What’s Causing Raynaud Phenomenon Severity to Rise With High Temperatures?

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Mon, 09/09/2024 - 11:09

 

TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

  • Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
  • Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
  • In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

  • Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
  • Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
  • The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
  • Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

  • Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
  • Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
  • This spike at higher temperatures is presumably due to air conditioning, the authors said.
  • In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

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

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TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

  • Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
  • Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
  • In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

  • Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
  • Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
  • The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
  • Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

  • Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
  • Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
  • This spike at higher temperatures is presumably due to air conditioning, the authors said.
  • In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

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

 

TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

  • Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
  • Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
  • In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

  • Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
  • Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
  • The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
  • Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

  • Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
  • Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
  • This spike at higher temperatures is presumably due to air conditioning, the authors said.
  • In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

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

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Diets Higher in Ultra-Processed Foods Raise Risk for Rheumatoid Arthritis

Article Type
Changed
Mon, 09/09/2024 - 09:57

 

TOPLINE:

Middle-aged adults who consume more ultra-processed foods have an elevated risk for rheumatoid arthritis (RA) that is mediated in part through circulating biomarkers.

METHODOLOGY: 

  • Investigators conducted a retrospective cohort study of 207,012 middle-aged adults without RA from the UK Biobank who completed 24-hour dietary recalls.
  • Foods and beverages were classified as (1) unprocessed or minimally processed foods, (2) processed culinary ingredients, (3) processed foods, or (4) ultra-processed foods (eg, soft drinks, sweet or savory packaged snacks, reconstituted meat products, pre-prepared frozen dishes).
  • The main outcome was the incident RA based on hospital diagnoses.

TAKEAWAY:

  • Overall, 0.9% of participants received an RA diagnosis during a median follow-up of about 12 years.
  • Relative to peers in the lowest quintile of ultra-processed food consumption, participants in the highest quintile had a 17% greater adjusted risk for RA.
  • The risk rose across quintile (P < .05) and increased by 6% with each standard deviation increase in ultra-processed food intake.
  • Mediation analyses suggested that inflammatory, lipid, and liver enzyme biomarkers explained 3.1%-14.8% of the association between ultra-processed food intake and RA risk.
  • Findings were similar regardless of participants’ age, sex, body mass index, smoking status, household income, and healthy diet score.

IN PRACTICE: 

“Lower [ultra-processed food] consumption is recommended to reduce RA incidence,” the authors wrote, noting that up to half of the food consumed in the United Kingdom now falls into the ultra-processed category. “Dietary guidelines should prominently feature the detrimental effects of [ultra-processed foods], and recommendations to curtail their consumption should be integrated into public health initiatives, to mitigate the risk of RA,” they added.

SOURCE:

The study was led by Haodong Zhao, Soochow University, Suzhou, China, and was published online in The American Journal of Clinical Nutrition

LIMITATIONS:

Limitations included possible recall and social desirability biases, potential residual confounding, and uncertain causality of the observed associations.

DISCLOSURES:

The study was funded by grants from the National Natural Science Foundation of China and other institutions. The authors reported no conflicts of interest.

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

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TOPLINE:

Middle-aged adults who consume more ultra-processed foods have an elevated risk for rheumatoid arthritis (RA) that is mediated in part through circulating biomarkers.

METHODOLOGY: 

  • Investigators conducted a retrospective cohort study of 207,012 middle-aged adults without RA from the UK Biobank who completed 24-hour dietary recalls.
  • Foods and beverages were classified as (1) unprocessed or minimally processed foods, (2) processed culinary ingredients, (3) processed foods, or (4) ultra-processed foods (eg, soft drinks, sweet or savory packaged snacks, reconstituted meat products, pre-prepared frozen dishes).
  • The main outcome was the incident RA based on hospital diagnoses.

TAKEAWAY:

  • Overall, 0.9% of participants received an RA diagnosis during a median follow-up of about 12 years.
  • Relative to peers in the lowest quintile of ultra-processed food consumption, participants in the highest quintile had a 17% greater adjusted risk for RA.
  • The risk rose across quintile (P < .05) and increased by 6% with each standard deviation increase in ultra-processed food intake.
  • Mediation analyses suggested that inflammatory, lipid, and liver enzyme biomarkers explained 3.1%-14.8% of the association between ultra-processed food intake and RA risk.
  • Findings were similar regardless of participants’ age, sex, body mass index, smoking status, household income, and healthy diet score.

IN PRACTICE: 

“Lower [ultra-processed food] consumption is recommended to reduce RA incidence,” the authors wrote, noting that up to half of the food consumed in the United Kingdom now falls into the ultra-processed category. “Dietary guidelines should prominently feature the detrimental effects of [ultra-processed foods], and recommendations to curtail their consumption should be integrated into public health initiatives, to mitigate the risk of RA,” they added.

SOURCE:

The study was led by Haodong Zhao, Soochow University, Suzhou, China, and was published online in The American Journal of Clinical Nutrition

LIMITATIONS:

Limitations included possible recall and social desirability biases, potential residual confounding, and uncertain causality of the observed associations.

DISCLOSURES:

The study was funded by grants from the National Natural Science Foundation of China and other institutions. The authors reported no conflicts of interest.

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

 

TOPLINE:

Middle-aged adults who consume more ultra-processed foods have an elevated risk for rheumatoid arthritis (RA) that is mediated in part through circulating biomarkers.

METHODOLOGY: 

  • Investigators conducted a retrospective cohort study of 207,012 middle-aged adults without RA from the UK Biobank who completed 24-hour dietary recalls.
  • Foods and beverages were classified as (1) unprocessed or minimally processed foods, (2) processed culinary ingredients, (3) processed foods, or (4) ultra-processed foods (eg, soft drinks, sweet or savory packaged snacks, reconstituted meat products, pre-prepared frozen dishes).
  • The main outcome was the incident RA based on hospital diagnoses.

TAKEAWAY:

  • Overall, 0.9% of participants received an RA diagnosis during a median follow-up of about 12 years.
  • Relative to peers in the lowest quintile of ultra-processed food consumption, participants in the highest quintile had a 17% greater adjusted risk for RA.
  • The risk rose across quintile (P < .05) and increased by 6% with each standard deviation increase in ultra-processed food intake.
  • Mediation analyses suggested that inflammatory, lipid, and liver enzyme biomarkers explained 3.1%-14.8% of the association between ultra-processed food intake and RA risk.
  • Findings were similar regardless of participants’ age, sex, body mass index, smoking status, household income, and healthy diet score.

