Conference Coverage

CHARLOTTE, N.C. – Nearly one-fourth of patients with early-onset colorectal cancer don’t get referrals for genetic counseling or testing, and although acceptance of genetic counseling has improved over the last 10 years, there is still a notable gap between referrals and uptake, investigators have found.

Among 791 patients with young- or early-onset colorectal cancer (YOCRC) seen at a large medical center from 2010 through 2019, 62.1% were referred for genetic counseling, but only 80.1% of this group followed through with the referrals by scheduling an appointment with a counselor or having genetic testing performed, reported Hareem Syed, MD, from the department of internal medicine at the Cleveland Clinic.

“Our findings highlight the need for health systems to implement care pathways to optimize genetic counseling referral and testing in all young-onset colorectal cancer patients,” she said at the annual meeting of the American College of Gastroenterology.

The incidence of CRC diagnosed in persons younger than 50 years is increasing and has been projected to double by 2030, Dr. Syed noted.

In 2009, the Eastern Cooperative Oncology Group recommended that all patients with colorectal cancer be screened for the Lynch syndrome, and earlier this year the National Comprehensive Cancer Network issued a recommendation that patients with YOCRC undergo germline multigene panel testing (MGPT). MGPT has shown that as many as 30% of patients with YOCRC carry a germline pathogenic variant that predisposes them to CRC, regardless of family history, she said.

“We hypothesized that the rate of referral to genetic counseling in this population is low despite the high incidence of pathogenic germline variants, but the uptake of genetic counseling is high [when referred],” Dr. Syed said.
 

How often, and who needs it?

The investigators sought to determine the frequency of referral to genetic counseling and patient uptake of referrals to assess factors associated with referrals and with uptake, and to evaluate the results of genetic testing.

They reviewed records on all patients younger than 50 years seen at the Cleveland Clinic for CRC from 2010 through 2019, excluding those with appendiceal cancers, a family history of a hereditary cancer syndrome, or irritable bowel syndrome.

The information they extracted from electronic medical records included patient age, sex, family history of CRC, income, tumor stage, and the location and time period of CRC diagnosis.

They considered a genetic counseling referral to be either an order for counseling in the record; clinical documentation of a referral in an office visit with colorectal surgery, oncology, or gastroenterology specialists; or documentation of a completed visit with a genetic counselor.

They considered patient uptake of a counseling referral as either a completed visit to the counselor or documentation of genetic testing results.

The mean patient age at diagnosis was 44 years, with 57.3% of patients male, and 42.7% female. The large majority of patients (86.5%) were White. In all, 40.2% of patients had a family history of CRC.

As noted above, 62.1% of the 791 patients included in the study were referred for counseling, and 80.1% of those referred followed through with uptake. Of this group, nearly all (97.1%) completed genetic testing.

In univariate analysis, factors associated with referral included older patient age at diagnosis, which showed that patients approaching 50 were less likely to receive a referral (odds ratio, 0.904), year of diagnosis with patients diagnosed in the most recent period more likely to receive a referral (OR, 1.247), and family history of CRC (OR, 2.195).

In multivariate analysis, factors significantly associated with referral were age at diagnosis (OR, 0.89), family history of CRC (OR, 2.112), and year of diagnosis (for 2017-19 vs. 2010-13, OR, 5.361).

Among 377 patients who completed genetic testing, 21% were found to have a pathogenic variant, 23% had variants of unknown significance, and 56% had no variants detected. The most commonly detected pathogenic variants were the Lynch syndrome and adenomatous polyposis.
 

Educate patients and physicians

In an interview, Daniel J. Pambianco, MD, from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that patient perceptions about the consequences of genetic testing may be a barrier to either getting a referral for counseling or following through on one.

“Oftentimes patients will perceive anything with ‘genetic’ in it as if their genes are somehow being manipulated, and we need to do a better job at educating patients in that regard,” he said.

Physicians, both primary care practitioners and gastroenterologists, also need to fully appreciate the importance of genetic testing in this population, “because in essence there may be a 4%, 5%, or 6% risk of genetic syndromes that we’re missing and cannot pick up just from getting patients’ histories,” he said.

The investigators did not report a study funding source. Dr. Syed and Dr. Pambianco reported having no relevant financial disclosures.

CHARLOTTE, N.C. – Nearly one-fourth of patients with early-onset colorectal cancer don’t get referrals for genetic counseling or testing, and although acceptance of genetic counseling has improved over the last 10 years, there is still a notable gap between referrals and uptake, investigators have found.

Among 791 patients with young- or early-onset colorectal cancer (YOCRC) seen at a large medical center from 2010 through 2019, 62.1% were referred for genetic counseling, but only 80.1% of this group followed through with the referrals by scheduling an appointment with a counselor or having genetic testing performed, reported Hareem Syed, MD, from the department of internal medicine at the Cleveland Clinic.

“Our findings highlight the need for health systems to implement care pathways to optimize genetic counseling referral and testing in all young-onset colorectal cancer patients,” she said at the annual meeting of the American College of Gastroenterology.

The incidence of CRC diagnosed in persons younger than 50 years is increasing and has been projected to double by 2030, Dr. Syed noted.

In 2009, the Eastern Cooperative Oncology Group recommended that all patients with colorectal cancer be screened for the Lynch syndrome, and earlier this year the National Comprehensive Cancer Network issued a recommendation that patients with YOCRC undergo germline multigene panel testing (MGPT). MGPT has shown that as many as 30% of patients with YOCRC carry a germline pathogenic variant that predisposes them to CRC, regardless of family history, she said.

“We hypothesized that the rate of referral to genetic counseling in this population is low despite the high incidence of pathogenic germline variants, but the uptake of genetic counseling is high [when referred],” Dr. Syed said.
 

How often, and who needs it?

The investigators sought to determine the frequency of referral to genetic counseling and patient uptake of referrals to assess factors associated with referrals and with uptake, and to evaluate the results of genetic testing.

They reviewed records on all patients younger than 50 years seen at the Cleveland Clinic for CRC from 2010 through 2019, excluding those with appendiceal cancers, a family history of a hereditary cancer syndrome, or irritable bowel syndrome.

The information they extracted from electronic medical records included patient age, sex, family history of CRC, income, tumor stage, and the location and time period of CRC diagnosis.

They considered a genetic counseling referral to be either an order for counseling in the record; clinical documentation of a referral in an office visit with colorectal surgery, oncology, or gastroenterology specialists; or documentation of a completed visit with a genetic counselor.

They considered patient uptake of a counseling referral as either a completed visit to the counselor or documentation of genetic testing results.

The mean patient age at diagnosis was 44 years, with 57.3% of patients male, and 42.7% female. The large majority of patients (86.5%) were White. In all, 40.2% of patients had a family history of CRC.

As noted above, 62.1% of the 791 patients included in the study were referred for counseling, and 80.1% of those referred followed through with uptake. Of this group, nearly all (97.1%) completed genetic testing.

In univariate analysis, factors associated with referral included older patient age at diagnosis, which showed that patients approaching 50 were less likely to receive a referral (odds ratio, 0.904), year of diagnosis with patients diagnosed in the most recent period more likely to receive a referral (OR, 1.247), and family history of CRC (OR, 2.195).

In multivariate analysis, factors significantly associated with referral were age at diagnosis (OR, 0.89), family history of CRC (OR, 2.112), and year of diagnosis (for 2017-19 vs. 2010-13, OR, 5.361).

Among 377 patients who completed genetic testing, 21% were found to have a pathogenic variant, 23% had variants of unknown significance, and 56% had no variants detected. The most commonly detected pathogenic variants were the Lynch syndrome and adenomatous polyposis.
 

Educate patients and physicians

In an interview, Daniel J. Pambianco, MD, from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that patient perceptions about the consequences of genetic testing may be a barrier to either getting a referral for counseling or following through on one.

“Oftentimes patients will perceive anything with ‘genetic’ in it as if their genes are somehow being manipulated, and we need to do a better job at educating patients in that regard,” he said.

Physicians, both primary care practitioners and gastroenterologists, also need to fully appreciate the importance of genetic testing in this population, “because in essence there may be a 4%, 5%, or 6% risk of genetic syndromes that we’re missing and cannot pick up just from getting patients’ histories,” he said.

The investigators did not report a study funding source. Dr. Syed and Dr. Pambianco reported having no relevant financial disclosures.

CHARLOTTE, N.C. – Nearly one-fourth of patients with early-onset colorectal cancer don’t get referrals for genetic counseling or testing, and although acceptance of genetic counseling has improved over the last 10 years, there is still a notable gap between referrals and uptake, investigators have found.

Among 791 patients with young- or early-onset colorectal cancer (YOCRC) seen at a large medical center from 2010 through 2019, 62.1% were referred for genetic counseling, but only 80.1% of this group followed through with the referrals by scheduling an appointment with a counselor or having genetic testing performed, reported Hareem Syed, MD, from the department of internal medicine at the Cleveland Clinic.

“Our findings highlight the need for health systems to implement care pathways to optimize genetic counseling referral and testing in all young-onset colorectal cancer patients,” she said at the annual meeting of the American College of Gastroenterology.

The incidence of CRC diagnosed in persons younger than 50 years is increasing and has been projected to double by 2030, Dr. Syed noted.

In 2009, the Eastern Cooperative Oncology Group recommended that all patients with colorectal cancer be screened for the Lynch syndrome, and earlier this year the National Comprehensive Cancer Network issued a recommendation that patients with YOCRC undergo germline multigene panel testing (MGPT). MGPT has shown that as many as 30% of patients with YOCRC carry a germline pathogenic variant that predisposes them to CRC, regardless of family history, she said.

“We hypothesized that the rate of referral to genetic counseling in this population is low despite the high incidence of pathogenic germline variants, but the uptake of genetic counseling is high [when referred],” Dr. Syed said.
 

How often, and who needs it?

The investigators sought to determine the frequency of referral to genetic counseling and patient uptake of referrals to assess factors associated with referrals and with uptake, and to evaluate the results of genetic testing.

They reviewed records on all patients younger than 50 years seen at the Cleveland Clinic for CRC from 2010 through 2019, excluding those with appendiceal cancers, a family history of a hereditary cancer syndrome, or irritable bowel syndrome.

The information they extracted from electronic medical records included patient age, sex, family history of CRC, income, tumor stage, and the location and time period of CRC diagnosis.

They considered a genetic counseling referral to be either an order for counseling in the record; clinical documentation of a referral in an office visit with colorectal surgery, oncology, or gastroenterology specialists; or documentation of a completed visit with a genetic counselor.

They considered patient uptake of a counseling referral as either a completed visit to the counselor or documentation of genetic testing results.

The mean patient age at diagnosis was 44 years, with 57.3% of patients male, and 42.7% female. The large majority of patients (86.5%) were White. In all, 40.2% of patients had a family history of CRC.

As noted above, 62.1% of the 791 patients included in the study were referred for counseling, and 80.1% of those referred followed through with uptake. Of this group, nearly all (97.1%) completed genetic testing.

In univariate analysis, factors associated with referral included older patient age at diagnosis, which showed that patients approaching 50 were less likely to receive a referral (odds ratio, 0.904), year of diagnosis with patients diagnosed in the most recent period more likely to receive a referral (OR, 1.247), and family history of CRC (OR, 2.195).

In multivariate analysis, factors significantly associated with referral were age at diagnosis (OR, 0.89), family history of CRC (OR, 2.112), and year of diagnosis (for 2017-19 vs. 2010-13, OR, 5.361).

Among 377 patients who completed genetic testing, 21% were found to have a pathogenic variant, 23% had variants of unknown significance, and 56% had no variants detected. The most commonly detected pathogenic variants were the Lynch syndrome and adenomatous polyposis.
 

Educate patients and physicians

In an interview, Daniel J. Pambianco, MD, from Charlottesville (Va.) Gastroenterology Associates, who was not involved in the study, commented that patient perceptions about the consequences of genetic testing may be a barrier to either getting a referral for counseling or following through on one.

“Oftentimes patients will perceive anything with ‘genetic’ in it as if their genes are somehow being manipulated, and we need to do a better job at educating patients in that regard,” he said.

Physicians, both primary care practitioners and gastroenterologists, also need to fully appreciate the importance of genetic testing in this population, “because in essence there may be a 4%, 5%, or 6% risk of genetic syndromes that we’re missing and cannot pick up just from getting patients’ histories,” he said.

The investigators did not report a study funding source. Dr. Syed and Dr. Pambianco reported having no relevant financial disclosures.

