Conference Coverage

A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.

In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.

The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.

However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
 

Mistaken identity

Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.

Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.

Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.

“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
 

Challenging case

In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.

“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.

The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.

A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.

“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.

The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.

Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.

Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.

“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.

Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.

A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.

In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.

The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.

However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
 

Mistaken identity

Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.

Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.

Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.

“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
 

Challenging case

In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.

“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.

The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.

A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.

“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.

The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.

Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.

Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.

“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.

Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.

A fungal infection typically seen in the lungs may have a variety of unusual clinical presentations elsewhere in the body, even raising suspicion of cancer in some cases, a medical resident reported at the annual meeting of the American College of Chest Physicians.

In one recent and unusual presentation, a 58-year-old woman with persistent headaches had skull lesions on computed tomography (CT) was eventually diagnosed with disseminated coccidioidomycosis (Valley fever), a fungal infection endemic to the Southwestern U.S.

The imaging pattern of her head CT was initially concerning for cancer metastasis, according to Sharjeel Israr, MD, a third-year internal medicine resident at Creighton University in Phoenix, Ariz.

However, the subsequent chest CT revealed a suspicious chest mass. A biopsy of that mass led to the correct diagnosis of disseminated coccidioidomycosis, according to Dr. Israr, who presented the case report in an e-poster at the CHEST meeting, which was held virtually this year.
 

Mistaken identity

Coccidioidomycosis, caused by the fungus Coccidioides, usually affects the lungs, according to the Centers for Disease Control and Prevention. However, in severe cases it can spread to other parts of the body. In those cases, it’s referred to as disseminated coccidioidomycosis.

Arizona accounted for about 10,000 out of 18,000 reported Valley fever cases in 2019, according to the latest statistics from the CDC.

Coccidioidomycosis is frequently mistaken not only for cancer, but also for rheumatic conditions and bacterial infections, according to Valley fever specialist John Galgiani, MD, director of the Valley Fever Center for Excellence at the University of Arizona in Tucson.

“Where Valley fever is common, it should very frequently be in the differential for masses that are thought to be cancer,” Dr. Galgiani said in an interview. “This case is a good example of that.”
 

Challenging case

In an interview, Dr. Israr said the case was challenging to crack despite the fact that Valley fever is very common in Phoenix.

“It was definitely on the differential from the get-go, but it was very, very low our differential, just based on the presentation that she had,” said Dr. Israr.

The patient had history of diabetes and presented with headaches for 4 weeks. However, she had no pulmonary symptoms or meningeal signs, according to Dr. Israr.

A head CT revealed multiple osseous skull lesions and a left temporal lobe lesion.

“The fact that this patient had lesions in the skull, specifically, is something that raised our initial red flags for cancer – especially since she presented with just a headache as her only complaint,” he said.

The imaging pattern was concerning for metastasis, according to Dr. Israr, particularly since a subsequent CT of the chest showed multiple pulmonary nodules plus a 7.7-cm mass in the right lower lobe.

Once the biopsy confirmed coccidioidomycosis, the patient was started on fluconazole 600 mg twice daily, according to Dr. Israr.

Although severe disseminated coccidioidomycosis can be difficult to treat, the lung lesion had decreased in size from 7.7 cm to 4.2 cm about 3 months later, Dr. Israr said.

“At the end of the day, she didn’t have cancer, and it’s something that we’re treating and she’s actually doing better right now,” Dr. Israr said in the interview.

Dr. Israr and coauthors of the case reported they had no relevant relationships to disclose.

Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.

“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”

Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.

The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.

On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.

The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.

Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.

The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.

“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”

While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.

Dr. Huttler said she hopes her findings prompt further discussion of these disparities.

“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.

The experts interviewed disclosed no conflicts on interests.

Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.

“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”

Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.

The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.

On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.

The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.

Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.

The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.

“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”

While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.

Dr. Huttler said she hopes her findings prompt further discussion of these disparities.

“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.

The experts interviewed disclosed no conflicts on interests.

Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.

“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”

Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.

The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.

On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.

The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.

Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.

The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.

“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”

While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.

Dr. Huttler said she hopes her findings prompt further discussion of these disparities.

“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.

The experts interviewed disclosed no conflicts on interests.

Results of a new analysis based on benchmarks from the National Institute for Occupational Safety and Health (NIOSH) suggest that the levels of metals and volatile organic compounds generated during laser tattoo removal procedures are generally safe.

While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”

For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.

For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”

For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”

He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.

Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
 

Picosecond lasers

“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.

Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.

“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”

In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”

In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.

This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.

Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”

Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”

In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

dbrunk@mdedge.com

Results of a new analysis based on benchmarks from the National Institute for Occupational Safety and Health (NIOSH) suggest that the levels of metals and volatile organic compounds generated during laser tattoo removal procedures are generally safe.

While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”

For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.

For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”

For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”

He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.

Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
 

Picosecond lasers

“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.

Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.

“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”

In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”

In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.

This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.

Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”

Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”

In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

dbrunk@mdedge.com

Results of a new analysis based on benchmarks from the National Institute for Occupational Safety and Health (NIOSH) suggest that the levels of metals and volatile organic compounds generated during laser tattoo removal procedures are generally safe.

While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”

For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.

For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”

For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”

He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.

Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
 

Picosecond lasers

“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.

Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.

“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”

In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”

In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.

This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.

Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”

Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”

In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

dbrunk@mdedge.com

Self-administered external trigeminal nerve stimulation (E-TNS) that is available over the counter is superior to sham stimulation in relieving pain for patients with episodic migraine, results from a phase 3 study show.

This is great news for headache patients who want to explore nondrug treatment options, said study investigator Deena E. Kuruvilla, MD, neurologist and headache specialist at the Westport Headache Institute, Connecticut.

She added that such devices “aren’t always part of the conversation when we’re discussing preventive and acute treatments with our patients. Making this a regular part of the conversation might be helpful to patients.”

The findings were presented at ANA 2021: 146th Annual Meeting of the American Neurological Association (ANA), which was held online.
 

A key therapeutic target

The randomized, double-blind trial compared E-TNS with sham stimulation for the acute treatment of migraine.

The E-TNS device (Verum Cefaly Abortive Program) stimulates the supraorbital nerve in the forehead. “This nerve is a branch of the trigeminal nerve, which is thought to be the key player in migraine pathophysiology,” Dr. Kuruvilla noted.

The device has been cleared by the U.S. Food and Drug Administration for acute and preventive treatment of migraine.

During a run-in period before randomization, patients were asked to keep a detailed headache diary and to become comfortable using the trial device to treat an acute migraine attack at home.

The study enrolled 538 adult patients at 10 centers. The patients were aged 18 to 65 years, and they had been having episodic migraines, with or without aura, for at least a year. The participants had to have received a migraine diagnosis before age 50, and they had to be experiencing an attack of migraine 2 to 8 days per month.

The patients used the device only for a migraine of at least moderate intensity that was accompanied by at least one migraine-associated symptom, such as photophobia, phonophobia, or nausea. They were asked not to take rescue medication prior to or during a therapy session.

Study participants applied either neurostimulation or sham stimulation for a continuous 2-hour period within 4 hours of a migraine attack over the 2-month study period.

The two primary endpoints were pain freedom and freedom from the most bothersome migraine-associated symptoms at 2 hours.

Compared to sham treatment, active stimulation was more effective in achieving pain freedom (P = .043) and freedom from the most bothersome migraine-associated symptom (P = .001) at 2 hours.

“So the study did meet both primary endpoints with statistical significance,” said Dr. Kuruvilla.

The five secondary endpoints included pain relief at 2 hours; absence of all migraine-associated symptoms at 2 hours; use of rescue medication within 24 hours; sustained pain freedom at 24 hours; and sustained pain relief at 24 hours.

All but one of these endpoints reached statistical significance, showing superiority for the active intervention. The only exception was in regard to use of rescue medication.

The most common adverse event (AE) was forehead paresthesia, discomfort, or burning, which was more common in the active-treatment group than in the sham-treatment group (P = .009). There were four cases of nausea or vomiting in the active-treatment group and none in the sham-treatment group. There were no serious AEs.
 

Available over the counter

Both moderators of the headache poster tour that featured this study – Justin C. McArthur, MBBS, from Johns Hopkins University, Baltimore, and Steven Galetta, MD, from NYU Grossman School of Medicine – praised the presentation.

Dr. Galetta questioned whether patients were receiving preventive therapies. Dr. Kuruvilla said that the patients were allowed to enter the trial while taking preventive therapies, including antiepileptic treatments, blood pressure medications, and antidepressants, but that they had to be receiving stable doses.

The investigators didn’t distinguish between participants who were taking preventive therapies and those who weren’t, she said. “The aim was really to look at acute treatment for migraine,” and patients taking such medication “had been stable on their regimen for a pretty prolonged period of time.”

Dr. McArthur asked about the origin of the nausea some patients experienced.

It was difficult to determine whether the nausea was an aspect of an individual patient’s migraine attack or was an effect of the stimulation, said Dr. Kuruvilla. She noted that some patients found the vibrating sensation from the device uncomfortable and that nausea could be associated with pain at the site.

The device costs $300 to $400 (U.S.) and is available over the counter.

Dr. Kuruvilla is a consultant for Cefaly, Neurolief, Theranica, Now What Media, and Kx Advisors. She is on the speakers bureau for AbbVie/Allergan, Amgen/Novartis, Lilly, the American Headache Society, Biohaven, and CME meeting, and she is on an advisory board at AbbVie/Allergan, Lilly, Theranica, and Amgen/Novartis. She is editor and associate editor of Healthline and is an author for WebMD/Medscape, Healthline.

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

Self-administered external trigeminal nerve stimulation (E-TNS) that is available over the counter is superior to sham stimulation in relieving pain for patients with episodic migraine, results from a phase 3 study show.

This is great news for headache patients who want to explore nondrug treatment options, said study investigator Deena E. Kuruvilla, MD, neurologist and headache specialist at the Westport Headache Institute, Connecticut.

