Conference Coverage

DENVER – Real-world, US claims-based data show major gaps in the care and management of three major neurologic disorders: Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis (MS).

Investigators led by Nikki Win, PhD, medical manager/team lead, OMNI Scientific Strategy and Collaborations, US Medical Affairs, Genentech/Roche, found that patients with Parkinson’s disease were referred to a specialist most often, followed by those with MS and those with AD. 

The findings were presented at the 2024 annual meeting of the American Academy of Neurology (AAN).
 

National Neurologist Shortage

The national neurologist shortage, coupled with the growing incidence of Alzheimer’s disease, Parkinson’s disease, MS, and other conditions has led the AAN and other organizations to call for expanding the role of primary care physicians in the diagnosis and management of neurologic disorders, the leading global cause of disability.

“These neurological conditions are increasing in prevalence and there’s a limited number of neurologists, so we wanted to understand what this looks like in the US,” Dr. Win said.

“There is a need to understand the patient journey from primary care to neurology care, from presentation of a suspected neurological disorder to diagnosis, referral to a specialist, and the time elapsed before the specialist visit for Alzheimer’s disease, MS, and Parkinson’s disease in the US,” Dr. Win added. 

Timely and accurate diagnoses of neurologic disorders can optimize treatment outcomes. Because many of these diseases are first detected during a visit with a primary care physician, it is important to understand the timeline from the initial visit to a specialist referral, the investigators noted. 
 

Analyzing Trends in Specialist Referrals

Using claims data from the Optum Normative Health Information database, researchers identified 48,525 adults with Alzheimer’s disease, 26,431 with Parkinson’s disease, and 8169 with MS who received a diagnosis from a primary care physician between 2016 and 2021.

They examined the proportion, timing, and demographic factors associated with referrals from primary care clinicians or other healthcare providers to specialists including neurologists, neurosurgeons, psychiatrists, and geriatric medicine specialists.

Results showed that patients with Parkinson’s disease were referred to a specialist most often (53%), followed by those with MS (42%) and those with Alzheimer’s disease (27%).

Individuals with Alzheimer’s disease waited the longest for a specialist referral, with a median of 10 months between the time of referral and the first specialist visit compared with 5.7 months for patients with Parkinson’s disease and 2.6 months for MS patients.

“Some patients with common conditions like Alzheimer’s disease, MS, and Parkinson’s disease don’t see a neurologist, and when they do, it can take as long as 10 months,” said Dr. Win.

Using zip code heatmaps, researchers found that the proportion of referrals for all neurologic disorders was higher in the Midwest and Northeast, whereas patients in the South and West were less likely to receive a referral. 

Referrals for Alzheimer’s disease were low nationwide, except for some areas of Michigan and New England. California had the lowest referral rate for MS, followed by regions in the South and Northeast. Patients with Parkinson’s disease living in the Midwest and Northeast were more likely than those in the West to receive a specialist referral. 

Previous studies have reported regional shortages of neurologists, said Dr. Win. “Our data seem to correlate that in terms of the areas with lower referral patterns, but as to whether that is causative or correlative, we don’t know.” 

Odds of referral were also influenced by demographic characteristics such as sex, age, race, and ethnicity, investigators found. 

For example, there were fewer referrals with increasing age across all three neurologic disorders, and men were more likely than women to be referred for Alzheimer’s disease and Parkinson’s disease. Compared with White patients, Parkinson’s disease referrals were less likely among African American, Asian, and Hispanic patients and Alzheimer’s disease referrals were less common among Asian and Hispanic patients.

Insurance status also affected referrals. People with MS and Parkinson’s disease who had commercial insurance were referred more often than were those with Medicare Advantage, said Dr. Win.

She also noted, “Additional research is needed to understand how being referred or not being referred to a neurologist actually impacts patient treatment, care and outcomes.”
 

Neurology Challenges

Commenting on the research, Thomas Vidic, MD, a community neurologist in Elkhart, Indiana, and clinical professor of neurology at Indiana University School of Medicine at South Bend, said that he was surprised by the variation in wait times for patients.

This, he said, could reflect a study limitation or a higher comfort level among primary care doctors in treating dementia.

With respect to MS, Dr. Vidic said that he believes primary care physicians may not be uncertain about prescribing the approved medications for the disease because there are so many of them.

In addition, patients with Alzheimer’s disease are older and perhaps less accepting of being referred to a specialist that may be hours away.

The bottom line for Dr. Vidic, though, is the lack of specialists. “It comes back to the fact we’re not doing a good job of having community neurologists available to take care of these problems,” he said.

The issue of community neurologist shortages was underlined by the study’s findings about geographic gaps in specialist referrals across the country, he said.

Neurologists make up about 2% of the medical workforce and this has remained static for some time, Dr. Vidic noted. Meanwhile, people are living longer and developing more neurologic diseases.

Dr. Vidic also pointed to the lack of neurology training programs. “There has not been a significant change in the number of programs in the last 10-15 years,” he said.

Study funding was not disclosed. Dr. Win reports receiving personal compensation for serving as an employee of Genentech and has stock in Genentech. Dr. Vidic reports no relevant financial disclosures.

A version of this article appeared on Medscape.com.

DENVER – Real-world, US claims-based data show major gaps in the care and management of three major neurologic disorders: Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis (MS).

Investigators led by Nikki Win, PhD, medical manager/team lead, OMNI Scientific Strategy and Collaborations, US Medical Affairs, Genentech/Roche, found that patients with Parkinson’s disease were referred to a specialist most often, followed by those with MS and those with AD. 

The findings were presented at the 2024 annual meeting of the American Academy of Neurology (AAN).
 

National Neurologist Shortage

The national neurologist shortage, coupled with the growing incidence of Alzheimer’s disease, Parkinson’s disease, MS, and other conditions has led the AAN and other organizations to call for expanding the role of primary care physicians in the diagnosis and management of neurologic disorders, the leading global cause of disability.

“These neurological conditions are increasing in prevalence and there’s a limited number of neurologists, so we wanted to understand what this looks like in the US,” Dr. Win said.

“There is a need to understand the patient journey from primary care to neurology care, from presentation of a suspected neurological disorder to diagnosis, referral to a specialist, and the time elapsed before the specialist visit for Alzheimer’s disease, MS, and Parkinson’s disease in the US,” Dr. Win added. 

Timely and accurate diagnoses of neurologic disorders can optimize treatment outcomes. Because many of these diseases are first detected during a visit with a primary care physician, it is important to understand the timeline from the initial visit to a specialist referral, the investigators noted. 
 

Analyzing Trends in Specialist Referrals

Using claims data from the Optum Normative Health Information database, researchers identified 48,525 adults with Alzheimer’s disease, 26,431 with Parkinson’s disease, and 8169 with MS who received a diagnosis from a primary care physician between 2016 and 2021.

They examined the proportion, timing, and demographic factors associated with referrals from primary care clinicians or other healthcare providers to specialists including neurologists, neurosurgeons, psychiatrists, and geriatric medicine specialists.

Results showed that patients with Parkinson’s disease were referred to a specialist most often (53%), followed by those with MS (42%) and those with Alzheimer’s disease (27%).

Individuals with Alzheimer’s disease waited the longest for a specialist referral, with a median of 10 months between the time of referral and the first specialist visit compared with 5.7 months for patients with Parkinson’s disease and 2.6 months for MS patients.

“Some patients with common conditions like Alzheimer’s disease, MS, and Parkinson’s disease don’t see a neurologist, and when they do, it can take as long as 10 months,” said Dr. Win.

Using zip code heatmaps, researchers found that the proportion of referrals for all neurologic disorders was higher in the Midwest and Northeast, whereas patients in the South and West were less likely to receive a referral. 

Referrals for Alzheimer’s disease were low nationwide, except for some areas of Michigan and New England. California had the lowest referral rate for MS, followed by regions in the South and Northeast. Patients with Parkinson’s disease living in the Midwest and Northeast were more likely than those in the West to receive a specialist referral. 

Previous studies have reported regional shortages of neurologists, said Dr. Win. “Our data seem to correlate that in terms of the areas with lower referral patterns, but as to whether that is causative or correlative, we don’t know.” 

Odds of referral were also influenced by demographic characteristics such as sex, age, race, and ethnicity, investigators found. 

For example, there were fewer referrals with increasing age across all three neurologic disorders, and men were more likely than women to be referred for Alzheimer’s disease and Parkinson’s disease. Compared with White patients, Parkinson’s disease referrals were less likely among African American, Asian, and Hispanic patients and Alzheimer’s disease referrals were less common among Asian and Hispanic patients.

Insurance status also affected referrals. People with MS and Parkinson’s disease who had commercial insurance were referred more often than were those with Medicare Advantage, said Dr. Win.

She also noted, “Additional research is needed to understand how being referred or not being referred to a neurologist actually impacts patient treatment, care and outcomes.”
 

Neurology Challenges

Commenting on the research, Thomas Vidic, MD, a community neurologist in Elkhart, Indiana, and clinical professor of neurology at Indiana University School of Medicine at South Bend, said that he was surprised by the variation in wait times for patients.

This, he said, could reflect a study limitation or a higher comfort level among primary care doctors in treating dementia.

With respect to MS, Dr. Vidic said that he believes primary care physicians may not be uncertain about prescribing the approved medications for the disease because there are so many of them.

In addition, patients with Alzheimer’s disease are older and perhaps less accepting of being referred to a specialist that may be hours away.

The bottom line for Dr. Vidic, though, is the lack of specialists. “It comes back to the fact we’re not doing a good job of having community neurologists available to take care of these problems,” he said.

The issue of community neurologist shortages was underlined by the study’s findings about geographic gaps in specialist referrals across the country, he said.

Neurologists make up about 2% of the medical workforce and this has remained static for some time, Dr. Vidic noted. Meanwhile, people are living longer and developing more neurologic diseases.

Dr. Vidic also pointed to the lack of neurology training programs. “There has not been a significant change in the number of programs in the last 10-15 years,” he said.

Study funding was not disclosed. Dr. Win reports receiving personal compensation for serving as an employee of Genentech and has stock in Genentech. Dr. Vidic reports no relevant financial disclosures.

A version of this article appeared on Medscape.com.

DENVER – Real-world, US claims-based data show major gaps in the care and management of three major neurologic disorders: Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis (MS).

Investigators led by Nikki Win, PhD, medical manager/team lead, OMNI Scientific Strategy and Collaborations, US Medical Affairs, Genentech/Roche, found that patients with Parkinson’s disease were referred to a specialist most often, followed by those with MS and those with AD. 

The findings were presented at the 2024 annual meeting of the American Academy of Neurology (AAN).
 

National Neurologist Shortage

The national neurologist shortage, coupled with the growing incidence of Alzheimer’s disease, Parkinson’s disease, MS, and other conditions has led the AAN and other organizations to call for expanding the role of primary care physicians in the diagnosis and management of neurologic disorders, the leading global cause of disability.

“These neurological conditions are increasing in prevalence and there’s a limited number of neurologists, so we wanted to understand what this looks like in the US,” Dr. Win said.

“There is a need to understand the patient journey from primary care to neurology care, from presentation of a suspected neurological disorder to diagnosis, referral to a specialist, and the time elapsed before the specialist visit for Alzheimer’s disease, MS, and Parkinson’s disease in the US,” Dr. Win added. 

Timely and accurate diagnoses of neurologic disorders can optimize treatment outcomes. Because many of these diseases are first detected during a visit with a primary care physician, it is important to understand the timeline from the initial visit to a specialist referral, the investigators noted. 
 

Analyzing Trends in Specialist Referrals

Using claims data from the Optum Normative Health Information database, researchers identified 48,525 adults with Alzheimer’s disease, 26,431 with Parkinson’s disease, and 8169 with MS who received a diagnosis from a primary care physician between 2016 and 2021.

They examined the proportion, timing, and demographic factors associated with referrals from primary care clinicians or other healthcare providers to specialists including neurologists, neurosurgeons, psychiatrists, and geriatric medicine specialists.

Results showed that patients with Parkinson’s disease were referred to a specialist most often (53%), followed by those with MS (42%) and those with Alzheimer’s disease (27%).

Individuals with Alzheimer’s disease waited the longest for a specialist referral, with a median of 10 months between the time of referral and the first specialist visit compared with 5.7 months for patients with Parkinson’s disease and 2.6 months for MS patients.

“Some patients with common conditions like Alzheimer’s disease, MS, and Parkinson’s disease don’t see a neurologist, and when they do, it can take as long as 10 months,” said Dr. Win.

Using zip code heatmaps, researchers found that the proportion of referrals for all neurologic disorders was higher in the Midwest and Northeast, whereas patients in the South and West were less likely to receive a referral. 

Referrals for Alzheimer’s disease were low nationwide, except for some areas of Michigan and New England. California had the lowest referral rate for MS, followed by regions in the South and Northeast. Patients with Parkinson’s disease living in the Midwest and Northeast were more likely than those in the West to receive a specialist referral. 

Previous studies have reported regional shortages of neurologists, said Dr. Win. “Our data seem to correlate that in terms of the areas with lower referral patterns, but as to whether that is causative or correlative, we don’t know.” 

Odds of referral were also influenced by demographic characteristics such as sex, age, race, and ethnicity, investigators found. 

For example, there were fewer referrals with increasing age across all three neurologic disorders, and men were more likely than women to be referred for Alzheimer’s disease and Parkinson’s disease. Compared with White patients, Parkinson’s disease referrals were less likely among African American, Asian, and Hispanic patients and Alzheimer’s disease referrals were less common among Asian and Hispanic patients.

Insurance status also affected referrals. People with MS and Parkinson’s disease who had commercial insurance were referred more often than were those with Medicare Advantage, said Dr. Win.

She also noted, “Additional research is needed to understand how being referred or not being referred to a neurologist actually impacts patient treatment, care and outcomes.”
 