CHARLOTTE, N.C. – In a small proof-of-concept study, patients with small unresectable pancreatic cancers treated with endoscopic ultrasound–guided radiofrequency ablation (EUS-RFA) had a more than twofold improvement in overall survival compared with historical controls with a similar disease history, investigators in Thailand found.

In a weighted analysis, median weighted overall survival – the primary outcome – was 14 months among 11 patients who underwent EUS-RFA, compared with 6.1 months for 35 matched controls, translating into a hazard ratio for death with EUS-RFA of 0.38 (P = .016), reported Chawin Lopimpisuth, MD, from King Chulalongkorn Memorial Hospital in Bangkok, Thailand.

Median weighted progression-free survival (PFS) was longer among cases than controls, but did not differ significantly, at 6.1 months and 3.9 months, respectively.

“In patients with unresectable pancreatic ductal adenocarcinomas that are less than 4 cm, EUS-RFA alone or combined with chemotherapy resulted in significantly improved overall survival and tended to improve progression-free survival with minimal adverse events,” Dr. Lopimpisuth reported at the annual meeting of the American College of Gastroenterology.
 

Small but unresectable tumors

Endoscopically guided radiofrequency ablation of pancreatic ductal tumors has been shown to be both feasible and safe in previous studies, he said, prompting his group to explore whether EUS-RFA could help to control the primary tumor and improve survival outcomes.

They enrolled 11 patients with primary pancreatic ductal adenocarcinoma tumors less than 4 cm in diameter that were unresectable due to blood vessel involvement or distant metastasis, and used propensity-score matching to pair them with a total of 35 controls. Controls were matched by tumor size, staging, age-adjusted Charlson Comorbidity Index, chemotherapy regimen received, and interactions between CCI, regimen, and staging.

The results were weighted to assure that covariate distribution among patients treated with chemotherapy only equaled that of patients who underwent EUS-RFA.

Patients underwent EUS-RFA with a 19-gauge needle, with 50 watts of energy delivered with an impedance of 100 ohms. Those patients deemed able to tolerate chemotherapy received that as well.

After a minimum of 1 year of follow-up, the median weighted survival, as noted before, was 14 months for patients who received EUS-RFA, compared with 6.1 months for controls.

Adjusted survival probabilities at 6 and 12 months were 73% and 64%, respectively, for patients in the EUS-RFA group, compared with 69% and 17% for controls. Adjusted PFS rates at 6 and 12 months were 55% and 36% in the EUS-RFA group, compared with 28% and 4% in the control group.

The only adverse event of significance was mild abdominal pain, reported by 8.3% of total EUS-RFA procedures.
 

Promising but preliminary

In an interview with this news organization, ACG President Samir A. Shah, MD, from Brown University and Miriam Hospital in Providence, R.I., who was not involved in the study, commented that “we have limited options with these patients, so it’s really exciting to see an initial trend toward efficacy, and their survival improvement was significant by several months.”

Dr. Shah was a moderator of the presidential symposium where the data were presented.

Comoderator Brooks D. Cash, MD, from the University of Texas Health Science Center at Houston, said that the advantage of EUS-RFA is that it’s only minimally invasive and appears to offer a significant survival advantage for patients with few effective treatment options.

He cautioned, however, that “it’s a small study and needs to be replicated in a larger venue and different sites as well, but I think it looks very promising.”

The investigators did not report a funding source for the study. Dr. Lopimpisuth, Dr. Shah, and Dr. Cash all reported having no relevant financial relationships to disclose.

CHARLOTTE, N.C. – In a small proof-of-concept study, patients with small unresectable pancreatic cancers treated with endoscopic ultrasound–guided radiofrequency ablation (EUS-RFA) had a more than twofold improvement in overall survival compared with historical controls with a similar disease history, investigators in Thailand found.

In a weighted analysis, median weighted overall survival – the primary outcome – was 14 months among 11 patients who underwent EUS-RFA, compared with 6.1 months for 35 matched controls, translating into a hazard ratio for death with EUS-RFA of 0.38 (P = .016), reported Chawin Lopimpisuth, MD, from King Chulalongkorn Memorial Hospital in Bangkok, Thailand.

Median weighted progression-free survival (PFS) was longer among cases than controls, but did not differ significantly, at 6.1 months and 3.9 months, respectively.

“In patients with unresectable pancreatic ductal adenocarcinomas that are less than 4 cm, EUS-RFA alone or combined with chemotherapy resulted in significantly improved overall survival and tended to improve progression-free survival with minimal adverse events,” Dr. Lopimpisuth reported at the annual meeting of the American College of Gastroenterology.
 

Small but unresectable tumors

Endoscopically guided radiofrequency ablation of pancreatic ductal tumors has been shown to be both feasible and safe in previous studies, he said, prompting his group to explore whether EUS-RFA could help to control the primary tumor and improve survival outcomes.

They enrolled 11 patients with primary pancreatic ductal adenocarcinoma tumors less than 4 cm in diameter that were unresectable due to blood vessel involvement or distant metastasis, and used propensity-score matching to pair them with a total of 35 controls. Controls were matched by tumor size, staging, age-adjusted Charlson Comorbidity Index, chemotherapy regimen received, and interactions between CCI, regimen, and staging.

The results were weighted to assure that covariate distribution among patients treated with chemotherapy only equaled that of patients who underwent EUS-RFA.

Patients underwent EUS-RFA with a 19-gauge needle, with 50 watts of energy delivered with an impedance of 100 ohms. Those patients deemed able to tolerate chemotherapy received that as well.

After a minimum of 1 year of follow-up, the median weighted survival, as noted before, was 14 months for patients who received EUS-RFA, compared with 6.1 months for controls.

Adjusted survival probabilities at 6 and 12 months were 73% and 64%, respectively, for patients in the EUS-RFA group, compared with 69% and 17% for controls. Adjusted PFS rates at 6 and 12 months were 55% and 36% in the EUS-RFA group, compared with 28% and 4% in the control group.

The only adverse event of significance was mild abdominal pain, reported by 8.3% of total EUS-RFA procedures.
 

Promising but preliminary

In an interview with this news organization, ACG President Samir A. Shah, MD, from Brown University and Miriam Hospital in Providence, R.I., who was not involved in the study, commented that “we have limited options with these patients, so it’s really exciting to see an initial trend toward efficacy, and their survival improvement was significant by several months.”

Dr. Shah was a moderator of the presidential symposium where the data were presented.

Comoderator Brooks D. Cash, MD, from the University of Texas Health Science Center at Houston, said that the advantage of EUS-RFA is that it’s only minimally invasive and appears to offer a significant survival advantage for patients with few effective treatment options.

He cautioned, however, that “it’s a small study and needs to be replicated in a larger venue and different sites as well, but I think it looks very promising.”

The investigators did not report a funding source for the study. Dr. Lopimpisuth, Dr. Shah, and Dr. Cash all reported having no relevant financial relationships to disclose.

CHARLOTTE, N.C. – In a small proof-of-concept study, patients with small unresectable pancreatic cancers treated with endoscopic ultrasound–guided radiofrequency ablation (EUS-RFA) had a more than twofold improvement in overall survival compared with historical controls with a similar disease history, investigators in Thailand found.

In a weighted analysis, median weighted overall survival – the primary outcome – was 14 months among 11 patients who underwent EUS-RFA, compared with 6.1 months for 35 matched controls, translating into a hazard ratio for death with EUS-RFA of 0.38 (P = .016), reported Chawin Lopimpisuth, MD, from King Chulalongkorn Memorial Hospital in Bangkok, Thailand.

Median weighted progression-free survival (PFS) was longer among cases than controls, but did not differ significantly, at 6.1 months and 3.9 months, respectively.

“In patients with unresectable pancreatic ductal adenocarcinomas that are less than 4 cm, EUS-RFA alone or combined with chemotherapy resulted in significantly improved overall survival and tended to improve progression-free survival with minimal adverse events,” Dr. Lopimpisuth reported at the annual meeting of the American College of Gastroenterology.
 

Small but unresectable tumors

Endoscopically guided radiofrequency ablation of pancreatic ductal tumors has been shown to be both feasible and safe in previous studies, he said, prompting his group to explore whether EUS-RFA could help to control the primary tumor and improve survival outcomes.

They enrolled 11 patients with primary pancreatic ductal adenocarcinoma tumors less than 4 cm in diameter that were unresectable due to blood vessel involvement or distant metastasis, and used propensity-score matching to pair them with a total of 35 controls. Controls were matched by tumor size, staging, age-adjusted Charlson Comorbidity Index, chemotherapy regimen received, and interactions between CCI, regimen, and staging.

The results were weighted to assure that covariate distribution among patients treated with chemotherapy only equaled that of patients who underwent EUS-RFA.

Patients underwent EUS-RFA with a 19-gauge needle, with 50 watts of energy delivered with an impedance of 100 ohms. Those patients deemed able to tolerate chemotherapy received that as well.

After a minimum of 1 year of follow-up, the median weighted survival, as noted before, was 14 months for patients who received EUS-RFA, compared with 6.1 months for controls.

Adjusted survival probabilities at 6 and 12 months were 73% and 64%, respectively, for patients in the EUS-RFA group, compared with 69% and 17% for controls. Adjusted PFS rates at 6 and 12 months were 55% and 36% in the EUS-RFA group, compared with 28% and 4% in the control group.

The only adverse event of significance was mild abdominal pain, reported by 8.3% of total EUS-RFA procedures.
 

Promising but preliminary

In an interview with this news organization, ACG President Samir A. Shah, MD, from Brown University and Miriam Hospital in Providence, R.I., who was not involved in the study, commented that “we have limited options with these patients, so it’s really exciting to see an initial trend toward efficacy, and their survival improvement was significant by several months.”

Dr. Shah was a moderator of the presidential symposium where the data were presented.

Comoderator Brooks D. Cash, MD, from the University of Texas Health Science Center at Houston, said that the advantage of EUS-RFA is that it’s only minimally invasive and appears to offer a significant survival advantage for patients with few effective treatment options.

He cautioned, however, that “it’s a small study and needs to be replicated in a larger venue and different sites as well, but I think it looks very promising.”

The investigators did not report a funding source for the study. Dr. Lopimpisuth, Dr. Shah, and Dr. Cash all reported having no relevant financial relationships to disclose.

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

CINCINNATI – Neurology and psychiatry have an inherent kinship, as one often deals with the brain and the other always focuses on the mind. The two fields can be intertwined, since neurological conditions are often associated with psychiatric comorbidities amid complex relationships: For example, a young patient with a neurological disorder may experience anxiety due to life changes, his or her diagnosis, or altered biological pathways from the condition or medications used to treat it.

As a result, psychiatric comorbidities are often seen among pediatric patients with neurological conditions, and pediatric neurologists can play an important role in diagnosis and management of such disorders, according to Devin McNulty, PhD, who spoke on the topic at the 2022 annual meeting of the Child Neurology Society.
 

The ‘second pandemic’

Mental health conditions represent about 16% of the global burden of disease among people aged 10-19, and the COVID-19 pandemic has drastically worsened the problem, as shutdowns, school loss, and economic struggles have added to the burden. “I think we’ve really seen mental health as sort of the second pandemic. We’ve seen this in Chicago in our emergency room, and in outpatient clinics wait-lists are really high. I think adolescents are specifically at risk,” said Dr. McNulty during her talk. She is an assistant professor of psychiatry and behavioral sciences at Northwestern University and a child psychiatrist at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Common diagnoses include major depressive order, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, somatic symptom disorder, and functional neurological symptom disorder. The last can appear as neurological symptoms that are not consistent with neurological medical conditions, such as attacks or seizures, abnormal movements, sensory loss or gain, weakness or paralysis, or speech and swallowing issues. It is the second most commonly diagnosed disorder in neurology clinics and accounts for 10% of neurology hospitalizations, and it leads to high rates of health care utilization and functional impairment.

Overall, children with neurological conditions are at about a 5-fold increased risk for depression and anxiety disorders, with a range of contributing risk factors. These include biological factors like medication use, neurological dysfunction, and genetic vulnerability. Psychological factors include stressors, the child’s reaction to the diagnosis and illness, and the level of his or her coping skills. Psychiatric comorbidities may also be triggered by social factors such as familial stress, peer rejection and social isolation, and barriers to treatment for the neurological condition. As just one example, overprotective parenting behavior, while adaptive in moderation, can create a sort of feedback loop that can lead to separation anxiety.
 

A unique opportunity

“There’s an overlap,” Dr. McNulty said, “because the origin is often multifactorial.” A young patient has a medical condition, which can be chronic or disabling, and the age of onset and diagnosis comes during a critical developmental period. “Then we have issues such as the impact of treatments, whether that’s medication side effects or medical visits. And then disease-related environmental changes, such as family factors, social changes, and impact on school,” said Dr. McNulty.