She added that such devices “aren’t always part of the conversation when we’re discussing preventive and acute treatments with our patients. Making this a regular part of the conversation might be helpful to patients.”

The findings were presented at ANA 2021: 146th Annual Meeting of the American Neurological Association (ANA), which was held online.
 

A key therapeutic target

The randomized, double-blind trial compared E-TNS with sham stimulation for the acute treatment of migraine.

The E-TNS device (Verum Cefaly Abortive Program) stimulates the supraorbital nerve in the forehead. “This nerve is a branch of the trigeminal nerve, which is thought to be the key player in migraine pathophysiology,” Dr. Kuruvilla noted.

The device has been cleared by the U.S. Food and Drug Administration for acute and preventive treatment of migraine.

During a run-in period before randomization, patients were asked to keep a detailed headache diary and to become comfortable using the trial device to treat an acute migraine attack at home.

The study enrolled 538 adult patients at 10 centers. The patients were aged 18 to 65 years, and they had been having episodic migraines, with or without aura, for at least a year. The participants had to have received a migraine diagnosis before age 50, and they had to be experiencing an attack of migraine 2 to 8 days per month.

The patients used the device only for a migraine of at least moderate intensity that was accompanied by at least one migraine-associated symptom, such as photophobia, phonophobia, or nausea. They were asked not to take rescue medication prior to or during a therapy session.

Study participants applied either neurostimulation or sham stimulation for a continuous 2-hour period within 4 hours of a migraine attack over the 2-month study period.

The two primary endpoints were pain freedom and freedom from the most bothersome migraine-associated symptoms at 2 hours.

Compared to sham treatment, active stimulation was more effective in achieving pain freedom (P = .043) and freedom from the most bothersome migraine-associated symptom (P = .001) at 2 hours.

“So the study did meet both primary endpoints with statistical significance,” said Dr. Kuruvilla.

The five secondary endpoints included pain relief at 2 hours; absence of all migraine-associated symptoms at 2 hours; use of rescue medication within 24 hours; sustained pain freedom at 24 hours; and sustained pain relief at 24 hours.

All but one of these endpoints reached statistical significance, showing superiority for the active intervention. The only exception was in regard to use of rescue medication.

The most common adverse event (AE) was forehead paresthesia, discomfort, or burning, which was more common in the active-treatment group than in the sham-treatment group (P = .009). There were four cases of nausea or vomiting in the active-treatment group and none in the sham-treatment group. There were no serious AEs.
 

Available over the counter

Both moderators of the headache poster tour that featured this study – Justin C. McArthur, MBBS, from Johns Hopkins University, Baltimore, and Steven Galetta, MD, from NYU Grossman School of Medicine – praised the presentation.

Dr. Galetta questioned whether patients were receiving preventive therapies. Dr. Kuruvilla said that the patients were allowed to enter the trial while taking preventive therapies, including antiepileptic treatments, blood pressure medications, and antidepressants, but that they had to be receiving stable doses.

The investigators didn’t distinguish between participants who were taking preventive therapies and those who weren’t, she said. “The aim was really to look at acute treatment for migraine,” and patients taking such medication “had been stable on their regimen for a pretty prolonged period of time.”

Dr. McArthur asked about the origin of the nausea some patients experienced.

It was difficult to determine whether the nausea was an aspect of an individual patient’s migraine attack or was an effect of the stimulation, said Dr. Kuruvilla. She noted that some patients found the vibrating sensation from the device uncomfortable and that nausea could be associated with pain at the site.

The device costs $300 to $400 (U.S.) and is available over the counter.

Dr. Kuruvilla is a consultant for Cefaly, Neurolief, Theranica, Now What Media, and Kx Advisors. She is on the speakers bureau for AbbVie/Allergan, Amgen/Novartis, Lilly, the American Headache Society, Biohaven, and CME meeting, and she is on an advisory board at AbbVie/Allergan, Lilly, Theranica, and Amgen/Novartis. She is editor and associate editor of Healthline and is an author for WebMD/Medscape, Healthline.

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

Self-administered external trigeminal nerve stimulation (E-TNS) that is available over the counter is superior to sham stimulation in relieving pain for patients with episodic migraine, results from a phase 3 study show.

This is great news for headache patients who want to explore nondrug treatment options, said study investigator Deena E. Kuruvilla, MD, neurologist and headache specialist at the Westport Headache Institute, Connecticut.

She added that such devices “aren’t always part of the conversation when we’re discussing preventive and acute treatments with our patients. Making this a regular part of the conversation might be helpful to patients.”

The findings were presented at ANA 2021: 146th Annual Meeting of the American Neurological Association (ANA), which was held online.
 

A key therapeutic target

The randomized, double-blind trial compared E-TNS with sham stimulation for the acute treatment of migraine.

The E-TNS device (Verum Cefaly Abortive Program) stimulates the supraorbital nerve in the forehead. “This nerve is a branch of the trigeminal nerve, which is thought to be the key player in migraine pathophysiology,” Dr. Kuruvilla noted.

The device has been cleared by the U.S. Food and Drug Administration for acute and preventive treatment of migraine.

During a run-in period before randomization, patients were asked to keep a detailed headache diary and to become comfortable using the trial device to treat an acute migraine attack at home.

The study enrolled 538 adult patients at 10 centers. The patients were aged 18 to 65 years, and they had been having episodic migraines, with or without aura, for at least a year. The participants had to have received a migraine diagnosis before age 50, and they had to be experiencing an attack of migraine 2 to 8 days per month.

The patients used the device only for a migraine of at least moderate intensity that was accompanied by at least one migraine-associated symptom, such as photophobia, phonophobia, or nausea. They were asked not to take rescue medication prior to or during a therapy session.

Study participants applied either neurostimulation or sham stimulation for a continuous 2-hour period within 4 hours of a migraine attack over the 2-month study period.

The two primary endpoints were pain freedom and freedom from the most bothersome migraine-associated symptoms at 2 hours.

Compared to sham treatment, active stimulation was more effective in achieving pain freedom (P = .043) and freedom from the most bothersome migraine-associated symptom (P = .001) at 2 hours.

“So the study did meet both primary endpoints with statistical significance,” said Dr. Kuruvilla.

The five secondary endpoints included pain relief at 2 hours; absence of all migraine-associated symptoms at 2 hours; use of rescue medication within 24 hours; sustained pain freedom at 24 hours; and sustained pain relief at 24 hours.

All but one of these endpoints reached statistical significance, showing superiority for the active intervention. The only exception was in regard to use of rescue medication.

The most common adverse event (AE) was forehead paresthesia, discomfort, or burning, which was more common in the active-treatment group than in the sham-treatment group (P = .009). There were four cases of nausea or vomiting in the active-treatment group and none in the sham-treatment group. There were no serious AEs.
 

Available over the counter

Both moderators of the headache poster tour that featured this study – Justin C. McArthur, MBBS, from Johns Hopkins University, Baltimore, and Steven Galetta, MD, from NYU Grossman School of Medicine – praised the presentation.

Dr. Galetta questioned whether patients were receiving preventive therapies. Dr. Kuruvilla said that the patients were allowed to enter the trial while taking preventive therapies, including antiepileptic treatments, blood pressure medications, and antidepressants, but that they had to be receiving stable doses.

The investigators didn’t distinguish between participants who were taking preventive therapies and those who weren’t, she said. “The aim was really to look at acute treatment for migraine,” and patients taking such medication “had been stable on their regimen for a pretty prolonged period of time.”

Dr. McArthur asked about the origin of the nausea some patients experienced.

It was difficult to determine whether the nausea was an aspect of an individual patient’s migraine attack or was an effect of the stimulation, said Dr. Kuruvilla. She noted that some patients found the vibrating sensation from the device uncomfortable and that nausea could be associated with pain at the site.

The device costs $300 to $400 (U.S.) and is available over the counter.

Dr. Kuruvilla is a consultant for Cefaly, Neurolief, Theranica, Now What Media, and Kx Advisors. She is on the speakers bureau for AbbVie/Allergan, Amgen/Novartis, Lilly, the American Headache Society, Biohaven, and CME meeting, and she is on an advisory board at AbbVie/Allergan, Lilly, Theranica, and Amgen/Novartis. She is editor and associate editor of Healthline and is an author for WebMD/Medscape, Healthline.

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

A large international team of experts has developed two comprehensive guidelines for diagnosing, evaluating, and managing hypoparathyroidism and hyperparathyroidism, which replace guidelines issued 5 and 7 years ago.

Aliya A. Khan, MD, presented an overview of the hypoparathyroidism guidelines and John P. Bilezikian, MD, presented key aspects of the hyperparathyroidism guidelines at the American Society of Bone and Mineral Research (ASBMR) 2021 Annual Meeting.

The guidelines will be published as 17 articles in two issues of the society’s Journal of Bone and Mineral Research in 2022 – one on hypoparathyroidism and the other on hyperparathyroidism.

The work represents an “unprecedented effort” by more than 100 experts from 16 countries (United States, Canada, Australia, Brazil, China, Denmark, France, Germany, India, Italy, Israel, Lebanon, Singapore, Spain, Sweden, and the United Kingdom), Dr. Bilezikian told this news organization in an interview.

More than 100 international and national endocrine and osteoporosis organizations, societies, and patient advocacy groups from more than 50 countries have expressed interest in endorsing the guidelines.
 

Management of hypoparathyroidism

The new guidelines on hypoparathyroidism replace the guidelines issued in 2016 that were developed at the First International Conference on the Management of Hypoparathyroidism, Dr. Khan, from McMaster University, Hamilton, Ont., said in an email.

There was a need for new hypoparathyroidism guidelines, she explained, because of the better understanding of associated complications, how to predict who will develop hypoparathyroidism postoperatively (and how to prevent this), how and when to investigate a genetic cause further, when to consider parathyroid hormone (PTH) replacement therapy (and the benefits of the various molecules available today as well as those being evaluated in clinical research), and how to diagnose and manage hypoparathyroidism during pregnancy and lactation.

