Patient registry sheds light on the economic impact of MS

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Preliminary findings from a registry questionnaire reveal that 77% of patients with multiple sclerosis (MS) are employed either full or part time, with the rest being unemployed.

“MS seems to prevent people with MS from realizing their full potential at work or home,” said study coauthor Kottil Rammohan, MD, who summarized the study results in a video interview. Dr. Rammohan is professor of clinical neurology, director of the MS center of excellence, and chief of the multiple sclerosis division at the University of Miami. The study findings were presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

The North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) prospectively collects information about the health care economics of patients with MS and its effects on daily life. In 2017, NARCRMS established the health care economics outcomes research (HEOR) advisory group. NARCRMS developed a Health-Related Productivity Questionnaire and Health Resource Utilization Questionnaire. The questionnaires were incorporated into the existing case report forms that are completed by patients at enrollment, annual, and exacerbation visits.

This analysis was based on 480 patients who had completed HEOR case report forms. Among those, 77% are employed either full or part time; however, of those 15% were underemployed, meaning they wanted to work more than their current work levels. About 13% are on disability.


“What we found was there was a significant impact at home as well,” said Dr. Rammohan. Patients reported that MS kept them from completing household chores. “MS is a disease that seems to impact not only the work environment, but also the home environment.”

When polled to determine the main reason why these MS patients are not able to function, “what we found was that it was not because of gait or immobility, it was difficulty related to fatigue,” Dr. Rammohan said. The second most common impairment was related to cognition.

“These are what we call the silent or the transparent symptoms of MS.”

Dr. Rammohan disclosed consulting fees from EMD Serono, Biogen, Sanofi-Aventis, Genzyme, Novartis, Teva Neurosciences, Acorda, and Roche/Genentech.

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Preliminary findings from a registry questionnaire reveal that 77% of patients with multiple sclerosis (MS) are employed either full or part time, with the rest being unemployed.

“MS seems to prevent people with MS from realizing their full potential at work or home,” said study coauthor Kottil Rammohan, MD, who summarized the study results in a video interview. Dr. Rammohan is professor of clinical neurology, director of the MS center of excellence, and chief of the multiple sclerosis division at the University of Miami. The study findings were presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

The North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) prospectively collects information about the health care economics of patients with MS and its effects on daily life. In 2017, NARCRMS established the health care economics outcomes research (HEOR) advisory group. NARCRMS developed a Health-Related Productivity Questionnaire and Health Resource Utilization Questionnaire. The questionnaires were incorporated into the existing case report forms that are completed by patients at enrollment, annual, and exacerbation visits.

This analysis was based on 480 patients who had completed HEOR case report forms. Among those, 77% are employed either full or part time; however, of those 15% were underemployed, meaning they wanted to work more than their current work levels. About 13% are on disability.


“What we found was there was a significant impact at home as well,” said Dr. Rammohan. Patients reported that MS kept them from completing household chores. “MS is a disease that seems to impact not only the work environment, but also the home environment.”

When polled to determine the main reason why these MS patients are not able to function, “what we found was that it was not because of gait or immobility, it was difficulty related to fatigue,” Dr. Rammohan said. The second most common impairment was related to cognition.

“These are what we call the silent or the transparent symptoms of MS.”

Dr. Rammohan disclosed consulting fees from EMD Serono, Biogen, Sanofi-Aventis, Genzyme, Novartis, Teva Neurosciences, Acorda, and Roche/Genentech.

Preliminary findings from a registry questionnaire reveal that 77% of patients with multiple sclerosis (MS) are employed either full or part time, with the rest being unemployed.

“MS seems to prevent people with MS from realizing their full potential at work or home,” said study coauthor Kottil Rammohan, MD, who summarized the study results in a video interview. Dr. Rammohan is professor of clinical neurology, director of the MS center of excellence, and chief of the multiple sclerosis division at the University of Miami. The study findings were presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

The North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) prospectively collects information about the health care economics of patients with MS and its effects on daily life. In 2017, NARCRMS established the health care economics outcomes research (HEOR) advisory group. NARCRMS developed a Health-Related Productivity Questionnaire and Health Resource Utilization Questionnaire. The questionnaires were incorporated into the existing case report forms that are completed by patients at enrollment, annual, and exacerbation visits.

This analysis was based on 480 patients who had completed HEOR case report forms. Among those, 77% are employed either full or part time; however, of those 15% were underemployed, meaning they wanted to work more than their current work levels. About 13% are on disability.


“What we found was there was a significant impact at home as well,” said Dr. Rammohan. Patients reported that MS kept them from completing household chores. “MS is a disease that seems to impact not only the work environment, but also the home environment.”

When polled to determine the main reason why these MS patients are not able to function, “what we found was that it was not because of gait or immobility, it was difficulty related to fatigue,” Dr. Rammohan said. The second most common impairment was related to cognition.

“These are what we call the silent or the transparent symptoms of MS.”

Dr. Rammohan disclosed consulting fees from EMD Serono, Biogen, Sanofi-Aventis, Genzyme, Novartis, Teva Neurosciences, Acorda, and Roche/Genentech.

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VIDEO: Dr. Lihi Eder on the diagnostic challenges of psoriatic arthritis

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How strong are the links between psoriasis and psoriatic arthritis? What are the biggest challenges that keep clinicians from diagnosing PsA? And which approaches show promise in helping prevent PsA? In this expert analysis, Lihi Eder, MD, PhD, of Women’s College Research Institute, Toronto, and the University of Toronto offers answers to these questions and more.

 

 

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How strong are the links between psoriasis and psoriatic arthritis? What are the biggest challenges that keep clinicians from diagnosing PsA? And which approaches show promise in helping prevent PsA? In this expert analysis, Lihi Eder, MD, PhD, of Women’s College Research Institute, Toronto, and the University of Toronto offers answers to these questions and more.

 

 

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How strong are the links between psoriasis and psoriatic arthritis? What are the biggest challenges that keep clinicians from diagnosing PsA? And which approaches show promise in helping prevent PsA? In this expert analysis, Lihi Eder, MD, PhD, of Women’s College Research Institute, Toronto, and the University of Toronto offers answers to these questions and more.

 

 

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Ultra low-dose rituximab retains promise in rheumatoid arthritis

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– Retreatment of rheumatoid arthritis (RA) with an ultra low-dose of rituximab failed to meet the predefined noninferiority endpoint relative to a higher dose in a double-blind randomized trial, but the investigators still think this strategy may be viable in selected patients.

Lise M. Verhoef, MSc, a researcher in rheumatology at the Sint Maartenskliniek in Nijmegen, the Netherlands, who presented the data as a late-breaker at the European Congress of Rheumatology, explains in a video interview why the negative trial still might support an ultra low-dose strategy.

This trial, called REDO, was conceived after it was observed that most patients with RA are well controlled on a single injection of 1,000 mg of rituximab even though this is half the standard dose of two 1,000 mg doses given 15 days apart. The study was designed to determine whether even lower doses could be used.