Child neurologists are in a unique position to identify and ensure treatment of these psychiatric comorbidities, according to Dr. McNulty. “Child neurologists will see psychiatric symptoms in their patient population, and pediatric providers have a unique capacity and ability to treat these patients, especially when you’re seeing patients on a frequent basis. You get to know these patients and their families really well,” she said.

She specifically pointed to three areas: psychosocial screening, differential diagnosis, and treatment and management.

There are broad-based screening measures that can be useful, such as the Strengths and Difficulties Questionnaire and the Pediatric Symptom Checklist. Disorder-specific screening tools include the PHQ-9 (depression), GAD7 (anxiety), Vanderbilt (ADHD), and PROMIS measures for anxiety and depression. “The idea behind the screening measure is that all patients would fill this out and then if a patient screens positive, they would benefit from a more thorough evaluation and history,” said Dr. McNulty.

However, she noted that screening shouldn’t necessarily be a one-off effort. Research has shown that sequential screening is the most powerful strategy. “Then you can get a baseline of a patient’s emotional and behavioral functioning, and it’s actually the changes in some of these screening measures that might give them most clinical information,” said Dr. McNulty.

In fact, on October 11, 2022, the U.S. Preventive Services Task Force announced a recommendation that all children starting at age 8 should be screened for anxiety disorders. It is already recommended to screen children aged 12 and over for depressive disorders, although these documents are aimed primarily at pediatricians or primary care clinics. The American Academy of Neurology has also recommended routine screening of psychiatric and behavioral disorders among children with epilepsy.
 

A unique perspective

Once a disorder is identified, neurologists can bring a unique perspective to treatment. The neurologist can use his or her knowledge of the disease state to assess whether symptoms are due to poor adjustment to the neurological condition, a primary psychiatric disorder, or the biological underpinnings of the illness or prescribed medications. “I think their neurologist can sort of help tease that apart, [using] their knowledge of neurologic disorders and pathways and medications in a way that psychologists might not be able to do on their own,” said Dr. McNulty.

She also emphasized that there are effective treatments for psychiatric disorders, including cognitive behavioral therapy and various pharmacotherapy options. Other approaches for treating comorbid neurological and psychiatric disorders may include building adaptive coping skills, psychoeducation, and incorporating changes to the family or school environment.

During the Q&A period, one person commented that there should be more psychiatric training for neurology residents. “We do work with the same brain, so I completely agree with that,” said Dr. McNulty.

She was also asked how to identify psychiatric symptoms in nonverbal patients. “One thing that I pay close attention to when I ask parents about (their child) is changes in their physical (attributes). Oftentimes in anxiety in folks who are not severely impaired, if we’re feeling anxious we might be breathing a little faster, or we might get a little sweaty. So looking for physical manifestations is one thing. And then sometimes I’ll tell the parents, if we’re not quite sure, I’ll say ‘I’m not sure, but this is very common given the disorder that you have. Can we check?’ I’m always very clear that I may not be nailing it, but then when we go after it with targeted treatment and we see it getting better, we can say ‘Aha!’ ”

Dr. McNulty has no relevant financial disclosures.
 

CINCINNATI – Neurology and psychiatry have an inherent kinship, as one often deals with the brain and the other always focuses on the mind. The two fields can be intertwined, since neurological conditions are often associated with psychiatric comorbidities amid complex relationships: For example, a young patient with a neurological disorder may experience anxiety due to life changes, his or her diagnosis, or altered biological pathways from the condition or medications used to treat it.

As a result, psychiatric comorbidities are often seen among pediatric patients with neurological conditions, and pediatric neurologists can play an important role in diagnosis and management of such disorders, according to Devin McNulty, PhD, who spoke on the topic at the 2022 annual meeting of the Child Neurology Society.
 

The ‘second pandemic’

Mental health conditions represent about 16% of the global burden of disease among people aged 10-19, and the COVID-19 pandemic has drastically worsened the problem, as shutdowns, school loss, and economic struggles have added to the burden. “I think we’ve really seen mental health as sort of the second pandemic. We’ve seen this in Chicago in our emergency room, and in outpatient clinics wait-lists are really high. I think adolescents are specifically at risk,” said Dr. McNulty during her talk. She is an assistant professor of psychiatry and behavioral sciences at Northwestern University and a child psychiatrist at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Common diagnoses include major depressive order, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, somatic symptom disorder, and functional neurological symptom disorder. The last can appear as neurological symptoms that are not consistent with neurological medical conditions, such as attacks or seizures, abnormal movements, sensory loss or gain, weakness or paralysis, or speech and swallowing issues. It is the second most commonly diagnosed disorder in neurology clinics and accounts for 10% of neurology hospitalizations, and it leads to high rates of health care utilization and functional impairment.

Overall, children with neurological conditions are at about a 5-fold increased risk for depression and anxiety disorders, with a range of contributing risk factors. These include biological factors like medication use, neurological dysfunction, and genetic vulnerability. Psychological factors include stressors, the child’s reaction to the diagnosis and illness, and the level of his or her coping skills. Psychiatric comorbidities may also be triggered by social factors such as familial stress, peer rejection and social isolation, and barriers to treatment for the neurological condition. As just one example, overprotective parenting behavior, while adaptive in moderation, can create a sort of feedback loop that can lead to separation anxiety.
 

A unique opportunity

“There’s an overlap,” Dr. McNulty said, “because the origin is often multifactorial.” A young patient has a medical condition, which can be chronic or disabling, and the age of onset and diagnosis comes during a critical developmental period. “Then we have issues such as the impact of treatments, whether that’s medication side effects or medical visits. And then disease-related environmental changes, such as family factors, social changes, and impact on school,” said Dr. McNulty.

Child neurologists are in a unique position to identify and ensure treatment of these psychiatric comorbidities, according to Dr. McNulty. “Child neurologists will see psychiatric symptoms in their patient population, and pediatric providers have a unique capacity and ability to treat these patients, especially when you’re seeing patients on a frequent basis. You get to know these patients and their families really well,” she said.

She specifically pointed to three areas: psychosocial screening, differential diagnosis, and treatment and management.

There are broad-based screening measures that can be useful, such as the Strengths and Difficulties Questionnaire and the Pediatric Symptom Checklist. Disorder-specific screening tools include the PHQ-9 (depression), GAD7 (anxiety), Vanderbilt (ADHD), and PROMIS measures for anxiety and depression. “The idea behind the screening measure is that all patients would fill this out and then if a patient screens positive, they would benefit from a more thorough evaluation and history,” said Dr. McNulty.

However, she noted that screening shouldn’t necessarily be a one-off effort. Research has shown that sequential screening is the most powerful strategy. “Then you can get a baseline of a patient’s emotional and behavioral functioning, and it’s actually the changes in some of these screening measures that might give them most clinical information,” said Dr. McNulty.

In fact, on October 11, 2022, the U.S. Preventive Services Task Force announced a recommendation that all children starting at age 8 should be screened for anxiety disorders. It is already recommended to screen children aged 12 and over for depressive disorders, although these documents are aimed primarily at pediatricians or primary care clinics. The American Academy of Neurology has also recommended routine screening of psychiatric and behavioral disorders among children with epilepsy.
 

A unique perspective

Once a disorder is identified, neurologists can bring a unique perspective to treatment. The neurologist can use his or her knowledge of the disease state to assess whether symptoms are due to poor adjustment to the neurological condition, a primary psychiatric disorder, or the biological underpinnings of the illness or prescribed medications. “I think their neurologist can sort of help tease that apart, [using] their knowledge of neurologic disorders and pathways and medications in a way that psychologists might not be able to do on their own,” said Dr. McNulty.

She also emphasized that there are effective treatments for psychiatric disorders, including cognitive behavioral therapy and various pharmacotherapy options. Other approaches for treating comorbid neurological and psychiatric disorders may include building adaptive coping skills, psychoeducation, and incorporating changes to the family or school environment.

During the Q&A period, one person commented that there should be more psychiatric training for neurology residents. “We do work with the same brain, so I completely agree with that,” said Dr. McNulty.

She was also asked how to identify psychiatric symptoms in nonverbal patients. “One thing that I pay close attention to when I ask parents about (their child) is changes in their physical (attributes). Oftentimes in anxiety in folks who are not severely impaired, if we’re feeling anxious we might be breathing a little faster, or we might get a little sweaty. So looking for physical manifestations is one thing. And then sometimes I’ll tell the parents, if we’re not quite sure, I’ll say ‘I’m not sure, but this is very common given the disorder that you have. Can we check?’ I’m always very clear that I may not be nailing it, but then when we go after it with targeted treatment and we see it getting better, we can say ‘Aha!’ ”

Dr. McNulty has no relevant financial disclosures.
 

CINCINNATI – Neurology and psychiatry have an inherent kinship, as one often deals with the brain and the other always focuses on the mind. The two fields can be intertwined, since neurological conditions are often associated with psychiatric comorbidities amid complex relationships: For example, a young patient with a neurological disorder may experience anxiety due to life changes, his or her diagnosis, or altered biological pathways from the condition or medications used to treat it.

As a result, psychiatric comorbidities are often seen among pediatric patients with neurological conditions, and pediatric neurologists can play an important role in diagnosis and management of such disorders, according to Devin McNulty, PhD, who spoke on the topic at the 2022 annual meeting of the Child Neurology Society.
 

The ‘second pandemic’

Mental health conditions represent about 16% of the global burden of disease among people aged 10-19, and the COVID-19 pandemic has drastically worsened the problem, as shutdowns, school loss, and economic struggles have added to the burden. “I think we’ve really seen mental health as sort of the second pandemic. We’ve seen this in Chicago in our emergency room, and in outpatient clinics wait-lists are really high. I think adolescents are specifically at risk,” said Dr. McNulty during her talk. She is an assistant professor of psychiatry and behavioral sciences at Northwestern University and a child psychiatrist at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Common diagnoses include major depressive order, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, somatic symptom disorder, and functional neurological symptom disorder. The last can appear as neurological symptoms that are not consistent with neurological medical conditions, such as attacks or seizures, abnormal movements, sensory loss or gain, weakness or paralysis, or speech and swallowing issues. It is the second most commonly diagnosed disorder in neurology clinics and accounts for 10% of neurology hospitalizations, and it leads to high rates of health care utilization and functional impairment.

Overall, children with neurological conditions are at about a 5-fold increased risk for depression and anxiety disorders, with a range of contributing risk factors. These include biological factors like medication use, neurological dysfunction, and genetic vulnerability. Psychological factors include stressors, the child’s reaction to the diagnosis and illness, and the level of his or her coping skills. Psychiatric comorbidities may also be triggered by social factors such as familial stress, peer rejection and social isolation, and barriers to treatment for the neurological condition. As just one example, overprotective parenting behavior, while adaptive in moderation, can create a sort of feedback loop that can lead to separation anxiety.
 

A unique opportunity

“There’s an overlap,” Dr. McNulty said, “because the origin is often multifactorial.” A young patient has a medical condition, which can be chronic or disabling, and the age of onset and diagnosis comes during a critical developmental period. “Then we have issues such as the impact of treatments, whether that’s medication side effects or medical visits. And then disease-related environmental changes, such as family factors, social changes, and impact on school,” said Dr. McNulty.

Child neurologists are in a unique position to identify and ensure treatment of these psychiatric comorbidities, according to Dr. McNulty. “Child neurologists will see psychiatric symptoms in their patient population, and pediatric providers have a unique capacity and ability to treat these patients, especially when you’re seeing patients on a frequent basis. You get to know these patients and their families really well,” she said.

She specifically pointed to three areas: psychosocial screening, differential diagnosis, and treatment and management.

There are broad-based screening measures that can be useful, such as the Strengths and Difficulties Questionnaire and the Pediatric Symptom Checklist. Disorder-specific screening tools include the PHQ-9 (depression), GAD7 (anxiety), Vanderbilt (ADHD), and PROMIS measures for anxiety and depression. “The idea behind the screening measure is that all patients would fill this out and then if a patient screens positive, they would benefit from a more thorough evaluation and history,” said Dr. McNulty.

However, she noted that screening shouldn’t necessarily be a one-off effort. Research has shown that sequential screening is the most powerful strategy. “Then you can get a baseline of a patient’s emotional and behavioral functioning, and it’s actually the changes in some of these screening measures that might give them most clinical information,” said Dr. McNulty.