IN PRACTICE: 

“Lower [ultra-processed food] consumption is recommended to reduce RA incidence,” the authors wrote, noting that up to half of the food consumed in the United Kingdom now falls into the ultra-processed category. “Dietary guidelines should prominently feature the detrimental effects of [ultra-processed foods], and recommendations to curtail their consumption should be integrated into public health initiatives, to mitigate the risk of RA,” they added.

SOURCE:

The study was led by Haodong Zhao, Soochow University, Suzhou, China, and was published online in The American Journal of Clinical Nutrition

LIMITATIONS:

Limitations included possible recall and social desirability biases, potential residual confounding, and uncertain causality of the observed associations.

DISCLOSURES:

The study was funded by grants from the National Natural Science Foundation of China and other institutions. The authors reported no conflicts of interest.

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

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Kidney Disease May Accelerate With Higher Rheumatoid Arthritis Disease Activity

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Changed
Thu, 09/05/2024 - 15:04

 

TOPLINE:

Higher rheumatoid arthritis (RA) disease activity is associated with an accelerated kidney function decline and increased risk for chronic kidney disease (CKD) stages G3a and G3b.

METHODOLOGY:

  • Researchers analyzed data from the CorEvitas RA registry, a prospective observational cohort in the United States, between 2001 and 2022, to evaluate the longitudinal association between RA disease activity and changes in kidney function.
  • They included 31,129 patients with RA (median age, 58 years; 76.3% women) who had a baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m2 and received treatment with disease-modifying antirheumatic drugs (DMARDs).
  • The participants were categorized into those in remission (n = 6647) and those with low (n = 10,028), moderate (n = 8548), and high (n = 5906) disease activity based on the time-averaged Clinical Disease Activity Index and followed for a median duration of 3.5 years.
  • The primary outcome was a longitudinal change in eGFR, and the secondary outcomes were the development of CKD stage G3a (eGFR < 60 mL/min/1.73 m2) and stage G3b (eGFR < 45 mL/min/1.73 m2).

TAKEAWAY:

  • Higher RA disease activity was associated with a faster decline in eGFR, with those having moderate and high RA disease activity experiencing an additional mean annual decline of 0.17 mL/min per 1.73 m2 and 0.18 mL/min per 1.73 m2, respectively, compared with those in remission.
  • The decline in annual eGFR was even more accelerated when patients had consistently high disease activity since the time of enrollment (−0.43 mL/min per 1.73 m2).
  • Patients with high RA disease activity had a 1.27 times (adjusted hazard ratio, 1.27; 95% CI, 1.05-1.52) higher risk of developing CKD stage G3a and a 1.93 times (aHR, 1.93; 95% CI, 1.16-3.20) higher risk for CKD stage G3b, compared with those in remission.

IN PRACTICE:

“This study suggests that controlling disease activity may potentially contribute to preserving kidney function in patients with RA,” the authors wrote.

SOURCE:

This study was led by Sho Fukui, MD, Division of Rheumatology, Inflammation, and Immunity, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, Massachusetts, and was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

This study relied on serum creatinine and not cystatin C to estimate kidney function. It also did not collect information on the severity of comorbidities, which may have introduced residual confounding. Further studies are warranted to check the effect of DMARD therapy on renal function.

DISCLOSURES:

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported serving as scientific advisers or consultants, receiving consulting fees or salary support, or having other ties with pharmaceutical companies.

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

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TOPLINE:

Higher rheumatoid arthritis (RA) disease activity is associated with an accelerated kidney function decline and increased risk for chronic kidney disease (CKD) stages G3a and G3b.

METHODOLOGY:

  • Researchers analyzed data from the CorEvitas RA registry, a prospective observational cohort in the United States, between 2001 and 2022, to evaluate the longitudinal association between RA disease activity and changes in kidney function.
  • They included 31,129 patients with RA (median age, 58 years; 76.3% women) who had a baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m2 and received treatment with disease-modifying antirheumatic drugs (DMARDs).
  • The participants were categorized into those in remission (n = 6647) and those with low (n = 10,028), moderate (n = 8548), and high (n = 5906) disease activity based on the time-averaged Clinical Disease Activity Index and followed for a median duration of 3.5 years.
  • The primary outcome was a longitudinal change in eGFR, and the secondary outcomes were the development of CKD stage G3a (eGFR < 60 mL/min/1.73 m2) and stage G3b (eGFR < 45 mL/min/1.73 m2).

TAKEAWAY:

  • Higher RA disease activity was associated with a faster decline in eGFR, with those having moderate and high RA disease activity experiencing an additional mean annual decline of 0.17 mL/min per 1.73 m2 and 0.18 mL/min per 1.73 m2, respectively, compared with those in remission.
  • The decline in annual eGFR was even more accelerated when patients had consistently high disease activity since the time of enrollment (−0.43 mL/min per 1.73 m2).
  • Patients with high RA disease activity had a 1.27 times (adjusted hazard ratio, 1.27; 95% CI, 1.05-1.52) higher risk of developing CKD stage G3a and a 1.93 times (aHR, 1.93; 95% CI, 1.16-3.20) higher risk for CKD stage G3b, compared with those in remission.

IN PRACTICE:

“This study suggests that controlling disease activity may potentially contribute to preserving kidney function in patients with RA,” the authors wrote.

SOURCE:

This study was led by Sho Fukui, MD, Division of Rheumatology, Inflammation, and Immunity, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, Massachusetts, and was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

This study relied on serum creatinine and not cystatin C to estimate kidney function. It also did not collect information on the severity of comorbidities, which may have introduced residual confounding. Further studies are warranted to check the effect of DMARD therapy on renal function.

DISCLOSURES:

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported serving as scientific advisers or consultants, receiving consulting fees or salary support, or having other ties with pharmaceutical companies.

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

 

TOPLINE:

Higher rheumatoid arthritis (RA) disease activity is associated with an accelerated kidney function decline and increased risk for chronic kidney disease (CKD) stages G3a and G3b.