The experts in hypoparathyroidism were divided into four task forces that covered epidemiology and financial burden, etiology and pathophysiology, genetics and diagnosis, and patient evaluation and management.

The guidelines, developed over the past 18 months, provide detailed evidence-based graded (strong to weak) as well as ungraded (current practice) recommendations.

Summarizing a few key takeaways, Dr. Khan noted the guidelines recommend that clinicians treating patients with hypoparathyroidism should:

• Diagnose hypoparathyroidism if serum calcium corrected for albumin is low in the presence of a low or inappropriately normal PTH confirmed on two occasions 2 weeks apart (which may be supported by other specified abnormalities).
• Determine the cause for the hypoparathyroidism (which includes postsurgery, genetic variant, autoimmune, radiation, or idiopathic causes).
• Evaluate target organ damage.
• Try to achieve treatment goals and minimize risks for long-term complications.
• Consider PTH replacement therapy if patients have inadequate control, with symptoms of hypocalcemia or hypercalcemia, high phosphate, kidney disease, or high urine calcium, or poor quality of life. 

The guideline strongly recommends using PTH measurements after total thyroidectomy to try to predict which patients will develop permanent postsurgical hypoparathyroidism.

It provides a clinical approach for establishing the genetic etiology of hypoparathyroidism.

A meta-analysis of 81 studies identified that the most common symptoms/complications of chronic hypoparathyroidism were, in descending order, cataract (24%), infection (18%), nephrolithiasis, renal insufficiency, seizures, depression, ischemic heart disease, and arrhythmias.

Based on the best available evidence, the guideline advises that “clinicians need to carefully determine why a patient has hypoparathyroidism and develop an individualized treatment plan with conventional therapy consisting of calcium, active vitamin D, hydrochlorothiazide, and plain vitamin D,” Dr. Khan continued.

“If a patient has poorly controlled hypoparathyroidism with many symptoms or is not doing well, then clinicians must consider PTH replacement therapy, since this will replace the missing hormone, lower the urine calcium losses, bring the serum calcium back up to the normal reference range, and lower phosphate (which appears to be associated with kidney calcification and may also contribute to basal ganglia calcification and calcium deposits in the eye),” she noted.

The guideline also discusses the optimal way to monitor and treat patients during pregnancy, delivery, and breastfeeding to optimize outcomes for mother and baby. The key points are closer patient monitoring with normalization of calcium, urine calcium, phosphate, and vitamin D.  
 

Management of primary hyperparathyroidism

There was a need to update the previous 2014 guidelines developed at the Fourth International Workshop on the Management of Primary Hyperparathyroidism because, among other things, recent studies have provided new evidence about the different clinical phenotypes of primary hyperparathyroidism and ways the disease affects the skeleton and kidneys, Dr. Bilezikian, from the College of Physicians and Surgeons, Columbia University, New York, explained.

The experts in hyperparathyroidism were divided into four task forces that covered epidemiology, pathophysiology and genetics; classical and nonclassical disease manifestations; surgical aspects; and patient evaluation and management.

As part of these topics, the experts reviewed biochemical, skeletal, and renal findings, nonclassical features (such as neurocognitive complaints), nutritional and pharmacologic approaches, and disease course with or without surgical or medical intervention.

They made recommendations for diagnosis of hypercalcemic and normocalcemic phenotypes, differential diagnosis, evaluation of the skeleton and the kidney, indications for surgery, role of parathyroid imaging, indications for pharmacologic intervention, and monitoring.

“Consider the way this disease has appeared to change in the last 50 years,” said Dr. Bilezikian. In the 1940s, 50s, and 60s, patients with hyperparathyroidism were really sick and had severe bone disease and kidney disease. Then in the 70s, 80s, and 90s, the disease was more often discovered because of a screening test; high serum calcium was a hallmark of finding asymptomatic hyperparathyroidism.

In recent years, hyperparathyroidism is often discovered incidentally, when examining the skeleton or kidneys, he continued.

Primary hyperparathyroidism can now be subdivided into three types: patients who have target organ (kidney, bone) involvement, patients who don’t have this, and patients who have normocalcemic primary hyperparathyroidism.

The guideline discusses new medications that have become available for hyperparathyroidism, as well as surgery (the only cure), including how preoperative imaging can identify the overactive parathyroid gland, and the guidelines go into detail about how to monitor a patient and why a clinician would or would not recommend surgery, Dr. Bilezikian explained.

In the end, treatment is tailored to the individual.

Last, the guideline identifies eight areas where more research is needed.

The guidelines were funded by unrestricted educational grants from Amolyt, Ascendis, Calcilytix, and Takeda. Dr. Khan has reported participating on advisory boards for Alexion, Amgen, Amolyt, and Takeda, being a consultant for Amgen, receiving grants from Alexion, Amgen, Takeda, and Ascendis, being an investigator for Alexion, Amgen, Takeda, Ascendis, and Chugai, and being a speaker for Alexion, Amgen, Takeda, and Ultragenyx. Dr. Bilezikian has reported no relevant financial relationships.

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

A large international team of experts has developed two comprehensive guidelines for diagnosing, evaluating, and managing hypoparathyroidism and hyperparathyroidism, which replace guidelines issued 5 and 7 years ago.

Aliya A. Khan, MD, presented an overview of the hypoparathyroidism guidelines and John P. Bilezikian, MD, presented key aspects of the hyperparathyroidism guidelines at the American Society of Bone and Mineral Research (ASBMR) 2021 Annual Meeting.

The guidelines will be published as 17 articles in two issues of the society’s Journal of Bone and Mineral Research in 2022 – one on hypoparathyroidism and the other on hyperparathyroidism.

The work represents an “unprecedented effort” by more than 100 experts from 16 countries (United States, Canada, Australia, Brazil, China, Denmark, France, Germany, India, Italy, Israel, Lebanon, Singapore, Spain, Sweden, and the United Kingdom), Dr. Bilezikian told this news organization in an interview.

More than 100 international and national endocrine and osteoporosis organizations, societies, and patient advocacy groups from more than 50 countries have expressed interest in endorsing the guidelines.
 

Management of hypoparathyroidism

The new guidelines on hypoparathyroidism replace the guidelines issued in 2016 that were developed at the First International Conference on the Management of Hypoparathyroidism, Dr. Khan, from McMaster University, Hamilton, Ont., said in an email.

There was a need for new hypoparathyroidism guidelines, she explained, because of the better understanding of associated complications, how to predict who will develop hypoparathyroidism postoperatively (and how to prevent this), how and when to investigate a genetic cause further, when to consider parathyroid hormone (PTH) replacement therapy (and the benefits of the various molecules available today as well as those being evaluated in clinical research), and how to diagnose and manage hypoparathyroidism during pregnancy and lactation.

The experts in hypoparathyroidism were divided into four task forces that covered epidemiology and financial burden, etiology and pathophysiology, genetics and diagnosis, and patient evaluation and management.

The guidelines, developed over the past 18 months, provide detailed evidence-based graded (strong to weak) as well as ungraded (current practice) recommendations.

Summarizing a few key takeaways, Dr. Khan noted the guidelines recommend that clinicians treating patients with hypoparathyroidism should:

• Diagnose hypoparathyroidism if serum calcium corrected for albumin is low in the presence of a low or inappropriately normal PTH confirmed on two occasions 2 weeks apart (which may be supported by other specified abnormalities).
• Determine the cause for the hypoparathyroidism (which includes postsurgery, genetic variant, autoimmune, radiation, or idiopathic causes).
• Evaluate target organ damage.
• Try to achieve treatment goals and minimize risks for long-term complications.
• Consider PTH replacement therapy if patients have inadequate control, with symptoms of hypocalcemia or hypercalcemia, high phosphate, kidney disease, or high urine calcium, or poor quality of life. 

The guideline strongly recommends using PTH measurements after total thyroidectomy to try to predict which patients will develop permanent postsurgical hypoparathyroidism.

It provides a clinical approach for establishing the genetic etiology of hypoparathyroidism.

A meta-analysis of 81 studies identified that the most common symptoms/complications of chronic hypoparathyroidism were, in descending order, cataract (24%), infection (18%), nephrolithiasis, renal insufficiency, seizures, depression, ischemic heart disease, and arrhythmias.

Based on the best available evidence, the guideline advises that “clinicians need to carefully determine why a patient has hypoparathyroidism and develop an individualized treatment plan with conventional therapy consisting of calcium, active vitamin D, hydrochlorothiazide, and plain vitamin D,” Dr. Khan continued.

“If a patient has poorly controlled hypoparathyroidism with many symptoms or is not doing well, then clinicians must consider PTH replacement therapy, since this will replace the missing hormone, lower the urine calcium losses, bring the serum calcium back up to the normal reference range, and lower phosphate (which appears to be associated with kidney calcification and may also contribute to basal ganglia calcification and calcium deposits in the eye),” she noted.

The guideline also discusses the optimal way to monitor and treat patients during pregnancy, delivery, and breastfeeding to optimize outcomes for mother and baby. The key points are closer patient monitoring with normalization of calcium, urine calcium, phosphate, and vitamin D.  
 

Management of primary hyperparathyroidism

There was a need to update the previous 2014 guidelines developed at the Fourth International Workshop on the Management of Primary Hyperparathyroidism because, among other things, recent studies have provided new evidence about the different clinical phenotypes of primary hyperparathyroidism and ways the disease affects the skeleton and kidneys, Dr. Bilezikian, from the College of Physicians and Surgeons, Columbia University, New York, explained.

The experts in hyperparathyroidism were divided into four task forces that covered epidemiology, pathophysiology and genetics; classical and nonclassical disease manifestations; surgical aspects; and patient evaluation and management.

As part of these topics, the experts reviewed biochemical, skeletal, and renal findings, nonclassical features (such as neurocognitive complaints), nutritional and pharmacologic approaches, and disease course with or without surgical or medical intervention.

They made recommendations for diagnosis of hypercalcemic and normocalcemic phenotypes, differential diagnosis, evaluation of the skeleton and the kidney, indications for surgery, role of parathyroid imaging, indications for pharmacologic intervention, and monitoring.