In fact, on October 11, 2022, the U.S. Preventive Services Task Force announced a recommendation that all children starting at age 8 should be screened for anxiety disorders. It is already recommended to screen children aged 12 and over for depressive disorders, although these documents are aimed primarily at pediatricians or primary care clinics. The American Academy of Neurology has also recommended routine screening of psychiatric and behavioral disorders among children with epilepsy.
 

A unique perspective

Once a disorder is identified, neurologists can bring a unique perspective to treatment. The neurologist can use his or her knowledge of the disease state to assess whether symptoms are due to poor adjustment to the neurological condition, a primary psychiatric disorder, or the biological underpinnings of the illness or prescribed medications. “I think their neurologist can sort of help tease that apart, [using] their knowledge of neurologic disorders and pathways and medications in a way that psychologists might not be able to do on their own,” said Dr. McNulty.

She also emphasized that there are effective treatments for psychiatric disorders, including cognitive behavioral therapy and various pharmacotherapy options. Other approaches for treating comorbid neurological and psychiatric disorders may include building adaptive coping skills, psychoeducation, and incorporating changes to the family or school environment.

During the Q&A period, one person commented that there should be more psychiatric training for neurology residents. “We do work with the same brain, so I completely agree with that,” said Dr. McNulty.

She was also asked how to identify psychiatric symptoms in nonverbal patients. “One thing that I pay close attention to when I ask parents about (their child) is changes in their physical (attributes). Oftentimes in anxiety in folks who are not severely impaired, if we’re feeling anxious we might be breathing a little faster, or we might get a little sweaty. So looking for physical manifestations is one thing. And then sometimes I’ll tell the parents, if we’re not quite sure, I’ll say ‘I’m not sure, but this is very common given the disorder that you have. Can we check?’ I’m always very clear that I may not be nailing it, but then when we go after it with targeted treatment and we see it getting better, we can say ‘Aha!’ ”

Dr. McNulty has no relevant financial disclosures.
 

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

A small new study suggests – but doesn’t prove – that exposure to Wi-Fi signals from cell phones in pants pockets could disrupt male fertility. Researchers found that sperm placed next to an in-use iPhone on the Wi-Fi setting over 6 hours had less motility (50% vs. 38%, P = .024) and viability (60% vs. 47%, P = .003) than those set to 4G and 5G.

The findings, presented at the American Society for Reproductive Medicine’s 2022 meeting, don’t confirm that cell phones are harmful, lead author Kevin Y. Chu, MD, a Los Angeles urologist, said in an interview. “We cannot draw conclusions from this study, as the study population was too small. What we did observe was that Wi-Fi, which was previously less studied, may have had an impact on sperm. We did not see an effect on sperm quality by the 4G or 5G wireless spectrum.”

According to Dr. Chu, dozens of studies have examined the possible effect of cell phone exposure on sperm quality. “In human survey studies, there was no association of use and decline of sperm quality,” he said. “In human sperm in vitro studies, there was a decline of sperm motility and viability. And in animal studies, there was decline of sperm motility and viability.”

The new study is a pilot “to see if it is feasible to do a large-scale project” to analyze any possible effects from radiofrequency-electromagnetic radiation (RF-EMR) transmitted by cell phones, he said.

According to the study, cell phones emit radiation when they “transmit data for social media, web browsing, and music/podcast streaming,” and the rise of Bluetooth earbuds “presumably prolonged the amount of time the cell phone resides in the trouser pockets of men. This places the cell phone and its respective RF-EMR near the testicles for prolonged [periods].”

Researchers obtained semen samples from 27 men aged 25-35 who were fertile with normal sperm. Then they placed the samples on top of a current-generation iPhone that was set to talk mode via WhatsApp and transmitted/received signals via Wi-Fi, 4G, or 5G.

The researchers found no difference in sperm quality between control samples and those exposed to 4G or 5G (n = 9), but Wi-Fi (n = 18) seemed to have an effect. “We also tested conditions with the phone in a cover, as well as separating it by about 6 inches [from the sperm samples]. We found that both did dampen the effect of what we were seeing in comparison to direct exposure,” Dr. Chu said. “It appears that heat that is emanated from the device contributes to this effect.”

Dr. Chu cautioned that the study examined only ejaculated sperm, and “does not replicate real life where there is scrotal wall protection [and] pants material.”

For now, he said, there’s not enough evidence to allow clinicians to provide guidance to patients about possible links between cell phone exposure and male fertility. None of the study authors have changed their own use of cell phones as a result of the findings, he added.

Moving forward, he said, “continued research on exposure effects is needed and the current association should be considered cautiously as hypothesis generating.”

In an interview, University of Utah urologist James Hotaling, MD, who’s familiar with the study findings but didn’t take part in the research, said the authors “have done a good job looking at this issue,” but with acknowledged limitations.

The study size is very small, he said, “making generalizability difficult.” And “while the results, particularly on the Wi-Fi part, are interesting, they must be validated.”

In the big picture, he said, “the decline in sperm counts over the last 40 years is multifactorial so it cannot all be attributed to this. Finally, to really make the claim that Wi-Fi impacted fertility, you would need to have a much larger study and, ideally, look at pregnancy rates in couples trying to conceive.”

Overall, he said, the scientific community is “still skeptical” about a link between cell phone use and a decline in male fertility.

The study authors and Dr. Hotaling have no relevant disclosures.

A small new study suggests – but doesn’t prove – that exposure to Wi-Fi signals from cell phones in pants pockets could disrupt male fertility. Researchers found that sperm placed next to an in-use iPhone on the Wi-Fi setting over 6 hours had less motility (50% vs. 38%, P = .024) and viability (60% vs. 47%, P = .003) than those set to 4G and 5G.

The findings, presented at the American Society for Reproductive Medicine’s 2022 meeting, don’t confirm that cell phones are harmful, lead author Kevin Y. Chu, MD, a Los Angeles urologist, said in an interview. “We cannot draw conclusions from this study, as the study population was too small. What we did observe was that Wi-Fi, which was previously less studied, may have had an impact on sperm. We did not see an effect on sperm quality by the 4G or 5G wireless spectrum.”

According to Dr. Chu, dozens of studies have examined the possible effect of cell phone exposure on sperm quality. “In human survey studies, there was no association of use and decline of sperm quality,” he said. “In human sperm in vitro studies, there was a decline of sperm motility and viability. And in animal studies, there was decline of sperm motility and viability.”

The new study is a pilot “to see if it is feasible to do a large-scale project” to analyze any possible effects from radiofrequency-electromagnetic radiation (RF-EMR) transmitted by cell phones, he said.

According to the study, cell phones emit radiation when they “transmit data for social media, web browsing, and music/podcast streaming,” and the rise of Bluetooth earbuds “presumably prolonged the amount of time the cell phone resides in the trouser pockets of men. This places the cell phone and its respective RF-EMR near the testicles for prolonged [periods].”

Researchers obtained semen samples from 27 men aged 25-35 who were fertile with normal sperm. Then they placed the samples on top of a current-generation iPhone that was set to talk mode via WhatsApp and transmitted/received signals via Wi-Fi, 4G, or 5G.

The researchers found no difference in sperm quality between control samples and those exposed to 4G or 5G (n = 9), but Wi-Fi (n = 18) seemed to have an effect. “We also tested conditions with the phone in a cover, as well as separating it by about 6 inches [from the sperm samples]. We found that both did dampen the effect of what we were seeing in comparison to direct exposure,” Dr. Chu said. “It appears that heat that is emanated from the device contributes to this effect.”

Dr. Chu cautioned that the study examined only ejaculated sperm, and “does not replicate real life where there is scrotal wall protection [and] pants material.”

For now, he said, there’s not enough evidence to allow clinicians to provide guidance to patients about possible links between cell phone exposure and male fertility. None of the study authors have changed their own use of cell phones as a result of the findings, he added.

Moving forward, he said, “continued research on exposure effects is needed and the current association should be considered cautiously as hypothesis generating.”

In an interview, University of Utah urologist James Hotaling, MD, who’s familiar with the study findings but didn’t take part in the research, said the authors “have done a good job looking at this issue,” but with acknowledged limitations.

The study size is very small, he said, “making generalizability difficult.” And “while the results, particularly on the Wi-Fi part, are interesting, they must be validated.”

In the big picture, he said, “the decline in sperm counts over the last 40 years is multifactorial so it cannot all be attributed to this. Finally, to really make the claim that Wi-Fi impacted fertility, you would need to have a much larger study and, ideally, look at pregnancy rates in couples trying to conceive.”

Overall, he said, the scientific community is “still skeptical” about a link between cell phone use and a decline in male fertility.

The study authors and Dr. Hotaling have no relevant disclosures.

A small new study suggests – but doesn’t prove – that exposure to Wi-Fi signals from cell phones in pants pockets could disrupt male fertility. Researchers found that sperm placed next to an in-use iPhone on the Wi-Fi setting over 6 hours had less motility (50% vs. 38%, P = .024) and viability (60% vs. 47%, P = .003) than those set to 4G and 5G.

The findings, presented at the American Society for Reproductive Medicine’s 2022 meeting, don’t confirm that cell phones are harmful, lead author Kevin Y. Chu, MD, a Los Angeles urologist, said in an interview. “We cannot draw conclusions from this study, as the study population was too small. What we did observe was that Wi-Fi, which was previously less studied, may have had an impact on sperm. We did not see an effect on sperm quality by the 4G or 5G wireless spectrum.”

According to Dr. Chu, dozens of studies have examined the possible effect of cell phone exposure on sperm quality. “In human survey studies, there was no association of use and decline of sperm quality,” he said. “In human sperm in vitro studies, there was a decline of sperm motility and viability. And in animal studies, there was decline of sperm motility and viability.”

The new study is a pilot “to see if it is feasible to do a large-scale project” to analyze any possible effects from radiofrequency-electromagnetic radiation (RF-EMR) transmitted by cell phones, he said.

According to the study, cell phones emit radiation when they “transmit data for social media, web browsing, and music/podcast streaming,” and the rise of Bluetooth earbuds “presumably prolonged the amount of time the cell phone resides in the trouser pockets of men. This places the cell phone and its respective RF-EMR near the testicles for prolonged [periods].”

Researchers obtained semen samples from 27 men aged 25-35 who were fertile with normal sperm. Then they placed the samples on top of a current-generation iPhone that was set to talk mode via WhatsApp and transmitted/received signals via Wi-Fi, 4G, or 5G.

The researchers found no difference in sperm quality between control samples and those exposed to 4G or 5G (n = 9), but Wi-Fi (n = 18) seemed to have an effect. “We also tested conditions with the phone in a cover, as well as separating it by about 6 inches [from the sperm samples]. We found that both did dampen the effect of what we were seeing in comparison to direct exposure,” Dr. Chu said. “It appears that heat that is emanated from the device contributes to this effect.”

Dr. Chu cautioned that the study examined only ejaculated sperm, and “does not replicate real life where there is scrotal wall protection [and] pants material.”

For now, he said, there’s not enough evidence to allow clinicians to provide guidance to patients about possible links between cell phone exposure and male fertility. None of the study authors have changed their own use of cell phones as a result of the findings, he added.

Moving forward, he said, “continued research on exposure effects is needed and the current association should be considered cautiously as hypothesis generating.”

In an interview, University of Utah urologist James Hotaling, MD, who’s familiar with the study findings but didn’t take part in the research, said the authors “have done a good job looking at this issue,” but with acknowledged limitations.

The study size is very small, he said, “making generalizability difficult.” And “while the results, particularly on the Wi-Fi part, are interesting, they must be validated.”

In the big picture, he said, “the decline in sperm counts over the last 40 years is multifactorial so it cannot all be attributed to this. Finally, to really make the claim that Wi-Fi impacted fertility, you would need to have a much larger study and, ideally, look at pregnancy rates in couples trying to conceive.”

Overall, he said, the scientific community is “still skeptical” about a link between cell phone use and a decline in male fertility.

The study authors and Dr. Hotaling have no relevant disclosures.

MONTREAL – Patients who discontinue levothyroxine for subclinical hypothyroidism may gravitate towards becoming mildly hypothyroid again, but they importantly show no differences in terms of symptoms and quality of life – and sometimes show even improvement – compared with those who continue treatment, new research shows.

“Our results show feasibility of patient enrollment and safety of discontinuing levothyroxine in patients with subclinical hypothyroidism,” said first author Spyridoula Maraka, MD, when presenting the findings at the American Thyroid Association annual meeting.

Recommendations against levothyroxine for subclinical hypothyroidism

Subclinical hypothyroidism is commonly over-diagnosed, and treatment with thyroid hormone replacement, levothyroxine, has been shown to provide little, if any, benefit in terms of quality of life or relief of thyroid-related symptoms for these patients.

