the Massachusetts General Hospital cardiopulmonary laboratory, both in Boston. He has conducted invasive cardiopulmonary exercise testing in patients with ME/CFS and patients with long COVID.

Previously, Dr. Systrom and his team found that patients with ME/CFS have distinct defects in both ventricular filling pressure and oxygen extraction from the muscles. Neither of those are features of deconditioning, which is often blamed for exercise intolerance in people with ME/CFS. Rather, the major defect in deconditioning is decreased stroke volume and cardiac output. In ME/CFS patients, he found supranormal pulmonary blood flow, compared with VO₂ max, suggesting peripheral left-to-right shunting.

In addition, Dr. Systrom and colleagues found that a large proportion of ME/CFS patients with these peripheral vascular defects also have biopsy-demonstrated small-fiber neuropathy, suggesting that acute exercise intolerance is related to underlying autonomic nervous system dysfunction.

In Dr. Systrom and colleagues’ long COVID study, invasive cardiopulmonary exercise testing in 10 patients who had recovered from COVID-19 at least 6 months prior and did not have cardiopulmonary disease had significantly revealed reduced peak exercise aerobic capacity (VO₂ max), compared with 10 age- and sex-matched controls. The reduction in peak VO₂ was associated with impaired systemic oxygen extraction, compared with the controls, despite a preserved peak cardiac index.

The long-COVID patients also showed greater ventilatory inefficiency, which “is entirely related to hyperventilation, not intrinsic lung disease,” Dr. Systrom said, adding that while there may be subsets of patients with interstitial lung disease after acute respiratory distress syndrome, these patients didn’t have that. “This for all the world looks like ME/CFS. We think they are frighteningly similar, if not identical,” Dr. Systrom said.  

In a third study for which Dr. Systrom was a coauthor, published in Annals of Neurology, multisystem involvement was found in nine patients following mild COVID-19 infection, using standardized autonomic assessments including Valsalva maneuver, sudomotor and tilt tests, and skin biopsies for small-fiber neuropathy. The findings included cerebrovascular dysregulation with persistent cerebral arteriolar vasoconstriction, small-fiber neuropathy and related dysautonomia, respiratory dysregulation, and chronic inflammation.

Dr. Systrom’s conclusion: “Dyspnea and hyperventilation are common in ME/CFS and long COVID and there is significant overlap with POTS.”

Dr. Bateman disclosed that she is conducting research for Terra Biological. Dr. Systrom said he is conducting research for Astellas.

A version of this article first appeared on Medscape.com.

Emerging evidence is shedding light on the common underlying mechanisms contributing to the overlapping clinical phenomena of “long COVID,” myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and dysautonomia.

At the virtual annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFSME), speakers presented data showing similar pathophysiologic abnormalities in people with systemic symptoms associated with ME/CFS who had a prior SARS-CoV-2 infection and those who did not, including individuals whose illness preceded the COVID-19 pandemic.

Core clinical diagnostic criteria for ME/CFS established by the Institute of Medicine in 2015 include substantial decrement in functioning for 6 months or longer, postexertional malaise, or a worsening of symptoms following even minor exertion (often described by patients as “crashes”), unrefreshing sleep, and cognitive dysfunction and/or orthostatic intolerance that are frequent and severe.

Long COVID has been defined in several different ways using different terminology. The U.S. Centers for Disease Control and Prevention, for example, defines “post-COVID conditions” as those continuing four or more weeks beyond first symptoms. The World Health Organization’s clinical case definition of “post COVID-19 condition” includes otherwise unexplained symptoms 3 months from COVID-19 onset and lasting longer than 2 months.

Both ME/CFS and long COVID commonly involve numerous symptoms beyond the defining ones, affecting nearly every organ system in the body, including systemic, neurocognitive, endocrine, cardiovascular, pulmonary, musculoskeletal, and gastrointestinal, with wide variation among individuals. Autonomic dysfunction is common to both conditions, particularly postural orthostatic tachycardia syndrome (POTS).