METHODOLOGY:

  • Researchers analyzed data from the CorEvitas RA registry, a prospective observational cohort in the United States, between 2001 and 2022, to evaluate the longitudinal association between RA disease activity and changes in kidney function.
  • They included 31,129 patients with RA (median age, 58 years; 76.3% women) who had a baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m2 and received treatment with disease-modifying antirheumatic drugs (DMARDs).
  • The participants were categorized into those in remission (n = 6647) and those with low (n = 10,028), moderate (n = 8548), and high (n = 5906) disease activity based on the time-averaged Clinical Disease Activity Index and followed for a median duration of 3.5 years.
  • The primary outcome was a longitudinal change in eGFR, and the secondary outcomes were the development of CKD stage G3a (eGFR < 60 mL/min/1.73 m2) and stage G3b (eGFR < 45 mL/min/1.73 m2).

TAKEAWAY:

  • Higher RA disease activity was associated with a faster decline in eGFR, with those having moderate and high RA disease activity experiencing an additional mean annual decline of 0.17 mL/min per 1.73 m2 and 0.18 mL/min per 1.73 m2, respectively, compared with those in remission.
  • The decline in annual eGFR was even more accelerated when patients had consistently high disease activity since the time of enrollment (−0.43 mL/min per 1.73 m2).
  • Patients with high RA disease activity had a 1.27 times (adjusted hazard ratio, 1.27; 95% CI, 1.05-1.52) higher risk of developing CKD stage G3a and a 1.93 times (aHR, 1.93; 95% CI, 1.16-3.20) higher risk for CKD stage G3b, compared with those in remission.

IN PRACTICE:

“This study suggests that controlling disease activity may potentially contribute to preserving kidney function in patients with RA,” the authors wrote.

SOURCE:

This study was led by Sho Fukui, MD, Division of Rheumatology, Inflammation, and Immunity, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, Massachusetts, and was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

This study relied on serum creatinine and not cystatin C to estimate kidney function. It also did not collect information on the severity of comorbidities, which may have introduced residual confounding. Further studies are warranted to check the effect of DMARD therapy on renal function.

DISCLOSURES:

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported serving as scientific advisers or consultants, receiving consulting fees or salary support, or having other ties with pharmaceutical companies.

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

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Rheumatologist Volunteers Make a Difference to Those in Need at Home and Overseas

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Fri, 08/30/2024 - 15:50

As a resident, rheumatologist Daniel Albert, MD, did his first volunteer mission to Afghanistan. The clinic had one portable chest x-ray machine, and physicians could order a complete blood count but no other laboratory studies.

“We could do sputum stains, but that was about it. You had to use your clinical acumen and make decisions based on examining the patient and taking a history,” said Dr. Albert, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth, Hanover, and The Dartmouth Institute in Lebanon, both in New Hampshire. Such tasks can be difficult in a non–English-speaking country.

Dr. Daniel Albert

“There’s a language barrier no matter where you are,” Dr. Albert said.

In Nashville, Tennessee, James Gore, MD, had an epiphany about opening a free rheumatology clinic during a church service. His priest was discussing St. Sampson the Hospitable’s story and closed with “you don’t have to change the world. All you have to do is your little part,” Dr. Gore said. He knew he didn’t need much: a computer, a stethoscope, and a printer for prescriptions.

When his church expanded its building space, Dr. Gore took the opportunity to achieve his goal.

“I didn’t feel responsible for the clinic to succeed, but I did feel responsible to try my best,” he said. That was 14 years ago. To date, the monthly clinic has served 1124 patients representing 55 counties in Tennessee and several other patients from Kentucky.

Dr. James Gore


Volunteer work is a juggling act. Dr. Gore divides his time between the clinic and his work as associate professor of clinical medicine at Vanderbilt University Medical Center (VUMC), also in Nashville.

Dr. Albert often gave up his vacation time and had to balance commitments with his own medical practice and family to do his overseas missions. In his view, it’s worth the extra time and effort.

“It makes you a better physician because you make reasonable decisions and conclusions based on the resources available. Various places had various limitations, but none of them had the kind of resources that we routinely avail ourselves of in the US,” he said.

Tennessee Clients Get Access to Care, Medications

In some parts of the United States, good rheumatology care is hard to come by. One in four people in Tennessee have no health insurance. There’s a big need for rheumatology care in the state, Dr. Gore said.

On the second Saturday of each month, he volunteers his services at the St. Sampson Medical Clinic at Holy Trinity Greek Orthodox Church, Nashville, Tennessee, from 9 AM to 4 PM, providing care for uninsured adult rheumatology patients.

courtesy Tim Weeks
Reading materials for patients at the St. Sampson Medical Clinic.

Patients come by referral from a charity clinic or health department and appointment only. The clinic asks for a $10 payment for their visits. “If they can’t pay, we still see them. But we only take care of patients who don’t have insurance,” Dr. Gore said. Allowing patients to pay gives them an opportunity to show they are vested in their own care. Often, patients will donate extra in gratitude.

Dr. Gore, along with VUMC colleague and rheumatologist Narender Annapureddy, MD, and nurse practitioner Julie Barnes, treats a variety of rheumatic diseases. For Ms. Barnes, volunteering has many rewarding aspects, “as the patients would be unable to have the treatments they need without insurance,” she said.

“We have had patients waiting for many months or sometimes years and have not had a diagnosis, and in a short time, we have been able to diagnose and get them on specific treatment,” Dr. Annapureddy said.

Most people come in for rheumatoid arthritis (RA) and lupus and also positive antinuclear antibody tests. They also see patients with psoriatic arthritis, Sjögren’s disease, gout, scleroderma, Behçet disease, and leukocytoclastic vasculitis. On a typical clinic day, the team can treat up to 30-plus patients. The clinic recently expanded its services to include cardiology care, seeing about 10 patients each month.

Prior to St. Sampson, there were no volunteer clinics in Tennessee specifically dedicated to helping patients with rheumatologic disease. Untreated, these diseases may cause chronic, severe pain, lead to irreversible joint damage, and increase the risk for death.

Many patients have received medications such as adalimumab, etanercept, or tofacitinib for free. The drug companies will provide free medications, provided that they’re prescribed by a board-certified rheumatologist and the patient is uninsured and qualifies for the medication, Dr. Gore said.