Neurology Challenges

Commenting on the research, Thomas Vidic, MD, a community neurologist in Elkhart, Indiana, and clinical professor of neurology at Indiana University School of Medicine at South Bend, said that he was surprised by the variation in wait times for patients.

This, he said, could reflect a study limitation or a higher comfort level among primary care doctors in treating dementia.

With respect to MS, Dr. Vidic said that he believes primary care physicians may not be uncertain about prescribing the approved medications for the disease because there are so many of them.

In addition, patients with Alzheimer’s disease are older and perhaps less accepting of being referred to a specialist that may be hours away.

The bottom line for Dr. Vidic, though, is the lack of specialists. “It comes back to the fact we’re not doing a good job of having community neurologists available to take care of these problems,” he said.

The issue of community neurologist shortages was underlined by the study’s findings about geographic gaps in specialist referrals across the country, he said.

Neurologists make up about 2% of the medical workforce and this has remained static for some time, Dr. Vidic noted. Meanwhile, people are living longer and developing more neurologic diseases.

Dr. Vidic also pointed to the lack of neurology training programs. “There has not been a significant change in the number of programs in the last 10-15 years,” he said.

Study funding was not disclosed. Dr. Win reports receiving personal compensation for serving as an employee of Genentech and has stock in Genentech. Dr. Vidic reports no relevant financial disclosures.

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — An updated guideline from the British Society for Rheumatology (BSR) on the management of Sjögren disease asks rheumatologists and other clinicians caring for patients with the condition to “do the little things well” rather than overly focusing on rheumatologic treatments. The guideline’s new format provides recommendations for specific clinical questions and now also includes recommendations for managing the disease in children and adolescents. 

“The original guideline was published in 2017, and things move on very rapidly,” consultant rheumatologist Elizabeth Price, MBBCh, PhD, said ahead of her presentation of the updated guideline at the annual meeting of the British Society for Rheumatology.

Sara Freeman/Medscape Medical News

What’s in a Name?

The BSR guideline on the management of adult and juvenile onset Sjögren disease is published in Rheumatology and is available via the BSR website, where it is accompanied by a short summary sheet. 

The most notable change perhaps is the name the guideline now uses, Dr. Price said at BSR 2024. “We have been bold and called it Sjögren disease.” Previously, the guideline used the term primary Sjögren’s syndrome, but there has been a “move away from using eponymous syndromes and dropping s’s and apostrophes,” she explained. 

Another significant change is that advice on managing Sjögren disease in children and adolescents is now included where appropriate, meaning that the British guideline is now the first to cover Sjögren disease “across the ages,” Dr. Price said.

A pediatric/adolescent rheumatologist joined the guideline working group, which already consisted of several adult rheumatologists, ophthalmologists, and a dentistry consultant. The group now comprises 22 members total, including a general practitioner, an oncologist, a renal physician, an occupational therapist, two patients with Sjögren disease, and a librarian.
 

Confirming the Diagnosis

The first questions asked to help form the new recommendations were around confirming a diagnosis of Sjögren disease, such as what is the diagnostic accuracy of antinuclear antibodies (ANAs), extractable nuclear antigens (ENAs), and other novel antigens in Sjögren disease? And what is the diagnostic accuracy of salivary gland ultrasound, imaging in general, and salivary gland or lacrimal gland biopsies? 

The resulting recommendations advised not to measure ANAs in the absence of clinical indicators of Sjögren disease or any other connective tissue disease but to use it to screen if there was a clinical suspicion. And ENAs should be measured even if the ANAs were negative and there is a high index of suspicion. 

In terms of imaging, ultrasound of the salivary glands was thought to be useful, but other imaging was not recommended for routine practice at the current time. Minor lip but not lacrimal gland biopsies were recommended if clinical and serologic features were not enough to make a diagnosis.
 

Lymphoma Worries

The 2017 version of the guideline did not include information about lymphoma, but this is the thing that most patients with Sjögren disease will worry about, Dr. Price said. “They all look it up on YouTube, they all come back and tell me that they are really worried they’ll develop it.”

The question that was therefore posed was whether there were any measurable biomarkers that could predict the development of lymphoma in adults and children. Seven predictors were found, the strongest being a low level of complement C4 alone or together with low levels of C3. Other predictors were salivary gland enlargement, lymphadenopathy, anti-Ro/La and rheumatoid factor autoantibodies, cryoglobulinemia, monoclonal gammopathy, and a high focus score. 

All of these predictors put someone in a higher risk category for lymphoma. If two or fewer of those features are present, the lifetime risk is “probably below 2%,” Dr. Price said. However, if all seven are present, the lifetime risk is “approaching 100%.”

The recommendation made on the basis of these findings is that people with Sjögren disease need to be offered early further investigation if they present with any new salivary gland swelling or other symptoms that might suggest the development of lymphoma. In this regard, a labial salivary gland biopsy might provide additional prognostic information.
 

‘Do the Little Things Well’

“You have to do the little things well,” Dr. Price said. “Many of the patients [who] come to see me for a second opinion have not been prescribed the right eye drops, have not been given advice on dental care,” with their management taking “too much on the rheumatological treatments.”

Rheumatologists are of course not trained or expected to be experts in ophthalmology or dentistry, but “you need to look at their mouth and you do need to examine their eyes, and you do need to give them some advice,” Dr. Price advised.

Thankfully, that is where the updated guidelines should help, with a recommendation that people with Sjögren disease should use preservative-free eye drops every 2-3 hours.

“It’s vital you avoid preservatives, because preservatives flatten the corneal surface and reduce the surface area and can cause inflammation in their own right,” Dr. Price cautioned, adding that there are plenty of suitable eye drop formulations available. 

In regard to helping with dry mouth symptoms, the recommendation is to use a saliva substitute for symptomatic relief. For vaginal dryness, the recommendation is to consider advising topical nonhormonal vaginal moisturizers plus estrogen creams or pessaries in peri- or postmenopausal women with significant vaginal dryness. 

“Very important, however, is to maintain a neutral pH, an alkaline environment in the mouth because acid damages dental enamel,” Dr. Price said. Conversely, an acidic vaginal moisturizer is needed to treat vaginal dryness. 

Dental hygiene is important. Regular brushing with a fluoride-based toothpaste is advised. The use of xylitol-containing products has been shown to reduce bacteria known to increase the risk for dental decay. Telling patients not to eat between meals is also simple but important advice. 

“We do recommend that patients are assessed holistically,” Dr. Price said, noting that they should be offered access to cognitive-behavioral therapy and exercise therapies to help with the symptoms of fatigue and joint pain.
 

Watch Out for Comorbidities

Sjögren disease is associated with many comorbidities, some of which might be predicted from the age and demographics of the people who are normally affected. 

“This is on the whole an older, female population, so you see a lot of osteoarthritis, gastroesophageal reflux, and hypertension,” Dr. Price said. “However, you may not be aware that 1 in 5 of these patients develop thyroid disease,” and there is a higher rate of celiac disease and primary biliary cholangitis than is seen in the general background population. 

The recommendation, therefore, is to “be aware of and consider screening for commonly associated conditions, as guided by age and/or clinical presentation.” As such, it’s recommended that baseline and repeated investigations that look for signs of comorbidity are performed, such as thyroid function assessment and liver function tests, to name two.
 

Treatment Recommendations

As in the original guideline, the treatment of systemic disease is discussed, but the advice has been overhauled with the availability of new data. 

The updated guidance notes that a trial of hydroxychloroquine for 6-12 months is the recommended treatment approach for people with fatigue and systemic symptoms. 

Systemic steroids may be used in the short-term for specific indications but should not be offered routinely. 

Conventional immunosuppressive or biologic drugs and immunoglobulins are not currently recommended outside of managing specific systemic complications.

In juvenile cases, the treatment of recurrent swollen parotid glands that are not due to infection or stone disease should include a short course of a nonsteroidal anti-inflammatory drug or a short course of oral steroids. This should be combined with massage followed by washouts with saline or steroids. In refractory cases, escalation to anti–B-cell–targeted therapies may be considered in select situations.
 

View on Updates

Patient advocate Bridget Crampton, who leads the helpline team at Sjögren’s UK (formerly the British Sjögren’s Syndrome Association), commented on the importance of the guidelines during a roundtable held by the BSR. 

“I think it will help [patients] make better use of their own appointments. So, they’ll know what treatments might be offered. They’ll know what they want to talk about at their appointments,” she said. 

Ms. Crampton, who has lived with Sjögren disease herself for the past 20 years, added: “I think it’s important for patients that we have guidelines like this. It means that all clinicians can easily access information. My hope is that it might standardize care across the UK a little bit more.” 

No specific funding was received to create the guidelines, be that from any bodies in the public, commercial, or not-for-profit sectors. No conflicts of interests were expressed by any of the experts quoted in this article.

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — An updated guideline from the British Society for Rheumatology (BSR) on the management of Sjögren disease asks rheumatologists and other clinicians caring for patients with the condition to “do the little things well” rather than overly focusing on rheumatologic treatments. The guideline’s new format provides recommendations for specific clinical questions and now also includes recommendations for managing the disease in children and adolescents. 

“The original guideline was published in 2017, and things move on very rapidly,” consultant rheumatologist Elizabeth Price, MBBCh, PhD, said ahead of her presentation of the updated guideline at the annual meeting of the British Society for Rheumatology.

Sara Freeman/Medscape Medical News

What’s in a Name?

The BSR guideline on the management of adult and juvenile onset Sjögren disease is published in Rheumatology and is available via the BSR website, where it is accompanied by a short summary sheet. 

The most notable change perhaps is the name the guideline now uses, Dr. Price said at BSR 2024. “We have been bold and called it Sjögren disease.” Previously, the guideline used the term primary Sjögren’s syndrome, but there has been a “move away from using eponymous syndromes and dropping s’s and apostrophes,” she explained. 

Another significant change is that advice on managing Sjögren disease in children and adolescents is now included where appropriate, meaning that the British guideline is now the first to cover Sjögren disease “across the ages,” Dr. Price said.

A pediatric/adolescent rheumatologist joined the guideline working group, which already consisted of several adult rheumatologists, ophthalmologists, and a dentistry consultant. The group now comprises 22 members total, including a general practitioner, an oncologist, a renal physician, an occupational therapist, two patients with Sjögren disease, and a librarian.
 

Confirming the Diagnosis

The first questions asked to help form the new recommendations were around confirming a diagnosis of Sjögren disease, such as what is the diagnostic accuracy of antinuclear antibodies (ANAs), extractable nuclear antigens (ENAs), and other novel antigens in Sjögren disease? And what is the diagnostic accuracy of salivary gland ultrasound, imaging in general, and salivary gland or lacrimal gland biopsies? 

The resulting recommendations advised not to measure ANAs in the absence of clinical indicators of Sjögren disease or any other connective tissue disease but to use it to screen if there was a clinical suspicion. And ENAs should be measured even if the ANAs were negative and there is a high index of suspicion. 

In terms of imaging, ultrasound of the salivary glands was thought to be useful, but other imaging was not recommended for routine practice at the current time. Minor lip but not lacrimal gland biopsies were recommended if clinical and serologic features were not enough to make a diagnosis.
 

Lymphoma Worries

The 2017 version of the guideline did not include information about lymphoma, but this is the thing that most patients with Sjögren disease will worry about, Dr. Price said. “They all look it up on YouTube, they all come back and tell me that they are really worried they’ll develop it.”

The question that was therefore posed was whether there were any measurable biomarkers that could predict the development of lymphoma in adults and children. Seven predictors were found, the strongest being a low level of complement C4 alone or together with low levels of C3. Other predictors were salivary gland enlargement, lymphadenopathy, anti-Ro/La and rheumatoid factor autoantibodies, cryoglobulinemia, monoclonal gammopathy, and a high focus score. 

All of these predictors put someone in a higher risk category for lymphoma. If two or fewer of those features are present, the lifetime risk is “probably below 2%,” Dr. Price said. However, if all seven are present, the lifetime risk is “approaching 100%.”

The recommendation made on the basis of these findings is that people with Sjögren disease need to be offered early further investigation if they present with any new salivary gland swelling or other symptoms that might suggest the development of lymphoma. In this regard, a labial salivary gland biopsy might provide additional prognostic information.
 

‘Do the Little Things Well’

“You have to do the little things well,” Dr. Price said. “Many of the patients [who] come to see me for a second opinion have not been prescribed the right eye drops, have not been given advice on dental care,” with their management taking “too much on the rheumatological treatments.”

Rheumatologists are of course not trained or expected to be experts in ophthalmology or dentistry, but “you need to look at their mouth and you do need to examine their eyes, and you do need to give them some advice,” Dr. Price advised.

Thankfully, that is where the updated guidelines should help, with a recommendation that people with Sjögren disease should use preservative-free eye drops every 2-3 hours.

“It’s vital you avoid preservatives, because preservatives flatten the corneal surface and reduce the surface area and can cause inflammation in their own right,” Dr. Price cautioned, adding that there are plenty of suitable eye drop formulations available. 

In regard to helping with dry mouth symptoms, the recommendation is to use a saliva substitute for symptomatic relief. For vaginal dryness, the recommendation is to consider advising topical nonhormonal vaginal moisturizers plus estrogen creams or pessaries in peri- or postmenopausal women with significant vaginal dryness. 

“Very important, however, is to maintain a neutral pH, an alkaline environment in the mouth because acid damages dental enamel,” Dr. Price said. Conversely, an acidic vaginal moisturizer is needed to treat vaginal dryness. 

Dental hygiene is important. Regular brushing with a fluoride-based toothpaste is advised. The use of xylitol-containing products has been shown to reduce bacteria known to increase the risk for dental decay. Telling patients not to eat between meals is also simple but important advice. 

“We do recommend that patients are assessed holistically,” Dr. Price said, noting that they should be offered access to cognitive-behavioral therapy and exercise therapies to help with the symptoms of fatigue and joint pain.
 