The study enrolled 142 patients with RA who were being retreated with rituximab after responding previously to this therapy. In a 1:2:2 ratio, patients were randomized to single rituximab injections of 1,000 mg, 500 mg, or 200 mg. Outcome then were compared at the end of 6 months.

Noninferiority was defined as 0.5 difference in DAS28-CRP score (disease activity score using C-reactive protein instead of erythrocyte sedimentation rate) score adjusted for baseline disease status and use of conventional disease-modifying antirheumatic drugs (DMARDs).

Although noninferior at 3 months, the 500 mg dose did not meet the noninferiority criteria at 6 months. Due to a hierarchical design, evaluation of the 200 mg dose was precluded by the negative result with the 500 mg dose.

However, the majority of patients did respond to both the 500 mg and 200 mg dose. The failure to meet noninferiority was due to a limited number of patients who required rescue therapy for a flare. As a result, the investigators believe a trial of ultra low-dose therapy still might be reasonable.

In this interview, Ms. Verhoef explains that at her center patients who are well controlled on a 1,000 mg dose of rituximab now are being offered a 500 mg dose for retreatment. If they continue to respond, further retreatment with a 200 mg dose is considered.

Ms. Verhoef had no relevant financial disclosures.

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– Retreatment of rheumatoid arthritis (RA) with an ultra low-dose of rituximab failed to meet the predefined noninferiority endpoint relative to a higher dose in a double-blind randomized trial, but the investigators still think this strategy may be viable in selected patients.

Lise M. Verhoef, MSc, a researcher in rheumatology at the Sint Maartenskliniek in Nijmegen, the Netherlands, who presented the data as a late-breaker at the European Congress of Rheumatology, explains in a video interview why the negative trial still might support an ultra low-dose strategy.

This trial, called REDO, was conceived after it was observed that most patients with RA are well controlled on a single injection of 1,000 mg of rituximab even though this is half the standard dose of two 1,000 mg doses given 15 days apart. The study was designed to determine whether even lower doses could be used.

The study enrolled 142 patients with RA who were being retreated with rituximab after responding previously to this therapy. In a 1:2:2 ratio, patients were randomized to single rituximab injections of 1,000 mg, 500 mg, or 200 mg. Outcome then were compared at the end of 6 months.

Noninferiority was defined as 0.5 difference in DAS28-CRP score (disease activity score using C-reactive protein instead of erythrocyte sedimentation rate) score adjusted for baseline disease status and use of conventional disease-modifying antirheumatic drugs (DMARDs).

Although noninferior at 3 months, the 500 mg dose did not meet the noninferiority criteria at 6 months. Due to a hierarchical design, evaluation of the 200 mg dose was precluded by the negative result with the 500 mg dose.

However, the majority of patients did respond to both the 500 mg and 200 mg dose. The failure to meet noninferiority was due to a limited number of patients who required rescue therapy for a flare. As a result, the investigators believe a trial of ultra low-dose therapy still might be reasonable.

In this interview, Ms. Verhoef explains that at her center patients who are well controlled on a 1,000 mg dose of rituximab now are being offered a 500 mg dose for retreatment. If they continue to respond, further retreatment with a 200 mg dose is considered.

Ms. Verhoef had no relevant financial disclosures.

– Retreatment of rheumatoid arthritis (RA) with an ultra low-dose of rituximab failed to meet the predefined noninferiority endpoint relative to a higher dose in a double-blind randomized trial, but the investigators still think this strategy may be viable in selected patients.

Lise M. Verhoef, MSc, a researcher in rheumatology at the Sint Maartenskliniek in Nijmegen, the Netherlands, who presented the data as a late-breaker at the European Congress of Rheumatology, explains in a video interview why the negative trial still might support an ultra low-dose strategy.

This trial, called REDO, was conceived after it was observed that most patients with RA are well controlled on a single injection of 1,000 mg of rituximab even though this is half the standard dose of two 1,000 mg doses given 15 days apart. The study was designed to determine whether even lower doses could be used.

The study enrolled 142 patients with RA who were being retreated with rituximab after responding previously to this therapy. In a 1:2:2 ratio, patients were randomized to single rituximab injections of 1,000 mg, 500 mg, or 200 mg. Outcome then were compared at the end of 6 months.

Noninferiority was defined as 0.5 difference in DAS28-CRP score (disease activity score using C-reactive protein instead of erythrocyte sedimentation rate) score adjusted for baseline disease status and use of conventional disease-modifying antirheumatic drugs (DMARDs).

Although noninferior at 3 months, the 500 mg dose did not meet the noninferiority criteria at 6 months. Due to a hierarchical design, evaluation of the 200 mg dose was precluded by the negative result with the 500 mg dose.

However, the majority of patients did respond to both the 500 mg and 200 mg dose. The failure to meet noninferiority was due to a limited number of patients who required rescue therapy for a flare. As a result, the investigators believe a trial of ultra low-dose therapy still might be reasonable.

In this interview, Ms. Verhoef explains that at her center patients who are well controlled on a 1,000 mg dose of rituximab now are being offered a 500 mg dose for retreatment. If they continue to respond, further retreatment with a 200 mg dose is considered.

Ms. Verhoef had no relevant financial disclosures.

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Systemic sclerosis gastrointestinal symptoms helped by gut microbiota transplant

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More patients with limited cutaneous systemic sclerosis (SSc) experienced improvement in gastrointestinal (GI) symptoms when given a gut microbiota transplant, compared with control subjects in a 16-week randomized, double-blind, placebo-controlled pilot study presented at the European Congress of Rheumatology.

The effects were most pronounced on lower GI symptoms, including bloating, diarrhea, and fecal incontinence, with improvement reported by three of five of the patients given the gut microbiota transplant, compared with two of the five patients who received placebo.

“We were surprised by the effect the patients reported, as all had longstanding SSc with GI symptoms,” Anna-Maria Hoffmann-Vold, MD, PhD, of Oslo University Hospital, said in an interview ahead of the congress. “We were especially surprised at the strong effect FMT had on fecal incontinence.”“Patients with systemic sclerosis are very prone to having gastrointestinal involvement – up to 90% of patients have GI symptoms, and it’s associated with very high morbidity and mortality,” she observed during her presentation at the Congress. Despite that, there currently are no disease-modifying treatments that specifically addresses GI involvement in SSc.

It’s been known for a while that patients with SSc have a different intestinal microbiota composition, or dysbiosis, compared with healthy controls, and the possibility of permanent modification of the microbiome through fecal microbiota transplant (FMT) from healthy to ill individuals has become a subject of increased attention in the scientific literature in recent years,. Dr. Hoffmann-Vold said.

In particular, FMT has shown promising results in the treatment of Clostridium difficile infections. While the current study did not focus on mechanistic pathways by which FMT might be exerting its effects, such studies are definitely warranted, she said. “One could speculate that there is a mechanistic link between dysmotility and dysbiosis in SSc, and that the manipulation of gut microbiota with FMT primarily affects motility patterns, which in turn leads to improvement of GI symptoms.”