Drugs like these can cost about $50,000 a year. “We have pharmacists that donate their time to help these patients get approved for those medicines,” Dr. Gore said. To date, more than 100 patients have received a biologic or targeted synthetic disease-modifying antirheumatic drug through the clinic.

The clinic has received more than $100,000 in donated professional fees, including $48,706 for consultations. Dr. Gore and colleagues relied on other volunteers to bring the clinic to life. He worked with his sister to develop an electronic medical record system that the clinic still uses today. “We did not buy expensive laptops or printers. I had a very generous volunteer, Damon Miltner, our IT guy, who set everything up to make our intranet secure,” he said.

courtesy Tim Weeks
Nurse practitioner Julie Barnes enters data into St. Sampson Medical Clinic's electronic health record system.

The volunteer nurses, IT, and front desk all work together to make the clinic run efficiently, said Ms. Barnes, who also works as a nurse practitioner with Vanderbilt Rheumatology Cool Springs in Franklin, Tennessee. “We share a lunch together, all in a beautiful and holy church. I do not think of this as work, but as spending time with people who are appreciative and kind,” she said.

“It is amazing to see patients who are able to walk in by themselves after having used a cane for years,” Dr. Annapureddy said. “While doing this on weekends with young kids is challenging, having a supportive spouse who shares the same value makes it much easier to be able to do volunteer work.”
 

 

 

Working Outside Your Comfort Zone

Dr. Albert has traveled to all parts of the world to volunteer his services as a rheumatologist and general practitioner. This includes missions to Uganda, Rwanda, Ecuador, Peru, Nepal, and Borneo. He’s participated with several volunteer organizations, among them the International Student & Scholar Services program at the University of Pennsylvania, CARE, Global Volunteers, Project Amazonas, Asha Nepal, Health in Harmony, and several others.

Rheumatologists who volunteer in underdeveloped countries should be prepared to work outside of their specialty — and their comfort zone. In some instances, Dr. Albert took care of AIDS-related infectious diseases. “It’s not something I am particularly knowledgeable about, and I actually spent a fair amount of time reading about it before I went on the plane in order to get some comfort level.”

Dr. Albert often found himself doing more primary care and general pediatrics than rheumatology care. “I would see rheumatic conditions. But there’s not a lot of RA in developing countries, which is something that people have noted before. And the same goes for other autoimmune conditions. They’re just not that common.”

He did see a lot of septic arthritis and tuberculosis in Uganda. “We had a rheum clinic and saw a mixture of the consequences of septic arthritis and also a few RA and lupus patients.”

Limited resources are another thing to prepare for.

Whenever he traveled to a place that didn’t have a lot of resources, Dr. Albert would collect as many supplies as he could from the nearest hospital, pack them away, and try to get the supplies to the mission location.

Sometimes it worked out, and sometimes it didn’t, he said. “I probably had $10,000 worth of medical supplies when I went to Armenia, and American Airlines lost it. It ended up back in my apartment 3 months later. That was unfortunate because there was lot of good stuff there.”

He thought about FedEx-ing some supplies to a mission in Uganda, but it was astronomically expensive, so that didn’t work.

Luggage weight restrictions are another obstacle that sometimes requires a waiver. Dr. Albert once had to get the Red Cross to work with an airline to get a luggage waiver. “Other airlines were very good and didn’t have those kinds of restrictions. But most of the time I got some supplies to go with me, and sometimes that was a very helpful addition,” especially if the mission site was lacking in resources, he said.
 

When Charity Work Produces Success Stories

During one of his missions in Uganda with the University of Pennsylvania, Dr. Albert helped the Makerere University Medical School, Kampala, to establish a rheumatology clinic, which was affiliated with Mulago National Specialised Hospital. The clinic operated once a week for half a day, mostly treating patients with RA and lupus.

The mission also established an AIDS clinic. Many of the patients with musculoskeletal complaints also had HIV and were able to get antiretroviral drugs through the clinic, he said.

For Dr. Gore, seeing patients from more than half the counties in Tennessee was one of the clinic’s biggest accomplishments. “That was all through word of mouth,” he said.

In rheumatology, many patients may feel their condition is hopeless, Ms. Barnes noted. “There have been many patients that, through months of proper treatment, have normal lives. A high percentage would be disabled without the needed medical therapies.”

Dr. Gore has seen patients who literally couldn’t walk or had severe, painful psoriasis all over their body. The clinic would put them on medicine that would give them new life. The psoriasis would clear up, or their joints would heal, and they could walk again.

One of Dr. Gore’s patients, a woman in her mid-50s, got on an expensive medication that brought her arthritis into remission. She’s now able to care for her grandchildren.

The fact that the clinic, with the help of volunteer pharmacologists, can provide medications to enable patients to have a less destructive disease and improved quality of life “is a major reward,” Ms. Barnes said.
 

 

 

Balancing Your Priorities

Overseas missions can last for a few weeks to several months, depending on the mission, the organization, and the type of care involved.

Rheumatologists who want to volunteer need to do so in a way that doesn’t generate a lot of angst with supervisors or colleagues. Dr. Albert balanced this by keeping his missions reasonably short. “I would have someone cover my service. And since there’s reciprocity in the places I worked for, if they covered me for a month, I would cover them for a month, so it wasn’t a burden on anybody.”

“By and large, I used my vacation time to do it, and it does cost some money, but it’s a lot less than the cost of a typical vacation,” Dr. Albert said.

Volunteer work can also compete with family time. Dr. Albert ended up taking his family along on several of his missions to Ecuador and Uganda. He would tell the organization: “My family wants to come. Is there anything they can do while I’m working in the program? And they usually found an occupation.”

At St. Sampson, volunteering is also a family affair. “My wife acts as the administrator, so she’s the one that helps schedule patients and deals with a lot of the faxes.” It’s a big commitment for Dr. Gore’s family and for the church, which gives up a significant chunk of the building one Saturday a month.

“However, for us, I think that it’s a real manifestation of giving back and trying to help those in need and doing what we can do,” he said.
 