The treatment is meanwhile associated with burdens including cost and lifestyle adjustments, and one guideline panel recently issued a strong recommendation against routine levothyroxine use in most adults with subclinical hypothyroidism.

Nevertheless, levothyroxine treatment has soared in popularity and become one of the most commonly prescribed drugs in the United States.

With research lacking on one key solution of discontinuation of the therapy, Dr. Maraka, who is part of the Division of Endocrinology and Metabolism at the University of Arkansas for Medical Sciences, Little Rock, and colleagues conducted a double-blind, placebo-controlled trial at the Central Arkansas Veterans Healthcare System. In total, 50 patients treated for subclinical hypothyroidism were randomized 1:1 to continue receiving levothyroxine (25-75 mcg daily) or to discontinue treatment and receive a placebo instead, with a planned 6-month follow-up.

In the current interim analysis, Dr. Maraka reported results for the first 40 patients, including 20 randomized to levothyroxine and 20 to discontinuation.

There were no significant differences between the discontinuation and levothyroxine groups at baseline, which were of a similar age (66.2 vs. 70.8 years) and gender (75% women vs. 85% men).

The groups had similar baseline thyroid-stimulating hormone (TSH) levels (3.0 vs. 2.6 mIU/L), free T4 (both 0.9 ng/dL), thyroid peroxidase antibody positivity (17% vs. 11%), and similar clinical symptoms. All patients had at least one elevated TSH reading prior to starting levothyroxine.

With a follow-up of 6-8 weeks, 36.8% of patients in the discontinuation group had subclinical hypothyroidism, compared with 10% of patients who remained on levothyroxine (P = .0648), TSH levels were 5.5 versus 2.7 mIU/L (P = .001) and free T4 levels were 0.8 versus 0.9 ng/dL (P = .011).
 

No differences in symptoms, quality of life between groups

Importantly, there were no significant differences between the discontinuation versus levothyroxine groups in terms of symptoms, and even some improvements with discontinuation, including Thyroid-Specific Quality of Life Patient-Reported Outcome (ThyPRO)-Hypothyroid Symptoms score (4.6 reduction vs. 2.2 increase), tiredness (2.6 reduction vs. 1.1 increase), and EuroQoL 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life score, for which there were no differences between groups.

There were no reports of overt hypothyroidism; hyperthyroidism; cardiovascular events including atrial fibrillation, stroke, or heart failure; osteoporotic fractures; or deaths.

One patient in the discontinuation group had a TSH level of 11 mIU/L at 6-8 weeks and switched to open-label levothyroxine 75 mcg daily. Another patient in the discontinuation group switched to open-label levothyroxine 75 mcg daily at 10 weeks due to fatigue; however, the patient was diagnosed with metastatic colon cancer 1 month later.

The finding that only about a third of patients who discontinued levothyroxine developed subclinical hypothyroidism was lower than expected, Dr. Maraka noted.

“This was ... unexpected ... for us,” she said. “We were expecting a larger number of patients to develop hypothyroidism, but to our surprise, that was not the case.”

“But what is more important is that there was no difference in the quality of life measures,” she added. “If anything, the placebo group was a little better, though the [differences] were not statistically significant.”

Dr. Maraka also noted that in further research and a final 6-month analysis, the authors will look at factors associated with developing subclinical hypothyroidism after treatment discontinuation, among other issues.
 

Discontinuation of levothyroxine is manageable

The results are encouraging, as they provide assurance that discontinuation of levothyroxine is manageable.

“This research will pave the way for initiatives to promote levothyroxine deprescription and implementation of evidence-based care for patients with subclinical hypothyroidism,” she said.

In further comments, Dr. Hennessey noted that the dilemma of having patients on levothyroxine who may not be benefitting from treatment is “significant,” with patients sometimes reluctant to discontinue treatment due to concerns of developing hypothyroidism-associated symptoms such as brain fog and weight gain.

He noted, however, that “many with mildly elevated TSH actually go on to normalize with time, so they are not really hypothyroid, [and] if we remove thyroxine from people with normal thyroid function, they will remain normal.”

Dr. Maraka has reported no relevant financial relationships. Dr. Hennessey has reported consulting for pharmaceutical companies to design clinical studies for thyroid medications.

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

MONTREAL – Patients who discontinue levothyroxine for subclinical hypothyroidism may gravitate towards becoming mildly hypothyroid again, but they importantly show no differences in terms of symptoms and quality of life – and sometimes show even improvement – compared with those who continue treatment, new research shows.

“Our results show feasibility of patient enrollment and safety of discontinuing levothyroxine in patients with subclinical hypothyroidism,” said first author Spyridoula Maraka, MD, when presenting the findings at the American Thyroid Association annual meeting.

Recommendations against levothyroxine for subclinical hypothyroidism

Subclinical hypothyroidism is commonly over-diagnosed, and treatment with thyroid hormone replacement, levothyroxine, has been shown to provide little, if any, benefit in terms of quality of life or relief of thyroid-related symptoms for these patients.

The treatment is meanwhile associated with burdens including cost and lifestyle adjustments, and one guideline panel recently issued a strong recommendation against routine levothyroxine use in most adults with subclinical hypothyroidism.

Nevertheless, levothyroxine treatment has soared in popularity and become one of the most commonly prescribed drugs in the United States.

With research lacking on one key solution of discontinuation of the therapy, Dr. Maraka, who is part of the Division of Endocrinology and Metabolism at the University of Arkansas for Medical Sciences, Little Rock, and colleagues conducted a double-blind, placebo-controlled trial at the Central Arkansas Veterans Healthcare System. In total, 50 patients treated for subclinical hypothyroidism were randomized 1:1 to continue receiving levothyroxine (25-75 mcg daily) or to discontinue treatment and receive a placebo instead, with a planned 6-month follow-up.

In the current interim analysis, Dr. Maraka reported results for the first 40 patients, including 20 randomized to levothyroxine and 20 to discontinuation.

There were no significant differences between the discontinuation and levothyroxine groups at baseline, which were of a similar age (66.2 vs. 70.8 years) and gender (75% women vs. 85% men).

The groups had similar baseline thyroid-stimulating hormone (TSH) levels (3.0 vs. 2.6 mIU/L), free T4 (both 0.9 ng/dL), thyroid peroxidase antibody positivity (17% vs. 11%), and similar clinical symptoms. All patients had at least one elevated TSH reading prior to starting levothyroxine.

With a follow-up of 6-8 weeks, 36.8% of patients in the discontinuation group had subclinical hypothyroidism, compared with 10% of patients who remained on levothyroxine (P = .0648), TSH levels were 5.5 versus 2.7 mIU/L (P = .001) and free T4 levels were 0.8 versus 0.9 ng/dL (P = .011).
 

No differences in symptoms, quality of life between groups

Importantly, there were no significant differences between the discontinuation versus levothyroxine groups in terms of symptoms, and even some improvements with discontinuation, including Thyroid-Specific Quality of Life Patient-Reported Outcome (ThyPRO)-Hypothyroid Symptoms score (4.6 reduction vs. 2.2 increase), tiredness (2.6 reduction vs. 1.1 increase), and EuroQoL 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life score, for which there were no differences between groups.

There were no reports of overt hypothyroidism; hyperthyroidism; cardiovascular events including atrial fibrillation, stroke, or heart failure; osteoporotic fractures; or deaths.

One patient in the discontinuation group had a TSH level of 11 mIU/L at 6-8 weeks and switched to open-label levothyroxine 75 mcg daily. Another patient in the discontinuation group switched to open-label levothyroxine 75 mcg daily at 10 weeks due to fatigue; however, the patient was diagnosed with metastatic colon cancer 1 month later.

The finding that only about a third of patients who discontinued levothyroxine developed subclinical hypothyroidism was lower than expected, Dr. Maraka noted.

“This was ... unexpected ... for us,” she said. “We were expecting a larger number of patients to develop hypothyroidism, but to our surprise, that was not the case.”

“But what is more important is that there was no difference in the quality of life measures,” she added. “If anything, the placebo group was a little better, though the [differences] were not statistically significant.”

Dr. Maraka also noted that in further research and a final 6-month analysis, the authors will look at factors associated with developing subclinical hypothyroidism after treatment discontinuation, among other issues.
 

Discontinuation of levothyroxine is manageable

The results are encouraging, as they provide assurance that discontinuation of levothyroxine is manageable.

“This research will pave the way for initiatives to promote levothyroxine deprescription and implementation of evidence-based care for patients with subclinical hypothyroidism,” she said.

In further comments, Dr. Hennessey noted that the dilemma of having patients on levothyroxine who may not be benefitting from treatment is “significant,” with patients sometimes reluctant to discontinue treatment due to concerns of developing hypothyroidism-associated symptoms such as brain fog and weight gain.

He noted, however, that “many with mildly elevated TSH actually go on to normalize with time, so they are not really hypothyroid, [and] if we remove thyroxine from people with normal thyroid function, they will remain normal.”

Dr. Maraka has reported no relevant financial relationships. Dr. Hennessey has reported consulting for pharmaceutical companies to design clinical studies for thyroid medications.

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

MONTREAL – Patients who discontinue levothyroxine for subclinical hypothyroidism may gravitate towards becoming mildly hypothyroid again, but they importantly show no differences in terms of symptoms and quality of life – and sometimes show even improvement – compared with those who continue treatment, new research shows.

“Our results show feasibility of patient enrollment and safety of discontinuing levothyroxine in patients with subclinical hypothyroidism,” said first author Spyridoula Maraka, MD, when presenting the findings at the American Thyroid Association annual meeting.

Recommendations against levothyroxine for subclinical hypothyroidism

Subclinical hypothyroidism is commonly over-diagnosed, and treatment with thyroid hormone replacement, levothyroxine, has been shown to provide little, if any, benefit in terms of quality of life or relief of thyroid-related symptoms for these patients.

The treatment is meanwhile associated with burdens including cost and lifestyle adjustments, and one guideline panel recently issued a strong recommendation against routine levothyroxine use in most adults with subclinical hypothyroidism.

Nevertheless, levothyroxine treatment has soared in popularity and become one of the most commonly prescribed drugs in the United States.

With research lacking on one key solution of discontinuation of the therapy, Dr. Maraka, who is part of the Division of Endocrinology and Metabolism at the University of Arkansas for Medical Sciences, Little Rock, and colleagues conducted a double-blind, placebo-controlled trial at the Central Arkansas Veterans Healthcare System. In total, 50 patients treated for subclinical hypothyroidism were randomized 1:1 to continue receiving levothyroxine (25-75 mcg daily) or to discontinue treatment and receive a placebo instead, with a planned 6-month follow-up.

In the current interim analysis, Dr. Maraka reported results for the first 40 patients, including 20 randomized to levothyroxine and 20 to discontinuation.

There were no significant differences between the discontinuation and levothyroxine groups at baseline, which were of a similar age (66.2 vs. 70.8 years) and gender (75% women vs. 85% men).

The groups had similar baseline thyroid-stimulating hormone (TSH) levels (3.0 vs. 2.6 mIU/L), free T4 (both 0.9 ng/dL), thyroid peroxidase antibody positivity (17% vs. 11%), and similar clinical symptoms. All patients had at least one elevated TSH reading prior to starting levothyroxine.

With a follow-up of 6-8 weeks, 36.8% of patients in the discontinuation group had subclinical hypothyroidism, compared with 10% of patients who remained on levothyroxine (P = .0648), TSH levels were 5.5 versus 2.7 mIU/L (P = .001) and free T4 levels were 0.8 versus 0.9 ng/dL (P = .011).
 

No differences in symptoms, quality of life between groups

Importantly, there were no significant differences between the discontinuation versus levothyroxine groups in terms of symptoms, and even some improvements with discontinuation, including Thyroid-Specific Quality of Life Patient-Reported Outcome (ThyPRO)-Hypothyroid Symptoms score (4.6 reduction vs. 2.2 increase), tiredness (2.6 reduction vs. 1.1 increase), and EuroQoL 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life score, for which there were no differences between groups.

There were no reports of overt hypothyroidism; hyperthyroidism; cardiovascular events including atrial fibrillation, stroke, or heart failure; osteoporotic fractures; or deaths.

One patient in the discontinuation group had a TSH level of 11 mIU/L at 6-8 weeks and switched to open-label levothyroxine 75 mcg daily. Another patient in the discontinuation group switched to open-label levothyroxine 75 mcg daily at 10 weeks due to fatigue; however, the patient was diagnosed with metastatic colon cancer 1 month later.