Together with colleagues at the Oslo University Hospital, Dr. Hoffmann-Vold randomly assigned 10 patients – all women – with limited cutaneous SSc either to treatment with a commercially-available gut microbiota preparation known as anaerobic cultivated human intestinal microbiota (ACHIM) or to placebo. Both ACHIM and placebo were given via gastroduodenoscopy. Their aim was to determine the safety of the approach, as well as to obtain preliminary data on its therapeutic potential.

The UCLA GIT 2.0 score questionnaire was used to assess GI symptoms, with patients defined as responders if they met the questionnaire’s definition of a minimally clinically important difference.

Primary endpoints were safety and clinical efficacy on GI symptoms assessed at weeks 4 and 16, and safety was assessed by observation, interviews, and a standardized safety form.

Results showed improvement in GI symptoms (total UCLA GIT score) in three of the five patients who received the gut microbiota transplant versus two of the five placebo-treated patients at 16 weeks. Two patients in the active treatment versus one in the placebo group had unchanged symptoms, and one patient in the placebo group had worsening symptoms.

Adverse events associated with treatment were “transient and mild”. However, one procedure-related serious adverse event occurred in a placebo-treated patient, which was a duodenal perforation.

Concluding her presentation, Dr. Hoffman-Vold said: “FMT of commercially-available ACHIM in patients with SSc appeared safe, had beneficial effects on lower GI symptoms, altered gut microbiota composition – richness and diversity – and appeared to affect the mucosal immune system.”

The research team has just received national funding for a larger randomized clinical trial that will involve 70 SSc patients and should start towards the end of the year.

The study was sponsored by Helse Sør-øst and NKS. Dr. Hoffmann-Vold has received research funding, consulting fees, or other remuneration from Boehringer Ingelheim, GlaxoSmithKline, and Actelion. A coauthor is the owner of the company that provided the gut microbiota.

SOURCE: Hoffmann-Vold AM et al., Ann Rheum Dis. 2019 Jun. doi: 10.1136/annrheumdis-2019-eular.4684 .

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More patients with limited cutaneous systemic sclerosis (SSc) experienced improvement in gastrointestinal (GI) symptoms when given a gut microbiota transplant, compared with control subjects in a 16-week randomized, double-blind, placebo-controlled pilot study presented at the European Congress of Rheumatology.

The effects were most pronounced on lower GI symptoms, including bloating, diarrhea, and fecal incontinence, with improvement reported by three of five of the patients given the gut microbiota transplant, compared with two of the five patients who received placebo.

“We were surprised by the effect the patients reported, as all had longstanding SSc with GI symptoms,” Anna-Maria Hoffmann-Vold, MD, PhD, of Oslo University Hospital, said in an interview ahead of the congress. “We were especially surprised at the strong effect FMT had on fecal incontinence.”“Patients with systemic sclerosis are very prone to having gastrointestinal involvement – up to 90% of patients have GI symptoms, and it’s associated with very high morbidity and mortality,” she observed during her presentation at the Congress. Despite that, there currently are no disease-modifying treatments that specifically addresses GI involvement in SSc.

It’s been known for a while that patients with SSc have a different intestinal microbiota composition, or dysbiosis, compared with healthy controls, and the possibility of permanent modification of the microbiome through fecal microbiota transplant (FMT) from healthy to ill individuals has become a subject of increased attention in the scientific literature in recent years,. Dr. Hoffmann-Vold said.

In particular, FMT has shown promising results in the treatment of Clostridium difficile infections. While the current study did not focus on mechanistic pathways by which FMT might be exerting its effects, such studies are definitely warranted, she said. “One could speculate that there is a mechanistic link between dysmotility and dysbiosis in SSc, and that the manipulation of gut microbiota with FMT primarily affects motility patterns, which in turn leads to improvement of GI symptoms.”

Together with colleagues at the Oslo University Hospital, Dr. Hoffmann-Vold randomly assigned 10 patients – all women – with limited cutaneous SSc either to treatment with a commercially-available gut microbiota preparation known as anaerobic cultivated human intestinal microbiota (ACHIM) or to placebo. Both ACHIM and placebo were given via gastroduodenoscopy. Their aim was to determine the safety of the approach, as well as to obtain preliminary data on its therapeutic potential.

The UCLA GIT 2.0 score questionnaire was used to assess GI symptoms, with patients defined as responders if they met the questionnaire’s definition of a minimally clinically important difference.

Primary endpoints were safety and clinical efficacy on GI symptoms assessed at weeks 4 and 16, and safety was assessed by observation, interviews, and a standardized safety form.

Results showed improvement in GI symptoms (total UCLA GIT score) in three of the five patients who received the gut microbiota transplant versus two of the five placebo-treated patients at 16 weeks. Two patients in the active treatment versus one in the placebo group had unchanged symptoms, and one patient in the placebo group had worsening symptoms.

Adverse events associated with treatment were “transient and mild”. However, one procedure-related serious adverse event occurred in a placebo-treated patient, which was a duodenal perforation.

Concluding her presentation, Dr. Hoffman-Vold said: “FMT of commercially-available ACHIM in patients with SSc appeared safe, had beneficial effects on lower GI symptoms, altered gut microbiota composition – richness and diversity – and appeared to affect the mucosal immune system.”

The research team has just received national funding for a larger randomized clinical trial that will involve 70 SSc patients and should start towards the end of the year.

The study was sponsored by Helse Sør-øst and NKS. Dr. Hoffmann-Vold has received research funding, consulting fees, or other remuneration from Boehringer Ingelheim, GlaxoSmithKline, and Actelion. A coauthor is the owner of the company that provided the gut microbiota.

SOURCE: Hoffmann-Vold AM et al., Ann Rheum Dis. 2019 Jun. doi: 10.1136/annrheumdis-2019-eular.4684 .

More patients with limited cutaneous systemic sclerosis (SSc) experienced improvement in gastrointestinal (GI) symptoms when given a gut microbiota transplant, compared with control subjects in a 16-week randomized, double-blind, placebo-controlled pilot study presented at the European Congress of Rheumatology.

The effects were most pronounced on lower GI symptoms, including bloating, diarrhea, and fecal incontinence, with improvement reported by three of five of the patients given the gut microbiota transplant, compared with two of the five patients who received placebo.

“We were surprised by the effect the patients reported, as all had longstanding SSc with GI symptoms,” Anna-Maria Hoffmann-Vold, MD, PhD, of Oslo University Hospital, said in an interview ahead of the congress. “We were especially surprised at the strong effect FMT had on fecal incontinence.”“Patients with systemic sclerosis are very prone to having gastrointestinal involvement – up to 90% of patients have GI symptoms, and it’s associated with very high morbidity and mortality,” she observed during her presentation at the Congress. Despite that, there currently are no disease-modifying treatments that specifically addresses GI involvement in SSc.

It’s been known for a while that patients with SSc have a different intestinal microbiota composition, or dysbiosis, compared with healthy controls, and the possibility of permanent modification of the microbiome through fecal microbiota transplant (FMT) from healthy to ill individuals has become a subject of increased attention in the scientific literature in recent years,. Dr. Hoffmann-Vold said.