Volunteer Work Involves Prep Work

Establishing the St. Sampson clinic took some planning. Dr. Gore and colleagues had to fill out a 501(c)(3) application; establish a charter, bylaws, articles of incorporation, policies, and procedures; and obtain medical malpractice and general liability insurance.

The clinic was able to get financing from the Mid-South Chapter of the Lupus Foundation of America as well as in-kind donations from the church. “We’ve had a lot of different companies who were very generous in donating money and excited to help the clinic continue,” Dr. Gore said.

All volunteers sign a Health Insurance Portability and Accountability Act consent form.

Although the clinic operates for about 7 hours a month, it’s still important to have malpractice insurance, Dr. Gore said. He and his colleagues also have tail insurance that covers medical malpractice insurance for up to 7 years if the clinic closes.

“If somebody were to slip and fall and then try to sue the church, we have a separate policy for the clinic for that. We also have a director’s and officer’s insurance policy,” he said.

Anyone who volunteers abroad should get a travel medicine clinic consultation. “Most of the time, it’s of very little consequence. You might have to get [a] yellow fever vaccine” when traveling to certain parts of the world, Dr. Albert said.

“If you’re going into an area that is all volatile politically or in some way a threat to your personal security, I think you have to think very carefully about that,” he said, suggesting that doctors consult with the US Department of State about potential dangers.

Talk to other physicians who have gone on missions and your sponsoring institution. “By and large, you want to go with a large organization that’s been doing ongoing work,” Dr. Albert said.

Volunteer work teaches you about the breadth of humanist endeavors across the world, he noted. “The people that you deal with are very grateful for your help. Whether you’re successful or not, they’re still very appreciative of the efforts that you’re making to help.”

Dr. Albert and Dr. Gore had no disclosures. Dr. Annapureddy has done consulting for GlaxoSmithKline. Ms. Barnes had no disclosures.

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

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As a resident, rheumatologist Daniel Albert, MD, did his first volunteer mission to Afghanistan. The clinic had one portable chest x-ray machine, and physicians could order a complete blood count but no other laboratory studies.

“We could do sputum stains, but that was about it. You had to use your clinical acumen and make decisions based on examining the patient and taking a history,” said Dr. Albert, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth, Hanover, and The Dartmouth Institute in Lebanon, both in New Hampshire. Such tasks can be difficult in a non–English-speaking country.

Dr. Daniel Albert

“There’s a language barrier no matter where you are,” Dr. Albert said.

In Nashville, Tennessee, James Gore, MD, had an epiphany about opening a free rheumatology clinic during a church service. His priest was discussing St. Sampson the Hospitable’s story and closed with “you don’t have to change the world. All you have to do is your little part,” Dr. Gore said. He knew he didn’t need much: a computer, a stethoscope, and a printer for prescriptions.

When his church expanded its building space, Dr. Gore took the opportunity to achieve his goal.

“I didn’t feel responsible for the clinic to succeed, but I did feel responsible to try my best,” he said. That was 14 years ago. To date, the monthly clinic has served 1124 patients representing 55 counties in Tennessee and several other patients from Kentucky.

Dr. James Gore


Volunteer work is a juggling act. Dr. Gore divides his time between the clinic and his work as associate professor of clinical medicine at Vanderbilt University Medical Center (VUMC), also in Nashville.

Dr. Albert often gave up his vacation time and had to balance commitments with his own medical practice and family to do his overseas missions. In his view, it’s worth the extra time and effort.

“It makes you a better physician because you make reasonable decisions and conclusions based on the resources available. Various places had various limitations, but none of them had the kind of resources that we routinely avail ourselves of in the US,” he said.

Tennessee Clients Get Access to Care, Medications

In some parts of the United States, good rheumatology care is hard to come by. One in four people in Tennessee have no health insurance. There’s a big need for rheumatology care in the state, Dr. Gore said.

On the second Saturday of each month, he volunteers his services at the St. Sampson Medical Clinic at Holy Trinity Greek Orthodox Church, Nashville, Tennessee, from 9 AM to 4 PM, providing care for uninsured adult rheumatology patients.

courtesy Tim Weeks
Reading materials for patients at the St. Sampson Medical Clinic.

Patients come by referral from a charity clinic or health department and appointment only. The clinic asks for a $10 payment for their visits. “If they can’t pay, we still see them. But we only take care of patients who don’t have insurance,” Dr. Gore said. Allowing patients to pay gives them an opportunity to show they are vested in their own care. Often, patients will donate extra in gratitude.

Dr. Gore, along with VUMC colleague and rheumatologist Narender Annapureddy, MD, and nurse practitioner Julie Barnes, treats a variety of rheumatic diseases. For Ms. Barnes, volunteering has many rewarding aspects, “as the patients would be unable to have the treatments they need without insurance,” she said.

“We have had patients waiting for many months or sometimes years and have not had a diagnosis, and in a short time, we have been able to diagnose and get them on specific treatment,” Dr. Annapureddy said.

Most people come in for rheumatoid arthritis (RA) and lupus and also positive antinuclear antibody tests. They also see patients with psoriatic arthritis, Sjögren’s disease, gout, scleroderma, Behçet disease, and leukocytoclastic vasculitis. On a typical clinic day, the team can treat up to 30-plus patients. The clinic recently expanded its services to include cardiology care, seeing about 10 patients each month.

Prior to St. Sampson, there were no volunteer clinics in Tennessee specifically dedicated to helping patients with rheumatologic disease. Untreated, these diseases may cause chronic, severe pain, lead to irreversible joint damage, and increase the risk for death.

Many patients have received medications such as adalimumab, etanercept, or tofacitinib for free. The drug companies will provide free medications, provided that they’re prescribed by a board-certified rheumatologist and the patient is uninsured and qualifies for the medication, Dr. Gore said.

Drugs like these can cost about $50,000 a year. “We have pharmacists that donate their time to help these patients get approved for those medicines,” Dr. Gore said. To date, more than 100 patients have received a biologic or targeted synthetic disease-modifying antirheumatic drug through the clinic.

The clinic has received more than $100,000 in donated professional fees, including $48,706 for consultations. Dr. Gore and colleagues relied on other volunteers to bring the clinic to life. He worked with his sister to develop an electronic medical record system that the clinic still uses today. “We did not buy expensive laptops or printers. I had a very generous volunteer, Damon Miltner, our IT guy, who set everything up to make our intranet secure,” he said.

courtesy Tim Weeks
Nurse practitioner Julie Barnes enters data into St. Sampson Medical Clinic's electronic health record system.