“Consider the way this disease has appeared to change in the last 50 years,” said Dr. Bilezikian. In the 1940s, 50s, and 60s, patients with hyperparathyroidism were really sick and had severe bone disease and kidney disease. Then in the 70s, 80s, and 90s, the disease was more often discovered because of a screening test; high serum calcium was a hallmark of finding asymptomatic hyperparathyroidism.

In recent years, hyperparathyroidism is often discovered incidentally, when examining the skeleton or kidneys, he continued.

Primary hyperparathyroidism can now be subdivided into three types: patients who have target organ (kidney, bone) involvement, patients who don’t have this, and patients who have normocalcemic primary hyperparathyroidism.

The guideline discusses new medications that have become available for hyperparathyroidism, as well as surgery (the only cure), including how preoperative imaging can identify the overactive parathyroid gland, and the guidelines go into detail about how to monitor a patient and why a clinician would or would not recommend surgery, Dr. Bilezikian explained.

In the end, treatment is tailored to the individual.

Last, the guideline identifies eight areas where more research is needed.

The guidelines were funded by unrestricted educational grants from Amolyt, Ascendis, Calcilytix, and Takeda. Dr. Khan has reported participating on advisory boards for Alexion, Amgen, Amolyt, and Takeda, being a consultant for Amgen, receiving grants from Alexion, Amgen, Takeda, and Ascendis, being an investigator for Alexion, Amgen, Takeda, Ascendis, and Chugai, and being a speaker for Alexion, Amgen, Takeda, and Ultragenyx. Dr. Bilezikian has reported no relevant financial relationships.

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

A large international team of experts has developed two comprehensive guidelines for diagnosing, evaluating, and managing hypoparathyroidism and hyperparathyroidism, which replace guidelines issued 5 and 7 years ago.

Aliya A. Khan, MD, presented an overview of the hypoparathyroidism guidelines and John P. Bilezikian, MD, presented key aspects of the hyperparathyroidism guidelines at the American Society of Bone and Mineral Research (ASBMR) 2021 Annual Meeting.

The guidelines will be published as 17 articles in two issues of the society’s Journal of Bone and Mineral Research in 2022 – one on hypoparathyroidism and the other on hyperparathyroidism.

The work represents an “unprecedented effort” by more than 100 experts from 16 countries (United States, Canada, Australia, Brazil, China, Denmark, France, Germany, India, Italy, Israel, Lebanon, Singapore, Spain, Sweden, and the United Kingdom), Dr. Bilezikian told this news organization in an interview.

More than 100 international and national endocrine and osteoporosis organizations, societies, and patient advocacy groups from more than 50 countries have expressed interest in endorsing the guidelines.
 

Management of hypoparathyroidism

The new guidelines on hypoparathyroidism replace the guidelines issued in 2016 that were developed at the First International Conference on the Management of Hypoparathyroidism, Dr. Khan, from McMaster University, Hamilton, Ont., said in an email.

There was a need for new hypoparathyroidism guidelines, she explained, because of the better understanding of associated complications, how to predict who will develop hypoparathyroidism postoperatively (and how to prevent this), how and when to investigate a genetic cause further, when to consider parathyroid hormone (PTH) replacement therapy (and the benefits of the various molecules available today as well as those being evaluated in clinical research), and how to diagnose and manage hypoparathyroidism during pregnancy and lactation.

The experts in hypoparathyroidism were divided into four task forces that covered epidemiology and financial burden, etiology and pathophysiology, genetics and diagnosis, and patient evaluation and management.

The guidelines, developed over the past 18 months, provide detailed evidence-based graded (strong to weak) as well as ungraded (current practice) recommendations.

Summarizing a few key takeaways, Dr. Khan noted the guidelines recommend that clinicians treating patients with hypoparathyroidism should:

• Diagnose hypoparathyroidism if serum calcium corrected for albumin is low in the presence of a low or inappropriately normal PTH confirmed on two occasions 2 weeks apart (which may be supported by other specified abnormalities).
• Determine the cause for the hypoparathyroidism (which includes postsurgery, genetic variant, autoimmune, radiation, or idiopathic causes).
• Evaluate target organ damage.
• Try to achieve treatment goals and minimize risks for long-term complications.
• Consider PTH replacement therapy if patients have inadequate control, with symptoms of hypocalcemia or hypercalcemia, high phosphate, kidney disease, or high urine calcium, or poor quality of life. 

The guideline strongly recommends using PTH measurements after total thyroidectomy to try to predict which patients will develop permanent postsurgical hypoparathyroidism.

It provides a clinical approach for establishing the genetic etiology of hypoparathyroidism.

A meta-analysis of 81 studies identified that the most common symptoms/complications of chronic hypoparathyroidism were, in descending order, cataract (24%), infection (18%), nephrolithiasis, renal insufficiency, seizures, depression, ischemic heart disease, and arrhythmias.

Based on the best available evidence, the guideline advises that “clinicians need to carefully determine why a patient has hypoparathyroidism and develop an individualized treatment plan with conventional therapy consisting of calcium, active vitamin D, hydrochlorothiazide, and plain vitamin D,” Dr. Khan continued.

“If a patient has poorly controlled hypoparathyroidism with many symptoms or is not doing well, then clinicians must consider PTH replacement therapy, since this will replace the missing hormone, lower the urine calcium losses, bring the serum calcium back up to the normal reference range, and lower phosphate (which appears to be associated with kidney calcification and may also contribute to basal ganglia calcification and calcium deposits in the eye),” she noted.

The guideline also discusses the optimal way to monitor and treat patients during pregnancy, delivery, and breastfeeding to optimize outcomes for mother and baby. The key points are closer patient monitoring with normalization of calcium, urine calcium, phosphate, and vitamin D.  
 

Management of primary hyperparathyroidism

There was a need to update the previous 2014 guidelines developed at the Fourth International Workshop on the Management of Primary Hyperparathyroidism because, among other things, recent studies have provided new evidence about the different clinical phenotypes of primary hyperparathyroidism and ways the disease affects the skeleton and kidneys, Dr. Bilezikian, from the College of Physicians and Surgeons, Columbia University, New York, explained.

The experts in hyperparathyroidism were divided into four task forces that covered epidemiology, pathophysiology and genetics; classical and nonclassical disease manifestations; surgical aspects; and patient evaluation and management.

As part of these topics, the experts reviewed biochemical, skeletal, and renal findings, nonclassical features (such as neurocognitive complaints), nutritional and pharmacologic approaches, and disease course with or without surgical or medical intervention.

They made recommendations for diagnosis of hypercalcemic and normocalcemic phenotypes, differential diagnosis, evaluation of the skeleton and the kidney, indications for surgery, role of parathyroid imaging, indications for pharmacologic intervention, and monitoring.

“Consider the way this disease has appeared to change in the last 50 years,” said Dr. Bilezikian. In the 1940s, 50s, and 60s, patients with hyperparathyroidism were really sick and had severe bone disease and kidney disease. Then in the 70s, 80s, and 90s, the disease was more often discovered because of a screening test; high serum calcium was a hallmark of finding asymptomatic hyperparathyroidism.

In recent years, hyperparathyroidism is often discovered incidentally, when examining the skeleton or kidneys, he continued.

Primary hyperparathyroidism can now be subdivided into three types: patients who have target organ (kidney, bone) involvement, patients who don’t have this, and patients who have normocalcemic primary hyperparathyroidism.

The guideline discusses new medications that have become available for hyperparathyroidism, as well as surgery (the only cure), including how preoperative imaging can identify the overactive parathyroid gland, and the guidelines go into detail about how to monitor a patient and why a clinician would or would not recommend surgery, Dr. Bilezikian explained.

In the end, treatment is tailored to the individual.

Last, the guideline identifies eight areas where more research is needed.

The guidelines were funded by unrestricted educational grants from Amolyt, Ascendis, Calcilytix, and Takeda. Dr. Khan has reported participating on advisory boards for Alexion, Amgen, Amolyt, and Takeda, being a consultant for Amgen, receiving grants from Alexion, Amgen, Takeda, and Ascendis, being an investigator for Alexion, Amgen, Takeda, Ascendis, and Chugai, and being a speaker for Alexion, Amgen, Takeda, and Ultragenyx. Dr. Bilezikian has reported no relevant financial relationships.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

Women with systemic lupus erythematous (SLE) who are at risk for preeclampsia may benefit from timely treatment with low-dose aspirin and perhaps hydroxychloroquine, according to German researchers.

©American Heart Association

In a prospective, real-world study of 190 pregnancies in 148 women (average age, 30 years), the use of low-dose aspirin starting around the 16th week of gestation was associated with a lower risk for preeclampsia than was no aspirin use (adjusted odds ratio [aOR], 0.21; P < .05).

The use of hydroxychloroquine starting in the first trimester had a “moderating effect,” said Isabell Haase, MD, a senior clinician scientist in the department of rheumatology at Hiller-Research Unit, Düsseldorf, Germany. Although this was not a statistically significant effect (aOR, 0.47; P = .21), the association strengthened if only high-risk pregnancies were considered (aOR, 0.28; P = .075).

“I think this once more shows us that counseling and risk assessment in our lupus patients is very important to find out those with the highest risk and treat them as good as possible,” Dr. Haase said at an international congress on systemic lupus erythematosus.

Preeclampsia and lupus

“Women with SLE face a high risk of preeclampsia because of their autoimmune disease,” Dr. Haase explained. “This [risk] can be further increased if a woman carries additional risk factors, like hypertension or lupus nephritis.”

Low-dose aspirin is known to protect against the development of preeclampsia in women without autoimmune disease if started before the 16th gestational week of pregnancy, Dr. Haase added. That is why it’s recommended by both the American College of Rheumatology and the European Alliance of Associations for Rheumatology.

“For hydroxychloroquine, we only have some small studies and its mechanism of action that lead us to the idea that it could also have a beneficial effect on preeclampsia in lupus patients,” she said.
 