“My way of understanding these illnesses is that they’re not just multisystem illnesses, but all these interactive systems that lean on each other are dysregulated. … I would say that a very common underlying mediator of both ME/CFS and long COVID is autonomic dysfunction, and it presents as POTS,” Nancy Klimas, MD, director of the Institute for Neuro-Immune Medicine at Nova Southeastern University, Fort Lauderdale, Fla., told this news organization.

Dr. Klimas, who is also director of Clinical Immunology Research at the Miami Veterans Affairs Medical Center, added that “if basic bioenergetics are disrupted and in an oxidative-stress state [then] they have downregulated energy production at the cellular level, which seems to be the case in ME/CFS and now in long COVID.”
 

New ICD-10 codes better characterize the syndromes

New ICD-10 codes for 2023, being implemented on Oct. 1, will enable clinicians to better document all of these interrelated conditions.

Under the existing G93.3, Postviral and related fatigue syndromes, there will now be:

• G93.31 – Postviral fatigue syndrome.
• G93.32 – Myalgic encephalomyelitis/chronic fatigue syndrome (and the separate terms).
• G93.39 – Other postinfection and related fatigue syndromes.

The old R53.82, “Chronic fatigue, unspecified” code now excludes all of the above conditions.

The additional code U09.9 for “post COVID-19 condition, unspecified,” may also be used if applicable.

In addition, a new code for POTS, G90.A, which wasn’t previously mentioned in ICD-10, may also be used starting Oct. 1.

Lucinda Bateman, MD, founder and director of the Bateman Horne Center, Salt Lake City, advises using all applicable codes for a given patient. “If a patient came into my office with long COVID and met criteria for ME/CFS, we would code both, and also any other syndrome criteria that they may meet, such as POTS or fibromyalgia.

“If people use the codes appropriately, then you can understand the overlap better. It increases the likelihood of reimbursement, creates a more accurate medical record for the patient, and provides them with a better tool should they require disability benefits.”

Dr. Bateman advises in-office orthostatic evaluation for all patients with this symptom constellation, using a passive standing evaluation such as the 10-minute NASA Lean test.

“Clinicians should take the time to do orthostatic testing in these patients because it provides objective markers and will help lead us to potential interventions to help improve people’s function.”

The Bateman Horne center offers clinician resources on management of ME/CFS and related conditions.
 

How common is ME/CFS after COVID-19?

According to one published meta-analysis, the global prevalence of “post-acute sequelae of SARS-CoV-2,” defined by any symptom, is about 43% of patients overall following infection, and 49% at 120 days. Fatigue was the most commonly reported symptom, followed by memory problems. As of March 22, the World Health Organization estimated that there have been more than 470 million COVID-19 cases, which would give a figure of about 200 million people who are experiencing a wide range of long-COVID symptoms. 

On the final day of the IACFSME conference, Luis Nacul, MD, of the University of British Columbia, Vancouver, presented several sets of data from his group and others aiming to determine the proportion of individuals who develop symptoms suggestive of ME/CFS following a COVID-19 infection.   

Among a cohort of 88 adults hospitalized with confirmed SARS-CoV-2 infections during the first pandemic wave in 2020 and followed up in the respiratory clinic, rates of reported generalized fatigue were 67% at 3 months and 59.5% at 6 months. Substantial fatigue (that is, present most days and affecting activity levels) were reported by 16% at 3 months and 7% at 6 months. “This should represent in principle the maximum prevalence of cases who would meet the criteria for ME/CFS,” Dr. Nacul said.

Baseline age was indirectly associated with fatigue at 3 and 6 months, while the number of comorbidities a patient had was directly associated. Comorbidities also predicted severe fatigue at 3 months, but the numbers were too small for assessment at 6 months.

Studies involving nonhospitalized patients suggested lower rates. One meta-analysis showed 1-year rates of fatigue in 32% and cognitive impairment in 22%. Another showed very similar rates, reporting fatigue in 28% and memory/concentration difficulties in 18%-19%.   