Watch Out for Comorbidities

Sjögren disease is associated with many comorbidities, some of which might be predicted from the age and demographics of the people who are normally affected. 

“This is on the whole an older, female population, so you see a lot of osteoarthritis, gastroesophageal reflux, and hypertension,” Dr. Price said. “However, you may not be aware that 1 in 5 of these patients develop thyroid disease,” and there is a higher rate of celiac disease and primary biliary cholangitis than is seen in the general background population. 

The recommendation, therefore, is to “be aware of and consider screening for commonly associated conditions, as guided by age and/or clinical presentation.” As such, it’s recommended that baseline and repeated investigations that look for signs of comorbidity are performed, such as thyroid function assessment and liver function tests, to name two.
 

Treatment Recommendations

As in the original guideline, the treatment of systemic disease is discussed, but the advice has been overhauled with the availability of new data. 

The updated guidance notes that a trial of hydroxychloroquine for 6-12 months is the recommended treatment approach for people with fatigue and systemic symptoms. 

Systemic steroids may be used in the short-term for specific indications but should not be offered routinely. 

Conventional immunosuppressive or biologic drugs and immunoglobulins are not currently recommended outside of managing specific systemic complications.

In juvenile cases, the treatment of recurrent swollen parotid glands that are not due to infection or stone disease should include a short course of a nonsteroidal anti-inflammatory drug or a short course of oral steroids. This should be combined with massage followed by washouts with saline or steroids. In refractory cases, escalation to anti–B-cell–targeted therapies may be considered in select situations.
 

View on Updates

Patient advocate Bridget Crampton, who leads the helpline team at Sjögren’s UK (formerly the British Sjögren’s Syndrome Association), commented on the importance of the guidelines during a roundtable held by the BSR. 

“I think it will help [patients] make better use of their own appointments. So, they’ll know what treatments might be offered. They’ll know what they want to talk about at their appointments,” she said. 

Ms. Crampton, who has lived with Sjögren disease herself for the past 20 years, added: “I think it’s important for patients that we have guidelines like this. It means that all clinicians can easily access information. My hope is that it might standardize care across the UK a little bit more.” 

No specific funding was received to create the guidelines, be that from any bodies in the public, commercial, or not-for-profit sectors. No conflicts of interests were expressed by any of the experts quoted in this article.

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — An updated guideline from the British Society for Rheumatology (BSR) on the management of Sjögren disease asks rheumatologists and other clinicians caring for patients with the condition to “do the little things well” rather than overly focusing on rheumatologic treatments. The guideline’s new format provides recommendations for specific clinical questions and now also includes recommendations for managing the disease in children and adolescents. 

“The original guideline was published in 2017, and things move on very rapidly,” consultant rheumatologist Elizabeth Price, MBBCh, PhD, said ahead of her presentation of the updated guideline at the annual meeting of the British Society for Rheumatology.

Sara Freeman/Medscape Medical News

What’s in a Name?

The BSR guideline on the management of adult and juvenile onset Sjögren disease is published in Rheumatology and is available via the BSR website, where it is accompanied by a short summary sheet. 

The most notable change perhaps is the name the guideline now uses, Dr. Price said at BSR 2024. “We have been bold and called it Sjögren disease.” Previously, the guideline used the term primary Sjögren’s syndrome, but there has been a “move away from using eponymous syndromes and dropping s’s and apostrophes,” she explained. 

Another significant change is that advice on managing Sjögren disease in children and adolescents is now included where appropriate, meaning that the British guideline is now the first to cover Sjögren disease “across the ages,” Dr. Price said.

A pediatric/adolescent rheumatologist joined the guideline working group, which already consisted of several adult rheumatologists, ophthalmologists, and a dentistry consultant. The group now comprises 22 members total, including a general practitioner, an oncologist, a renal physician, an occupational therapist, two patients with Sjögren disease, and a librarian.
 

Confirming the Diagnosis

The first questions asked to help form the new recommendations were around confirming a diagnosis of Sjögren disease, such as what is the diagnostic accuracy of antinuclear antibodies (ANAs), extractable nuclear antigens (ENAs), and other novel antigens in Sjögren disease? And what is the diagnostic accuracy of salivary gland ultrasound, imaging in general, and salivary gland or lacrimal gland biopsies? 

The resulting recommendations advised not to measure ANAs in the absence of clinical indicators of Sjögren disease or any other connective tissue disease but to use it to screen if there was a clinical suspicion. And ENAs should be measured even if the ANAs were negative and there is a high index of suspicion. 

In terms of imaging, ultrasound of the salivary glands was thought to be useful, but other imaging was not recommended for routine practice at the current time. Minor lip but not lacrimal gland biopsies were recommended if clinical and serologic features were not enough to make a diagnosis.
 

Lymphoma Worries

The 2017 version of the guideline did not include information about lymphoma, but this is the thing that most patients with Sjögren disease will worry about, Dr. Price said. “They all look it up on YouTube, they all come back and tell me that they are really worried they’ll develop it.”

The question that was therefore posed was whether there were any measurable biomarkers that could predict the development of lymphoma in adults and children. Seven predictors were found, the strongest being a low level of complement C4 alone or together with low levels of C3. Other predictors were salivary gland enlargement, lymphadenopathy, anti-Ro/La and rheumatoid factor autoantibodies, cryoglobulinemia, monoclonal gammopathy, and a high focus score. 

All of these predictors put someone in a higher risk category for lymphoma. If two or fewer of those features are present, the lifetime risk is “probably below 2%,” Dr. Price said. However, if all seven are present, the lifetime risk is “approaching 100%.”

The recommendation made on the basis of these findings is that people with Sjögren disease need to be offered early further investigation if they present with any new salivary gland swelling or other symptoms that might suggest the development of lymphoma. In this regard, a labial salivary gland biopsy might provide additional prognostic information.
 

‘Do the Little Things Well’

“You have to do the little things well,” Dr. Price said. “Many of the patients [who] come to see me for a second opinion have not been prescribed the right eye drops, have not been given advice on dental care,” with their management taking “too much on the rheumatological treatments.”

Rheumatologists are of course not trained or expected to be experts in ophthalmology or dentistry, but “you need to look at their mouth and you do need to examine their eyes, and you do need to give them some advice,” Dr. Price advised.

Thankfully, that is where the updated guidelines should help, with a recommendation that people with Sjögren disease should use preservative-free eye drops every 2-3 hours.

“It’s vital you avoid preservatives, because preservatives flatten the corneal surface and reduce the surface area and can cause inflammation in their own right,” Dr. Price cautioned, adding that there are plenty of suitable eye drop formulations available. 

In regard to helping with dry mouth symptoms, the recommendation is to use a saliva substitute for symptomatic relief. For vaginal dryness, the recommendation is to consider advising topical nonhormonal vaginal moisturizers plus estrogen creams or pessaries in peri- or postmenopausal women with significant vaginal dryness. 

“Very important, however, is to maintain a neutral pH, an alkaline environment in the mouth because acid damages dental enamel,” Dr. Price said. Conversely, an acidic vaginal moisturizer is needed to treat vaginal dryness. 

Dental hygiene is important. Regular brushing with a fluoride-based toothpaste is advised. The use of xylitol-containing products has been shown to reduce bacteria known to increase the risk for dental decay. Telling patients not to eat between meals is also simple but important advice. 

“We do recommend that patients are assessed holistically,” Dr. Price said, noting that they should be offered access to cognitive-behavioral therapy and exercise therapies to help with the symptoms of fatigue and joint pain.
 

Watch Out for Comorbidities

Sjögren disease is associated with many comorbidities, some of which might be predicted from the age and demographics of the people who are normally affected. 

“This is on the whole an older, female population, so you see a lot of osteoarthritis, gastroesophageal reflux, and hypertension,” Dr. Price said. “However, you may not be aware that 1 in 5 of these patients develop thyroid disease,” and there is a higher rate of celiac disease and primary biliary cholangitis than is seen in the general background population. 

The recommendation, therefore, is to “be aware of and consider screening for commonly associated conditions, as guided by age and/or clinical presentation.” As such, it’s recommended that baseline and repeated investigations that look for signs of comorbidity are performed, such as thyroid function assessment and liver function tests, to name two.
 

Treatment Recommendations

As in the original guideline, the treatment of systemic disease is discussed, but the advice has been overhauled with the availability of new data. 

The updated guidance notes that a trial of hydroxychloroquine for 6-12 months is the recommended treatment approach for people with fatigue and systemic symptoms. 

Systemic steroids may be used in the short-term for specific indications but should not be offered routinely. 

Conventional immunosuppressive or biologic drugs and immunoglobulins are not currently recommended outside of managing specific systemic complications.

In juvenile cases, the treatment of recurrent swollen parotid glands that are not due to infection or stone disease should include a short course of a nonsteroidal anti-inflammatory drug or a short course of oral steroids. This should be combined with massage followed by washouts with saline or steroids. In refractory cases, escalation to anti–B-cell–targeted therapies may be considered in select situations.
 

View on Updates

Patient advocate Bridget Crampton, who leads the helpline team at Sjögren’s UK (formerly the British Sjögren’s Syndrome Association), commented on the importance of the guidelines during a roundtable held by the BSR. 

“I think it will help [patients] make better use of their own appointments. So, they’ll know what treatments might be offered. They’ll know what they want to talk about at their appointments,” she said. 

Ms. Crampton, who has lived with Sjögren disease herself for the past 20 years, added: “I think it’s important for patients that we have guidelines like this. It means that all clinicians can easily access information. My hope is that it might standardize care across the UK a little bit more.” 

No specific funding was received to create the guidelines, be that from any bodies in the public, commercial, or not-for-profit sectors. No conflicts of interests were expressed by any of the experts quoted in this article.

A version of this article appeared on Medscape.com.

DENVER — A first-in-class monoclonal antibody (riliprubart, Sanofi) that inhibits complement activation showed good activity versus IVIG in chronic inflammatory demyelinating polyneuropathy (CIDP), with good results in treatment-refractory and treatment-naive patients, according to results from a phase 2 clinical trial.

‘Impressive’ Results

The results were impressive, especially given that riliprubart outperformed IVIG, according to Frank Tennigkeit, PhD, senior director of pediatric development rare diseases at UCB Biosciences, who attended the session at the 2024 annual meeting of the American Academy of Neurology, where the study was presented. “There are few trials on CIDP, and the standard data are IVIG data.

“This is really amazing, especially in refractory patients. I turned to my neighbor [during the presentation] and said, ‘I’ve never seen CIDP data that good in my life. It works in all kinds of different patient populations, and also on the refractory ones. That’s what you want. That’s where the need is. And you saw a consistent effect and a strong effect on top of standard of care,” said Dr. Tennigkeit.

“It’s impressive. The only problem with CIDP is that it’s very difficult to compare treatments, because everyone has a different outcome. This was an open-label study, so there’s always a confounding bias. The proof of the pudding is going to be in a phase 3 blinded, randomized trial, but what I really admire about them, and I thought was very gutsy, is that they’re going head-to-head versus IVIG. I haven’t seen anyone who’s done that yet [in CIDP],” said Shalom Patole, MD, an internist and telehealth consultant in India, who also attended the session.
 

An Open-Label Phase 2 Study

The study had a somewhat unique design, according to Richard Lewis, MD, who presented the results. It was an open-label design that examined three subpopulations: 25 who had objective response to treatments (standard of care [SOC]–treated, mean age, 58.2 years; 80% male), 18 refractory patients who had been off treatment for up to 12 weeks (SOC-refractory, mean age, 63.9 years; 61% male), and 12 patients who had not been treated at all for at least 6 months or were treatment-naive (SOC-naive, mean age, 59.1 years; 67% male).

At 24 weeks, “if you looked at the treated group, 88% of those patients improved to remain stable, and only 12% relapsed. Most significantly, these patients who had responded to their IVIG, who were supposedly doing pretty well, 44% of those actually got better, so they improved from what would have been a pretty good baseline. The refractory patients, despite flunking the other treatments, 50% actually passed or improved with the treatment, so a significant response rate in a group that was not responding so well,” said Dr. Lewis, who is a neurologist at Cedars Sinai Medical Center.

The researchers also found that treatment with riliprubart led to inhibition of complement activity and a trend in reduction in neurofilament light chain levels by week 24 in all three groups.

Treatment-emergent adverse events occurred in 60% of the SOC-treated group, 72% of the SOC-refractory group, and 75% of the SOC-naive group, though grade 3 or higher events were rare (4%, 17%, and 8%, respectively). There was one death in the SOC-treated group and one in the SOC-refractory group. Both patients were elderly and had comorbid conditions.
 

Challenging the Current Standard of Care

The data have led to two additional phase 3 trials, one in refractory patients (Mobilize), and another for patients treated with IVIG who have residual disability (Vitalize). Sanofi is also planning a phase 3, placebo-controlled trial with one arm that will compare the antibody to IVIG, “which is a pretty ambitious trial design,” admitted Dr. Lewis.

Such a strategy is risky, but it could represent a big payoff for Sanofi if the phase 3 studies replicate the phase 2 studies. “No one would be using IVIG anymore if you beat IVIG by 50%. That will be the standard. If you do the trial [versus IVIG], you have a higher risk, but if you win it, you will win big,” said Dr. Tennigkeit.

The study was funded by Sanofi. Dr. Lewis has financial relationships with CSL Behring, Grifols, Pfizer, Sanofi, Argenx, Pharnext, Roche, Johnson & Johnson, Takeda, Boehringer Ingelheim, Nuvig, Dianthus, Janssen, Medscape, Alexion, Alnylam, and Novartis. Dr. Tennigkeit is an employee of UCB Biosciences. Dr. Patole has no relevant financial disclosures.

DENVER — A first-in-class monoclonal antibody (riliprubart, Sanofi) that inhibits complement activation showed good activity versus IVIG in chronic inflammatory demyelinating polyneuropathy (CIDP), with good results in treatment-refractory and treatment-naive patients, according to results from a phase 2 clinical trial.