The volunteer nurses, IT, and front desk all work together to make the clinic run efficiently, said Ms. Barnes, who also works as a nurse practitioner with Vanderbilt Rheumatology Cool Springs in Franklin, Tennessee. “We share a lunch together, all in a beautiful and holy church. I do not think of this as work, but as spending time with people who are appreciative and kind,” she said.

“It is amazing to see patients who are able to walk in by themselves after having used a cane for years,” Dr. Annapureddy said. “While doing this on weekends with young kids is challenging, having a supportive spouse who shares the same value makes it much easier to be able to do volunteer work.”
 

 

 

Working Outside Your Comfort Zone

Dr. Albert has traveled to all parts of the world to volunteer his services as a rheumatologist and general practitioner. This includes missions to Uganda, Rwanda, Ecuador, Peru, Nepal, and Borneo. He’s participated with several volunteer organizations, among them the International Student & Scholar Services program at the University of Pennsylvania, CARE, Global Volunteers, Project Amazonas, Asha Nepal, Health in Harmony, and several others.

Rheumatologists who volunteer in underdeveloped countries should be prepared to work outside of their specialty — and their comfort zone. In some instances, Dr. Albert took care of AIDS-related infectious diseases. “It’s not something I am particularly knowledgeable about, and I actually spent a fair amount of time reading about it before I went on the plane in order to get some comfort level.”

Dr. Albert often found himself doing more primary care and general pediatrics than rheumatology care. “I would see rheumatic conditions. But there’s not a lot of RA in developing countries, which is something that people have noted before. And the same goes for other autoimmune conditions. They’re just not that common.”

He did see a lot of septic arthritis and tuberculosis in Uganda. “We had a rheum clinic and saw a mixture of the consequences of septic arthritis and also a few RA and lupus patients.”

Limited resources are another thing to prepare for.

Whenever he traveled to a place that didn’t have a lot of resources, Dr. Albert would collect as many supplies as he could from the nearest hospital, pack them away, and try to get the supplies to the mission location.

Sometimes it worked out, and sometimes it didn’t, he said. “I probably had $10,000 worth of medical supplies when I went to Armenia, and American Airlines lost it. It ended up back in my apartment 3 months later. That was unfortunate because there was lot of good stuff there.”

He thought about FedEx-ing some supplies to a mission in Uganda, but it was astronomically expensive, so that didn’t work.

Luggage weight restrictions are another obstacle that sometimes requires a waiver. Dr. Albert once had to get the Red Cross to work with an airline to get a luggage waiver. “Other airlines were very good and didn’t have those kinds of restrictions. But most of the time I got some supplies to go with me, and sometimes that was a very helpful addition,” especially if the mission site was lacking in resources, he said.
 

When Charity Work Produces Success Stories

During one of his missions in Uganda with the University of Pennsylvania, Dr. Albert helped the Makerere University Medical School, Kampala, to establish a rheumatology clinic, which was affiliated with Mulago National Specialised Hospital. The clinic operated once a week for half a day, mostly treating patients with RA and lupus.

The mission also established an AIDS clinic. Many of the patients with musculoskeletal complaints also had HIV and were able to get antiretroviral drugs through the clinic, he said.

For Dr. Gore, seeing patients from more than half the counties in Tennessee was one of the clinic’s biggest accomplishments. “That was all through word of mouth,” he said.

In rheumatology, many patients may feel their condition is hopeless, Ms. Barnes noted. “There have been many patients that, through months of proper treatment, have normal lives. A high percentage would be disabled without the needed medical therapies.”

Dr. Gore has seen patients who literally couldn’t walk or had severe, painful psoriasis all over their body. The clinic would put them on medicine that would give them new life. The psoriasis would clear up, or their joints would heal, and they could walk again.

One of Dr. Gore’s patients, a woman in her mid-50s, got on an expensive medication that brought her arthritis into remission. She’s now able to care for her grandchildren.

The fact that the clinic, with the help of volunteer pharmacologists, can provide medications to enable patients to have a less destructive disease and improved quality of life “is a major reward,” Ms. Barnes said.
 

 

 

Balancing Your Priorities

Overseas missions can last for a few weeks to several months, depending on the mission, the organization, and the type of care involved.

Rheumatologists who want to volunteer need to do so in a way that doesn’t generate a lot of angst with supervisors or colleagues. Dr. Albert balanced this by keeping his missions reasonably short. “I would have someone cover my service. And since there’s reciprocity in the places I worked for, if they covered me for a month, I would cover them for a month, so it wasn’t a burden on anybody.”

“By and large, I used my vacation time to do it, and it does cost some money, but it’s a lot less than the cost of a typical vacation,” Dr. Albert said.

Volunteer work can also compete with family time. Dr. Albert ended up taking his family along on several of his missions to Ecuador and Uganda. He would tell the organization: “My family wants to come. Is there anything they can do while I’m working in the program? And they usually found an occupation.”

At St. Sampson, volunteering is also a family affair. “My wife acts as the administrator, so she’s the one that helps schedule patients and deals with a lot of the faxes.” It’s a big commitment for Dr. Gore’s family and for the church, which gives up a significant chunk of the building one Saturday a month.

“However, for us, I think that it’s a real manifestation of giving back and trying to help those in need and doing what we can do,” he said.
 

Volunteer Work Involves Prep Work

Establishing the St. Sampson clinic took some planning. Dr. Gore and colleagues had to fill out a 501(c)(3) application; establish a charter, bylaws, articles of incorporation, policies, and procedures; and obtain medical malpractice and general liability insurance.

The clinic was able to get financing from the Mid-South Chapter of the Lupus Foundation of America as well as in-kind donations from the church. “We’ve had a lot of different companies who were very generous in donating money and excited to help the clinic continue,” Dr. Gore said.

All volunteers sign a Health Insurance Portability and Accountability Act consent form.

Although the clinic operates for about 7 hours a month, it’s still important to have malpractice insurance, Dr. Gore said. He and his colleagues also have tail insurance that covers medical malpractice insurance for up to 7 years if the clinic closes.