The finding that only about a third of patients who discontinued levothyroxine developed subclinical hypothyroidism was lower than expected, Dr. Maraka noted.

“This was ... unexpected ... for us,” she said. “We were expecting a larger number of patients to develop hypothyroidism, but to our surprise, that was not the case.”

“But what is more important is that there was no difference in the quality of life measures,” she added. “If anything, the placebo group was a little better, though the [differences] were not statistically significant.”

Dr. Maraka also noted that in further research and a final 6-month analysis, the authors will look at factors associated with developing subclinical hypothyroidism after treatment discontinuation, among other issues.
 

Discontinuation of levothyroxine is manageable

The results are encouraging, as they provide assurance that discontinuation of levothyroxine is manageable.

“This research will pave the way for initiatives to promote levothyroxine deprescription and implementation of evidence-based care for patients with subclinical hypothyroidism,” she said.

In further comments, Dr. Hennessey noted that the dilemma of having patients on levothyroxine who may not be benefitting from treatment is “significant,” with patients sometimes reluctant to discontinue treatment due to concerns of developing hypothyroidism-associated symptoms such as brain fog and weight gain.

He noted, however, that “many with mildly elevated TSH actually go on to normalize with time, so they are not really hypothyroid, [and] if we remove thyroxine from people with normal thyroid function, they will remain normal.”

Dr. Maraka has reported no relevant financial relationships. Dr. Hennessey has reported consulting for pharmaceutical companies to design clinical studies for thyroid medications.

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

VIENNA – Following a healthy, balanced diet and avoiding excessive consumption of stressful news helped prevent anxiety and depressive symptoms during the COVID-19 pandemic, new research suggests.

Results from a longitudinal Spanish survey study of more than 1,000 adults showed that being outside, relaxing, participating in physical activities, and drinking plenty of water were also beneficial. However, social contact with friends and relatives, following a routine, and pursuing hobbies had no significant impact.

“This was a little surprising,” lead author Joaquim Radua, MD, PhD, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, said in a release.

“Like many people, we had assumed that personal contact would play a bigger part in avoiding anxiety and depression during stressful times,” he added.

However, Dr. Radua said that because the study was conducted during the COVID-19 pandemic, “people who socialized may also have been anxious about getting infected.”

Consequently, “it may be that this specific behavior cannot be extrapolated to other times, when there is no pandemic,” he said.

The findings were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Correlational versus longitudinal studies

Dr. Radua emphasized that individuals “should socialize,” of course.

“We think it’s important that people continue to follow what works for them and that if you enjoy seeing friends or following a hobby, you continue to do so,” he said.

“Our work was centered on COVID, but we now need to see if these factors apply to other stressful circumstances. These simple behaviors may prevent anxiety and depression, and prevention is better than cure,” he added.

The researchers note that, in “times of uncertainty” such as the COVID-19 pandemic, many individuals experience increases in both anxiety and depressive symptoms.

Although a range of behaviors are recommended to help people cope, the investigators add that some of the recommendations are based on correlational studies.

Indeed, the researchers previously identified a correlation between following a healthy/balanced diet, among other measures, and lower anxiety and depressive symptoms during the pandemic.

However, it is unclear from cross-sectional studies whether the behavior alters the symptoms, in which case the behavior could be considered “helpful,” or conversely whether the symptoms alter an individual’s behavior, in which case the behaviors “may be useless,” the investigators note.

The investigative team therefore set out to provide more robust evidence for making recommendations and conducted a prospective longitudinal study.

They recruited 1,049 adults online via social networks, matching them to the regional, age and sex, and urbanicity distribution of the overall Spanish population.

Every 2 weeks for 12 months, the researchers administered the General Anxiety Disorder (GAD)-7, the Patient Health Questionnaire (PHQ)-9, and a two-item ecological momentary assessment to minimize recall bias, among other measures. They also asked about 10 self-report coping behaviors.
 

Significant coping behaviors

The study was completed by 942 individuals, indicating a retention of 90%.

Among both completers and non-completers there was an over-representation of individuals aged 18-34 years and women, compared with the general population, and fewer participants aged at least 65 years.

Pre-recruitment, the mean baseline GAD-7 score among completers was 7.4, falling to around 5.5 at the time of the first questionnaire. Scores on the PHQ-9 were 7.6 and 5.6, respectively.

Performing population-weighted autoregressive moving average models to analyze the relationship between the current frequency of the coping behaviors and future changes in anxiety and depressive symptoms, the investigators found that the greatest effect was from following a healthy, balanced diet, with an impact size of 0.95.

This was followed by avoiding too much stressful news (impact size, 0.91), staying outdoors or looking outside (0.40), doing relaxing activities (0.33), participating in physical exercise (0.32), and drinking water to hydrate (0.25).

Overall, these coping behaviors were associated with a significant reduction in anxiety and depressive symptoms (all, P < .001).

On the other hand, there was no impact on future symptoms from socializing with friends and relatives, whether or not they lived in the same household. There was also no effect from following a routine, pursuing hobbies, or performing home tasks.

The researchers note that similar results were obtained when excluding participants with hazardous alcohol consumption, defined as a score on the Alcohol Use Disorders Identification Test of 8 or higher.

However, they point out that despite its prospective design and large cohort, the study was not interventional. Therefore, they “cannot rule out the possibility that decreasing the frequency of a behavior is an early sign of some mechanism that later leads to increased anxiety and depression symptoms.”

Nevertheless, they believe that possibility “seems unlikely.”
 

Reflective of a unique time?

Commenting on the findings, Catherine Harmer, PhD, director of the Psychopharmacology and Emotional Research Lab, department of psychiatry, University of Oxford (England), said in the release this was an “interesting study” that “provides some important insights as to which behaviors may protect our mental health during times of significant stress.”

She said the finding that social contact was not beneficial was “surprising” but may reflect the fact that, during the pandemic, it was “stressful even to have those social contacts, even if we managed to meet a friend outside.”

The results of the study may therefore be “reflective of the unique experience” of the COVID-19 pandemic, said Dr. Harmer, who was not involved with the research.

“I wouldn’t think that reading too much news would generally be something that has a negative impact on depression and anxiety, but I think it was very much at the time,” she said.

With the pandemic overwhelming one country after another, “the more you read about it, the more frightening it was,” she added, noting that it is “easy to forget how frightened we were at the beginning.”

Dr. Harmer noted that “it would be interesting” if the study was repeated and the same factors came out – or if they were unique to that time.

This would be “useful to know, as these times may come again. And the more information we have to cope with a pandemic, the better,” she concluded.

The research was supported by the AXA Research Fund via an AXA Award granted to Dr. Radua from the call for projects “mitigating risk in the wake of the COVID-19 pandemic.” The investigators and Dr. Harmer report no relevant financial relationships.

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

VIENNA – Following a healthy, balanced diet and avoiding excessive consumption of stressful news helped prevent anxiety and depressive symptoms during the COVID-19 pandemic, new research suggests.

Results from a longitudinal Spanish survey study of more than 1,000 adults showed that being outside, relaxing, participating in physical activities, and drinking plenty of water were also beneficial. However, social contact with friends and relatives, following a routine, and pursuing hobbies had no significant impact.

“This was a little surprising,” lead author Joaquim Radua, MD, PhD, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, said in a release.

“Like many people, we had assumed that personal contact would play a bigger part in avoiding anxiety and depression during stressful times,” he added.

However, Dr. Radua said that because the study was conducted during the COVID-19 pandemic, “people who socialized may also have been anxious about getting infected.”

Consequently, “it may be that this specific behavior cannot be extrapolated to other times, when there is no pandemic,” he said.

The findings were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Correlational versus longitudinal studies

Dr. Radua emphasized that individuals “should socialize,” of course.

“We think it’s important that people continue to follow what works for them and that if you enjoy seeing friends or following a hobby, you continue to do so,” he said.

“Our work was centered on COVID, but we now need to see if these factors apply to other stressful circumstances. These simple behaviors may prevent anxiety and depression, and prevention is better than cure,” he added.

The researchers note that, in “times of uncertainty” such as the COVID-19 pandemic, many individuals experience increases in both anxiety and depressive symptoms.

Although a range of behaviors are recommended to help people cope, the investigators add that some of the recommendations are based on correlational studies.

Indeed, the researchers previously identified a correlation between following a healthy/balanced diet, among other measures, and lower anxiety and depressive symptoms during the pandemic.

However, it is unclear from cross-sectional studies whether the behavior alters the symptoms, in which case the behavior could be considered “helpful,” or conversely whether the symptoms alter an individual’s behavior, in which case the behaviors “may be useless,” the investigators note.

The investigative team therefore set out to provide more robust evidence for making recommendations and conducted a prospective longitudinal study.

They recruited 1,049 adults online via social networks, matching them to the regional, age and sex, and urbanicity distribution of the overall Spanish population.

Every 2 weeks for 12 months, the researchers administered the General Anxiety Disorder (GAD)-7, the Patient Health Questionnaire (PHQ)-9, and a two-item ecological momentary assessment to minimize recall bias, among other measures. They also asked about 10 self-report coping behaviors.
 

Significant coping behaviors

The study was completed by 942 individuals, indicating a retention of 90%.

Among both completers and non-completers there was an over-representation of individuals aged 18-34 years and women, compared with the general population, and fewer participants aged at least 65 years.

Pre-recruitment, the mean baseline GAD-7 score among completers was 7.4, falling to around 5.5 at the time of the first questionnaire. Scores on the PHQ-9 were 7.6 and 5.6, respectively.

Performing population-weighted autoregressive moving average models to analyze the relationship between the current frequency of the coping behaviors and future changes in anxiety and depressive symptoms, the investigators found that the greatest effect was from following a healthy, balanced diet, with an impact size of 0.95.

This was followed by avoiding too much stressful news (impact size, 0.91), staying outdoors or looking outside (0.40), doing relaxing activities (0.33), participating in physical exercise (0.32), and drinking water to hydrate (0.25).

Overall, these coping behaviors were associated with a significant reduction in anxiety and depressive symptoms (all, P < .001).

On the other hand, there was no impact on future symptoms from socializing with friends and relatives, whether or not they lived in the same household. There was also no effect from following a routine, pursuing hobbies, or performing home tasks.

The researchers note that similar results were obtained when excluding participants with hazardous alcohol consumption, defined as a score on the Alcohol Use Disorders Identification Test of 8 or higher.

However, they point out that despite its prospective design and large cohort, the study was not interventional. Therefore, they “cannot rule out the possibility that decreasing the frequency of a behavior is an early sign of some mechanism that later leads to increased anxiety and depression symptoms.”

Nevertheless, they believe that possibility “seems unlikely.”
 

Reflective of a unique time?

Commenting on the findings, Catherine Harmer, PhD, director of the Psychopharmacology and Emotional Research Lab, department of psychiatry, University of Oxford (England), said in the release this was an “interesting study” that “provides some important insights as to which behaviors may protect our mental health during times of significant stress.”

She said the finding that social contact was not beneficial was “surprising” but may reflect the fact that, during the pandemic, it was “stressful even to have those social contacts, even if we managed to meet a friend outside.”

The results of the study may therefore be “reflective of the unique experience” of the COVID-19 pandemic, said Dr. Harmer, who was not involved with the research.

“I wouldn’t think that reading too much news would generally be something that has a negative impact on depression and anxiety, but I think it was very much at the time,” she said.

With the pandemic overwhelming one country after another, “the more you read about it, the more frightening it was,” she added, noting that it is “easy to forget how frightened we were at the beginning.”

Dr. Harmer noted that “it would be interesting” if the study was repeated and the same factors came out – or if they were unique to that time.

This would be “useful to know, as these times may come again. And the more information we have to cope with a pandemic, the better,” she concluded.

The research was supported by the AXA Research Fund via an AXA Award granted to Dr. Radua from the call for projects “mitigating risk in the wake of the COVID-19 pandemic.” The investigators and Dr. Harmer report no relevant financial relationships.

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

VIENNA – Following a healthy, balanced diet and avoiding excessive consumption of stressful news helped prevent anxiety and depressive symptoms during the COVID-19 pandemic, new research suggests.

Results from a longitudinal Spanish survey study of more than 1,000 adults showed that being outside, relaxing, participating in physical activities, and drinking plenty of water were also beneficial. However, social contact with friends and relatives, following a routine, and pursuing hobbies had no significant impact.

“This was a little surprising,” lead author Joaquim Radua, MD, PhD, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, said in a release.

“Like many people, we had assumed that personal contact would play a bigger part in avoiding anxiety and depression during stressful times,” he added.