Study design and results

The aim of the study was to see in a real-world cohort whether there was any beneficial effect of either aspirin or hydroxychloroquine regarding the development of preeclampsia.

The researchers used prospectively collected data from pregnancies seen at an outpatient pregnancy clinic during 1995-2019. They used multiple logistic regression to determine whether there was any effect of four treatments on the development of preeclampsia: aspirin (n = 39 patients) or hydroxychloroquine (n = 39) alone, in combination (n = 43), or neither drug (n = 69).

Overall, 56% of the women had significant risk factors for preeclampsia, including a prior history, multifetal gestation, chronic hypertension, lupus nephritis, or antiphospholipid antibodies (aPL). A further 28% had moderate risk factors, including not having had children, a body mass index >30 kg/m², and being older than 35 years.

The overall rate of preeclampsia in the study population was 13.2%, “which is in line with other studies in lupus pregnancies,” Dr. Haase said. Rates in each of the four treatment groups were 15.4% with aspirin alone, 7.7% with hydroxychloroquine alone, 14% with both drugs, and 14.5% with neither.

The odds of developing preeclampsia were lower with both aspirin and hydroxychloroquine. Factors that raised the odds were high disease activity in the first trimester (aOR, 4.55), a BMI of >30 kg/m² (aOR, 6.14), having high-risk aPL or antiphospholipid syndrome (aOR, 8.02), and a history of preeclampsia (aOR, 9.78).

Only high disease activity in the first trimester and BMI >30 kg/m² remained independent predictors of preeclampsia when the researchers considered only high-risk pregnancies (aOR, 7.74 for high disease activity in first trimester and 10.04 for a high BMI).

The results are “really impressive,” said Angela Tincani, MD, senior consultant at the Rheumatology and Clinical Immunology Unit of ASST–Spedali Civili di Brescia, in Italy.

Dr. Tincani observed that the study had covered a “large number of years” (1995-2020).

“I think that our attitude in looking after lupus patients [changed] during this time,” she said.

“As an example, I think that we probably use less corticosteroids now than in the 90s,” she said.

When asked whether changes in practices have influenced the findings, she acknowledged, “You can see that the prescription of the different medications has changed a lot. We also thought that we have to take into account the years as a confounder, but we haven’t statistically analyzed that, but it’s definitely something that we are going to do next.”

The study received no outside funding. Dr. Haase has received travel fees from AbbVie, Celgene, Chugai, Janssen-Cilag, Eli Lilly, and Medac. Dr. Tincani has disclosed no relevant financial relationships.

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

Women with systemic lupus erythematous (SLE) who are at risk for preeclampsia may benefit from timely treatment with low-dose aspirin and perhaps hydroxychloroquine, according to German researchers.

©American Heart Association

In a prospective, real-world study of 190 pregnancies in 148 women (average age, 30 years), the use of low-dose aspirin starting around the 16th week of gestation was associated with a lower risk for preeclampsia than was no aspirin use (adjusted odds ratio [aOR], 0.21; P < .05).

The use of hydroxychloroquine starting in the first trimester had a “moderating effect,” said Isabell Haase, MD, a senior clinician scientist in the department of rheumatology at Hiller-Research Unit, Düsseldorf, Germany. Although this was not a statistically significant effect (aOR, 0.47; P = .21), the association strengthened if only high-risk pregnancies were considered (aOR, 0.28; P = .075).

“I think this once more shows us that counseling and risk assessment in our lupus patients is very important to find out those with the highest risk and treat them as good as possible,” Dr. Haase said at an international congress on systemic lupus erythematosus.

Preeclampsia and lupus

“Women with SLE face a high risk of preeclampsia because of their autoimmune disease,” Dr. Haase explained. “This [risk] can be further increased if a woman carries additional risk factors, like hypertension or lupus nephritis.”

Low-dose aspirin is known to protect against the development of preeclampsia in women without autoimmune disease if started before the 16th gestational week of pregnancy, Dr. Haase added. That is why it’s recommended by both the American College of Rheumatology and the European Alliance of Associations for Rheumatology.

“For hydroxychloroquine, we only have some small studies and its mechanism of action that lead us to the idea that it could also have a beneficial effect on preeclampsia in lupus patients,” she said.
 

Study design and results

The aim of the study was to see in a real-world cohort whether there was any beneficial effect of either aspirin or hydroxychloroquine regarding the development of preeclampsia.

The researchers used prospectively collected data from pregnancies seen at an outpatient pregnancy clinic during 1995-2019. They used multiple logistic regression to determine whether there was any effect of four treatments on the development of preeclampsia: aspirin (n = 39 patients) or hydroxychloroquine (n = 39) alone, in combination (n = 43), or neither drug (n = 69).

Overall, 56% of the women had significant risk factors for preeclampsia, including a prior history, multifetal gestation, chronic hypertension, lupus nephritis, or antiphospholipid antibodies (aPL). A further 28% had moderate risk factors, including not having had children, a body mass index >30 kg/m², and being older than 35 years.

The overall rate of preeclampsia in the study population was 13.2%, “which is in line with other studies in lupus pregnancies,” Dr. Haase said. Rates in each of the four treatment groups were 15.4% with aspirin alone, 7.7% with hydroxychloroquine alone, 14% with both drugs, and 14.5% with neither.

The odds of developing preeclampsia were lower with both aspirin and hydroxychloroquine. Factors that raised the odds were high disease activity in the first trimester (aOR, 4.55), a BMI of >30 kg/m² (aOR, 6.14), having high-risk aPL or antiphospholipid syndrome (aOR, 8.02), and a history of preeclampsia (aOR, 9.78).

Only high disease activity in the first trimester and BMI >30 kg/m² remained independent predictors of preeclampsia when the researchers considered only high-risk pregnancies (aOR, 7.74 for high disease activity in first trimester and 10.04 for a high BMI).

The results are “really impressive,” said Angela Tincani, MD, senior consultant at the Rheumatology and Clinical Immunology Unit of ASST–Spedali Civili di Brescia, in Italy.

Dr. Tincani observed that the study had covered a “large number of years” (1995-2020).

“I think that our attitude in looking after lupus patients [changed] during this time,” she said.

“As an example, I think that we probably use less corticosteroids now than in the 90s,” she said.

When asked whether changes in practices have influenced the findings, she acknowledged, “You can see that the prescription of the different medications has changed a lot. We also thought that we have to take into account the years as a confounder, but we haven’t statistically analyzed that, but it’s definitely something that we are going to do next.”

The study received no outside funding. Dr. Haase has received travel fees from AbbVie, Celgene, Chugai, Janssen-Cilag, Eli Lilly, and Medac. Dr. Tincani has disclosed no relevant financial relationships.

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

Women with systemic lupus erythematous (SLE) who are at risk for preeclampsia may benefit from timely treatment with low-dose aspirin and perhaps hydroxychloroquine, according to German researchers.

©American Heart Association

In a prospective, real-world study of 190 pregnancies in 148 women (average age, 30 years), the use of low-dose aspirin starting around the 16th week of gestation was associated with a lower risk for preeclampsia than was no aspirin use (adjusted odds ratio [aOR], 0.21; P < .05).

The use of hydroxychloroquine starting in the first trimester had a “moderating effect,” said Isabell Haase, MD, a senior clinician scientist in the department of rheumatology at Hiller-Research Unit, Düsseldorf, Germany. Although this was not a statistically significant effect (aOR, 0.47; P = .21), the association strengthened if only high-risk pregnancies were considered (aOR, 0.28; P = .075).

“I think this once more shows us that counseling and risk assessment in our lupus patients is very important to find out those with the highest risk and treat them as good as possible,” Dr. Haase said at an international congress on systemic lupus erythematosus.

Preeclampsia and lupus

“Women with SLE face a high risk of preeclampsia because of their autoimmune disease,” Dr. Haase explained. “This [risk] can be further increased if a woman carries additional risk factors, like hypertension or lupus nephritis.”

Low-dose aspirin is known to protect against the development of preeclampsia in women without autoimmune disease if started before the 16th gestational week of pregnancy, Dr. Haase added. That is why it’s recommended by both the American College of Rheumatology and the European Alliance of Associations for Rheumatology.

“For hydroxychloroquine, we only have some small studies and its mechanism of action that lead us to the idea that it could also have a beneficial effect on preeclampsia in lupus patients,” she said.
 

Study design and results

The aim of the study was to see in a real-world cohort whether there was any beneficial effect of either aspirin or hydroxychloroquine regarding the development of preeclampsia.

The researchers used prospectively collected data from pregnancies seen at an outpatient pregnancy clinic during 1995-2019. They used multiple logistic regression to determine whether there was any effect of four treatments on the development of preeclampsia: aspirin (n = 39 patients) or hydroxychloroquine (n = 39) alone, in combination (n = 43), or neither drug (n = 69).

Overall, 56% of the women had significant risk factors for preeclampsia, including a prior history, multifetal gestation, chronic hypertension, lupus nephritis, or antiphospholipid antibodies (aPL). A further 28% had moderate risk factors, including not having had children, a body mass index >30 kg/m², and being older than 35 years.

The overall rate of preeclampsia in the study population was 13.2%, “which is in line with other studies in lupus pregnancies,” Dr. Haase said. Rates in each of the four treatment groups were 15.4% with aspirin alone, 7.7% with hydroxychloroquine alone, 14% with both drugs, and 14.5% with neither.

The odds of developing preeclampsia were lower with both aspirin and hydroxychloroquine. Factors that raised the odds were high disease activity in the first trimester (aOR, 4.55), a BMI of >30 kg/m² (aOR, 6.14), having high-risk aPL or antiphospholipid syndrome (aOR, 8.02), and a history of preeclampsia (aOR, 9.78).

Only high disease activity in the first trimester and BMI >30 kg/m² remained independent predictors of preeclampsia when the researchers considered only high-risk pregnancies (aOR, 7.74 for high disease activity in first trimester and 10.04 for a high BMI).