“If somebody were to slip and fall and then try to sue the church, we have a separate policy for the clinic for that. We also have a director’s and officer’s insurance policy,” he said.

Anyone who volunteers abroad should get a travel medicine clinic consultation. “Most of the time, it’s of very little consequence. You might have to get [a] yellow fever vaccine” when traveling to certain parts of the world, Dr. Albert said.

“If you’re going into an area that is all volatile politically or in some way a threat to your personal security, I think you have to think very carefully about that,” he said, suggesting that doctors consult with the US Department of State about potential dangers.

Talk to other physicians who have gone on missions and your sponsoring institution. “By and large, you want to go with a large organization that’s been doing ongoing work,” Dr. Albert said.

Volunteer work teaches you about the breadth of humanist endeavors across the world, he noted. “The people that you deal with are very grateful for your help. Whether you’re successful or not, they’re still very appreciative of the efforts that you’re making to help.”

Dr. Albert and Dr. Gore had no disclosures. Dr. Annapureddy has done consulting for GlaxoSmithKline. Ms. Barnes had no disclosures.

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

As a resident, rheumatologist Daniel Albert, MD, did his first volunteer mission to Afghanistan. The clinic had one portable chest x-ray machine, and physicians could order a complete blood count but no other laboratory studies.

“We could do sputum stains, but that was about it. You had to use your clinical acumen and make decisions based on examining the patient and taking a history,” said Dr. Albert, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth, Hanover, and The Dartmouth Institute in Lebanon, both in New Hampshire. Such tasks can be difficult in a non–English-speaking country.

Dr. Daniel Albert

“There’s a language barrier no matter where you are,” Dr. Albert said.

In Nashville, Tennessee, James Gore, MD, had an epiphany about opening a free rheumatology clinic during a church service. His priest was discussing St. Sampson the Hospitable’s story and closed with “you don’t have to change the world. All you have to do is your little part,” Dr. Gore said. He knew he didn’t need much: a computer, a stethoscope, and a printer for prescriptions.

When his church expanded its building space, Dr. Gore took the opportunity to achieve his goal.

“I didn’t feel responsible for the clinic to succeed, but I did feel responsible to try my best,” he said. That was 14 years ago. To date, the monthly clinic has served 1124 patients representing 55 counties in Tennessee and several other patients from Kentucky.

Dr. James Gore


Volunteer work is a juggling act. Dr. Gore divides his time between the clinic and his work as associate professor of clinical medicine at Vanderbilt University Medical Center (VUMC), also in Nashville.

Dr. Albert often gave up his vacation time and had to balance commitments with his own medical practice and family to do his overseas missions. In his view, it’s worth the extra time and effort.

“It makes you a better physician because you make reasonable decisions and conclusions based on the resources available. Various places had various limitations, but none of them had the kind of resources that we routinely avail ourselves of in the US,” he said.

Tennessee Clients Get Access to Care, Medications

In some parts of the United States, good rheumatology care is hard to come by. One in four people in Tennessee have no health insurance. There’s a big need for rheumatology care in the state, Dr. Gore said.

On the second Saturday of each month, he volunteers his services at the St. Sampson Medical Clinic at Holy Trinity Greek Orthodox Church, Nashville, Tennessee, from 9 AM to 4 PM, providing care for uninsured adult rheumatology patients.

courtesy Tim Weeks
Reading materials for patients at the St. Sampson Medical Clinic.

Patients come by referral from a charity clinic or health department and appointment only. The clinic asks for a $10 payment for their visits. “If they can’t pay, we still see them. But we only take care of patients who don’t have insurance,” Dr. Gore said. Allowing patients to pay gives them an opportunity to show they are vested in their own care. Often, patients will donate extra in gratitude.

Dr. Gore, along with VUMC colleague and rheumatologist Narender Annapureddy, MD, and nurse practitioner Julie Barnes, treats a variety of rheumatic diseases. For Ms. Barnes, volunteering has many rewarding aspects, “as the patients would be unable to have the treatments they need without insurance,” she said.

“We have had patients waiting for many months or sometimes years and have not had a diagnosis, and in a short time, we have been able to diagnose and get them on specific treatment,” Dr. Annapureddy said.

Most people come in for rheumatoid arthritis (RA) and lupus and also positive antinuclear antibody tests. They also see patients with psoriatic arthritis, Sjögren’s disease, gout, scleroderma, Behçet disease, and leukocytoclastic vasculitis. On a typical clinic day, the team can treat up to 30-plus patients. The clinic recently expanded its services to include cardiology care, seeing about 10 patients each month.

Prior to St. Sampson, there were no volunteer clinics in Tennessee specifically dedicated to helping patients with rheumatologic disease. Untreated, these diseases may cause chronic, severe pain, lead to irreversible joint damage, and increase the risk for death.

Many patients have received medications such as adalimumab, etanercept, or tofacitinib for free. The drug companies will provide free medications, provided that they’re prescribed by a board-certified rheumatologist and the patient is uninsured and qualifies for the medication, Dr. Gore said.

Drugs like these can cost about $50,000 a year. “We have pharmacists that donate their time to help these patients get approved for those medicines,” Dr. Gore said. To date, more than 100 patients have received a biologic or targeted synthetic disease-modifying antirheumatic drug through the clinic.

The clinic has received more than $100,000 in donated professional fees, including $48,706 for consultations. Dr. Gore and colleagues relied on other volunteers to bring the clinic to life. He worked with his sister to develop an electronic medical record system that the clinic still uses today. “We did not buy expensive laptops or printers. I had a very generous volunteer, Damon Miltner, our IT guy, who set everything up to make our intranet secure,” he said.

courtesy Tim Weeks
Nurse practitioner Julie Barnes enters data into St. Sampson Medical Clinic's electronic health record system.

The volunteer nurses, IT, and front desk all work together to make the clinic run efficiently, said Ms. Barnes, who also works as a nurse practitioner with Vanderbilt Rheumatology Cool Springs in Franklin, Tennessee. “We share a lunch together, all in a beautiful and holy church. I do not think of this as work, but as spending time with people who are appreciative and kind,” she said.