‘Impressive’ Results

The results were impressive, especially given that riliprubart outperformed IVIG, according to Frank Tennigkeit, PhD, senior director of pediatric development rare diseases at UCB Biosciences, who attended the session at the 2024 annual meeting of the American Academy of Neurology, where the study was presented. “There are few trials on CIDP, and the standard data are IVIG data.

“This is really amazing, especially in refractory patients. I turned to my neighbor [during the presentation] and said, ‘I’ve never seen CIDP data that good in my life. It works in all kinds of different patient populations, and also on the refractory ones. That’s what you want. That’s where the need is. And you saw a consistent effect and a strong effect on top of standard of care,” said Dr. Tennigkeit.

“It’s impressive. The only problem with CIDP is that it’s very difficult to compare treatments, because everyone has a different outcome. This was an open-label study, so there’s always a confounding bias. The proof of the pudding is going to be in a phase 3 blinded, randomized trial, but what I really admire about them, and I thought was very gutsy, is that they’re going head-to-head versus IVIG. I haven’t seen anyone who’s done that yet [in CIDP],” said Shalom Patole, MD, an internist and telehealth consultant in India, who also attended the session.
 

An Open-Label Phase 2 Study

The study had a somewhat unique design, according to Richard Lewis, MD, who presented the results. It was an open-label design that examined three subpopulations: 25 who had objective response to treatments (standard of care [SOC]–treated, mean age, 58.2 years; 80% male), 18 refractory patients who had been off treatment for up to 12 weeks (SOC-refractory, mean age, 63.9 years; 61% male), and 12 patients who had not been treated at all for at least 6 months or were treatment-naive (SOC-naive, mean age, 59.1 years; 67% male).

At 24 weeks, “if you looked at the treated group, 88% of those patients improved to remain stable, and only 12% relapsed. Most significantly, these patients who had responded to their IVIG, who were supposedly doing pretty well, 44% of those actually got better, so they improved from what would have been a pretty good baseline. The refractory patients, despite flunking the other treatments, 50% actually passed or improved with the treatment, so a significant response rate in a group that was not responding so well,” said Dr. Lewis, who is a neurologist at Cedars Sinai Medical Center.

The researchers also found that treatment with riliprubart led to inhibition of complement activity and a trend in reduction in neurofilament light chain levels by week 24 in all three groups.

Treatment-emergent adverse events occurred in 60% of the SOC-treated group, 72% of the SOC-refractory group, and 75% of the SOC-naive group, though grade 3 or higher events were rare (4%, 17%, and 8%, respectively). There was one death in the SOC-treated group and one in the SOC-refractory group. Both patients were elderly and had comorbid conditions.
 

Challenging the Current Standard of Care

The data have led to two additional phase 3 trials, one in refractory patients (Mobilize), and another for patients treated with IVIG who have residual disability (Vitalize). Sanofi is also planning a phase 3, placebo-controlled trial with one arm that will compare the antibody to IVIG, “which is a pretty ambitious trial design,” admitted Dr. Lewis.

Such a strategy is risky, but it could represent a big payoff for Sanofi if the phase 3 studies replicate the phase 2 studies. “No one would be using IVIG anymore if you beat IVIG by 50%. That will be the standard. If you do the trial [versus IVIG], you have a higher risk, but if you win it, you will win big,” said Dr. Tennigkeit.

The study was funded by Sanofi. Dr. Lewis has financial relationships with CSL Behring, Grifols, Pfizer, Sanofi, Argenx, Pharnext, Roche, Johnson & Johnson, Takeda, Boehringer Ingelheim, Nuvig, Dianthus, Janssen, Medscape, Alexion, Alnylam, and Novartis. Dr. Tennigkeit is an employee of UCB Biosciences. Dr. Patole has no relevant financial disclosures.

DENVER — A first-in-class monoclonal antibody (riliprubart, Sanofi) that inhibits complement activation showed good activity versus IVIG in chronic inflammatory demyelinating polyneuropathy (CIDP), with good results in treatment-refractory and treatment-naive patients, according to results from a phase 2 clinical trial.

‘Impressive’ Results

The results were impressive, especially given that riliprubart outperformed IVIG, according to Frank Tennigkeit, PhD, senior director of pediatric development rare diseases at UCB Biosciences, who attended the session at the 2024 annual meeting of the American Academy of Neurology, where the study was presented. “There are few trials on CIDP, and the standard data are IVIG data.

“This is really amazing, especially in refractory patients. I turned to my neighbor [during the presentation] and said, ‘I’ve never seen CIDP data that good in my life. It works in all kinds of different patient populations, and also on the refractory ones. That’s what you want. That’s where the need is. And you saw a consistent effect and a strong effect on top of standard of care,” said Dr. Tennigkeit.

“It’s impressive. The only problem with CIDP is that it’s very difficult to compare treatments, because everyone has a different outcome. This was an open-label study, so there’s always a confounding bias. The proof of the pudding is going to be in a phase 3 blinded, randomized trial, but what I really admire about them, and I thought was very gutsy, is that they’re going head-to-head versus IVIG. I haven’t seen anyone who’s done that yet [in CIDP],” said Shalom Patole, MD, an internist and telehealth consultant in India, who also attended the session.
 

An Open-Label Phase 2 Study

The study had a somewhat unique design, according to Richard Lewis, MD, who presented the results. It was an open-label design that examined three subpopulations: 25 who had objective response to treatments (standard of care [SOC]–treated, mean age, 58.2 years; 80% male), 18 refractory patients who had been off treatment for up to 12 weeks (SOC-refractory, mean age, 63.9 years; 61% male), and 12 patients who had not been treated at all for at least 6 months or were treatment-naive (SOC-naive, mean age, 59.1 years; 67% male).

At 24 weeks, “if you looked at the treated group, 88% of those patients improved to remain stable, and only 12% relapsed. Most significantly, these patients who had responded to their IVIG, who were supposedly doing pretty well, 44% of those actually got better, so they improved from what would have been a pretty good baseline. The refractory patients, despite flunking the other treatments, 50% actually passed or improved with the treatment, so a significant response rate in a group that was not responding so well,” said Dr. Lewis, who is a neurologist at Cedars Sinai Medical Center.

The researchers also found that treatment with riliprubart led to inhibition of complement activity and a trend in reduction in neurofilament light chain levels by week 24 in all three groups.

Treatment-emergent adverse events occurred in 60% of the SOC-treated group, 72% of the SOC-refractory group, and 75% of the SOC-naive group, though grade 3 or higher events were rare (4%, 17%, and 8%, respectively). There was one death in the SOC-treated group and one in the SOC-refractory group. Both patients were elderly and had comorbid conditions.
 

Challenging the Current Standard of Care

The data have led to two additional phase 3 trials, one in refractory patients (Mobilize), and another for patients treated with IVIG who have residual disability (Vitalize). Sanofi is also planning a phase 3, placebo-controlled trial with one arm that will compare the antibody to IVIG, “which is a pretty ambitious trial design,” admitted Dr. Lewis.

Such a strategy is risky, but it could represent a big payoff for Sanofi if the phase 3 studies replicate the phase 2 studies. “No one would be using IVIG anymore if you beat IVIG by 50%. That will be the standard. If you do the trial [versus IVIG], you have a higher risk, but if you win it, you will win big,” said Dr. Tennigkeit.

The study was funded by Sanofi. Dr. Lewis has financial relationships with CSL Behring, Grifols, Pfizer, Sanofi, Argenx, Pharnext, Roche, Johnson & Johnson, Takeda, Boehringer Ingelheim, Nuvig, Dianthus, Janssen, Medscape, Alexion, Alnylam, and Novartis. Dr. Tennigkeit is an employee of UCB Biosciences. Dr. Patole has no relevant financial disclosures.

ASUNCIÓN, PARAGUAY — The Lancet Diabetes & Endocrinology’s Commission for the Definition and Diagnosis of Clinical Obesity will soon publish criteria for distinguishing between clinical obesity and other preclinical phases. The criteria are intended to limit the negative connotations and misunderstandings associated with the word obesity and to clearly convey the idea that it is a disease and not just a condition that increases the risk for other pathologies.

One of the two Latin American experts on the 60-member commission, Ricardo Cohen, MD, PhD, coordinator of the Obesity and Diabetes Center at the Oswaldo Cruz German Hospital in São Paulo, Brazil, discussed this effort with this news organization.

The proposal being finalized would acknowledge a preclinical stage of obesity characterized by alterations in cells or tissues that lead to changes in organ structure, but not function. This stage can be measured by body mass index (BMI) or waist circumference.

The clinical stage occurs when “obesity already affects [the function of] organs, tissues, and functions like mobility. Here, it is a disease per se. And an active disease requires treatment,” said Dr. Cohen. The health risks associated with excess adiposity have already materialized and can be objectively documented through specific signs and symptoms.

Various experts from Latin America who participated in the XV Congress of the Latin American Obesity Societies (FLASO) and II Paraguayan Obesity Congress expressed to this news organization their reservations about the proposed name change and its practical effects. They highlighted the pros and cons of various terminologies that had been considered in recent years.

“Stigma undoubtedly exists. There’s also no doubt that this stigma and daily pressure on a person’s self-esteem influence behavior and condition a poor future clinical outcome because they promote denial of the disease. Healthcare professionals can make these mistakes. But I’m not sure that changing the name of a known disease will make a difference,” said Rafael Figueredo Grijalba, MD, president of FLASO and director of the Nutrition program at the Faculty of Health Sciences of the Nuestra Señora de la Asunción Catholic University in Paraguay.

Spotlight on Adiposity 

An alternative term for obesity proposed in 2016 by what is now the American Association of Clinical Endocrinology and by the American College of Endocrinology is “adiposity-based chronic disease (ABCD).” This designation “is on the right track,” said Violeta Jiménez, MD, internal medicine and endocrinology specialist at the Clinical Hospital of the National University of Asunción and the Comprehensive Diabetes Care Network of the Paraguay Social Security Institute.

The word obese is perceived as an insult, and the health impact of obesity is related to the quantity, distribution, and function of adipose tissue, said Dr. Jiménez. The BMI, the most used parameter in practice to determine overweight and obesity, “does not predict excess adiposity or determine a disease here and now, just as waist circumference does not confirm the condition.” 

Will the public be attracted to ABCD? What disease do these initials refer to, asked Dr. Jiménez. “What I like about the term ABCD is that it is not solely based on weight. It brings up the issue that a person who may not have obesity by BMI has adiposity and therefore has a disease brewing inside them.”

“Any obesity denomination is useful as long as the impact of comorbidities is taken into account, as well as the fact that it is not an aesthetic problem and treatment will be escalated aiming to benefit not only weight loss but also comorbidities,” said Paul Camperos Sánchez, MD, internal medicine and endocrinology specialist and head of research at La Trinidad Teaching Medical Center in Caracas, Venezuela, and former president of the Venezuelan Association for the Study of Obesity. 

Dr. Camperos Sánchez added that the classification of overweight and obesity into grades on the basis of BMI, which is recognized by the World Health Organization, “is the most known and for me remains the most comfortable. I will accept any other approach, but in my clinical practice, I continue to do it this way.” 

Fundamentally, knowledge can reduce social stigma and even prejudice from the medical community itself. “We must be respectful and compassionate and understand well what we are treating and the best way to approach each patient with realistic expectations. Evaluate whether, in addition to medication or intensive lifestyle changes, behavioral interventions or physiotherapy are required. If you don’t manage it well and find it challenging, perhaps that’s why we see so much stigmatization or humiliation of the patient. And that has nothing to do with the name [of the disease],” said Dr. Camperos Sánchez.

‘Biological Injustices’

Julio Montero, MD, nutritionist, president of the Argentine Society of Obesity and Eating Disorders, and former president of FLASO, told this news organization that the topic of nomenclatures “provides a lot of grounds for debate,” but he prefers the term “clinical obesity” because it has a medical meaning, is appropriate for statistical purposes, better conveys the concept of obesity as a disease, and distinguishes patients who have high weight or a spherical figure but may be free of weight-dependent conditions.

“Clinical obesity suggests that it is a person with high weight who has health problems and life expectancy issues related to excessive corpulence (weight-fat). The addition of the adjective clinical suggests that the patient has been evaluated by phenotype, fat distribution, hypertension, blood glucose, triglycerides, apnea, cardiac dilation, and mechanical problems, and based on that analysis, the diagnosis has been made,” said Dr. Montero.

Other positive aspects of the designation include not assuming that comorbidities are a direct consequence of adipose tissue accumulation because “lean mass often increases in patients with obesity, and diet and sedentary lifestyle also have an influence” nor does the term exclude people with central obesity. On the other hand, it does not propose a specific weight or fat that defines the disease, just like BMI does (which defines obesity but not its clinical consequences).

Regarding the proposed term ABCD, Montero pointed out that it focuses the diagnosis on the concept that adipose fat and adipocyte function are protagonists of the disease in question, even though there are chronic metabolic diseases like gout, porphyrias, and type 1 diabetes that do not depend on adiposity.

“ABCD also involves some degree of biological injustice, since femorogluteal adiposity (aside from aesthetic problems and excluding possible mechanical effects) is normal and healthy during pregnancy, lactation, growth, or situations of food scarcity risk, among others. Besides, it is an expression that is difficult to interpret for the untrained professional and even more so for communication to the population,” Dr. Montero concluded.

Dr. Cohen, Dr. Figueredo Grijalba, Dr. Jiménez, Dr. Camperos Sánchez, and Dr. Montero declared no relevant financial conflicts of interest. 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

ASUNCIÓN, PARAGUAY — The Lancet Diabetes & Endocrinology’s Commission for the Definition and Diagnosis of Clinical Obesity will soon publish criteria for distinguishing between clinical obesity and other preclinical phases. The criteria are intended to limit the negative connotations and misunderstandings associated with the word obesity and to clearly convey the idea that it is a disease and not just a condition that increases the risk for other pathologies.