Dr. Nacul cautioned that these figures are likely overestimates since many of the study populations are taken from respiratory or long-COVID clinics. “The evidence on ‘post-COVID fatigue syndrome’ or ME/CFS following COVID is still evolving. There is a huge need for studies looking more closely at cases meeting well-defined ME/CFS criteria. This unfortunately hasn’t been done for most studies.”
 

Immune system dysfunction appears to underlie many cases

In a keynote address during the conference, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., pointed out that long COVID and ME/CFS are among many unexplained postacute infection syndromes associated with a long list of viral pathogens, including Ebola, the prior SARS viruses, Epstein-Barr virus, and Dengue, as well as nonviral pathogens such as Coxiella burnetii (Q fever syndrome) and Borrelia (posttreatment Lyme disease syndrome).

Dr. Iwasaki cited a recent Nature Medicine review article that she coauthored on this topic with an ME/CFS patient, noting: “We really need to understand why some people are failing to recover from these types of diseases.”

Emerging evidence supports four different hypotheses regarding pathogenesis: viral reservoir/viral pathogen-associated molecular pattern molecules, autoimmunity, dysbiosis/viral reactivation, and tissue damage

“Right now, it’s too early to exclude or make any conclusions about these. We need to have an open mind to dissect these various possibilities,” she said.

Two speakers reported findings of immune dysregulation in both ME/CFS and long COVID. Wakiro Sato, MD, PhD, of the National Center of Neurology and Psychiatry, Tokyo, reported that anti–G-protein coupled receptor antibodies were found in 33 (55%) of 60 patients with long COVID, and more than 40% had peripheral immune cell profile abnormalities. These findings were similar to those found in patients with ME/CFS, published by Sato’s team (Brain Behav Immun. 2021 Mar 29. doi: 10.1016/j.bbi.2021.03.023) and other researchers in Germany.  

Liisa K. Selin, MD, PhD, professor of pathology at the University of Massachusetts, Worcester, presented data for an analysis of peripheral blood mononuclear cells from 26 donors with ME/CFS (8 with long COVID) and 24 healthy controls. In both patient groups, they found altered expression of inflammatory markers and decreases in CD8 T-cell number and function. The patients with long COVID showed evidence of sustained activation of both T-cell populations with increased CD38 and HLA-DR, associated with a compensatory increased frequency of activated CD4+CD8+ T cells.

“These results are consistent with immune dysregulation associated with overactivation and exhaustion of CD8 T cells, as observed in chronic viral infections and tumor environments,” Dr. Selin said.
 

ME/CFS and long COVID ‘frighteningly similar, if not identical’

Data for a different system derangement in long COVID and ME/CFS, the pathophysiology of exercise intolerance, were presented in another keynote talk by David M. Systrom, MD, a pulmonary and critical care medicine specialist at Brigham and Women’s Hospital and director of the Massachusetts General Hospital cardiopulmonary laboratory, both in Boston. He has conducted invasive cardiopulmonary exercise testing in patients with ME/CFS and patients with long COVID.

Previously, Dr. Systrom and his team found that patients with ME/CFS have distinct defects in both ventricular filling pressure and oxygen extraction from the muscles. Neither of those are features of deconditioning, which is often blamed for exercise intolerance in people with ME/CFS. Rather, the major defect in deconditioning is decreased stroke volume and cardiac output. In ME/CFS patients, he found supranormal pulmonary blood flow, compared with VO₂ max, suggesting peripheral left-to-right shunting.

In addition, Dr. Systrom and colleagues found that a large proportion of ME/CFS patients with these peripheral vascular defects also have biopsy-demonstrated small-fiber neuropathy, suggesting that acute exercise intolerance is related to underlying autonomic nervous system dysfunction.

In Dr. Systrom and colleagues’ long COVID study, invasive cardiopulmonary exercise testing in 10 patients who had recovered from COVID-19 at least 6 months prior and did not have cardiopulmonary disease had significantly revealed reduced peak exercise aerobic capacity (VO₂ max), compared with 10 age- and sex-matched controls. The reduction in peak VO₂ was associated with impaired systemic oxygen extraction, compared with the controls, despite a preserved peak cardiac index.