In particular, FMT has shown promising results in the treatment of Clostridium difficile infections. While the current study did not focus on mechanistic pathways by which FMT might be exerting its effects, such studies are definitely warranted, she said. “One could speculate that there is a mechanistic link between dysmotility and dysbiosis in SSc, and that the manipulation of gut microbiota with FMT primarily affects motility patterns, which in turn leads to improvement of GI symptoms.”

Together with colleagues at the Oslo University Hospital, Dr. Hoffmann-Vold randomly assigned 10 patients – all women – with limited cutaneous SSc either to treatment with a commercially-available gut microbiota preparation known as anaerobic cultivated human intestinal microbiota (ACHIM) or to placebo. Both ACHIM and placebo were given via gastroduodenoscopy. Their aim was to determine the safety of the approach, as well as to obtain preliminary data on its therapeutic potential.

The UCLA GIT 2.0 score questionnaire was used to assess GI symptoms, with patients defined as responders if they met the questionnaire’s definition of a minimally clinically important difference.

Primary endpoints were safety and clinical efficacy on GI symptoms assessed at weeks 4 and 16, and safety was assessed by observation, interviews, and a standardized safety form.

Results showed improvement in GI symptoms (total UCLA GIT score) in three of the five patients who received the gut microbiota transplant versus two of the five placebo-treated patients at 16 weeks. Two patients in the active treatment versus one in the placebo group had unchanged symptoms, and one patient in the placebo group had worsening symptoms.

Adverse events associated with treatment were “transient and mild”. However, one procedure-related serious adverse event occurred in a placebo-treated patient, which was a duodenal perforation.

Concluding her presentation, Dr. Hoffman-Vold said: “FMT of commercially-available ACHIM in patients with SSc appeared safe, had beneficial effects on lower GI symptoms, altered gut microbiota composition – richness and diversity – and appeared to affect the mucosal immune system.”

The research team has just received national funding for a larger randomized clinical trial that will involve 70 SSc patients and should start towards the end of the year.

The study was sponsored by Helse Sør-øst and NKS. Dr. Hoffmann-Vold has received research funding, consulting fees, or other remuneration from Boehringer Ingelheim, GlaxoSmithKline, and Actelion. A coauthor is the owner of the company that provided the gut microbiota.

SOURCE: Hoffmann-Vold AM et al., Ann Rheum Dis. 2019 Jun. doi: 10.1136/annrheumdis-2019-eular.4684 .

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Retention rates comparable for biosimilars, original drug in spondyloarthritis

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Patients achieve comparable long-term control of spondyloarthritis on biosimilars as they do on the originator biologic drug, judging from data drawn from registries in five Scandinavian countries in a study that evaluated retention rates after 1 year of therapy.

Bente Glintborg, MD, PhD, from the Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, explains in a video interview that the indication provided to biosimilars for spondyloarthritis was extended from comparisons conducted in rheumatoid arthritis (RA).

In the absence of a randomized trial in spondyloarthritis, she suggested that this comparison might be the best opportunity to evaluate whether biosimilars perform as well as their biologic originator. This is an important aim based on the theoretical possibility that equivalence in RA does not translate into equivalence in other rheumatic conditions where biologics are indicated.

As she explains, 1,015 biologic-naïve patients initiating etanercept, a tumor necrosis factor (TNF) inhibitor, or a biosimilar were assessed at baseline and at the end of 1 year of therapy. The patients were enrolled in biologic registries maintained in Denmark, Finland, Iceland, Norway, or Sweden.

Retention rates at 1 year were numerically lower on etanercept than the biosimilars, but the difference was not significant (66% vs. 73%; P = 0.18). There also were no significant differences between the biosimilars and etanercept when disease activity was compared at 6 months.

Retention rates are a reasonable surrogate for both efficacy and tolerability based on the expectation that more patients would switch or discontinue agents in the event of lack of efficacy or unacceptable side effects, Dr. Glintborg said at the European Congress of Rheumatology.

In this interview, she notes that a similar study from the Nordic registries led by a coinvestigator also showed equivalent retention rates among spondyloarthritis patients when biosimilars and infliximab were compared at 2 years.

Dr. Glintborg received research support from Biogen, Pfizer, and Abbievie.

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Patients achieve comparable long-term control of spondyloarthritis on biosimilars as they do on the originator biologic drug, judging from data drawn from registries in five Scandinavian countries in a study that evaluated retention rates after 1 year of therapy.

Bente Glintborg, MD, PhD, from the Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, explains in a video interview that the indication provided to biosimilars for spondyloarthritis was extended from comparisons conducted in rheumatoid arthritis (RA).

In the absence of a randomized trial in spondyloarthritis, she suggested that this comparison might be the best opportunity to evaluate whether biosimilars perform as well as their biologic originator. This is an important aim based on the theoretical possibility that equivalence in RA does not translate into equivalence in other rheumatic conditions where biologics are indicated.

As she explains, 1,015 biologic-naïve patients initiating etanercept, a tumor necrosis factor (TNF) inhibitor, or a biosimilar were assessed at baseline and at the end of 1 year of therapy. The patients were enrolled in biologic registries maintained in Denmark, Finland, Iceland, Norway, or Sweden.

Retention rates at 1 year were numerically lower on etanercept than the biosimilars, but the difference was not significant (66% vs. 73%; P = 0.18). There also were no significant differences between the biosimilars and etanercept when disease activity was compared at 6 months.

Retention rates are a reasonable surrogate for both efficacy and tolerability based on the expectation that more patients would switch or discontinue agents in the event of lack of efficacy or unacceptable side effects, Dr. Glintborg said at the European Congress of Rheumatology.

In this interview, she notes that a similar study from the Nordic registries led by a coinvestigator also showed equivalent retention rates among spondyloarthritis patients when biosimilars and infliximab were compared at 2 years.

Dr. Glintborg received research support from Biogen, Pfizer, and Abbievie.

Patients achieve comparable long-term control of spondyloarthritis on biosimilars as they do on the originator biologic drug, judging from data drawn from registries in five Scandinavian countries in a study that evaluated retention rates after 1 year of therapy.

Bente Glintborg, MD, PhD, from the Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, explains in a video interview that the indication provided to biosimilars for spondyloarthritis was extended from comparisons conducted in rheumatoid arthritis (RA).

In the absence of a randomized trial in spondyloarthritis, she suggested that this comparison might be the best opportunity to evaluate whether biosimilars perform as well as their biologic originator. This is an important aim based on the theoretical possibility that equivalence in RA does not translate into equivalence in other rheumatic conditions where biologics are indicated.

As she explains, 1,015 biologic-naïve patients initiating etanercept, a tumor necrosis factor (TNF) inhibitor, or a biosimilar were assessed at baseline and at the end of 1 year of therapy. The patients were enrolled in biologic registries maintained in Denmark, Finland, Iceland, Norway, or Sweden.