One of the two Latin American experts on the 60-member commission, Ricardo Cohen, MD, PhD, coordinator of the Obesity and Diabetes Center at the Oswaldo Cruz German Hospital in São Paulo, Brazil, discussed this effort with this news organization.

The proposal being finalized would acknowledge a preclinical stage of obesity characterized by alterations in cells or tissues that lead to changes in organ structure, but not function. This stage can be measured by body mass index (BMI) or waist circumference.

The clinical stage occurs when “obesity already affects [the function of] organs, tissues, and functions like mobility. Here, it is a disease per se. And an active disease requires treatment,” said Dr. Cohen. The health risks associated with excess adiposity have already materialized and can be objectively documented through specific signs and symptoms.

Various experts from Latin America who participated in the XV Congress of the Latin American Obesity Societies (FLASO) and II Paraguayan Obesity Congress expressed to this news organization their reservations about the proposed name change and its practical effects. They highlighted the pros and cons of various terminologies that had been considered in recent years.

“Stigma undoubtedly exists. There’s also no doubt that this stigma and daily pressure on a person’s self-esteem influence behavior and condition a poor future clinical outcome because they promote denial of the disease. Healthcare professionals can make these mistakes. But I’m not sure that changing the name of a known disease will make a difference,” said Rafael Figueredo Grijalba, MD, president of FLASO and director of the Nutrition program at the Faculty of Health Sciences of the Nuestra Señora de la Asunción Catholic University in Paraguay.

Spotlight on Adiposity 

An alternative term for obesity proposed in 2016 by what is now the American Association of Clinical Endocrinology and by the American College of Endocrinology is “adiposity-based chronic disease (ABCD).” This designation “is on the right track,” said Violeta Jiménez, MD, internal medicine and endocrinology specialist at the Clinical Hospital of the National University of Asunción and the Comprehensive Diabetes Care Network of the Paraguay Social Security Institute.

The word obese is perceived as an insult, and the health impact of obesity is related to the quantity, distribution, and function of adipose tissue, said Dr. Jiménez. The BMI, the most used parameter in practice to determine overweight and obesity, “does not predict excess adiposity or determine a disease here and now, just as waist circumference does not confirm the condition.” 

Will the public be attracted to ABCD? What disease do these initials refer to, asked Dr. Jiménez. “What I like about the term ABCD is that it is not solely based on weight. It brings up the issue that a person who may not have obesity by BMI has adiposity and therefore has a disease brewing inside them.”

“Any obesity denomination is useful as long as the impact of comorbidities is taken into account, as well as the fact that it is not an aesthetic problem and treatment will be escalated aiming to benefit not only weight loss but also comorbidities,” said Paul Camperos Sánchez, MD, internal medicine and endocrinology specialist and head of research at La Trinidad Teaching Medical Center in Caracas, Venezuela, and former president of the Venezuelan Association for the Study of Obesity. 

Dr. Camperos Sánchez added that the classification of overweight and obesity into grades on the basis of BMI, which is recognized by the World Health Organization, “is the most known and for me remains the most comfortable. I will accept any other approach, but in my clinical practice, I continue to do it this way.” 

Fundamentally, knowledge can reduce social stigma and even prejudice from the medical community itself. “We must be respectful and compassionate and understand well what we are treating and the best way to approach each patient with realistic expectations. Evaluate whether, in addition to medication or intensive lifestyle changes, behavioral interventions or physiotherapy are required. If you don’t manage it well and find it challenging, perhaps that’s why we see so much stigmatization or humiliation of the patient. And that has nothing to do with the name [of the disease],” said Dr. Camperos Sánchez.

‘Biological Injustices’

Julio Montero, MD, nutritionist, president of the Argentine Society of Obesity and Eating Disorders, and former president of FLASO, told this news organization that the topic of nomenclatures “provides a lot of grounds for debate,” but he prefers the term “clinical obesity” because it has a medical meaning, is appropriate for statistical purposes, better conveys the concept of obesity as a disease, and distinguishes patients who have high weight or a spherical figure but may be free of weight-dependent conditions.

“Clinical obesity suggests that it is a person with high weight who has health problems and life expectancy issues related to excessive corpulence (weight-fat). The addition of the adjective clinical suggests that the patient has been evaluated by phenotype, fat distribution, hypertension, blood glucose, triglycerides, apnea, cardiac dilation, and mechanical problems, and based on that analysis, the diagnosis has been made,” said Dr. Montero.

Other positive aspects of the designation include not assuming that comorbidities are a direct consequence of adipose tissue accumulation because “lean mass often increases in patients with obesity, and diet and sedentary lifestyle also have an influence” nor does the term exclude people with central obesity. On the other hand, it does not propose a specific weight or fat that defines the disease, just like BMI does (which defines obesity but not its clinical consequences).

Regarding the proposed term ABCD, Montero pointed out that it focuses the diagnosis on the concept that adipose fat and adipocyte function are protagonists of the disease in question, even though there are chronic metabolic diseases like gout, porphyrias, and type 1 diabetes that do not depend on adiposity.

“ABCD also involves some degree of biological injustice, since femorogluteal adiposity (aside from aesthetic problems and excluding possible mechanical effects) is normal and healthy during pregnancy, lactation, growth, or situations of food scarcity risk, among others. Besides, it is an expression that is difficult to interpret for the untrained professional and even more so for communication to the population,” Dr. Montero concluded.

Dr. Cohen, Dr. Figueredo Grijalba, Dr. Jiménez, Dr. Camperos Sánchez, and Dr. Montero declared no relevant financial conflicts of interest. 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

ASUNCIÓN, PARAGUAY — The Lancet Diabetes & Endocrinology’s Commission for the Definition and Diagnosis of Clinical Obesity will soon publish criteria for distinguishing between clinical obesity and other preclinical phases. The criteria are intended to limit the negative connotations and misunderstandings associated with the word obesity and to clearly convey the idea that it is a disease and not just a condition that increases the risk for other pathologies.

One of the two Latin American experts on the 60-member commission, Ricardo Cohen, MD, PhD, coordinator of the Obesity and Diabetes Center at the Oswaldo Cruz German Hospital in São Paulo, Brazil, discussed this effort with this news organization.

The proposal being finalized would acknowledge a preclinical stage of obesity characterized by alterations in cells or tissues that lead to changes in organ structure, but not function. This stage can be measured by body mass index (BMI) or waist circumference.

The clinical stage occurs when “obesity already affects [the function of] organs, tissues, and functions like mobility. Here, it is a disease per se. And an active disease requires treatment,” said Dr. Cohen. The health risks associated with excess adiposity have already materialized and can be objectively documented through specific signs and symptoms.

Various experts from Latin America who participated in the XV Congress of the Latin American Obesity Societies (FLASO) and II Paraguayan Obesity Congress expressed to this news organization their reservations about the proposed name change and its practical effects. They highlighted the pros and cons of various terminologies that had been considered in recent years.

“Stigma undoubtedly exists. There’s also no doubt that this stigma and daily pressure on a person’s self-esteem influence behavior and condition a poor future clinical outcome because they promote denial of the disease. Healthcare professionals can make these mistakes. But I’m not sure that changing the name of a known disease will make a difference,” said Rafael Figueredo Grijalba, MD, president of FLASO and director of the Nutrition program at the Faculty of Health Sciences of the Nuestra Señora de la Asunción Catholic University in Paraguay.

Spotlight on Adiposity 

An alternative term for obesity proposed in 2016 by what is now the American Association of Clinical Endocrinology and by the American College of Endocrinology is “adiposity-based chronic disease (ABCD).” This designation “is on the right track,” said Violeta Jiménez, MD, internal medicine and endocrinology specialist at the Clinical Hospital of the National University of Asunción and the Comprehensive Diabetes Care Network of the Paraguay Social Security Institute.

The word obese is perceived as an insult, and the health impact of obesity is related to the quantity, distribution, and function of adipose tissue, said Dr. Jiménez. The BMI, the most used parameter in practice to determine overweight and obesity, “does not predict excess adiposity or determine a disease here and now, just as waist circumference does not confirm the condition.” 

Will the public be attracted to ABCD? What disease do these initials refer to, asked Dr. Jiménez. “What I like about the term ABCD is that it is not solely based on weight. It brings up the issue that a person who may not have obesity by BMI has adiposity and therefore has a disease brewing inside them.”

“Any obesity denomination is useful as long as the impact of comorbidities is taken into account, as well as the fact that it is not an aesthetic problem and treatment will be escalated aiming to benefit not only weight loss but also comorbidities,” said Paul Camperos Sánchez, MD, internal medicine and endocrinology specialist and head of research at La Trinidad Teaching Medical Center in Caracas, Venezuela, and former president of the Venezuelan Association for the Study of Obesity. 

Dr. Camperos Sánchez added that the classification of overweight and obesity into grades on the basis of BMI, which is recognized by the World Health Organization, “is the most known and for me remains the most comfortable. I will accept any other approach, but in my clinical practice, I continue to do it this way.” 

Fundamentally, knowledge can reduce social stigma and even prejudice from the medical community itself. “We must be respectful and compassionate and understand well what we are treating and the best way to approach each patient with realistic expectations. Evaluate whether, in addition to medication or intensive lifestyle changes, behavioral interventions or physiotherapy are required. If you don’t manage it well and find it challenging, perhaps that’s why we see so much stigmatization or humiliation of the patient. And that has nothing to do with the name [of the disease],” said Dr. Camperos Sánchez.

‘Biological Injustices’

Julio Montero, MD, nutritionist, president of the Argentine Society of Obesity and Eating Disorders, and former president of FLASO, told this news organization that the topic of nomenclatures “provides a lot of grounds for debate,” but he prefers the term “clinical obesity” because it has a medical meaning, is appropriate for statistical purposes, better conveys the concept of obesity as a disease, and distinguishes patients who have high weight or a spherical figure but may be free of weight-dependent conditions.

“Clinical obesity suggests that it is a person with high weight who has health problems and life expectancy issues related to excessive corpulence (weight-fat). The addition of the adjective clinical suggests that the patient has been evaluated by phenotype, fat distribution, hypertension, blood glucose, triglycerides, apnea, cardiac dilation, and mechanical problems, and based on that analysis, the diagnosis has been made,” said Dr. Montero.

Other positive aspects of the designation include not assuming that comorbidities are a direct consequence of adipose tissue accumulation because “lean mass often increases in patients with obesity, and diet and sedentary lifestyle also have an influence” nor does the term exclude people with central obesity. On the other hand, it does not propose a specific weight or fat that defines the disease, just like BMI does (which defines obesity but not its clinical consequences).

Regarding the proposed term ABCD, Montero pointed out that it focuses the diagnosis on the concept that adipose fat and adipocyte function are protagonists of the disease in question, even though there are chronic metabolic diseases like gout, porphyrias, and type 1 diabetes that do not depend on adiposity.

“ABCD also involves some degree of biological injustice, since femorogluteal adiposity (aside from aesthetic problems and excluding possible mechanical effects) is normal and healthy during pregnancy, lactation, growth, or situations of food scarcity risk, among others. Besides, it is an expression that is difficult to interpret for the untrained professional and even more so for communication to the population,” Dr. Montero concluded.

Dr. Cohen, Dr. Figueredo Grijalba, Dr. Jiménez, Dr. Camperos Sánchez, and Dr. Montero declared no relevant financial conflicts of interest. 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

In an extension study of patients with dystrophic epidermolysis bullosa (DEB) treated with the topical gene therapy beremagene geperpavec, wound closure rates and adverse events were similar to those seen in the phase 3 study and no new safety signals were identified.

The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.

In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.

In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.

The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).

Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.

Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.

Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.

In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.

Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.

A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.

Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.

Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

A significant proportion of patients with moderate to severe plaque psoriasis achieved at least a 75% improvement in the Psoriasis Area and Severity Score (PASI 75) compared with those on placebo after 12 weeks of treatment with an investigational oral tyrosine kinase 2 (TYK2) inhibitor, in a phase 2 study presented during a late breaker presentation at the annual meeting of the American Academy of Dermatology.

ESK-001 is a highly-selective TYK2 inhibitor that “reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-alpha,” according to Alumis, the company developing ESK-001.

The STRIDE trial enrolled 228 adults (mean age, 48 years) with a mean PASI score of 17.8 at baseline, randomized to one of five doses of ESK-001, or placebo. Nearly 70% of those enrolled were men, 82.5% were White, nearly 6% were Asian, and about 4% were Black.

The proportion of patients achieving at least a PASI-75 at 12 weeks, the primary endpoint, ranged from 19.4% among those on the lower dose (10 mg a day) to 56.4% among those on 20 mg twice a day and those on 40 mg once a day, and 64.1% among those on 40 mg twice a day, the highest dose evaluated, compared with 0% of those on placebo.

In addition, 38.5% and 15.4% of those on the highest dose achieved a PASI 90 and PASI 100, respectively, at 12 weeks, according to results presented at the meeting by Kim A. Papp, MD.

Improvements in static Physician’s Global Assessment (sPGA) scores, a secondary endpoint, at 12 weeks were also observed; including 59% of those on the highest dose (40 mg twice a day) achieving an sPGA of 0/1 at 12 weeks, according to Dr. Papp, president of Probity Medical Research, in Waterloo, Ontario, and a study investigator.

Treatment was “generally safe and well tolerated” at all doses, and most treatment-emergent adverse events were “mild to moderate” and self-limited, he said.

The most frequent treatment emergent adverse events included headache and nasopharyngitis (also reported in the placebo group), and upper respiratory tract infections. No cases of treatment-related serious adverse events were reported, and there were no cases of MACE (major adverse cardiovascular events), serious infections, thromboses related to treatment, or lab or ECG findings of concern.

In an ongoing open label extension study, 165 patients on 40 mg once a day and those on 40 mg twice a day are continuing to be evaluated, and at week 16, have continued to show significant efficacy, with a favorable risk-benefit profile to date, according to Dr. Papp.