The long-COVID patients also showed greater ventilatory inefficiency, which “is entirely related to hyperventilation, not intrinsic lung disease,” Dr. Systrom said, adding that while there may be subsets of patients with interstitial lung disease after acute respiratory distress syndrome, these patients didn’t have that. “This for all the world looks like ME/CFS. We think they are frighteningly similar, if not identical,” Dr. Systrom said.  

In a third study for which Dr. Systrom was a coauthor, published in Annals of Neurology, multisystem involvement was found in nine patients following mild COVID-19 infection, using standardized autonomic assessments including Valsalva maneuver, sudomotor and tilt tests, and skin biopsies for small-fiber neuropathy. The findings included cerebrovascular dysregulation with persistent cerebral arteriolar vasoconstriction, small-fiber neuropathy and related dysautonomia, respiratory dysregulation, and chronic inflammation.

Dr. Systrom’s conclusion: “Dyspnea and hyperventilation are common in ME/CFS and long COVID and there is significant overlap with POTS.”

Dr. Bateman disclosed that she is conducting research for Terra Biological. Dr. Systrom said he is conducting research for Astellas.

A version of this article first appeared on Medscape.com.

Emerging evidence is shedding light on the common underlying mechanisms contributing to the overlapping clinical phenomena of “long COVID,” myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and dysautonomia.

At the virtual annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFSME), speakers presented data showing similar pathophysiologic abnormalities in people with systemic symptoms associated with ME/CFS who had a prior SARS-CoV-2 infection and those who did not, including individuals whose illness preceded the COVID-19 pandemic.

Core clinical diagnostic criteria for ME/CFS established by the Institute of Medicine in 2015 include substantial decrement in functioning for 6 months or longer, postexertional malaise, or a worsening of symptoms following even minor exertion (often described by patients as “crashes”), unrefreshing sleep, and cognitive dysfunction and/or orthostatic intolerance that are frequent and severe.

Long COVID has been defined in several different ways using different terminology. The U.S. Centers for Disease Control and Prevention, for example, defines “post-COVID conditions” as those continuing four or more weeks beyond first symptoms. The World Health Organization’s clinical case definition of “post COVID-19 condition” includes otherwise unexplained symptoms 3 months from COVID-19 onset and lasting longer than 2 months.

Both ME/CFS and long COVID commonly involve numerous symptoms beyond the defining ones, affecting nearly every organ system in the body, including systemic, neurocognitive, endocrine, cardiovascular, pulmonary, musculoskeletal, and gastrointestinal, with wide variation among individuals. Autonomic dysfunction is common to both conditions, particularly postural orthostatic tachycardia syndrome (POTS).

“My way of understanding these illnesses is that they’re not just multisystem illnesses, but all these interactive systems that lean on each other are dysregulated. … I would say that a very common underlying mediator of both ME/CFS and long COVID is autonomic dysfunction, and it presents as POTS,” Nancy Klimas, MD, director of the Institute for Neuro-Immune Medicine at Nova Southeastern University, Fort Lauderdale, Fla., told this news organization.

Dr. Klimas, who is also director of Clinical Immunology Research at the Miami Veterans Affairs Medical Center, added that “if basic bioenergetics are disrupted and in an oxidative-stress state [then] they have downregulated energy production at the cellular level, which seems to be the case in ME/CFS and now in long COVID.”
 

New ICD-10 codes better characterize the syndromes

New ICD-10 codes for 2023, being implemented on Oct. 1, will enable clinicians to better document all of these interrelated conditions.

Under the existing G93.3, Postviral and related fatigue syndromes, there will now be:

• G93.31 – Postviral fatigue syndrome.
• G93.32 – Myalgic encephalomyelitis/chronic fatigue syndrome (and the separate terms).
• G93.39 – Other postinfection and related fatigue syndromes.

The old R53.82, “Chronic fatigue, unspecified” code now excludes all of the above conditions.