The results are “really impressive,” said Angela Tincani, MD, senior consultant at the Rheumatology and Clinical Immunology Unit of ASST–Spedali Civili di Brescia, in Italy.

Dr. Tincani observed that the study had covered a “large number of years” (1995-2020).

“I think that our attitude in looking after lupus patients [changed] during this time,” she said.

“As an example, I think that we probably use less corticosteroids now than in the 90s,” she said.

When asked whether changes in practices have influenced the findings, she acknowledged, “You can see that the prescription of the different medications has changed a lot. We also thought that we have to take into account the years as a confounder, but we haven’t statistically analyzed that, but it’s definitely something that we are going to do next.”

The study received no outside funding. Dr. Haase has received travel fees from AbbVie, Celgene, Chugai, Janssen-Cilag, Eli Lilly, and Medac. Dr. Tincani has disclosed no relevant financial relationships.

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

People with systemic lupus erythematosus (SLE) have a threefold greater likelihood of having up to five or more comorbidities in comparison with people in the general population, according to the results of two separate U.S. population-based studies.

The higher rate of comorbidities seen included many of those commonly reported before, such as cardiovascular and renal disease, but also some that may be less frequently associated with SLE, notably chronic obstructive pulmonary disease (COPD) and cardiac arrhythmias.

“In the past, the characterization of SLE comorbidities has relied on individual comorbidity assessment,” Alí Duarte García, MD, said at the 14th International Congress on Systemic Lupus Erythematosus, held together will the 6th International Congress on Controversies in Rheumatology and Autoimmunity.

“However, a patient-centric approach where a patient as a whole is seen and how many comorbidities they accrue has not been performed.” added Duarte García, who is a rheumatologist at the Mayo Clinic in Rochester, Minn.


 

Multiple conditions “overrepresented” in SLE patients

Dr. Duarte García reported the findings of one of the studies, both of which used data from the Rochester Epidemiology Project, a record-linkage system that collates clinical and hospital data from individuals who live in 19 counties in southeast Minnesota and eight counties in western Wisconsin; these patients have agreed to share their medical records for research.

The study population included 479 individuals diagnosed with SLE according to joint 2019 European Alliance of Associations for Rheumatology and American College of Rheumatology criteria. These were matched by age, sex, race, and county to 479 individuals without SLE.

The mean age of the study population was 53 years, 82% were women, and 86% were White.

“We defined multimorbidity as those patients who have two or more comorbidities and substantial multimorbidity as those patients who have five or more comorbidities,” Dr. Duarte García explained.

A previously published list of 44 categories of comorbidities was used to classify the multimorbidity seen, and 27 of these were “overrepresented” in patients with SLE.

Patients with SLE averaged 5.3 comorbidities, whereas control study subjects had 2.9. Comparing SLE with non-SLE individuals, the odds ratio for having two or more comorbid conditions was 2.96, and for five or more comorbidities it was 3.06.

The highest odds ratio comparing SLE with non-SLE individuals was seen for pulmonary disorders (39.0).

Dr. Duarte García highlighted four comorbidities that occurred in SLE patients that were perhaps more unusual: congestive heart failure (OR, 13.3), valvular heart disease (OR, 4.2), cardiac arrhythmias (OR, 2.85), and COPD (OR, 2.7).

“Given the association of multimorbidity with poor outcomes, care delivery strategies to manage multimorbidity are needed in SLE,” Dr. Duarte García concluded.
 

Similar findings seen in cutaneous lupus

There is also an excess of comorbid conditions in people with cutaneous lupus erythematosus (CLE), Mehmet Hocaoglu, MD, said in reporting the findings of the second study.

Dr. Hocaoglu, an internal medicine resident at the University of Maryland Medical Center in Baltimore, and part of the same team of researchers as Dr. Duarte García, noted that in skin-related lupus the risk of multimorbidity was about doubled.

For this separate analysis, a total of 303 patients with cutaneous lupus had been matched to 303 controls from the general population. Odds ratios for having two or more or five or more comorbidities were a respective 2.27 and 1.65.

Among the comorbidities seen that were higher in those with cutaneous lupus than in the general population subjects were fibromyalgia, liver disease, hypertension, anemia, hypothyroidism, and COPD.

“Further research is definitely needed to identify if the driver of this multimorbidity in CLE patients is the disease itself or the treatments CLE patients are receiving or a multifactorial cause that is driving the disease association,” Dr. Hocaoglu said.
 

Comment and perspective

“Comorbidities that are not appropriate to the general population, compared to SLE,” seem to have been included in the overall SLE and the cutaneous lupus analyses, Raquel Faria, MD, suggested.

Dr. Faria, an internal medicine consultant at Unidade de Imunologia Clínica – Centro Hospitalar Universitário Porto (Portugal), chaired the poster discussion session in which the two studies had been presented.

She wondered if the researchers had analyzed the data while accounting for “the comorbidities that you knew are due to activity in lupus, like anemia?”

The number of patients with SLE who had pulmonary circulation disorders – 7.5% vs. 0.2% of the general population – also caught Dr. Faria’s attention.

That’s “a really huge number,” Dr. Faria pointed out, “I think it is pretty overrepresented.”

Dr. Duarte García acknowledged that they “took a very broad approach” in using a “very large comorbidity index.”

“What we were observing initially is precisely what you’re mentioning,” he responded to Dr. Faria.

“We were pulling patients who were having disease manifestation rather than a comorbidity,” Dr. Duarte-García said.

These are initial and very exploratory data, he stressed. “We have now moved on to modify the index.” Some of the changes that they have made were to incorporate the SLICC Damage Index Score and tighten up the list of ICD codes used.

No outside funding was received for either of the studies. Dr. Duarte García and Dr. Hocaoglu individually stated that they had no actual or potential conflicts of interest in relation to their presentations.

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

People with systemic lupus erythematosus (SLE) have a threefold greater likelihood of having up to five or more comorbidities in comparison with people in the general population, according to the results of two separate U.S. population-based studies.

The higher rate of comorbidities seen included many of those commonly reported before, such as cardiovascular and renal disease, but also some that may be less frequently associated with SLE, notably chronic obstructive pulmonary disease (COPD) and cardiac arrhythmias.

“In the past, the characterization of SLE comorbidities has relied on individual comorbidity assessment,” Alí Duarte García, MD, said at the 14th International Congress on Systemic Lupus Erythematosus, held together will the 6th International Congress on Controversies in Rheumatology and Autoimmunity.

“However, a patient-centric approach where a patient as a whole is seen and how many comorbidities they accrue has not been performed.” added Duarte García, who is a rheumatologist at the Mayo Clinic in Rochester, Minn.


 

Multiple conditions “overrepresented” in SLE patients

Dr. Duarte García reported the findings of one of the studies, both of which used data from the Rochester Epidemiology Project, a record-linkage system that collates clinical and hospital data from individuals who live in 19 counties in southeast Minnesota and eight counties in western Wisconsin; these patients have agreed to share their medical records for research.

The study population included 479 individuals diagnosed with SLE according to joint 2019 European Alliance of Associations for Rheumatology and American College of Rheumatology criteria. These were matched by age, sex, race, and county to 479 individuals without SLE.

The mean age of the study population was 53 years, 82% were women, and 86% were White.

“We defined multimorbidity as those patients who have two or more comorbidities and substantial multimorbidity as those patients who have five or more comorbidities,” Dr. Duarte García explained.

A previously published list of 44 categories of comorbidities was used to classify the multimorbidity seen, and 27 of these were “overrepresented” in patients with SLE.

Patients with SLE averaged 5.3 comorbidities, whereas control study subjects had 2.9. Comparing SLE with non-SLE individuals, the odds ratio for having two or more comorbid conditions was 2.96, and for five or more comorbidities it was 3.06.

The highest odds ratio comparing SLE with non-SLE individuals was seen for pulmonary disorders (39.0).

Dr. Duarte García highlighted four comorbidities that occurred in SLE patients that were perhaps more unusual: congestive heart failure (OR, 13.3), valvular heart disease (OR, 4.2), cardiac arrhythmias (OR, 2.85), and COPD (OR, 2.7).

“Given the association of multimorbidity with poor outcomes, care delivery strategies to manage multimorbidity are needed in SLE,” Dr. Duarte García concluded.
 

Similar findings seen in cutaneous lupus

There is also an excess of comorbid conditions in people with cutaneous lupus erythematosus (CLE), Mehmet Hocaoglu, MD, said in reporting the findings of the second study.

Dr. Hocaoglu, an internal medicine resident at the University of Maryland Medical Center in Baltimore, and part of the same team of researchers as Dr. Duarte García, noted that in skin-related lupus the risk of multimorbidity was about doubled.

For this separate analysis, a total of 303 patients with cutaneous lupus had been matched to 303 controls from the general population. Odds ratios for having two or more or five or more comorbidities were a respective 2.27 and 1.65.

Among the comorbidities seen that were higher in those with cutaneous lupus than in the general population subjects were fibromyalgia, liver disease, hypertension, anemia, hypothyroidism, and COPD.

“Further research is definitely needed to identify if the driver of this multimorbidity in CLE patients is the disease itself or the treatments CLE patients are receiving or a multifactorial cause that is driving the disease association,” Dr. Hocaoglu said.
 

Comment and perspective

“Comorbidities that are not appropriate to the general population, compared to SLE,” seem to have been included in the overall SLE and the cutaneous lupus analyses, Raquel Faria, MD, suggested.

Dr. Faria, an internal medicine consultant at Unidade de Imunologia Clínica – Centro Hospitalar Universitário Porto (Portugal), chaired the poster discussion session in which the two studies had been presented.

She wondered if the researchers had analyzed the data while accounting for “the comorbidities that you knew are due to activity in lupus, like anemia?”

The number of patients with SLE who had pulmonary circulation disorders – 7.5% vs. 0.2% of the general population – also caught Dr. Faria’s attention.

That’s “a really huge number,” Dr. Faria pointed out, “I think it is pretty overrepresented.”

Dr. Duarte García acknowledged that they “took a very broad approach” in using a “very large comorbidity index.”