ESK-001 is also being evaluated in a phase 2b study of patients with systemic lupus erythematosus, and a phase 2 proof-of-concept study of patients with non-infectious uveitis, according to Alumis.

In addition to being an investigator for Alumis, Dr. Papp disclosed serving as an adviser, consultant, investigator, and/or speaker for multiple other pharmaceutical companies.

The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.

Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.

Dearth of Research Persists

Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.

Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
 

No Evidence in OUD

Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.

Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
 

Potential Harms

If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug. 

But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
 

Use With Other Controlled Substances

Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.

Dr. Grossman reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.

Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.

Dearth of Research Persists

Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.

Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
 

No Evidence in OUD

Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.

Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
 

Potential Harms

If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug. 

But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
 

Use With Other Controlled Substances

Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.

Dr. Grossman reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

The utility of cannabinoids to treat most medical conditions remains uncertain at best, but for at least three indications the data lean in favor of effectiveness, Ellie Grossman, MD, MPH, told attendees recently at the 2024 American College of Physicians Internal Medicine meeting.

Those are neuropathic pain, chemotherapy-induced nausea or vomiting, and spasticity in people with multiple sclerosis, said Dr. Grossman, an instructor at Harvard Medical School in Boston and medical director for primary care/behavioral health integration at Cambridge Health Alliance in Somerville, Massachusetts.

Dearth of Research Persists

Research is sorely lacking and of low quality in the field for many reasons, Dr. Grossman said. Most of the products tested come from outside the United States and often are synthetic and taken orally — which does not match the real-world use when patients go to dispensaries for cannabis derived directly from plants (or the plant product itself). And studies often rely on self-report.

Chronic pain is by far the top reason patients say they use medical cannabis, Dr. Grossman said. A Cochrane review of 16 studies found only that the potential benefits of cannabis may outweigh the potential harms for chronic neuropathic pain.
 

No Evidence in OUD

Dr. Grossman said she is frequently asked if cannabis can help people quit taking opioids. The answer seems to be no. A study published earlier this year in states with legalized medical or recreational cannabis found no difference between rates of opioid overdose compared with states with no such laws. “It seems like it doesn’t do anything to help us with our opioid problem,” she said.

Nor does high-quality evidence exist showing use of cannabis can improve sleep, she said. A 2022 systematic review found fewer than half of studies showed the substance useful for sleep outcomes. “Where studies were positives, it was in people who had chronic pain,” Dr. Grossman noted. Research indicates cannabis may have substantial benefit for chronic pain compared with placebo.
 

Potential Harms

If the medical benefits of cannabis are murky, the evidence for its potential harms, at least in the short term, are clearer, according to Dr. Grossman. A simplified guideline for prescribing medical cannabinoids in primary care includes sedation, feeling high, dizziness, speech disorders, muscle twitching, hypotension, and several other conditions among the potential hazards of the drug. 

But the potential for long-term harm is uncertain. “All the evidence comes from people who have been using it for recreational reasons,” where there may be co-use of tobacco, self-reported outcomes, and recall bias, she said. The characteristics of people using cannabis recreationally often differ from those using it medicinally.
 

Use With Other Controlled Substances

Dr. Grossman said clinicians should consider whether the co-use of cannabis and other controlled substances, such as benzodiazepines, opioids, or Adderall, raises the potential risks associated with those drugs. “Ultimately it comes down to talking to your patients,” she said. If a toxicity screen shows the presence of controlled substances, ask about their experience with the drugs they are using and let them know your main concern is their safety.

Dr. Grossman reported no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.

Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.

However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.

In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
 

RA and VTE Risk

The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.

“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.

“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.

He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”

To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.

One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.

For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
 

Observational Data Challenged

“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.

Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.

Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.

“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.

“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
 

Age, Sex, and Bodyweight

Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.

“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”

Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
 

Duration of RA

As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.

The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.

“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”

Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
 

Oral Contraceptives and HRT

Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.

“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.

The overall VTE risk was 52% higher in women with RA than in those without RA.

Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
 

Assess and Monitor

Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.

“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.

The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.

The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.

Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.

However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.

In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
 

RA and VTE Risk

The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.

“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.

“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.

He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”

To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.

One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.

For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
 

Observational Data Challenged

“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.

Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.

Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.

“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.

“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
 

Age, Sex, and Bodyweight

Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.

“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”

Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
 

Duration of RA

As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.

The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.

“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”

Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
 

Oral Contraceptives and HRT

Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.

“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.

The overall VTE risk was 52% higher in women with RA than in those without RA.

Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
 

Assess and Monitor

Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.

“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.

The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.

The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — People with rheumatoid arthritis (RA) have a consistently higher risk for venous thromboembolism (VTE) than the general population, but the reasons for this remain unclear, research presented at the annual meeting of the British Society for Rheumatology (BSR) reaffirmed.

Regardless of age, sex, body mass index (BMI), duration of disease, use of estrogen-based oral contraceptives, or hormone replacement therapy (HRT), people with RA are more likely to experience a pulmonary embolism or deep vein thrombosis than those without RA.

However, “these are rare events,” James Galloway, MBChB, PhD, professor of rheumatology and deputy head of the Centre for Rheumatic Diseases at King’s College London in England, said at the meeting.

In one analysis of data from 117,050 individuals living in England and Wales that are held within a large primary care practice database, Dr. Galloway and colleagues found that the unadjusted incidence of VTE in people diagnosed with RA (n = 23,410) was 0.44% vs 0.26% for matched controls within the general population (n = 93,640).
 

RA and VTE Risk

The overall risk for VTE was 46% higher among people with RA than among those without, although the absolute difference was small, Dr. Galloway reported.

“RA is associated with an increased risk of VTE; that’s been well described over the years,” Dr. Galloway told this news organization. Past research into why there is an elevated risk for VTE in patients with RA has often focused on the role of disease activity and inflammation.

“In the last few years, a new class of drugs, the JAK [Janus kinase] inhibitors, have emerged in which we have seen a signal of increased VTE risk from a number of studies. And I think that puts a spotlight on our understanding of VTE risk,” Dr. Galloway said.

He added “JAK inhibitors are very powerful at controlling inflammation, but if you take away inflammation, there is still an excess risk. What else could be driving that?”

To examine the excess risk for VTE seen in people with RA, Dr. Galloway and colleagues performed three separate analyses using data collected between January 1999 and December 2018 by the Royal College of General Practitioners Research and Surveillance Center.

One analysis looked at VTE risk according to age, sex, and BMI; another looked at the effect of the duration of RA; and a third analysis focused on the use of estrogen-based oral contraceptives or HRT.

For all three analyses, those with RA were matched in a 4:1 ratio to people from the general population without RA on the basis of current age, sex, calendar time, and years since registration at the primary care practice.
 

Observational Data Challenged

“These are observational data, so it’s important to weigh up the strengths and limitations,” Dr. Galloway acknowledged. Strengths are the large sample size and long follow-up provided by the database, which assesses and monitors more than 2000 primary care practices in England and Wales.

Confounding is still possible, despite adjusting for multiple factors that included sociodemographic factors; clinical features; and VTE risk factors such as smoking status, alcohol use, thrombophilia, reduced mobility, lower limb fracture, and a family history of VTE if data had been available. There wasn’t information on disease activity, for example, and disease duration was used as a surrogate marker for this.

Sitting in the audience, Marwan Bukhari, MBBS, PhD, challenged the population-matching process.

“Do you think maybe it was the matching that was the problem?” asked Dr. Bukhari, who is consultant rheumatologist at University Hospitals of Morecambe Bay NHS Foundation Trust and an honorary senior lecturer at the University of Manchester, both in England.

“They’re not entirely matched completely, correctly. Even if it is 4:1, there’s a difference between the populations,” he said.
 

Age, Sex, and Bodyweight

Over an average of 8.2 years’ follow-up, the adjusted hazard ratios (aHRs) comparing VTE risk in women and men with and without RA were a respective 1.62 and 1.52. The corresponding aHRs for VTE according to different age groups were 2.13 for age 18-49 years, 1.57 for age 50-69 years, and 1.34 for age 70 years and older.

“The highest excess risk was in the youngest age group,” Dr. Galloway pointed out, “but all age groups showing a significant increased risk of venous thromboembolism.”

Similar findings were seen across different BMI categories, with the highest risk occurring in those in the lowest BMI group. The aHRs were 1.66, 1.60, and 1.41 for the BMI categories of less than 25 kg/m2, 25-30 kg/m2, and more than 30 kg/m2, respectively.
 

Duration of RA

As for disease duration, nearly two thirds (63.9%) of the 23,410 adults with RA included in this analysis were included at or within 2 years of a diagnosis of RA, 7.8% within 2-5 years of diagnosis, 9.8% within 5-10 years of diagnosis, and 18.5% at 10 or more years after diagnosis.

The aHR for an increased relative risk for VTE in people with RA vs the control group ranged from 1.49 for 0-2 years of diagnosis up to 1.63 for more than 10 years since diagnosis.

“We could see no evidence that the VTE excess risk in rheumatoid arthritis was with a specific time since diagnosis,” Dr. Galloway said in the interview. “It appears that the risk is increased in people with established RA, whether you’ve had the disease for 2 years or 10 years.”

Similar findings were also seen when they looked at aHRs for pulmonary embolism (1.46-2.02) and deep vein thrombosis (1.43-1.89) separately.
 

Oral Contraceptives and HRT

Data on the use of estrogen-based oral contraceptives or HRT were detailed in a virtual poster presentation. In this analysis, there were 16,664 women with and 65,448 without RA, and the average follow-up was 8.3 years.

“The number of people available for this analysis was small, and bigger studies are needed,” Dr. Galloway said in the interview. Indeed, in the RA group, just 3.3% had used an estrogen-based oral contraceptive and 4.5% had used HRT compared with 3.9% and 3.8% in the control group, respectively.

The overall VTE risk was 52% higher in women with RA than in those without RA.

Risk for VTE was higher among women with RA regardless of the use of estrogen-based oral contraceptives or not (aHRs, 1.43 and 1.52, respectively) and regardless of the use of HRT or not (aHRs, 2.32 and 1.51).
 

Assess and Monitor

Together these data increase understanding of how age, gender, obesity, duration of disease, and estrogen-based contraception and HRT may make a difference to someone’s VTE risk.

“In all people with RA, we observe an increased risk of venous thromboembolism, and that is both relevant in a contemporary era when we think about prescribing and the different risks of drugs we use for therapeutic strategies,” Dr. Galloway said.

The overall take-home message, he said, is that VTE risk should be considered in everyone with RA and assessed and monitored accordingly. This includes those who may have traditionally been thought of as having a lower risk than others, such as men vs women, younger vs older individuals, and those who may have had RA for a few years.

The research was funded by Pfizer. Dr. Galloway reported receiving honoraria from Pfizer, AbbVie, Biovitrum, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Janssen, Lilly, Novartis, Roche, Sanofi, Sobi, and UCB. Two coauthors of the work were employees of Pfizer. Dr. Bukhari had no conflicts of interest and was not involved in the research.

A version of this article appeared on Medscape.com.

ASUNCIÓN, PARAGUAY — Sarcopenic obesity, which is characterized by excess adiposity and muscle loss, is an “underestimated and underdiagnosed” condition, said the panelists at a session of the XV Latin American Obesity Congress (FLASO 2024) and II Paraguayan Congress of Obesity. The condition often affects older adults but can also occur at any age as a result of unhealthy habits or intensive or repeated weight loss efforts. 

“The drugs currently used for managing obesity promote significant weight loss, but by losing fat, muscle is also lost,” said Fabiola Romero Gómez, MD, a professor of medicine at the National University of Asunción and president of the Paraguayan Society of Endocrinology and Metabolism. “We must handle [these drugs] with extreme care. When we employ a strategy that achieves this significant weight loss, we must ensure that the patient receives a good protein intake and engages in resistance exercises, because otherwise, the cure may be worse than the disease.”

Some patients develop sarcopenic obesity after using glucagon-like peptide-1 (GLP-1) analogs, undergoing bariatric surgery, or pursuing restrictive diets, Dr. Romero said in an interview. The condition is more common when there are long-standing cycles of weight loss and subsequent gain, “which accounts for the majority of our patients,” she said.

“An important, largely ignored aspect of weight loss, whether through pharmacological or lifestyle intervention, is that a portion of the weight loss comprises lean muscle,” according to a recent editorial in Nature Medicine. “Weight regain, however, is almost entirely fat. People with chronic obesity often lose and regain weight in repeated cycles, each of which results in body-composition changes (even if they experience some net weight loss). This cycling puts people unable to sustain weight loss at risk of being metabolically less healthy than they were before the initial weight loss was achieved — in effect, at risk of developing sarcopenic obesity.”
 

A ‘Hidden’ Problem

Sarcopenic obesity is “something hidden, something that we often do not see. Why? Because if we do not make measurements of body composition, we will not realize it,” said Dr. Romero.

According to the 2022 consensus of the European Society for Clinical Nutrition and Metabolism and the European Association for the Study of Obesity, clinical signs or factors suggesting sarcopenic obesity include age over 70 years, diagnosis of a chronic disease, repeated falls or weakness, and nutritional events such as recent weight loss or rapid gain, long-standing restrictive diets, and bariatric surgery. 

The European guidelines also propose screening in individuals at risk to check for an increased body mass index (BMI) or waist circumference and suspicion parameters of sarcopenia. In this group of patients, the diagnosis should be made based on the analysis of alterations in muscle-skeletal functional parameters, such as grip or pinch strength or the 30-second chair stand test, followed by a determination of body mass alteration using dual-energy x-ray absorptiometry or electrical bioimpedance. 

Electrical bioimpedance is Dr. Romero’s preferred method. It is an economical, simple, and easily transportable test that calculates lean muscle mass, fat mass, and body water based on electrical conductivity, she said. Experts have pointed out that bioimpedance scales “will revolutionize the way we measure obesity,” she added. 