Retention rates at 1 year were numerically lower on etanercept than the biosimilars, but the difference was not significant (66% vs. 73%; P = 0.18). There also were no significant differences between the biosimilars and etanercept when disease activity was compared at 6 months.

Retention rates are a reasonable surrogate for both efficacy and tolerability based on the expectation that more patients would switch or discontinue agents in the event of lack of efficacy or unacceptable side effects, Dr. Glintborg said at the European Congress of Rheumatology.

In this interview, she notes that a similar study from the Nordic registries led by a coinvestigator also showed equivalent retention rates among spondyloarthritis patients when biosimilars and infliximab were compared at 2 years.

Dr. Glintborg received research support from Biogen, Pfizer, and Abbievie.

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Video program engages patients in treat-to-target concept

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A video-based educational program on the goals of treatment in rheumatoid arthritis (RA) is showing promise as a tool to engage patients in their own care, according to data generated from a randomized trial.

One of the major goals of the video program is to inform patients about the treat-to-target concept of RA management, explained Maria I. Danila, MD, a rheumatologist at the University of Alabama at Birmingham.

Although physicians know this to be a guiding tenet for RA management, she explains in this video interview that 50% or more of patients are unaware of this therapeutic goal.

For patients who resist treatment escalation for fear of side effects, this lack of awareness might provide one explanation for failing to adhere to guideline-recommended therapy, Dr. Danila said at the European Congress of Rheumatology. She believes that patients need more information about the potential for treatment escalation to improve function.

To address this issue, a short video was developed to explain the treat-to-target concept. It was then tested in a randomized trial. Those who viewed the video expressed greater willingness to change intervention on the advice of their rheumatologist relative to those who did not (P = 0.01).

Further studies are planned, including studies to test whether willingness to escalate treatment results in better outcomes and whether linking patient behavioral goals such as being able to play golf again will enhance treatment adherence. Dr. Danila envisions wide distribution of this video if further studies demonstrate that it helps patients cooperate with treatment escalation when needed.

Dr. Danila received research support from Pfizer.

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A video-based educational program on the goals of treatment in rheumatoid arthritis (RA) is showing promise as a tool to engage patients in their own care, according to data generated from a randomized trial.

One of the major goals of the video program is to inform patients about the treat-to-target concept of RA management, explained Maria I. Danila, MD, a rheumatologist at the University of Alabama at Birmingham.

Although physicians know this to be a guiding tenet for RA management, she explains in this video interview that 50% or more of patients are unaware of this therapeutic goal.

For patients who resist treatment escalation for fear of side effects, this lack of awareness might provide one explanation for failing to adhere to guideline-recommended therapy, Dr. Danila said at the European Congress of Rheumatology. She believes that patients need more information about the potential for treatment escalation to improve function.

To address this issue, a short video was developed to explain the treat-to-target concept. It was then tested in a randomized trial. Those who viewed the video expressed greater willingness to change intervention on the advice of their rheumatologist relative to those who did not (P = 0.01).

Further studies are planned, including studies to test whether willingness to escalate treatment results in better outcomes and whether linking patient behavioral goals such as being able to play golf again will enhance treatment adherence. Dr. Danila envisions wide distribution of this video if further studies demonstrate that it helps patients cooperate with treatment escalation when needed.

Dr. Danila received research support from Pfizer.

A video-based educational program on the goals of treatment in rheumatoid arthritis (RA) is showing promise as a tool to engage patients in their own care, according to data generated from a randomized trial.

One of the major goals of the video program is to inform patients about the treat-to-target concept of RA management, explained Maria I. Danila, MD, a rheumatologist at the University of Alabama at Birmingham.

Although physicians know this to be a guiding tenet for RA management, she explains in this video interview that 50% or more of patients are unaware of this therapeutic goal.

For patients who resist treatment escalation for fear of side effects, this lack of awareness might provide one explanation for failing to adhere to guideline-recommended therapy, Dr. Danila said at the European Congress of Rheumatology. She believes that patients need more information about the potential for treatment escalation to improve function.

To address this issue, a short video was developed to explain the treat-to-target concept. It was then tested in a randomized trial. Those who viewed the video expressed greater willingness to change intervention on the advice of their rheumatologist relative to those who did not (P = 0.01).

Further studies are planned, including studies to test whether willingness to escalate treatment results in better outcomes and whether linking patient behavioral goals such as being able to play golf again will enhance treatment adherence. Dr. Danila envisions wide distribution of this video if further studies demonstrate that it helps patients cooperate with treatment escalation when needed.

Dr. Danila received research support from Pfizer.

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Cardiovascular events in U.S. RA patients fall to non-RA level

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– U.S. patients with rheumatoid arthritis stopped having an excess of cardiovascular disease events during the 2000s.

During both the 1980s and 1990s, patients with rheumatoid arthritis (RA) residing in a 27-county region in southeastern Minnesota and northwestern Wisconsin had cardiovascular disease event rates that were more than twice the rates in similar adults without RA, but that changed during the 2000s, Elena Myasoedova, MD, said in a poster she presented at the European Congress of Rheumatology. During 2000-2009, RA patients enrolled in the Rochester (Minn.) Epidemiology Project had an incidence of cardiovascular disease events at a rate that was 12% lower, compared with matched adults without RA who were also enrolled in the same regional database, reported Dr. Myasoedova, a rheumatologist at the Mayo Clinic in Rochester, and her associates.

“We hypothesize that improved management of RA, including implementation of a treat-to-target strategy and the introduction of biological drugs could have influenced this, as well as increased awareness of and improved prevention of cardiovascular disease,” Dr. Myasoedova said in an interview. The findings “give us a hint that tight control of RA disease activity is also likely to help cardiovascular disease burden.”

She and her associates identified 906 people enrolled in the Rochester Epidemiology Project who had incident RA based on the 1987 criteria of the American College of Rheumatology and matched them by age, sex, and index year with 905 people in the registry without RA. These cohorts included roughly 200 people from each subgroup tracked during the 1980s, 300 from each subgroup tracked during the 1990s, and about 400 in each subgroup tracked during the 2000s. They averaged about 56 years old, and about two-thirds were women.

During the 1980s, the cumulative incidence of nonfatal MI, nonfatal stroke, or cardiovascular disease (CVD) death was 2.11-fold more common among the RA patients than in the matched controls without RA, and during the 1990s this ratio showed a 2.13-fold excess of CVD events among the RA patients. The between-group differences in both decades were statistically significant. During the 2000s, the RA patients actually had a nominally lower rate of CVD events, at 0.88 times the rate of the controls, a difference that was not statistically significant.


Dr. Myasoedova and her associates had previously reported a similar finding in an analysis that used a smaller number of people and focused exclusively on rates of CVD (J Rheumatol. 2017 Jun;44[6]:732-9).

A few factors limit the generalizability of the finding, Dr. Myasoedova cautioned. First, the population studied was about 90% white. Also, people in the Rochester Epidemiology Project receive their medical care from clinicians at the Mayo Clinic or an affiliated hospital in the region covered by the Project.