“What we were observing initially is precisely what you’re mentioning,” he responded to Dr. Faria.

“We were pulling patients who were having disease manifestation rather than a comorbidity,” Dr. Duarte-García said.

These are initial and very exploratory data, he stressed. “We have now moved on to modify the index.” Some of the changes that they have made were to incorporate the SLICC Damage Index Score and tighten up the list of ICD codes used.

No outside funding was received for either of the studies. Dr. Duarte García and Dr. Hocaoglu individually stated that they had no actual or potential conflicts of interest in relation to their presentations.

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

People with systemic lupus erythematosus (SLE) have a threefold greater likelihood of having up to five or more comorbidities in comparison with people in the general population, according to the results of two separate U.S. population-based studies.

The higher rate of comorbidities seen included many of those commonly reported before, such as cardiovascular and renal disease, but also some that may be less frequently associated with SLE, notably chronic obstructive pulmonary disease (COPD) and cardiac arrhythmias.

“In the past, the characterization of SLE comorbidities has relied on individual comorbidity assessment,” Alí Duarte García, MD, said at the 14th International Congress on Systemic Lupus Erythematosus, held together will the 6th International Congress on Controversies in Rheumatology and Autoimmunity.

“However, a patient-centric approach where a patient as a whole is seen and how many comorbidities they accrue has not been performed.” added Duarte García, who is a rheumatologist at the Mayo Clinic in Rochester, Minn.


 

Multiple conditions “overrepresented” in SLE patients

Dr. Duarte García reported the findings of one of the studies, both of which used data from the Rochester Epidemiology Project, a record-linkage system that collates clinical and hospital data from individuals who live in 19 counties in southeast Minnesota and eight counties in western Wisconsin; these patients have agreed to share their medical records for research.

The study population included 479 individuals diagnosed with SLE according to joint 2019 European Alliance of Associations for Rheumatology and American College of Rheumatology criteria. These were matched by age, sex, race, and county to 479 individuals without SLE.

The mean age of the study population was 53 years, 82% were women, and 86% were White.

“We defined multimorbidity as those patients who have two or more comorbidities and substantial multimorbidity as those patients who have five or more comorbidities,” Dr. Duarte García explained.

A previously published list of 44 categories of comorbidities was used to classify the multimorbidity seen, and 27 of these were “overrepresented” in patients with SLE.

Patients with SLE averaged 5.3 comorbidities, whereas control study subjects had 2.9. Comparing SLE with non-SLE individuals, the odds ratio for having two or more comorbid conditions was 2.96, and for five or more comorbidities it was 3.06.

The highest odds ratio comparing SLE with non-SLE individuals was seen for pulmonary disorders (39.0).

Dr. Duarte García highlighted four comorbidities that occurred in SLE patients that were perhaps more unusual: congestive heart failure (OR, 13.3), valvular heart disease (OR, 4.2), cardiac arrhythmias (OR, 2.85), and COPD (OR, 2.7).

“Given the association of multimorbidity with poor outcomes, care delivery strategies to manage multimorbidity are needed in SLE,” Dr. Duarte García concluded.
 

Similar findings seen in cutaneous lupus

There is also an excess of comorbid conditions in people with cutaneous lupus erythematosus (CLE), Mehmet Hocaoglu, MD, said in reporting the findings of the second study.

Dr. Hocaoglu, an internal medicine resident at the University of Maryland Medical Center in Baltimore, and part of the same team of researchers as Dr. Duarte García, noted that in skin-related lupus the risk of multimorbidity was about doubled.

For this separate analysis, a total of 303 patients with cutaneous lupus had been matched to 303 controls from the general population. Odds ratios for having two or more or five or more comorbidities were a respective 2.27 and 1.65.

Among the comorbidities seen that were higher in those with cutaneous lupus than in the general population subjects were fibromyalgia, liver disease, hypertension, anemia, hypothyroidism, and COPD.

“Further research is definitely needed to identify if the driver of this multimorbidity in CLE patients is the disease itself or the treatments CLE patients are receiving or a multifactorial cause that is driving the disease association,” Dr. Hocaoglu said.
 

Comment and perspective

“Comorbidities that are not appropriate to the general population, compared to SLE,” seem to have been included in the overall SLE and the cutaneous lupus analyses, Raquel Faria, MD, suggested.

Dr. Faria, an internal medicine consultant at Unidade de Imunologia Clínica – Centro Hospitalar Universitário Porto (Portugal), chaired the poster discussion session in which the two studies had been presented.

She wondered if the researchers had analyzed the data while accounting for “the comorbidities that you knew are due to activity in lupus, like anemia?”

The number of patients with SLE who had pulmonary circulation disorders – 7.5% vs. 0.2% of the general population – also caught Dr. Faria’s attention.

That’s “a really huge number,” Dr. Faria pointed out, “I think it is pretty overrepresented.”

Dr. Duarte García acknowledged that they “took a very broad approach” in using a “very large comorbidity index.”

“What we were observing initially is precisely what you’re mentioning,” he responded to Dr. Faria.

“We were pulling patients who were having disease manifestation rather than a comorbidity,” Dr. Duarte-García said.

These are initial and very exploratory data, he stressed. “We have now moved on to modify the index.” Some of the changes that they have made were to incorporate the SLICC Damage Index Score and tighten up the list of ICD codes used.

No outside funding was received for either of the studies. Dr. Duarte García and Dr. Hocaoglu individually stated that they had no actual or potential conflicts of interest in relation to their presentations.

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

A rare and potentially life-threatening adverse effect of bronchodilator therapy may be overlooked among patients with chronic obstructive pulmonary disease (COPD) or asthma, according to a researcher who reviewed spirometry test results from U.S. military veterans.

Courtesy of Dr. Kaul

Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.

However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.

“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.

“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
 

Recognizing paradoxical bronchospasm

In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.

“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.

Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.

If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.

Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.

Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
 

Latest study results

Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.

A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.

Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.

Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.

Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.

A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
 

Greater awareness needed

Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.

“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.

Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.

Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.

A rare and potentially life-threatening adverse effect of bronchodilator therapy may be overlooked among patients with chronic obstructive pulmonary disease (COPD) or asthma, according to a researcher who reviewed spirometry test results from U.S. military veterans.

Courtesy of Dr. Kaul

Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.

However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.

“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.

“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
 

Recognizing paradoxical bronchospasm

In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.

“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.

Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.

If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.

Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.

Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
 

Latest study results

Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.

A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.

Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.

Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.

Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.

A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
 

Greater awareness needed

Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.

“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.

Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.

Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.

A rare and potentially life-threatening adverse effect of bronchodilator therapy may be overlooked among patients with chronic obstructive pulmonary disease (COPD) or asthma, according to a researcher who reviewed spirometry test results from U.S. military veterans.

Courtesy of Dr. Kaul

Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.

However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.

“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.

“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
 

Recognizing paradoxical bronchospasm

In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.

“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.

Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.

If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.

Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.

Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
 

Latest study results

Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.

A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.

Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.

Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.

Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.

A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
 

Greater awareness needed

Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.

“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.

Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.

Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.

The first European consensus on vaccination in patients with multiple sclerosis (MS) has been developed by the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN).

The document, announced at the annual ECTRIMS meeting, proposes a standard for vaccination in patients with MS, including a global vaccination strategy for the general MS patient population and selected subpopulations.

The document does not include any recommendations regarding vaccination against COVID-19, which is the subject of a separate report, announced at the annual meeting. 

The main conclusions in the new report are as follows:

• Vaccinations in general are considered safe for patients with MS and do not modify disease activity/progression.
• Live attenuated vaccines, however, are contraindicated with immunosuppressants.
• Inactivated vaccines can be used safely, but their efficacy may be decreased with immunosuppressants.
• Vaccinations should be considered early in MS management before using immunosuppressants whenever possible.

Presenting the vaccination consensus document, Susana Otero-Romero, MD, from the Multiple Sclerosis Center of Catalonia, Spain, explained that vaccination has become an important part of the risk management strategy in patients with MS treated with highly active drugs but that questions remain as to when and whether to introduce a particular vaccine and which disease-modifying treatments affect vaccine response. 

“The current reference tool has been developed to help professionals to decide on the best vaccination strategy for their patients,” she said.  

The consensus document recommends that, in general, vaccination should be performed at the time of diagnosis of MS or in the early stages of the disease to prevent future delays in starting therapies.

“Ideally, vaccination should take place before the onset of disease-modifying treatment,” Dr. Otero-Romero said. The consensus document recommends inactivated vaccines to be given 2-3 weeks before immunosuppressive therapy is started, and live attenuated vaccines at least 4 weeks beforehand.

In the case of relapse, vaccination should be delayed until clinical resolution or stabilization if possible, the consensus statement recommends.

Serological testing for vaccine-induced antibody titers can be performed 1-2 months after the last dose of the vaccine (suggested for hepatitis B, measles, mumps, and varicella). For attenuated live vaccines, serological tests should be done before starting immunosuppressive therapy. In the case of insufficient response, consideration should be given to administering a booster dose of the vaccine, except for hepatitis B, in which a complete revaccination is recommended, according to the document.

As for vaccination during immunosuppressive therapy, this is considered safe for patients on interferon or glatiramer acetate when indicated, the report says. 

Vaccination should ideally be avoided in patients on dimethyl fumarate, teriflunomide (Aubagio) or natalizumab (Tysabri), although it can be considered in exceptional cases when the potential risk of acquiring the infection is greater than the risk of developing vaccine-related infections (unless the absolute lymphocyte count is below 800/mm³), it adds.

Vaccination should be avoided in patients on S1P modulators (for example, fingolimod [Gilenya]), anti-CD20 therapies, and before immune restoration for cladribine (Leustatin) and alemtuzumab (Lemtrada).

In the case of patients stopping immunosuppressive therapy, inactivated vaccines can be given any time after the discontinuation of therapy but preferably after immune restoration. Live attenuated vaccines should only be administered after a safety interval ensures immune restoration has been met.
 

Which vaccines?