In an as-yet-unpublished study that received an honorable mention at the 3rd Paraguayan Congress of Endocrinology, Diabetes, and Metabolism last year, Dr. Romero and colleagues studied 126 patients (median age, 45 years) with obesity defined by percentage of fat mass determined by bioimpedance. When their BMI was analyzed, 11.1% were “normal” weight, and 35.7% were “overweight.” Even waist circumference measurement suggested that about 15% of participants were without obesity. Moreover, almost one in four participants presented with sarcopenia, “implying a decrease in quality of life and physical disability in the future if not investigated, diagnosed, and treated correctly,” said Dr. Romero. 
 

Prevention and Recommendations

Exercise and nutrition are two key components in the prevention and management of sarcopenic obesity. Physicians prescribing GLP-1 receptor agonists “must also counsel patients about incorporating aerobic exercise and resistance training as part of the treatment plan, as well as ensuring they eat a high-protein diet,” Yoon Ji Ahn, MD, and Vibha Singhal, MD, MPH, of the Weight Management Center of Massachusetts General Hospital in Boston, wrote in a commentary published by this news organization.

Paraguayan nutritionist Patricia López Soto, a diabetes educator with postgraduate degrees in obesity, diabetes, and bariatric surgery from Favaloro University in Buenos Aires, shared with this news organization the following general recommendations to prevent sarcopenic obesity in patients undergoing weight loss treatment: 

• Follow a healthy and balanced Mediterranean or DASH-style diet.
• Increase protein intake at the three to four main meals to a minimum of 1.4-1.5 g/kg/day.
• Try to make the protein intake mostly of high biological value: Beef, chicken, fish, eggs, seafood, cheese, skim milk, and yogurt.
• Ensure protein intake at each meal of between 25 g and 30 g to increase protein synthesis. For example, a 150 g portion of meat or chicken provides 30 g of protein.
• If the protein intake is not achieved through food, a supplement measure like isolated and hydrolyzed whey protein is a good option.
• Engage in strength or resistance training (weightlifting) three to four times per week and 30 minutes of cardiovascular exercise every day.
• To improve adherence, treatment should be carried out with a multidisciplinary team that includes a physician, nutritionist, and physical trainer, with frequent check-ups and body composition studies by bioimpedance.

Dr. Romero and Ms. López declared no relevant financial relationships. 
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

ASUNCIÓN, PARAGUAY — Sarcopenic obesity, which is characterized by excess adiposity and muscle loss, is an “underestimated and underdiagnosed” condition, said the panelists at a session of the XV Latin American Obesity Congress (FLASO 2024) and II Paraguayan Congress of Obesity. The condition often affects older adults but can also occur at any age as a result of unhealthy habits or intensive or repeated weight loss efforts. 

“The drugs currently used for managing obesity promote significant weight loss, but by losing fat, muscle is also lost,” said Fabiola Romero Gómez, MD, a professor of medicine at the National University of Asunción and president of the Paraguayan Society of Endocrinology and Metabolism. “We must handle [these drugs] with extreme care. When we employ a strategy that achieves this significant weight loss, we must ensure that the patient receives a good protein intake and engages in resistance exercises, because otherwise, the cure may be worse than the disease.”

Some patients develop sarcopenic obesity after using glucagon-like peptide-1 (GLP-1) analogs, undergoing bariatric surgery, or pursuing restrictive diets, Dr. Romero said in an interview. The condition is more common when there are long-standing cycles of weight loss and subsequent gain, “which accounts for the majority of our patients,” she said.

“An important, largely ignored aspect of weight loss, whether through pharmacological or lifestyle intervention, is that a portion of the weight loss comprises lean muscle,” according to a recent editorial in Nature Medicine. “Weight regain, however, is almost entirely fat. People with chronic obesity often lose and regain weight in repeated cycles, each of which results in body-composition changes (even if they experience some net weight loss). This cycling puts people unable to sustain weight loss at risk of being metabolically less healthy than they were before the initial weight loss was achieved — in effect, at risk of developing sarcopenic obesity.”
 

A ‘Hidden’ Problem

Sarcopenic obesity is “something hidden, something that we often do not see. Why? Because if we do not make measurements of body composition, we will not realize it,” said Dr. Romero.

According to the 2022 consensus of the European Society for Clinical Nutrition and Metabolism and the European Association for the Study of Obesity, clinical signs or factors suggesting sarcopenic obesity include age over 70 years, diagnosis of a chronic disease, repeated falls or weakness, and nutritional events such as recent weight loss or rapid gain, long-standing restrictive diets, and bariatric surgery. 

The European guidelines also propose screening in individuals at risk to check for an increased body mass index (BMI) or waist circumference and suspicion parameters of sarcopenia. In this group of patients, the diagnosis should be made based on the analysis of alterations in muscle-skeletal functional parameters, such as grip or pinch strength or the 30-second chair stand test, followed by a determination of body mass alteration using dual-energy x-ray absorptiometry or electrical bioimpedance. 

Electrical bioimpedance is Dr. Romero’s preferred method. It is an economical, simple, and easily transportable test that calculates lean muscle mass, fat mass, and body water based on electrical conductivity, she said. Experts have pointed out that bioimpedance scales “will revolutionize the way we measure obesity,” she added. 

In an as-yet-unpublished study that received an honorable mention at the 3rd Paraguayan Congress of Endocrinology, Diabetes, and Metabolism last year, Dr. Romero and colleagues studied 126 patients (median age, 45 years) with obesity defined by percentage of fat mass determined by bioimpedance. When their BMI was analyzed, 11.1% were “normal” weight, and 35.7% were “overweight.” Even waist circumference measurement suggested that about 15% of participants were without obesity. Moreover, almost one in four participants presented with sarcopenia, “implying a decrease in quality of life and physical disability in the future if not investigated, diagnosed, and treated correctly,” said Dr. Romero. 
 

Prevention and Recommendations

Exercise and nutrition are two key components in the prevention and management of sarcopenic obesity. Physicians prescribing GLP-1 receptor agonists “must also counsel patients about incorporating aerobic exercise and resistance training as part of the treatment plan, as well as ensuring they eat a high-protein diet,” Yoon Ji Ahn, MD, and Vibha Singhal, MD, MPH, of the Weight Management Center of Massachusetts General Hospital in Boston, wrote in a commentary published by this news organization.

Paraguayan nutritionist Patricia López Soto, a diabetes educator with postgraduate degrees in obesity, diabetes, and bariatric surgery from Favaloro University in Buenos Aires, shared with this news organization the following general recommendations to prevent sarcopenic obesity in patients undergoing weight loss treatment: 

• Follow a healthy and balanced Mediterranean or DASH-style diet.
• Increase protein intake at the three to four main meals to a minimum of 1.4-1.5 g/kg/day.
• Try to make the protein intake mostly of high biological value: Beef, chicken, fish, eggs, seafood, cheese, skim milk, and yogurt.
• Ensure protein intake at each meal of between 25 g and 30 g to increase protein synthesis. For example, a 150 g portion of meat or chicken provides 30 g of protein.
• If the protein intake is not achieved through food, a supplement measure like isolated and hydrolyzed whey protein is a good option.
• Engage in strength or resistance training (weightlifting) three to four times per week and 30 minutes of cardiovascular exercise every day.
• To improve adherence, treatment should be carried out with a multidisciplinary team that includes a physician, nutritionist, and physical trainer, with frequent check-ups and body composition studies by bioimpedance.

Dr. Romero and Ms. López declared no relevant financial relationships. 
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

ASUNCIÓN, PARAGUAY — Sarcopenic obesity, which is characterized by excess adiposity and muscle loss, is an “underestimated and underdiagnosed” condition, said the panelists at a session of the XV Latin American Obesity Congress (FLASO 2024) and II Paraguayan Congress of Obesity. The condition often affects older adults but can also occur at any age as a result of unhealthy habits or intensive or repeated weight loss efforts. 

“The drugs currently used for managing obesity promote significant weight loss, but by losing fat, muscle is also lost,” said Fabiola Romero Gómez, MD, a professor of medicine at the National University of Asunción and president of the Paraguayan Society of Endocrinology and Metabolism. “We must handle [these drugs] with extreme care. When we employ a strategy that achieves this significant weight loss, we must ensure that the patient receives a good protein intake and engages in resistance exercises, because otherwise, the cure may be worse than the disease.”

Some patients develop sarcopenic obesity after using glucagon-like peptide-1 (GLP-1) analogs, undergoing bariatric surgery, or pursuing restrictive diets, Dr. Romero said in an interview. The condition is more common when there are long-standing cycles of weight loss and subsequent gain, “which accounts for the majority of our patients,” she said.

“An important, largely ignored aspect of weight loss, whether through pharmacological or lifestyle intervention, is that a portion of the weight loss comprises lean muscle,” according to a recent editorial in Nature Medicine. “Weight regain, however, is almost entirely fat. People with chronic obesity often lose and regain weight in repeated cycles, each of which results in body-composition changes (even if they experience some net weight loss). This cycling puts people unable to sustain weight loss at risk of being metabolically less healthy than they were before the initial weight loss was achieved — in effect, at risk of developing sarcopenic obesity.”
 

A ‘Hidden’ Problem

Sarcopenic obesity is “something hidden, something that we often do not see. Why? Because if we do not make measurements of body composition, we will not realize it,” said Dr. Romero.

According to the 2022 consensus of the European Society for Clinical Nutrition and Metabolism and the European Association for the Study of Obesity, clinical signs or factors suggesting sarcopenic obesity include age over 70 years, diagnosis of a chronic disease, repeated falls or weakness, and nutritional events such as recent weight loss or rapid gain, long-standing restrictive diets, and bariatric surgery. 

The European guidelines also propose screening in individuals at risk to check for an increased body mass index (BMI) or waist circumference and suspicion parameters of sarcopenia. In this group of patients, the diagnosis should be made based on the analysis of alterations in muscle-skeletal functional parameters, such as grip or pinch strength or the 30-second chair stand test, followed by a determination of body mass alteration using dual-energy x-ray absorptiometry or electrical bioimpedance. 

Electrical bioimpedance is Dr. Romero’s preferred method. It is an economical, simple, and easily transportable test that calculates lean muscle mass, fat mass, and body water based on electrical conductivity, she said. Experts have pointed out that bioimpedance scales “will revolutionize the way we measure obesity,” she added. 

In an as-yet-unpublished study that received an honorable mention at the 3rd Paraguayan Congress of Endocrinology, Diabetes, and Metabolism last year, Dr. Romero and colleagues studied 126 patients (median age, 45 years) with obesity defined by percentage of fat mass determined by bioimpedance. When their BMI was analyzed, 11.1% were “normal” weight, and 35.7% were “overweight.” Even waist circumference measurement suggested that about 15% of participants were without obesity. Moreover, almost one in four participants presented with sarcopenia, “implying a decrease in quality of life and physical disability in the future if not investigated, diagnosed, and treated correctly,” said Dr. Romero. 
 

Prevention and Recommendations

Exercise and nutrition are two key components in the prevention and management of sarcopenic obesity. Physicians prescribing GLP-1 receptor agonists “must also counsel patients about incorporating aerobic exercise and resistance training as part of the treatment plan, as well as ensuring they eat a high-protein diet,” Yoon Ji Ahn, MD, and Vibha Singhal, MD, MPH, of the Weight Management Center of Massachusetts General Hospital in Boston, wrote in a commentary published by this news organization.

Paraguayan nutritionist Patricia López Soto, a diabetes educator with postgraduate degrees in obesity, diabetes, and bariatric surgery from Favaloro University in Buenos Aires, shared with this news organization the following general recommendations to prevent sarcopenic obesity in patients undergoing weight loss treatment: 

• Follow a healthy and balanced Mediterranean or DASH-style diet.
• Increase protein intake at the three to four main meals to a minimum of 1.4-1.5 g/kg/day.
• Try to make the protein intake mostly of high biological value: Beef, chicken, fish, eggs, seafood, cheese, skim milk, and yogurt.
• Ensure protein intake at each meal of between 25 g and 30 g to increase protein synthesis. For example, a 150 g portion of meat or chicken provides 30 g of protein.
• If the protein intake is not achieved through food, a supplement measure like isolated and hydrolyzed whey protein is a good option.
• Engage in strength or resistance training (weightlifting) three to four times per week and 30 minutes of cardiovascular exercise every day.
• To improve adherence, treatment should be carried out with a multidisciplinary team that includes a physician, nutritionist, and physical trainer, with frequent check-ups and body composition studies by bioimpedance.

Dr. Romero and Ms. López declared no relevant financial relationships. 
 

This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — Optimizing how people experiencing a gout flare are managed in hospital and then followed-up afterwards can substantially increase the uptake of guideline-recommended urate-lowering therapy (ULT), researchers reported at the annual meeting of the British Society for Rheumatology (BSR).

In a prospective study, 92% of 97 people admitted to hospital for gout flares were using ULT within 6 months of discharge after a multifaceted intervention was introduced. By comparison, 49% of 94 people admitted for gout flares before the introduction of the intervention were taking ULT within the same postdischarge time frame. 

Moreover, a higher proportion of individuals had urate blood tests done at least once within the 6-month postdischarge period after the intervention’s introduction (58% vs 32%) and fewer (9% vs 15%) needed repeated hospital treatment. 

“Gout is the most common inflammatory arthritis affecting one in 30 adults in the United Kingdom, yet it’s one of the most poorly managed,” study investigator Mark D. Russell, MB, BChir, pointed out during a poster presentation. 

“There are very effective treatments,” added Dr. Russell, a rheumatology registrar and postdoctoral research fellow at King’s College London in London, England. “Urate-lowering therapies such as allopurinol, which when taken at the correct dose, in the long term, effectively cures patients of their symptoms and prevents complications.” 

Dr. Russell said in an interview that there was still work to be done as the rate of people achieving urate levels below the recommended threshold of 360 micromol/L (6 mg/dL) within 6 months was still low, at 27%, even it if was still better than the 11% seen before the intervention was introduced.
 