The additional code U09.9 for “post COVID-19 condition, unspecified,” may also be used if applicable.

In addition, a new code for POTS, G90.A, which wasn’t previously mentioned in ICD-10, may also be used starting Oct. 1.

Lucinda Bateman, MD, founder and director of the Bateman Horne Center, Salt Lake City, advises using all applicable codes for a given patient. “If a patient came into my office with long COVID and met criteria for ME/CFS, we would code both, and also any other syndrome criteria that they may meet, such as POTS or fibromyalgia.

“If people use the codes appropriately, then you can understand the overlap better. It increases the likelihood of reimbursement, creates a more accurate medical record for the patient, and provides them with a better tool should they require disability benefits.”

Dr. Bateman advises in-office orthostatic evaluation for all patients with this symptom constellation, using a passive standing evaluation such as the 10-minute NASA Lean test.

“Clinicians should take the time to do orthostatic testing in these patients because it provides objective markers and will help lead us to potential interventions to help improve people’s function.”

The Bateman Horne center offers clinician resources on management of ME/CFS and related conditions.
 

How common is ME/CFS after COVID-19?

According to one published meta-analysis, the global prevalence of “post-acute sequelae of SARS-CoV-2,” defined by any symptom, is about 43% of patients overall following infection, and 49% at 120 days. Fatigue was the most commonly reported symptom, followed by memory problems. As of March 22, the World Health Organization estimated that there have been more than 470 million COVID-19 cases, which would give a figure of about 200 million people who are experiencing a wide range of long-COVID symptoms. 

On the final day of the IACFSME conference, Luis Nacul, MD, of the University of British Columbia, Vancouver, presented several sets of data from his group and others aiming to determine the proportion of individuals who develop symptoms suggestive of ME/CFS following a COVID-19 infection.   

Among a cohort of 88 adults hospitalized with confirmed SARS-CoV-2 infections during the first pandemic wave in 2020 and followed up in the respiratory clinic, rates of reported generalized fatigue were 67% at 3 months and 59.5% at 6 months. Substantial fatigue (that is, present most days and affecting activity levels) were reported by 16% at 3 months and 7% at 6 months. “This should represent in principle the maximum prevalence of cases who would meet the criteria for ME/CFS,” Dr. Nacul said.

Baseline age was indirectly associated with fatigue at 3 and 6 months, while the number of comorbidities a patient had was directly associated. Comorbidities also predicted severe fatigue at 3 months, but the numbers were too small for assessment at 6 months.

Studies involving nonhospitalized patients suggested lower rates. One meta-analysis showed 1-year rates of fatigue in 32% and cognitive impairment in 22%. Another showed very similar rates, reporting fatigue in 28% and memory/concentration difficulties in 18%-19%.   

Dr. Nacul cautioned that these figures are likely overestimates since many of the study populations are taken from respiratory or long-COVID clinics. “The evidence on ‘post-COVID fatigue syndrome’ or ME/CFS following COVID is still evolving. There is a huge need for studies looking more closely at cases meeting well-defined ME/CFS criteria. This unfortunately hasn’t been done for most studies.”
 

Immune system dysfunction appears to underlie many cases

In a keynote address during the conference, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., pointed out that long COVID and ME/CFS are among many unexplained postacute infection syndromes associated with a long list of viral pathogens, including Ebola, the prior SARS viruses, Epstein-Barr virus, and Dengue, as well as nonviral pathogens such as Coxiella burnetii (Q fever syndrome) and Borrelia (posttreatment Lyme disease syndrome).

Dr. Iwasaki cited a recent Nature Medicine review article that she coauthored on this topic with an ME/CFS patient, noting: “We really need to understand why some people are failing to recover from these types of diseases.”

Emerging evidence supports four different hypotheses regarding pathogenesis: viral reservoir/viral pathogen-associated molecular pattern molecules, autoimmunity, dysbiosis/viral reactivation, and tissue damage

“Right now, it’s too early to exclude or make any conclusions about these. We need to have an open mind to dissect these various possibilities,” she said.