On which vaccines are needed in patients with MS, the consensus document recommends the same routine vaccination schedule as for the general population. In addition, it advises influenza and pneumococcal vaccination if patients are immunosuppressed or have significant disability.

It also recommends human papillomavirus vaccine in women and men independent of their age if they are to be treated with alemtuzumab, fingolimod, cladribine, or anti-CD20 drugs. Hepatitis B vaccination is also advised in patients treated with anti-CD20 drugs.
 

Special populations: pregnancy/elderly

In patients with MS who are pregnant, inactivated flu vaccine can be given in any trimester at the start of the flu season, and vaccination against diphtheria, tetanus, and pertussis can be given during the third trimester, the report says. Live attenuated vaccines should be completed at least 1 month before pregnancy or after delivery and 4-6 weeks prior to the initiation of immunosuppressive therapy.

Elderly patients with MS should receive flu and pneumococcal vaccines annually and would also benefit from the inactivated herpes zoster vaccine.
 

Travel vaccines

On vaccinations needed for travel, the report recommends that patients with MS consult a specialized travel clinic or vaccination expert and start immunizations 2-3 months before departure. Patients with MS with or without immunosuppressive therapy can receive hepatitis A, rabies, Japanese encephalitis, tic-borne encephalitis, polio, and inactivated typhoid vaccine. But yellow fever and oral typhoid are contraindicated in patients on immunosuppressive therapies.

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

The first European consensus on vaccination in patients with multiple sclerosis (MS) has been developed by the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN).

The document, announced at the annual ECTRIMS meeting, proposes a standard for vaccination in patients with MS, including a global vaccination strategy for the general MS patient population and selected subpopulations.

The document does not include any recommendations regarding vaccination against COVID-19, which is the subject of a separate report, announced at the annual meeting. 

The main conclusions in the new report are as follows:

• Vaccinations in general are considered safe for patients with MS and do not modify disease activity/progression.
• Live attenuated vaccines, however, are contraindicated with immunosuppressants.
• Inactivated vaccines can be used safely, but their efficacy may be decreased with immunosuppressants.
• Vaccinations should be considered early in MS management before using immunosuppressants whenever possible.

Presenting the vaccination consensus document, Susana Otero-Romero, MD, from the Multiple Sclerosis Center of Catalonia, Spain, explained that vaccination has become an important part of the risk management strategy in patients with MS treated with highly active drugs but that questions remain as to when and whether to introduce a particular vaccine and which disease-modifying treatments affect vaccine response. 

“The current reference tool has been developed to help professionals to decide on the best vaccination strategy for their patients,” she said.  

The consensus document recommends that, in general, vaccination should be performed at the time of diagnosis of MS or in the early stages of the disease to prevent future delays in starting therapies.

“Ideally, vaccination should take place before the onset of disease-modifying treatment,” Dr. Otero-Romero said. The consensus document recommends inactivated vaccines to be given 2-3 weeks before immunosuppressive therapy is started, and live attenuated vaccines at least 4 weeks beforehand.

In the case of relapse, vaccination should be delayed until clinical resolution or stabilization if possible, the consensus statement recommends.

Serological testing for vaccine-induced antibody titers can be performed 1-2 months after the last dose of the vaccine (suggested for hepatitis B, measles, mumps, and varicella). For attenuated live vaccines, serological tests should be done before starting immunosuppressive therapy. In the case of insufficient response, consideration should be given to administering a booster dose of the vaccine, except for hepatitis B, in which a complete revaccination is recommended, according to the document.

As for vaccination during immunosuppressive therapy, this is considered safe for patients on interferon or glatiramer acetate when indicated, the report says. 

Vaccination should ideally be avoided in patients on dimethyl fumarate, teriflunomide (Aubagio) or natalizumab (Tysabri), although it can be considered in exceptional cases when the potential risk of acquiring the infection is greater than the risk of developing vaccine-related infections (unless the absolute lymphocyte count is below 800/mm³), it adds.

Vaccination should be avoided in patients on S1P modulators (for example, fingolimod [Gilenya]), anti-CD20 therapies, and before immune restoration for cladribine (Leustatin) and alemtuzumab (Lemtrada).

In the case of patients stopping immunosuppressive therapy, inactivated vaccines can be given any time after the discontinuation of therapy but preferably after immune restoration. Live attenuated vaccines should only be administered after a safety interval ensures immune restoration has been met.
 

Which vaccines?

On which vaccines are needed in patients with MS, the consensus document recommends the same routine vaccination schedule as for the general population. In addition, it advises influenza and pneumococcal vaccination if patients are immunosuppressed or have significant disability.

It also recommends human papillomavirus vaccine in women and men independent of their age if they are to be treated with alemtuzumab, fingolimod, cladribine, or anti-CD20 drugs. Hepatitis B vaccination is also advised in patients treated with anti-CD20 drugs.
 

Special populations: pregnancy/elderly

In patients with MS who are pregnant, inactivated flu vaccine can be given in any trimester at the start of the flu season, and vaccination against diphtheria, tetanus, and pertussis can be given during the third trimester, the report says. Live attenuated vaccines should be completed at least 1 month before pregnancy or after delivery and 4-6 weeks prior to the initiation of immunosuppressive therapy.

Elderly patients with MS should receive flu and pneumococcal vaccines annually and would also benefit from the inactivated herpes zoster vaccine.
 

Travel vaccines

On vaccinations needed for travel, the report recommends that patients with MS consult a specialized travel clinic or vaccination expert and start immunizations 2-3 months before departure. Patients with MS with or without immunosuppressive therapy can receive hepatitis A, rabies, Japanese encephalitis, tic-borne encephalitis, polio, and inactivated typhoid vaccine. But yellow fever and oral typhoid are contraindicated in patients on immunosuppressive therapies.

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

The first European consensus on vaccination in patients with multiple sclerosis (MS) has been developed by the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN).

The document, announced at the annual ECTRIMS meeting, proposes a standard for vaccination in patients with MS, including a global vaccination strategy for the general MS patient population and selected subpopulations.

The document does not include any recommendations regarding vaccination against COVID-19, which is the subject of a separate report, announced at the annual meeting. 

The main conclusions in the new report are as follows:

• Vaccinations in general are considered safe for patients with MS and do not modify disease activity/progression.
• Live attenuated vaccines, however, are contraindicated with immunosuppressants.
• Inactivated vaccines can be used safely, but their efficacy may be decreased with immunosuppressants.
• Vaccinations should be considered early in MS management before using immunosuppressants whenever possible.

Presenting the vaccination consensus document, Susana Otero-Romero, MD, from the Multiple Sclerosis Center of Catalonia, Spain, explained that vaccination has become an important part of the risk management strategy in patients with MS treated with highly active drugs but that questions remain as to when and whether to introduce a particular vaccine and which disease-modifying treatments affect vaccine response. 

“The current reference tool has been developed to help professionals to decide on the best vaccination strategy for their patients,” she said.  

The consensus document recommends that, in general, vaccination should be performed at the time of diagnosis of MS or in the early stages of the disease to prevent future delays in starting therapies.

“Ideally, vaccination should take place before the onset of disease-modifying treatment,” Dr. Otero-Romero said. The consensus document recommends inactivated vaccines to be given 2-3 weeks before immunosuppressive therapy is started, and live attenuated vaccines at least 4 weeks beforehand.

In the case of relapse, vaccination should be delayed until clinical resolution or stabilization if possible, the consensus statement recommends.

Serological testing for vaccine-induced antibody titers can be performed 1-2 months after the last dose of the vaccine (suggested for hepatitis B, measles, mumps, and varicella). For attenuated live vaccines, serological tests should be done before starting immunosuppressive therapy. In the case of insufficient response, consideration should be given to administering a booster dose of the vaccine, except for hepatitis B, in which a complete revaccination is recommended, according to the document.

As for vaccination during immunosuppressive therapy, this is considered safe for patients on interferon or glatiramer acetate when indicated, the report says. 

Vaccination should ideally be avoided in patients on dimethyl fumarate, teriflunomide (Aubagio) or natalizumab (Tysabri), although it can be considered in exceptional cases when the potential risk of acquiring the infection is greater than the risk of developing vaccine-related infections (unless the absolute lymphocyte count is below 800/mm³), it adds.

Vaccination should be avoided in patients on S1P modulators (for example, fingolimod [Gilenya]), anti-CD20 therapies, and before immune restoration for cladribine (Leustatin) and alemtuzumab (Lemtrada).

In the case of patients stopping immunosuppressive therapy, inactivated vaccines can be given any time after the discontinuation of therapy but preferably after immune restoration. Live attenuated vaccines should only be administered after a safety interval ensures immune restoration has been met.
 

Which vaccines?

On which vaccines are needed in patients with MS, the consensus document recommends the same routine vaccination schedule as for the general population. In addition, it advises influenza and pneumococcal vaccination if patients are immunosuppressed or have significant disability.

It also recommends human papillomavirus vaccine in women and men independent of their age if they are to be treated with alemtuzumab, fingolimod, cladribine, or anti-CD20 drugs. Hepatitis B vaccination is also advised in patients treated with anti-CD20 drugs.
 

Special populations: pregnancy/elderly

In patients with MS who are pregnant, inactivated flu vaccine can be given in any trimester at the start of the flu season, and vaccination against diphtheria, tetanus, and pertussis can be given during the third trimester, the report says. Live attenuated vaccines should be completed at least 1 month before pregnancy or after delivery and 4-6 weeks prior to the initiation of immunosuppressive therapy.

Elderly patients with MS should receive flu and pneumococcal vaccines annually and would also benefit from the inactivated herpes zoster vaccine.
 

Travel vaccines

On vaccinations needed for travel, the report recommends that patients with MS consult a specialized travel clinic or vaccination expert and start immunizations 2-3 months before departure. Patients with MS with or without immunosuppressive therapy can receive hepatitis A, rabies, Japanese encephalitis, tic-borne encephalitis, polio, and inactivated typhoid vaccine. But yellow fever and oral typhoid are contraindicated in patients on immunosuppressive therapies.

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