However, Dr. Radua said that because the study was conducted during the COVID-19 pandemic, “people who socialized may also have been anxious about getting infected.”

Consequently, “it may be that this specific behavior cannot be extrapolated to other times, when there is no pandemic,” he said.

The findings were presented at the 35th European College of Neuropsychopharmacology (ECNP) Congress.
 

Correlational versus longitudinal studies

Dr. Radua emphasized that individuals “should socialize,” of course.

“We think it’s important that people continue to follow what works for them and that if you enjoy seeing friends or following a hobby, you continue to do so,” he said.

“Our work was centered on COVID, but we now need to see if these factors apply to other stressful circumstances. These simple behaviors may prevent anxiety and depression, and prevention is better than cure,” he added.

The researchers note that, in “times of uncertainty” such as the COVID-19 pandemic, many individuals experience increases in both anxiety and depressive symptoms.

Although a range of behaviors are recommended to help people cope, the investigators add that some of the recommendations are based on correlational studies.

Indeed, the researchers previously identified a correlation between following a healthy/balanced diet, among other measures, and lower anxiety and depressive symptoms during the pandemic.

However, it is unclear from cross-sectional studies whether the behavior alters the symptoms, in which case the behavior could be considered “helpful,” or conversely whether the symptoms alter an individual’s behavior, in which case the behaviors “may be useless,” the investigators note.

The investigative team therefore set out to provide more robust evidence for making recommendations and conducted a prospective longitudinal study.

They recruited 1,049 adults online via social networks, matching them to the regional, age and sex, and urbanicity distribution of the overall Spanish population.

Every 2 weeks for 12 months, the researchers administered the General Anxiety Disorder (GAD)-7, the Patient Health Questionnaire (PHQ)-9, and a two-item ecological momentary assessment to minimize recall bias, among other measures. They also asked about 10 self-report coping behaviors.
 

Significant coping behaviors

The study was completed by 942 individuals, indicating a retention of 90%.

Among both completers and non-completers there was an over-representation of individuals aged 18-34 years and women, compared with the general population, and fewer participants aged at least 65 years.

Pre-recruitment, the mean baseline GAD-7 score among completers was 7.4, falling to around 5.5 at the time of the first questionnaire. Scores on the PHQ-9 were 7.6 and 5.6, respectively.

Performing population-weighted autoregressive moving average models to analyze the relationship between the current frequency of the coping behaviors and future changes in anxiety and depressive symptoms, the investigators found that the greatest effect was from following a healthy, balanced diet, with an impact size of 0.95.

This was followed by avoiding too much stressful news (impact size, 0.91), staying outdoors or looking outside (0.40), doing relaxing activities (0.33), participating in physical exercise (0.32), and drinking water to hydrate (0.25).

Overall, these coping behaviors were associated with a significant reduction in anxiety and depressive symptoms (all, P < .001).

On the other hand, there was no impact on future symptoms from socializing with friends and relatives, whether or not they lived in the same household. There was also no effect from following a routine, pursuing hobbies, or performing home tasks.

The researchers note that similar results were obtained when excluding participants with hazardous alcohol consumption, defined as a score on the Alcohol Use Disorders Identification Test of 8 or higher.

However, they point out that despite its prospective design and large cohort, the study was not interventional. Therefore, they “cannot rule out the possibility that decreasing the frequency of a behavior is an early sign of some mechanism that later leads to increased anxiety and depression symptoms.”

Nevertheless, they believe that possibility “seems unlikely.”
 

Reflective of a unique time?

Commenting on the findings, Catherine Harmer, PhD, director of the Psychopharmacology and Emotional Research Lab, department of psychiatry, University of Oxford (England), said in the release this was an “interesting study” that “provides some important insights as to which behaviors may protect our mental health during times of significant stress.”

She said the finding that social contact was not beneficial was “surprising” but may reflect the fact that, during the pandemic, it was “stressful even to have those social contacts, even if we managed to meet a friend outside.”

The results of the study may therefore be “reflective of the unique experience” of the COVID-19 pandemic, said Dr. Harmer, who was not involved with the research.

“I wouldn’t think that reading too much news would generally be something that has a negative impact on depression and anxiety, but I think it was very much at the time,” she said.

With the pandemic overwhelming one country after another, “the more you read about it, the more frightening it was,” she added, noting that it is “easy to forget how frightened we were at the beginning.”

Dr. Harmer noted that “it would be interesting” if the study was repeated and the same factors came out – or if they were unique to that time.

This would be “useful to know, as these times may come again. And the more information we have to cope with a pandemic, the better,” she concluded.

The research was supported by the AXA Research Fund via an AXA Award granted to Dr. Radua from the call for projects “mitigating risk in the wake of the COVID-19 pandemic.” The investigators and Dr. Harmer report no relevant financial relationships.

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

NASHVILLE, TENN. – For children with uncontrolled asthma on standard therapies and meeting criteria of a type 2 (T2) inflammatory phenotype, a prospective 1-year extension from a phase 3 trial supports the biologic dupilumab as a potential treatment standard, according to the investigator who presented the findings at the annual meeting of the American College of Chest Physicians (CHEST).

“The appropriate candidate is a child with the T2 inflammatory phenotype who is still experiencing exacerbations on at least a medium dose of inhaled corticosteroids plus a second controller medication,” said Leonard B. Bacharier, MD, section chief, division of pediatric allergy, immunology, and pulmonary medicine, Vanderbilt University Medical Center, Nashville, Tenn.

By T2 inflammatory phenotype, Dr. Bacharier specified that key features include an eosinophil count of at least 150 cells/mL and a FENO level of at least 20 ppb. If children meet these and inadequate standard-therapy response criteria, Dr. Bacharier thinks the extension data support dupilumab as a routine therapy despite the cost.

“As a pediatrician, I think it is really important that children with asthma finish their childhood with the best bone health and the lowest risk of other steroid-associated adverse events,” Dr. Bacharier said.

Over the course of the 1-year extension, called EXCURSION, there was no evidence of diminished efficacy nor of any new safety signal. In other words, patients have remained well controlled for 2 years with a well-tolerated therapy. Dr. Bacharier pointed out, however, that one of the most compelling reasons to consider this as a potential standard was the very low rates at which patients required a course of steroids.

At the end of 1 year in the extension trial, called VOYAGE, the unadjusted annualized total number of steroid courses per patient was 0.414 in the dupilumab group vs. 0.816 in the placebo group. At the end of EXCURSION, following an additional year of therapy, the rate was 0.152.

“This means that fewer than 2 patients out of 10 required prednisone in the previous year,” Dr. Bacharier said.

The EXCURSION extension study did not capture data on steroid-related adverse events, but Dr. Bacharier said that these data are reassuring for both acute and long-term risks of steroid exposure.

“We know that the adverse effects associated with oral steroids are related to cumulative exposure. The more you receive, the greater the risk of adverse effects,” he said.

In patients who were randomly assigned to placebo in the VOYAGE trial and then switched to dupilumab in the EXCURSION extension, steroid exposure was also very low, but whether evaluated as annualized total courses (0.152 vs. 0.181) or by proportion of patients with any steroid intake (10.5% vs. 13.2%), there was a numerical advantage for starting and remaining on dupilumab over the 2-year follow-up.

In VOYAGE, which was published last year in the New England Journal of Medicine, 408 children from ages 6 to 11 years were randomly assigned in a 2:1 ratio to dupilumab or matching placebo. For children weighing less than 30 kg, the dose was 200 mg. For those who weighed less, the dose was 100 mg. Both doses were administered every 2 weeks.

As previously reported, the study met the primary endpoint of annualized rate of severe asthma exacerbations, which was 0.31 in the dupilumab group vs. 0.75 in the placebo group, a relative reduction of 59.3% (P < .001). Dupilumab was also superior on several secondary endpoints, including measures of lung function and asthma control.

The EXCURSION extension study enrolled 365 of the patients who participated in VOYAGE. This included 125 of the 135 randomly assigned to placebo and 240 of the 273 randomly assigned to dupilumab. Those initially randomly assigned to placebo were transitioned to dupilumab. The same weight-based dosing was employed.

At baseline, the children enrolled in VOYAGE had an annualized rate of 2.560 severe exacerbations. At the end of VOYAGE, this rate was 0.330. At the end of EXCURSION after 2 years on dupilumab, the rate was 0.118. In the group switched from placebo to dupilumab, the rate was 0.124.

During EXCURSION, treatment-emergent adverse events occurred in 2.5% of those who remained on dupilumab and 0.8% of those switched from placebo to dupilumab. Three patients (1.3%) permanently discontinued therapy because of a treatment-related event. The most common adverse events involved upper respiratory complaints, such as nasopharyngitis, pharyngitis, upper respiratory tract infections, and rhinitis influenza, but all were reported in fewer than 10% of patients. Other reported side effects, such as injection-site reactions and diarrhea, occurred in 5% or fewer of patients.

“Over the 2 years, dupilumab was well tolerated, and there was evidence of an increased risk of adverse events for longer exposure,” Dr. Bacharier reported.

It is for this reason that Dr. Bacharier concluded that children with repeated exacerbations requiring steroids despite standard therapies should be considered for dupilumab if they also meet criteria for the T2 inflammatory phenotype. This last point is important.

“In children with low levels of eosinophil and low phenol, we are not seeing these kinds of response,” Dr. Bacharier said. Rather, in the absence of eosinophilia, “there is probably no difference between dupilumab and placebo.”

An important steroid-sparing effect is “suggested” by the data, but Sally E. Wenzel, MD, director of the University of Pittsburgh Asthma and Environmental Lung Health Institute in Pittsburgh, characterized the idea that dupilumab is emerging to be a standard in uncontrolled asthma in children with the T2 phenotype as “a bit premature.”

She challenged the conclusion that the EXCURSION data associated dupilumab with a reduction in annualized steroid courses over time. While the number was lower after 2 years of treatment than after 1, Dr. Wenzel pointed out that all patients were on dupilumab in the second year, “so we don’t know what really happens without treatment.” She said there are other potential explanations, including the possibility that aging children have less active disease.

More importantly, Dr. Wenzel said in an interview that she would also hesitate to urge biologics in every child who meets the criteria that Dr. Bacharier outlined.

“The most important concern is that we do not know how long one should continue the dupilumab and if the long-term treatment adversely or positively affects a growing immune system,” she said.

There is reason to be concerned that blockage of an entire immune pathway with a biologic could adversely affect autoimmunity as well as susceptibility to cancer, according to Dr. Wenzel. She hopes this does not prove to be the case, but she encouraged prudence until there are more data to judge.

While extension data for dupilumab “sound good,” she thinks moving toward any type of standard of care with biologics in children “has to be done with caution and constant evaluation and reevaluation.”

Dr. Bacharier disclosed relationships with AstraZeneca, GlaxoSmithKline, Regeneron and Sanofi. The two latter companies collaborated on the development and marketing of dupilumab. Dr. Wenzel disclosed relationships with AstraZeneca, GlaxoSmithKline, Knopp Pharmaceuticals, Pieris, and Sanofi-Regeneron.

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

NASHVILLE, TENN. – For children with uncontrolled asthma on standard therapies and meeting criteria of a type 2 (T2) inflammatory phenotype, a prospective 1-year extension from a phase 3 trial supports the biologic dupilumab as a potential treatment standard, according to the investigator who presented the findings at the annual meeting of the American College of Chest Physicians (CHEST).

“The appropriate candidate is a child with the T2 inflammatory phenotype who is still experiencing exacerbations on at least a medium dose of inhaled corticosteroids plus a second controller medication,” said Leonard B. Bacharier, MD, section chief, division of pediatric allergy, immunology, and pulmonary medicine, Vanderbilt University Medical Center, Nashville, Tenn.

By T2 inflammatory phenotype, Dr. Bacharier specified that key features include an eosinophil count of at least 150 cells/mL and a FENO level of at least 20 ppb. If children meet these and inadequate standard-therapy response criteria, Dr. Bacharier thinks the extension data support dupilumab as a routine therapy despite the cost.

“As a pediatrician, I think it is really important that children with asthma finish their childhood with the best bone health and the lowest risk of other steroid-associated adverse events,” Dr. Bacharier said.

Over the course of the 1-year extension, called EXCURSION, there was no evidence of diminished efficacy nor of any new safety signal. In other words, patients have remained well controlled for 2 years with a well-tolerated therapy. Dr. Bacharier pointed out, however, that one of the most compelling reasons to consider this as a potential standard was the very low rates at which patients required a course of steroids.