“These data are from a large, tertiary care center,” and so the findings are most directly applicable to patients who receive medical care in a similar setting that provides guideline-directed management of both RA and CVD risk.

A long-standing hypothesis is that CVD has an inflammatory component. These data support that concept by suggesting that when inflammatory disease is well controlled in RA patients, their CVD risk drops, Dr. Myasoedova said. “CVD has been seen as the number one comorbidity for RA patients, and it remains that way, but it’s very reassuring that the CVD rate has improved. It shows we’re doing something right.”

The study received no commercial funding. Dr. Myasoedova had no relevant disclosures.

SOURCE: Myasoedova E et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):1024-5. Abstract FRI0654. DOI: 10.1136/annrheumdis-2019-eular.4996.

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– U.S. patients with rheumatoid arthritis stopped having an excess of cardiovascular disease events during the 2000s.

During both the 1980s and 1990s, patients with rheumatoid arthritis (RA) residing in a 27-county region in southeastern Minnesota and northwestern Wisconsin had cardiovascular disease event rates that were more than twice the rates in similar adults without RA, but that changed during the 2000s, Elena Myasoedova, MD, said in a poster she presented at the European Congress of Rheumatology. During 2000-2009, RA patients enrolled in the Rochester (Minn.) Epidemiology Project had an incidence of cardiovascular disease events at a rate that was 12% lower, compared with matched adults without RA who were also enrolled in the same regional database, reported Dr. Myasoedova, a rheumatologist at the Mayo Clinic in Rochester, and her associates.

“We hypothesize that improved management of RA, including implementation of a treat-to-target strategy and the introduction of biological drugs could have influenced this, as well as increased awareness of and improved prevention of cardiovascular disease,” Dr. Myasoedova said in an interview. The findings “give us a hint that tight control of RA disease activity is also likely to help cardiovascular disease burden.”

She and her associates identified 906 people enrolled in the Rochester Epidemiology Project who had incident RA based on the 1987 criteria of the American College of Rheumatology and matched them by age, sex, and index year with 905 people in the registry without RA. These cohorts included roughly 200 people from each subgroup tracked during the 1980s, 300 from each subgroup tracked during the 1990s, and about 400 in each subgroup tracked during the 2000s. They averaged about 56 years old, and about two-thirds were women.

During the 1980s, the cumulative incidence of nonfatal MI, nonfatal stroke, or cardiovascular disease (CVD) death was 2.11-fold more common among the RA patients than in the matched controls without RA, and during the 1990s this ratio showed a 2.13-fold excess of CVD events among the RA patients. The between-group differences in both decades were statistically significant. During the 2000s, the RA patients actually had a nominally lower rate of CVD events, at 0.88 times the rate of the controls, a difference that was not statistically significant.


Dr. Myasoedova and her associates had previously reported a similar finding in an analysis that used a smaller number of people and focused exclusively on rates of CVD (J Rheumatol. 2017 Jun;44[6]:732-9).

A few factors limit the generalizability of the finding, Dr. Myasoedova cautioned. First, the population studied was about 90% white. Also, people in the Rochester Epidemiology Project receive their medical care from clinicians at the Mayo Clinic or an affiliated hospital in the region covered by the Project.

“These data are from a large, tertiary care center,” and so the findings are most directly applicable to patients who receive medical care in a similar setting that provides guideline-directed management of both RA and CVD risk.

A long-standing hypothesis is that CVD has an inflammatory component. These data support that concept by suggesting that when inflammatory disease is well controlled in RA patients, their CVD risk drops, Dr. Myasoedova said. “CVD has been seen as the number one comorbidity for RA patients, and it remains that way, but it’s very reassuring that the CVD rate has improved. It shows we’re doing something right.”

The study received no commercial funding. Dr. Myasoedova had no relevant disclosures.

SOURCE: Myasoedova E et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):1024-5. Abstract FRI0654. DOI: 10.1136/annrheumdis-2019-eular.4996.

– U.S. patients with rheumatoid arthritis stopped having an excess of cardiovascular disease events during the 2000s.

During both the 1980s and 1990s, patients with rheumatoid arthritis (RA) residing in a 27-county region in southeastern Minnesota and northwestern Wisconsin had cardiovascular disease event rates that were more than twice the rates in similar adults without RA, but that changed during the 2000s, Elena Myasoedova, MD, said in a poster she presented at the European Congress of Rheumatology. During 2000-2009, RA patients enrolled in the Rochester (Minn.) Epidemiology Project had an incidence of cardiovascular disease events at a rate that was 12% lower, compared with matched adults without RA who were also enrolled in the same regional database, reported Dr. Myasoedova, a rheumatologist at the Mayo Clinic in Rochester, and her associates.

“We hypothesize that improved management of RA, including implementation of a treat-to-target strategy and the introduction of biological drugs could have influenced this, as well as increased awareness of and improved prevention of cardiovascular disease,” Dr. Myasoedova said in an interview. The findings “give us a hint that tight control of RA disease activity is also likely to help cardiovascular disease burden.”

She and her associates identified 906 people enrolled in the Rochester Epidemiology Project who had incident RA based on the 1987 criteria of the American College of Rheumatology and matched them by age, sex, and index year with 905 people in the registry without RA. These cohorts included roughly 200 people from each subgroup tracked during the 1980s, 300 from each subgroup tracked during the 1990s, and about 400 in each subgroup tracked during the 2000s. They averaged about 56 years old, and about two-thirds were women.

During the 1980s, the cumulative incidence of nonfatal MI, nonfatal stroke, or cardiovascular disease (CVD) death was 2.11-fold more common among the RA patients than in the matched controls without RA, and during the 1990s this ratio showed a 2.13-fold excess of CVD events among the RA patients. The between-group differences in both decades were statistically significant. During the 2000s, the RA patients actually had a nominally lower rate of CVD events, at 0.88 times the rate of the controls, a difference that was not statistically significant.


Dr. Myasoedova and her associates had previously reported a similar finding in an analysis that used a smaller number of people and focused exclusively on rates of CVD (J Rheumatol. 2017 Jun;44[6]:732-9).

A few factors limit the generalizability of the finding, Dr. Myasoedova cautioned. First, the population studied was about 90% white. Also, people in the Rochester Epidemiology Project receive their medical care from clinicians at the Mayo Clinic or an affiliated hospital in the region covered by the Project.

“These data are from a large, tertiary care center,” and so the findings are most directly applicable to patients who receive medical care in a similar setting that provides guideline-directed management of both RA and CVD risk.

A long-standing hypothesis is that CVD has an inflammatory component. These data support that concept by suggesting that when inflammatory disease is well controlled in RA patients, their CVD risk drops, Dr. Myasoedova said. “CVD has been seen as the number one comorbidity for RA patients, and it remains that way, but it’s very reassuring that the CVD rate has improved. It shows we’re doing something right.”

The study received no commercial funding. Dr. Myasoedova had no relevant disclosures.