Two speakers reported findings of immune dysregulation in both ME/CFS and long COVID. Wakiro Sato, MD, PhD, of the National Center of Neurology and Psychiatry, Tokyo, reported that anti–G-protein coupled receptor antibodies were found in 33 (55%) of 60 patients with long COVID, and more than 40% had peripheral immune cell profile abnormalities. These findings were similar to those found in patients with ME/CFS, published by Sato’s team (Brain Behav Immun. 2021 Mar 29. doi: 10.1016/j.bbi.2021.03.023) and other researchers in Germany.  

Liisa K. Selin, MD, PhD, professor of pathology at the University of Massachusetts, Worcester, presented data for an analysis of peripheral blood mononuclear cells from 26 donors with ME/CFS (8 with long COVID) and 24 healthy controls. In both patient groups, they found altered expression of inflammatory markers and decreases in CD8 T-cell number and function. The patients with long COVID showed evidence of sustained activation of both T-cell populations with increased CD38 and HLA-DR, associated with a compensatory increased frequency of activated CD4+CD8+ T cells.

“These results are consistent with immune dysregulation associated with overactivation and exhaustion of CD8 T cells, as observed in chronic viral infections and tumor environments,” Dr. Selin said.
 

ME/CFS and long COVID ‘frighteningly similar, if not identical’

Data for a different system derangement in long COVID and ME/CFS, the pathophysiology of exercise intolerance, were presented in another keynote talk by David M. Systrom, MD, a pulmonary and critical care medicine specialist at Brigham and Women’s Hospital and director of the Massachusetts General Hospital cardiopulmonary laboratory, both in Boston. He has conducted invasive cardiopulmonary exercise testing in patients with ME/CFS and patients with long COVID.

Previously, Dr. Systrom and his team found that patients with ME/CFS have distinct defects in both ventricular filling pressure and oxygen extraction from the muscles. Neither of those are features of deconditioning, which is often blamed for exercise intolerance in people with ME/CFS. Rather, the major defect in deconditioning is decreased stroke volume and cardiac output. In ME/CFS patients, he found supranormal pulmonary blood flow, compared with VO₂ max, suggesting peripheral left-to-right shunting.

In addition, Dr. Systrom and colleagues found that a large proportion of ME/CFS patients with these peripheral vascular defects also have biopsy-demonstrated small-fiber neuropathy, suggesting that acute exercise intolerance is related to underlying autonomic nervous system dysfunction.

In Dr. Systrom and colleagues’ long COVID study, invasive cardiopulmonary exercise testing in 10 patients who had recovered from COVID-19 at least 6 months prior and did not have cardiopulmonary disease had significantly revealed reduced peak exercise aerobic capacity (VO₂ max), compared with 10 age- and sex-matched controls. The reduction in peak VO₂ was associated with impaired systemic oxygen extraction, compared with the controls, despite a preserved peak cardiac index.

The long-COVID patients also showed greater ventilatory inefficiency, which “is entirely related to hyperventilation, not intrinsic lung disease,” Dr. Systrom said, adding that while there may be subsets of patients with interstitial lung disease after acute respiratory distress syndrome, these patients didn’t have that. “This for all the world looks like ME/CFS. We think they are frighteningly similar, if not identical,” Dr. Systrom said.  

In a third study for which Dr. Systrom was a coauthor, published in Annals of Neurology, multisystem involvement was found in nine patients following mild COVID-19 infection, using standardized autonomic assessments including Valsalva maneuver, sudomotor and tilt tests, and skin biopsies for small-fiber neuropathy. The findings included cerebrovascular dysregulation with persistent cerebral arteriolar vasoconstriction, small-fiber neuropathy and related dysautonomia, respiratory dysregulation, and chronic inflammation.

Dr. Systrom’s conclusion: “Dyspnea and hyperventilation are common in ME/CFS and long COVID and there is significant overlap with POTS.”

Dr. Bateman disclosed that she is conducting research for Terra Biological. Dr. Systrom said he is conducting research for Astellas.

A version of this article first appeared on Medscape.com.