At the end of 1 year in the extension trial, called VOYAGE, the unadjusted annualized total number of steroid courses per patient was 0.414 in the dupilumab group vs. 0.816 in the placebo group. At the end of EXCURSION, following an additional year of therapy, the rate was 0.152.

“This means that fewer than 2 patients out of 10 required prednisone in the previous year,” Dr. Bacharier said.

The EXCURSION extension study did not capture data on steroid-related adverse events, but Dr. Bacharier said that these data are reassuring for both acute and long-term risks of steroid exposure.

“We know that the adverse effects associated with oral steroids are related to cumulative exposure. The more you receive, the greater the risk of adverse effects,” he said.

In patients who were randomly assigned to placebo in the VOYAGE trial and then switched to dupilumab in the EXCURSION extension, steroid exposure was also very low, but whether evaluated as annualized total courses (0.152 vs. 0.181) or by proportion of patients with any steroid intake (10.5% vs. 13.2%), there was a numerical advantage for starting and remaining on dupilumab over the 2-year follow-up.

In VOYAGE, which was published last year in the New England Journal of Medicine, 408 children from ages 6 to 11 years were randomly assigned in a 2:1 ratio to dupilumab or matching placebo. For children weighing less than 30 kg, the dose was 200 mg. For those who weighed less, the dose was 100 mg. Both doses were administered every 2 weeks.

As previously reported, the study met the primary endpoint of annualized rate of severe asthma exacerbations, which was 0.31 in the dupilumab group vs. 0.75 in the placebo group, a relative reduction of 59.3% (P < .001). Dupilumab was also superior on several secondary endpoints, including measures of lung function and asthma control.

The EXCURSION extension study enrolled 365 of the patients who participated in VOYAGE. This included 125 of the 135 randomly assigned to placebo and 240 of the 273 randomly assigned to dupilumab. Those initially randomly assigned to placebo were transitioned to dupilumab. The same weight-based dosing was employed.

At baseline, the children enrolled in VOYAGE had an annualized rate of 2.560 severe exacerbations. At the end of VOYAGE, this rate was 0.330. At the end of EXCURSION after 2 years on dupilumab, the rate was 0.118. In the group switched from placebo to dupilumab, the rate was 0.124.

During EXCURSION, treatment-emergent adverse events occurred in 2.5% of those who remained on dupilumab and 0.8% of those switched from placebo to dupilumab. Three patients (1.3%) permanently discontinued therapy because of a treatment-related event. The most common adverse events involved upper respiratory complaints, such as nasopharyngitis, pharyngitis, upper respiratory tract infections, and rhinitis influenza, but all were reported in fewer than 10% of patients. Other reported side effects, such as injection-site reactions and diarrhea, occurred in 5% or fewer of patients.

“Over the 2 years, dupilumab was well tolerated, and there was evidence of an increased risk of adverse events for longer exposure,” Dr. Bacharier reported.

It is for this reason that Dr. Bacharier concluded that children with repeated exacerbations requiring steroids despite standard therapies should be considered for dupilumab if they also meet criteria for the T2 inflammatory phenotype. This last point is important.

“In children with low levels of eosinophil and low phenol, we are not seeing these kinds of response,” Dr. Bacharier said. Rather, in the absence of eosinophilia, “there is probably no difference between dupilumab and placebo.”

An important steroid-sparing effect is “suggested” by the data, but Sally E. Wenzel, MD, director of the University of Pittsburgh Asthma and Environmental Lung Health Institute in Pittsburgh, characterized the idea that dupilumab is emerging to be a standard in uncontrolled asthma in children with the T2 phenotype as “a bit premature.”

She challenged the conclusion that the EXCURSION data associated dupilumab with a reduction in annualized steroid courses over time. While the number was lower after 2 years of treatment than after 1, Dr. Wenzel pointed out that all patients were on dupilumab in the second year, “so we don’t know what really happens without treatment.” She said there are other potential explanations, including the possibility that aging children have less active disease.

More importantly, Dr. Wenzel said in an interview that she would also hesitate to urge biologics in every child who meets the criteria that Dr. Bacharier outlined.

“The most important concern is that we do not know how long one should continue the dupilumab and if the long-term treatment adversely or positively affects a growing immune system,” she said.

There is reason to be concerned that blockage of an entire immune pathway with a biologic could adversely affect autoimmunity as well as susceptibility to cancer, according to Dr. Wenzel. She hopes this does not prove to be the case, but she encouraged prudence until there are more data to judge.

While extension data for dupilumab “sound good,” she thinks moving toward any type of standard of care with biologics in children “has to be done with caution and constant evaluation and reevaluation.”

Dr. Bacharier disclosed relationships with AstraZeneca, GlaxoSmithKline, Regeneron and Sanofi. The two latter companies collaborated on the development and marketing of dupilumab. Dr. Wenzel disclosed relationships with AstraZeneca, GlaxoSmithKline, Knopp Pharmaceuticals, Pieris, and Sanofi-Regeneron.

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

NASHVILLE, TENN. – For children with uncontrolled asthma on standard therapies and meeting criteria of a type 2 (T2) inflammatory phenotype, a prospective 1-year extension from a phase 3 trial supports the biologic dupilumab as a potential treatment standard, according to the investigator who presented the findings at the annual meeting of the American College of Chest Physicians (CHEST).

“The appropriate candidate is a child with the T2 inflammatory phenotype who is still experiencing exacerbations on at least a medium dose of inhaled corticosteroids plus a second controller medication,” said Leonard B. Bacharier, MD, section chief, division of pediatric allergy, immunology, and pulmonary medicine, Vanderbilt University Medical Center, Nashville, Tenn.

By T2 inflammatory phenotype, Dr. Bacharier specified that key features include an eosinophil count of at least 150 cells/mL and a FENO level of at least 20 ppb. If children meet these and inadequate standard-therapy response criteria, Dr. Bacharier thinks the extension data support dupilumab as a routine therapy despite the cost.

“As a pediatrician, I think it is really important that children with asthma finish their childhood with the best bone health and the lowest risk of other steroid-associated adverse events,” Dr. Bacharier said.

Over the course of the 1-year extension, called EXCURSION, there was no evidence of diminished efficacy nor of any new safety signal. In other words, patients have remained well controlled for 2 years with a well-tolerated therapy. Dr. Bacharier pointed out, however, that one of the most compelling reasons to consider this as a potential standard was the very low rates at which patients required a course of steroids.

At the end of 1 year in the extension trial, called VOYAGE, the unadjusted annualized total number of steroid courses per patient was 0.414 in the dupilumab group vs. 0.816 in the placebo group. At the end of EXCURSION, following an additional year of therapy, the rate was 0.152.

“This means that fewer than 2 patients out of 10 required prednisone in the previous year,” Dr. Bacharier said.

The EXCURSION extension study did not capture data on steroid-related adverse events, but Dr. Bacharier said that these data are reassuring for both acute and long-term risks of steroid exposure.

“We know that the adverse effects associated with oral steroids are related to cumulative exposure. The more you receive, the greater the risk of adverse effects,” he said.

In patients who were randomly assigned to placebo in the VOYAGE trial and then switched to dupilumab in the EXCURSION extension, steroid exposure was also very low, but whether evaluated as annualized total courses (0.152 vs. 0.181) or by proportion of patients with any steroid intake (10.5% vs. 13.2%), there was a numerical advantage for starting and remaining on dupilumab over the 2-year follow-up.

In VOYAGE, which was published last year in the New England Journal of Medicine, 408 children from ages 6 to 11 years were randomly assigned in a 2:1 ratio to dupilumab or matching placebo. For children weighing less than 30 kg, the dose was 200 mg. For those who weighed less, the dose was 100 mg. Both doses were administered every 2 weeks.

As previously reported, the study met the primary endpoint of annualized rate of severe asthma exacerbations, which was 0.31 in the dupilumab group vs. 0.75 in the placebo group, a relative reduction of 59.3% (P < .001). Dupilumab was also superior on several secondary endpoints, including measures of lung function and asthma control.

The EXCURSION extension study enrolled 365 of the patients who participated in VOYAGE. This included 125 of the 135 randomly assigned to placebo and 240 of the 273 randomly assigned to dupilumab. Those initially randomly assigned to placebo were transitioned to dupilumab. The same weight-based dosing was employed.

At baseline, the children enrolled in VOYAGE had an annualized rate of 2.560 severe exacerbations. At the end of VOYAGE, this rate was 0.330. At the end of EXCURSION after 2 years on dupilumab, the rate was 0.118. In the group switched from placebo to dupilumab, the rate was 0.124.

During EXCURSION, treatment-emergent adverse events occurred in 2.5% of those who remained on dupilumab and 0.8% of those switched from placebo to dupilumab. Three patients (1.3%) permanently discontinued therapy because of a treatment-related event. The most common adverse events involved upper respiratory complaints, such as nasopharyngitis, pharyngitis, upper respiratory tract infections, and rhinitis influenza, but all were reported in fewer than 10% of patients. Other reported side effects, such as injection-site reactions and diarrhea, occurred in 5% or fewer of patients.

“Over the 2 years, dupilumab was well tolerated, and there was evidence of an increased risk of adverse events for longer exposure,” Dr. Bacharier reported.

It is for this reason that Dr. Bacharier concluded that children with repeated exacerbations requiring steroids despite standard therapies should be considered for dupilumab if they also meet criteria for the T2 inflammatory phenotype. This last point is important.

“In children with low levels of eosinophil and low phenol, we are not seeing these kinds of response,” Dr. Bacharier said. Rather, in the absence of eosinophilia, “there is probably no difference between dupilumab and placebo.”

An important steroid-sparing effect is “suggested” by the data, but Sally E. Wenzel, MD, director of the University of Pittsburgh Asthma and Environmental Lung Health Institute in Pittsburgh, characterized the idea that dupilumab is emerging to be a standard in uncontrolled asthma in children with the T2 phenotype as “a bit premature.”

She challenged the conclusion that the EXCURSION data associated dupilumab with a reduction in annualized steroid courses over time. While the number was lower after 2 years of treatment than after 1, Dr. Wenzel pointed out that all patients were on dupilumab in the second year, “so we don’t know what really happens without treatment.” She said there are other potential explanations, including the possibility that aging children have less active disease.

More importantly, Dr. Wenzel said in an interview that she would also hesitate to urge biologics in every child who meets the criteria that Dr. Bacharier outlined.

“The most important concern is that we do not know how long one should continue the dupilumab and if the long-term treatment adversely or positively affects a growing immune system,” she said.

There is reason to be concerned that blockage of an entire immune pathway with a biologic could adversely affect autoimmunity as well as susceptibility to cancer, according to Dr. Wenzel. She hopes this does not prove to be the case, but she encouraged prudence until there are more data to judge.

While extension data for dupilumab “sound good,” she thinks moving toward any type of standard of care with biologics in children “has to be done with caution and constant evaluation and reevaluation.”

Dr. Bacharier disclosed relationships with AstraZeneca, GlaxoSmithKline, Regeneron and Sanofi. The two latter companies collaborated on the development and marketing of dupilumab. Dr. Wenzel disclosed relationships with AstraZeneca, GlaxoSmithKline, Knopp Pharmaceuticals, Pieris, and Sanofi-Regeneron.

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

WASHINGTON – The life expectancy of non-Hispanic Black men who have sex with men (MSM) and are infected with HIV lags their White counterparts by 6.3 years under standard HIV care, new data from simulation modeling suggest.

Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.

“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”

Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.

• The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
• Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
• In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.

Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.

The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.

Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
 

Life expectancy gap ‘alarming’

“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”

With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”

Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.

They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.

Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.

“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.

Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.

Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.

Dr. McManus and the study authors have reported no relevant financial relationships.

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

WASHINGTON – The life expectancy of non-Hispanic Black men who have sex with men (MSM) and are infected with HIV lags their White counterparts by 6.3 years under standard HIV care, new data from simulation modeling suggest.

Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.

“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”

Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.

• The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
• Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
• In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.

Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.

The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.

Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
 

Life expectancy gap ‘alarming’

“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”

With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”

Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.

They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.

Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.

“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.

Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.

Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.

Dr. McManus and the study authors have reported no relevant financial relationships.

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

WASHINGTON – The life expectancy of non-Hispanic Black men who have sex with men (MSM) and are infected with HIV lags their White counterparts by 6.3 years under standard HIV care, new data from simulation modeling suggest.

Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.

“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”

Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.

• The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
• Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
• In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.

Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.

The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.

Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
 

Life expectancy gap ‘alarming’

“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”

With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”

Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.

They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.

Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.

“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.

Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.

Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.

Dr. McManus and the study authors have reported no relevant financial relationships.

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