SOURCE: Myasoedova E et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):1024-5. Abstract FRI0654. DOI: 10.1136/annrheumdis-2019-eular.4996.

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Lowering hyperuricemia improved endothelial function but failed as an antihypertensive

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– Using allopurinol to reduce hyperuricemia in young adults with prehypertension or stage 1 hypertension failed to significantly lower blood pressure but succeeded in significantly improving endothelial function as measured by increased flow-mediated arterial dilation in a single-center crossover study with 82 participants.

The finding of improved endothelial function suggests that reducing hyperuricemia may be a new way to manage hypertension or prevent progression to stage 1 hypertension, improve cardiovascular health, and ultimately cut cardiovascular events, Angelo L. Gaffo, MD, said at the European Congress of Rheumatology. The results indicated that the BP-lowering effect of allopurinol treatment was strongest in people who entered the study with the highest serum urate levels, greater than 6.5 mg/dL, an indication that the next step in developing this approach should be targeting it to people with serum urate levels in this range, said Dr. Gaffo, a rheumatologist at the University of Alabama at Birmingham.

“It’s just a matter of finding the right population to see the blood pressure reduction effect,” Dr. Gaffo said in an interview.

He and his associates designed the SURPHER (Serum Urate Reduction to Prevent Hypertension) study to assess the impact of allopurinol treatment in people aged 18-40 years with prehypertension or stage 1 hypertension as defined by U.S. BP standards at the time they launched the study in 2016 (Contemp Clin Trials. 2016 Sep;50:238-44). Enrolled participants had to be nonsmokers; have an estimated glomerular filtration rate of greater than 60 mL/min per 1.73 m2; have a serum urate level of at least 5.0 mg/dL in men and at least 4.0 mg/dL in women; and be without diabetes, antihypertensive medications, prior urate-lowering treatment, or a history of gout. The 99 people who started the study averaged 28 years old, nearly two-thirds were men, 40% were African Americans, and 52% were white. The participants’ average body mass index was nearly 31 kg/m2, and their average BP was 127/81 mm Hg. Average serum urate levels were 6.4 mg/dL in men and 4.9 mg/dL in women. Participants received 300 mg/day allopurinol or placebo, and after 4 weeks crossed to the alternate regimen, with 82 people completing the full protocol. While on allopurinol, serum urate levels fell by an average of 1.3 mg/dL, a statistically significant drop; on placebo, the levels showed no significant change from baseline.



The primary endpoint was the change in BP on allopurinol treatment, which overall showed no statistically significant difference, compared with when participants received placebo. The results also showed no significant impact of allopurinol treatment, compared with placebo, in serum levels of high-sensitivity C-reactive protein, a measure of inflammation. However, for the secondary endpoint of change in endothelial function as measured by a change in flow-mediated dilation (FMD), the results showed a statistically significant effect of allopurinol treatment. While on allopurinol, average FMD increased from 10.3% at baseline to 14.5% on the drug, a 41% relative increase, while on placebo the average FMD rate showed a slight reduction. Allopurinol treatment was safe and well tolerated during the study.

The results also showed that among people with a baseline serum urate level of greater than 6.5 mg/dL (15 of the 82 study completers) systolic BP fell by an average of about 5 mm Hg.

The results suggested that the concept of reducing hyperuricemia in people with early-stage hypertension or prehypertension might be viable for people with higher serum urate levels than most of those enrolled in SURPHER, Dr. Gaffo said. He noted that prior study results in obese adolescents showed that treating hyperuricemia was able to produce a meaningful BP reduction (Hypertension. 2012 Nov;60[5]:1148-56).

SURPHER received no commercial funding. Dr. Gaffo has received research funding from Amgen and AstraZeneca.

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– Using allopurinol to reduce hyperuricemia in young adults with prehypertension or stage 1 hypertension failed to significantly lower blood pressure but succeeded in significantly improving endothelial function as measured by increased flow-mediated arterial dilation in a single-center crossover study with 82 participants.

The finding of improved endothelial function suggests that reducing hyperuricemia may be a new way to manage hypertension or prevent progression to stage 1 hypertension, improve cardiovascular health, and ultimately cut cardiovascular events, Angelo L. Gaffo, MD, said at the European Congress of Rheumatology. The results indicated that the BP-lowering effect of allopurinol treatment was strongest in people who entered the study with the highest serum urate levels, greater than 6.5 mg/dL, an indication that the next step in developing this approach should be targeting it to people with serum urate levels in this range, said Dr. Gaffo, a rheumatologist at the University of Alabama at Birmingham.

“It’s just a matter of finding the right population to see the blood pressure reduction effect,” Dr. Gaffo said in an interview.

He and his associates designed the SURPHER (Serum Urate Reduction to Prevent Hypertension) study to assess the impact of allopurinol treatment in people aged 18-40 years with prehypertension or stage 1 hypertension as defined by U.S. BP standards at the time they launched the study in 2016 (Contemp Clin Trials. 2016 Sep;50:238-44). Enrolled participants had to be nonsmokers; have an estimated glomerular filtration rate of greater than 60 mL/min per 1.73 m2; have a serum urate level of at least 5.0 mg/dL in men and at least 4.0 mg/dL in women; and be without diabetes, antihypertensive medications, prior urate-lowering treatment, or a history of gout. The 99 people who started the study averaged 28 years old, nearly two-thirds were men, 40% were African Americans, and 52% were white. The participants’ average body mass index was nearly 31 kg/m2, and their average BP was 127/81 mm Hg. Average serum urate levels were 6.4 mg/dL in men and 4.9 mg/dL in women. Participants received 300 mg/day allopurinol or placebo, and after 4 weeks crossed to the alternate regimen, with 82 people completing the full protocol. While on allopurinol, serum urate levels fell by an average of 1.3 mg/dL, a statistically significant drop; on placebo, the levels showed no significant change from baseline.



The primary endpoint was the change in BP on allopurinol treatment, which overall showed no statistically significant difference, compared with when participants received placebo. The results also showed no significant impact of allopurinol treatment, compared with placebo, in serum levels of high-sensitivity C-reactive protein, a measure of inflammation. However, for the secondary endpoint of change in endothelial function as measured by a change in flow-mediated dilation (FMD), the results showed a statistically significant effect of allopurinol treatment. While on allopurinol, average FMD increased from 10.3% at baseline to 14.5% on the drug, a 41% relative increase, while on placebo the average FMD rate showed a slight reduction. Allopurinol treatment was safe and well tolerated during the study.

The results also showed that among people with a baseline serum urate level of greater than 6.5 mg/dL (15 of the 82 study completers) systolic BP fell by an average of about 5 mm Hg.

The results suggested that the concept of reducing hyperuricemia in people with early-stage hypertension or prehypertension might be viable for people with higher serum urate levels than most of those enrolled in SURPHER, Dr. Gaffo said. He noted that prior study results in obese adolescents showed that treating hyperuricemia was able to produce a meaningful BP reduction (Hypertension. 2012 Nov;60[5]:1148-56).

SURPHER received no commercial funding. Dr. Gaffo has received research funding from Amgen and AstraZeneca.