Improving the In- and Post-Hospital Pathway

“We developed and implemented an in-hospital management pathway which encouraged urate-lowering therapy initiation prior to discharge, followed by a post-discharge nurse-led review,” Dr. Russell explained. 

The in-hospital pathway was based upon BSR, European Alliance of Associations for Rheumatology, and American College of Rheumatology guidelines and involved diagnosing and managing the gout flare appropriately. This may have been via early joint aspiration, medication, or both, as directed by the rheumatology team. Affected individuals also received education and were directed where to obtain further information on the use of ULT. Outpatient follow-up was considered if an individual had severe or tophaceous gout, recurrent episodes, or contraindications or intolerances to ULT. Otherwise, a rheumatology nurse telephoned the individual 2 weeks later to review symptoms and discuss next steps.

The researchers recorded improvements in in-hospital outcomes. The frequency of in-hospital serum urate level measurements rose from 66% in the 12-month preimplementation period to 93% in the 12-month period after the intervention’s introduction. Almost two thirds (62%) of patients were discharged on ULT compared with 18% preimplementation. And gout-specific recommendations were given 86% of the time compared with 59% before the intervention.
 

Related Work on Gout Incidence

Separately, Dr. Russell also presented data from a nationwide, population-level cohort study that used data from OpenSAFELY, the secure data analytics platform used by the National Health Service in England. 

“We did an analysis previously using the CPRD [Clinical Research Practice Datalink], which is another good primary care database, showing that only a third of people with gout in the UK get urate-lowering drugs, when really it should be the vast majority,” he said in the interview.

“And then we wanted to look at, on top of that, what was the impact of the [COVID-19] pandemic,” Russell added. Specifically, the aim was to look at how the pandemic had affected the incidence, management, and prevalence of gout.

Between March 2015 and February 2023, 246,695 new cases of gout were identified among 17.9 million adults, seen in primary and secondary care. 
 

COVID-19 Pandemic Affected Cases

“The number of new cases of gout dropped by about one third in the first year of the pandemic,” Dr. Russell said. Incidence declined from 1.78 to 1.23 per 1000 adults. “Whether that was through people not feeling comfortable going to their GP [general practitioner] or not being able to get an appointment, we don’t know.”

While there was a subsequent increase in new cases of gout since this time, the rates still haven’t reached what they were before the pandemic. This implies that there could be a substantial number of people who may be undiagnosed because of the pandemic, Dr. Russell suggested. 

Moreover, he reported that in 2022-2023, the prevalence of gout was 3.21%, up slightly from the 3.07% recorded 7 years earlier in 2015-2016.
 

ULT Treatment Rates Low

“If you did see a GP, however, so as long as you saw someone, the treatment wasn’t any worse,” Dr. Russell said. Just under 30% of people with incident gout for whom follow-up data were available had initiated ULT within 6 months of their diagnosis. And, of these new starters, around a quarter had a serum urate level below a target of 360 micromol/L. 

“This doesn’t detract from the fact that this is pretty low. Despite guidelines, we’re still not getting the majority of people on these very effective urate-lowering drugs,” Dr. Russell said.

There is perhaps too much reliance on modifying diet and lifestyle, he added, which are important for many reasons but will not do much to lower blood urate levels. 

As a final word, Dr. Russell said, “It’s not just a case of preventing a bit of joint pain. People get lots of complications when they’re undertreated — erosive joint damage, work disability, impaired quality of life — and yet we’ve got very cheap, well-tolerated drugs.”

The work was independently funded. Dr. Russell acknowledged grant or research support from Eli Lilly, Janssen, Pfizer, and UCB and receipt of honoraria from AbbVie, Biogen, Eli Lilly, Galapagos, and Menarini. 

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — Optimizing how people experiencing a gout flare are managed in hospital and then followed-up afterwards can substantially increase the uptake of guideline-recommended urate-lowering therapy (ULT), researchers reported at the annual meeting of the British Society for Rheumatology (BSR).

In a prospective study, 92% of 97 people admitted to hospital for gout flares were using ULT within 6 months of discharge after a multifaceted intervention was introduced. By comparison, 49% of 94 people admitted for gout flares before the introduction of the intervention were taking ULT within the same postdischarge time frame. 

Moreover, a higher proportion of individuals had urate blood tests done at least once within the 6-month postdischarge period after the intervention’s introduction (58% vs 32%) and fewer (9% vs 15%) needed repeated hospital treatment. 

“Gout is the most common inflammatory arthritis affecting one in 30 adults in the United Kingdom, yet it’s one of the most poorly managed,” study investigator Mark D. Russell, MB, BChir, pointed out during a poster presentation. 

“There are very effective treatments,” added Dr. Russell, a rheumatology registrar and postdoctoral research fellow at King’s College London in London, England. “Urate-lowering therapies such as allopurinol, which when taken at the correct dose, in the long term, effectively cures patients of their symptoms and prevents complications.” 

Dr. Russell said in an interview that there was still work to be done as the rate of people achieving urate levels below the recommended threshold of 360 micromol/L (6 mg/dL) within 6 months was still low, at 27%, even it if was still better than the 11% seen before the intervention was introduced.
 

Improving the In- and Post-Hospital Pathway

“We developed and implemented an in-hospital management pathway which encouraged urate-lowering therapy initiation prior to discharge, followed by a post-discharge nurse-led review,” Dr. Russell explained. 

The in-hospital pathway was based upon BSR, European Alliance of Associations for Rheumatology, and American College of Rheumatology guidelines and involved diagnosing and managing the gout flare appropriately. This may have been via early joint aspiration, medication, or both, as directed by the rheumatology team. Affected individuals also received education and were directed where to obtain further information on the use of ULT. Outpatient follow-up was considered if an individual had severe or tophaceous gout, recurrent episodes, or contraindications or intolerances to ULT. Otherwise, a rheumatology nurse telephoned the individual 2 weeks later to review symptoms and discuss next steps.

The researchers recorded improvements in in-hospital outcomes. The frequency of in-hospital serum urate level measurements rose from 66% in the 12-month preimplementation period to 93% in the 12-month period after the intervention’s introduction. Almost two thirds (62%) of patients were discharged on ULT compared with 18% preimplementation. And gout-specific recommendations were given 86% of the time compared with 59% before the intervention.
 

Related Work on Gout Incidence

Separately, Dr. Russell also presented data from a nationwide, population-level cohort study that used data from OpenSAFELY, the secure data analytics platform used by the National Health Service in England. 

“We did an analysis previously using the CPRD [Clinical Research Practice Datalink], which is another good primary care database, showing that only a third of people with gout in the UK get urate-lowering drugs, when really it should be the vast majority,” he said in the interview.

“And then we wanted to look at, on top of that, what was the impact of the [COVID-19] pandemic,” Russell added. Specifically, the aim was to look at how the pandemic had affected the incidence, management, and prevalence of gout.

Between March 2015 and February 2023, 246,695 new cases of gout were identified among 17.9 million adults, seen in primary and secondary care. 
 

COVID-19 Pandemic Affected Cases

“The number of new cases of gout dropped by about one third in the first year of the pandemic,” Dr. Russell said. Incidence declined from 1.78 to 1.23 per 1000 adults. “Whether that was through people not feeling comfortable going to their GP [general practitioner] or not being able to get an appointment, we don’t know.”

While there was a subsequent increase in new cases of gout since this time, the rates still haven’t reached what they were before the pandemic. This implies that there could be a substantial number of people who may be undiagnosed because of the pandemic, Dr. Russell suggested. 

Moreover, he reported that in 2022-2023, the prevalence of gout was 3.21%, up slightly from the 3.07% recorded 7 years earlier in 2015-2016.
 

ULT Treatment Rates Low

“If you did see a GP, however, so as long as you saw someone, the treatment wasn’t any worse,” Dr. Russell said. Just under 30% of people with incident gout for whom follow-up data were available had initiated ULT within 6 months of their diagnosis. And, of these new starters, around a quarter had a serum urate level below a target of 360 micromol/L. 

“This doesn’t detract from the fact that this is pretty low. Despite guidelines, we’re still not getting the majority of people on these very effective urate-lowering drugs,” Dr. Russell said.

There is perhaps too much reliance on modifying diet and lifestyle, he added, which are important for many reasons but will not do much to lower blood urate levels. 

As a final word, Dr. Russell said, “It’s not just a case of preventing a bit of joint pain. People get lots of complications when they’re undertreated — erosive joint damage, work disability, impaired quality of life — and yet we’ve got very cheap, well-tolerated drugs.”

The work was independently funded. Dr. Russell acknowledged grant or research support from Eli Lilly, Janssen, Pfizer, and UCB and receipt of honoraria from AbbVie, Biogen, Eli Lilly, Galapagos, and Menarini. 

A version of this article appeared on Medscape.com.

LIVERPOOL, ENGLAND — Optimizing how people experiencing a gout flare are managed in hospital and then followed-up afterwards can substantially increase the uptake of guideline-recommended urate-lowering therapy (ULT), researchers reported at the annual meeting of the British Society for Rheumatology (BSR).

In a prospective study, 92% of 97 people admitted to hospital for gout flares were using ULT within 6 months of discharge after a multifaceted intervention was introduced. By comparison, 49% of 94 people admitted for gout flares before the introduction of the intervention were taking ULT within the same postdischarge time frame. 

Moreover, a higher proportion of individuals had urate blood tests done at least once within the 6-month postdischarge period after the intervention’s introduction (58% vs 32%) and fewer (9% vs 15%) needed repeated hospital treatment. 

“Gout is the most common inflammatory arthritis affecting one in 30 adults in the United Kingdom, yet it’s one of the most poorly managed,” study investigator Mark D. Russell, MB, BChir, pointed out during a poster presentation. 

“There are very effective treatments,” added Dr. Russell, a rheumatology registrar and postdoctoral research fellow at King’s College London in London, England. “Urate-lowering therapies such as allopurinol, which when taken at the correct dose, in the long term, effectively cures patients of their symptoms and prevents complications.” 

Dr. Russell said in an interview that there was still work to be done as the rate of people achieving urate levels below the recommended threshold of 360 micromol/L (6 mg/dL) within 6 months was still low, at 27%, even it if was still better than the 11% seen before the intervention was introduced.
 

Improving the In- and Post-Hospital Pathway

“We developed and implemented an in-hospital management pathway which encouraged urate-lowering therapy initiation prior to discharge, followed by a post-discharge nurse-led review,” Dr. Russell explained. 

The in-hospital pathway was based upon BSR, European Alliance of Associations for Rheumatology, and American College of Rheumatology guidelines and involved diagnosing and managing the gout flare appropriately. This may have been via early joint aspiration, medication, or both, as directed by the rheumatology team. Affected individuals also received education and were directed where to obtain further information on the use of ULT. Outpatient follow-up was considered if an individual had severe or tophaceous gout, recurrent episodes, or contraindications or intolerances to ULT. Otherwise, a rheumatology nurse telephoned the individual 2 weeks later to review symptoms and discuss next steps.

The researchers recorded improvements in in-hospital outcomes. The frequency of in-hospital serum urate level measurements rose from 66% in the 12-month preimplementation period to 93% in the 12-month period after the intervention’s introduction. Almost two thirds (62%) of patients were discharged on ULT compared with 18% preimplementation. And gout-specific recommendations were given 86% of the time compared with 59% before the intervention.
 

Related Work on Gout Incidence

Separately, Dr. Russell also presented data from a nationwide, population-level cohort study that used data from OpenSAFELY, the secure data analytics platform used by the National Health Service in England. 

“We did an analysis previously using the CPRD [Clinical Research Practice Datalink], which is another good primary care database, showing that only a third of people with gout in the UK get urate-lowering drugs, when really it should be the vast majority,” he said in the interview.

“And then we wanted to look at, on top of that, what was the impact of the [COVID-19] pandemic,” Russell added. Specifically, the aim was to look at how the pandemic had affected the incidence, management, and prevalence of gout.

Between March 2015 and February 2023, 246,695 new cases of gout were identified among 17.9 million adults, seen in primary and secondary care. 
 

COVID-19 Pandemic Affected Cases

“The number of new cases of gout dropped by about one third in the first year of the pandemic,” Dr. Russell said. Incidence declined from 1.78 to 1.23 per 1000 adults. “Whether that was through people not feeling comfortable going to their GP [general practitioner] or not being able to get an appointment, we don’t know.”

While there was a subsequent increase in new cases of gout since this time, the rates still haven’t reached what they were before the pandemic. This implies that there could be a substantial number of people who may be undiagnosed because of the pandemic, Dr. Russell suggested. 

Moreover, he reported that in 2022-2023, the prevalence of gout was 3.21%, up slightly from the 3.07% recorded 7 years earlier in 2015-2016.
 

ULT Treatment Rates Low

“If you did see a GP, however, so as long as you saw someone, the treatment wasn’t any worse,” Dr. Russell said. Just under 30% of people with incident gout for whom follow-up data were available had initiated ULT within 6 months of their diagnosis. And, of these new starters, around a quarter had a serum urate level below a target of 360 micromol/L. 

“This doesn’t detract from the fact that this is pretty low. Despite guidelines, we’re still not getting the majority of people on these very effective urate-lowering drugs,” Dr. Russell said.

There is perhaps too much reliance on modifying diet and lifestyle, he added, which are important for many reasons but will not do much to lower blood urate levels. 

As a final word, Dr. Russell said, “It’s not just a case of preventing a bit of joint pain. People get lots of complications when they’re undertreated — erosive joint damage, work disability, impaired quality of life — and yet we’ve got very cheap, well-tolerated drugs.”

The work was independently funded. Dr. Russell acknowledged grant or research support from Eli Lilly, Janssen, Pfizer, and UCB and receipt of honoraria from AbbVie, Biogen, Eli Lilly, Galapagos, and Menarini. 

A version of this article appeared on Medscape.com.