– Using allopurinol to reduce hyperuricemia in young adults with prehypertension or stage 1 hypertension failed to significantly lower blood pressure but succeeded in significantly improving endothelial function as measured by increased flow-mediated arterial dilation in a single-center crossover study with 82 participants.

The finding of improved endothelial function suggests that reducing hyperuricemia may be a new way to manage hypertension or prevent progression to stage 1 hypertension, improve cardiovascular health, and ultimately cut cardiovascular events, Angelo L. Gaffo, MD, said at the European Congress of Rheumatology. The results indicated that the BP-lowering effect of allopurinol treatment was strongest in people who entered the study with the highest serum urate levels, greater than 6.5 mg/dL, an indication that the next step in developing this approach should be targeting it to people with serum urate levels in this range, said Dr. Gaffo, a rheumatologist at the University of Alabama at Birmingham.

“It’s just a matter of finding the right population to see the blood pressure reduction effect,” Dr. Gaffo said in an interview.

He and his associates designed the SURPHER (Serum Urate Reduction to Prevent Hypertension) study to assess the impact of allopurinol treatment in people aged 18-40 years with prehypertension or stage 1 hypertension as defined by U.S. BP standards at the time they launched the study in 2016 (Contemp Clin Trials. 2016 Sep;50:238-44). Enrolled participants had to be nonsmokers; have an estimated glomerular filtration rate of greater than 60 mL/min per 1.73 m2; have a serum urate level of at least 5.0 mg/dL in men and at least 4.0 mg/dL in women; and be without diabetes, antihypertensive medications, prior urate-lowering treatment, or a history of gout. The 99 people who started the study averaged 28 years old, nearly two-thirds were men, 40% were African Americans, and 52% were white. The participants’ average body mass index was nearly 31 kg/m2, and their average BP was 127/81 mm Hg. Average serum urate levels were 6.4 mg/dL in men and 4.9 mg/dL in women. Participants received 300 mg/day allopurinol or placebo, and after 4 weeks crossed to the alternate regimen, with 82 people completing the full protocol. While on allopurinol, serum urate levels fell by an average of 1.3 mg/dL, a statistically significant drop; on placebo, the levels showed no significant change from baseline.



The primary endpoint was the change in BP on allopurinol treatment, which overall showed no statistically significant difference, compared with when participants received placebo. The results also showed no significant impact of allopurinol treatment, compared with placebo, in serum levels of high-sensitivity C-reactive protein, a measure of inflammation. However, for the secondary endpoint of change in endothelial function as measured by a change in flow-mediated dilation (FMD), the results showed a statistically significant effect of allopurinol treatment. While on allopurinol, average FMD increased from 10.3% at baseline to 14.5% on the drug, a 41% relative increase, while on placebo the average FMD rate showed a slight reduction. Allopurinol treatment was safe and well tolerated during the study.

The results also showed that among people with a baseline serum urate level of greater than 6.5 mg/dL (15 of the 82 study completers) systolic BP fell by an average of about 5 mm Hg.

The results suggested that the concept of reducing hyperuricemia in people with early-stage hypertension or prehypertension might be viable for people with higher serum urate levels than most of those enrolled in SURPHER, Dr. Gaffo said. He noted that prior study results in obese adolescents showed that treating hyperuricemia was able to produce a meaningful BP reduction (Hypertension. 2012 Nov;60[5]:1148-56).

SURPHER received no commercial funding. Dr. Gaffo has received research funding from Amgen and AstraZeneca.

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Patients with CAPS still improving on long-term canakinumab

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Wed, 06/09/2021 - 10:40

– An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

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– An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

– An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

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Psychiatry residents not getting training in treating chronic pain

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Wed, 10/21/2020 - 12:10

Up to 21% of psychiatry residency programs provide no training or supervision for managing and treating chronic pain, and pain-related training and supervision by remaining programs is minimal, a new national survey shows.

Given the unique role of psychiatrists in helping chronic pain patients with coping strategies and managing comorbid psychiatric illness, this void is concerning, said Ali Ahsan Ali, MD, a resident psychiatrist at the Micah School of Medicine at Mount Sinai/Elmhurst Hospital Center in New York, in an interview at the annual meeting of the American Psychiatric Association.

In a video interview, Dr. Ali spoke with Ahmar M. Butt, MD, about how and why Dr. Ali and his colleagues conducted the survey of all 221 U.S. psychiatry residency programs in January 2019. They also discuss the implications of these trends for patients, particularly in light of the country’s opioid crisis.

Dr. Ali had no disclosures. Dr. Butt is board certified in general psychiatry, child and adolescent psychiatry, and preventive medicine, with a subspecialty in addiction medicine. Dr. Butt is interim program director of the psychiatry residency program at Broadlawns UnityPointe Health, Des Moines, Iowa. He had no disclosures.

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Up to 21% of psychiatry residency programs provide no training or supervision for managing and treating chronic pain, and pain-related training and supervision by remaining programs is minimal, a new national survey shows.

Given the unique role of psychiatrists in helping chronic pain patients with coping strategies and managing comorbid psychiatric illness, this void is concerning, said Ali Ahsan Ali, MD, a resident psychiatrist at the Micah School of Medicine at Mount Sinai/Elmhurst Hospital Center in New York, in an interview at the annual meeting of the American Psychiatric Association.

In a video interview, Dr. Ali spoke with Ahmar M. Butt, MD, about how and why Dr. Ali and his colleagues conducted the survey of all 221 U.S. psychiatry residency programs in January 2019. They also discuss the implications of these trends for patients, particularly in light of the country’s opioid crisis.

Dr. Ali had no disclosures. Dr. Butt is board certified in general psychiatry, child and adolescent psychiatry, and preventive medicine, with a subspecialty in addiction medicine. Dr. Butt is interim program director of the psychiatry residency program at Broadlawns UnityPointe Health, Des Moines, Iowa. He had no disclosures.

Up to 21% of psychiatry residency programs provide no training or supervision for managing and treating chronic pain, and pain-related training and supervision by remaining programs is minimal, a new national survey shows.

Given the unique role of psychiatrists in helping chronic pain patients with coping strategies and managing comorbid psychiatric illness, this void is concerning, said Ali Ahsan Ali, MD, a resident psychiatrist at the Micah School of Medicine at Mount Sinai/Elmhurst Hospital Center in New York, in an interview at the annual meeting of the American Psychiatric Association.

In a video interview, Dr. Ali spoke with Ahmar M. Butt, MD, about how and why Dr. Ali and his colleagues conducted the survey of all 221 U.S. psychiatry residency programs in January 2019. They also discuss the implications of these trends for patients, particularly in light of the country’s opioid crisis.

Dr. Ali had no disclosures. Dr. Butt is board certified in general psychiatry, child and adolescent psychiatry, and preventive medicine, with a subspecialty in addiction medicine. Dr. Butt is interim program director of the psychiatry residency program at Broadlawns UnityPointe Health, Des Moines, Iowa. He had no disclosures.

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