“It is amazing to see patients who are able to walk in by themselves after having used a cane for years,” Dr. Annapureddy said. “While doing this on weekends with young kids is challenging, having a supportive spouse who shares the same value makes it much easier to be able to do volunteer work.”
 

 

 

Working Outside Your Comfort Zone

Dr. Albert has traveled to all parts of the world to volunteer his services as a rheumatologist and general practitioner. This includes missions to Uganda, Rwanda, Ecuador, Peru, Nepal, and Borneo. He’s participated with several volunteer organizations, among them the International Student & Scholar Services program at the University of Pennsylvania, CARE, Global Volunteers, Project Amazonas, Asha Nepal, Health in Harmony, and several others.

Rheumatologists who volunteer in underdeveloped countries should be prepared to work outside of their specialty — and their comfort zone. In some instances, Dr. Albert took care of AIDS-related infectious diseases. “It’s not something I am particularly knowledgeable about, and I actually spent a fair amount of time reading about it before I went on the plane in order to get some comfort level.”

Dr. Albert often found himself doing more primary care and general pediatrics than rheumatology care. “I would see rheumatic conditions. But there’s not a lot of RA in developing countries, which is something that people have noted before. And the same goes for other autoimmune conditions. They’re just not that common.”

He did see a lot of septic arthritis and tuberculosis in Uganda. “We had a rheum clinic and saw a mixture of the consequences of septic arthritis and also a few RA and lupus patients.”

Limited resources are another thing to prepare for.

Whenever he traveled to a place that didn’t have a lot of resources, Dr. Albert would collect as many supplies as he could from the nearest hospital, pack them away, and try to get the supplies to the mission location.

Sometimes it worked out, and sometimes it didn’t, he said. “I probably had $10,000 worth of medical supplies when I went to Armenia, and American Airlines lost it. It ended up back in my apartment 3 months later. That was unfortunate because there was lot of good stuff there.”

He thought about FedEx-ing some supplies to a mission in Uganda, but it was astronomically expensive, so that didn’t work.

Luggage weight restrictions are another obstacle that sometimes requires a waiver. Dr. Albert once had to get the Red Cross to work with an airline to get a luggage waiver. “Other airlines were very good and didn’t have those kinds of restrictions. But most of the time I got some supplies to go with me, and sometimes that was a very helpful addition,” especially if the mission site was lacking in resources, he said.
 

When Charity Work Produces Success Stories

During one of his missions in Uganda with the University of Pennsylvania, Dr. Albert helped the Makerere University Medical School, Kampala, to establish a rheumatology clinic, which was affiliated with Mulago National Specialised Hospital. The clinic operated once a week for half a day, mostly treating patients with RA and lupus.

The mission also established an AIDS clinic. Many of the patients with musculoskeletal complaints also had HIV and were able to get antiretroviral drugs through the clinic, he said.

For Dr. Gore, seeing patients from more than half the counties in Tennessee was one of the clinic’s biggest accomplishments. “That was all through word of mouth,” he said.

In rheumatology, many patients may feel their condition is hopeless, Ms. Barnes noted. “There have been many patients that, through months of proper treatment, have normal lives. A high percentage would be disabled without the needed medical therapies.”

Dr. Gore has seen patients who literally couldn’t walk or had severe, painful psoriasis all over their body. The clinic would put them on medicine that would give them new life. The psoriasis would clear up, or their joints would heal, and they could walk again.

One of Dr. Gore’s patients, a woman in her mid-50s, got on an expensive medication that brought her arthritis into remission. She’s now able to care for her grandchildren.

The fact that the clinic, with the help of volunteer pharmacologists, can provide medications to enable patients to have a less destructive disease and improved quality of life “is a major reward,” Ms. Barnes said.
 

 

 

Balancing Your Priorities

Overseas missions can last for a few weeks to several months, depending on the mission, the organization, and the type of care involved.

Rheumatologists who want to volunteer need to do so in a way that doesn’t generate a lot of angst with supervisors or colleagues. Dr. Albert balanced this by keeping his missions reasonably short. “I would have someone cover my service. And since there’s reciprocity in the places I worked for, if they covered me for a month, I would cover them for a month, so it wasn’t a burden on anybody.”

“By and large, I used my vacation time to do it, and it does cost some money, but it’s a lot less than the cost of a typical vacation,” Dr. Albert said.

Volunteer work can also compete with family time. Dr. Albert ended up taking his family along on several of his missions to Ecuador and Uganda. He would tell the organization: “My family wants to come. Is there anything they can do while I’m working in the program? And they usually found an occupation.”

At St. Sampson, volunteering is also a family affair. “My wife acts as the administrator, so she’s the one that helps schedule patients and deals with a lot of the faxes.” It’s a big commitment for Dr. Gore’s family and for the church, which gives up a significant chunk of the building one Saturday a month.

“However, for us, I think that it’s a real manifestation of giving back and trying to help those in need and doing what we can do,” he said.
 

Volunteer Work Involves Prep Work

Establishing the St. Sampson clinic took some planning. Dr. Gore and colleagues had to fill out a 501(c)(3) application; establish a charter, bylaws, articles of incorporation, policies, and procedures; and obtain medical malpractice and general liability insurance.

The clinic was able to get financing from the Mid-South Chapter of the Lupus Foundation of America as well as in-kind donations from the church. “We’ve had a lot of different companies who were very generous in donating money and excited to help the clinic continue,” Dr. Gore said.

All volunteers sign a Health Insurance Portability and Accountability Act consent form.

Although the clinic operates for about 7 hours a month, it’s still important to have malpractice insurance, Dr. Gore said. He and his colleagues also have tail insurance that covers medical malpractice insurance for up to 7 years if the clinic closes.

“If somebody were to slip and fall and then try to sue the church, we have a separate policy for the clinic for that. We also have a director’s and officer’s insurance policy,” he said.

Anyone who volunteers abroad should get a travel medicine clinic consultation. “Most of the time, it’s of very little consequence. You might have to get [a] yellow fever vaccine” when traveling to certain parts of the world, Dr. Albert said.

“If you’re going into an area that is all volatile politically or in some way a threat to your personal security, I think you have to think very carefully about that,” he said, suggesting that doctors consult with the US Department of State about potential dangers.

Talk to other physicians who have gone on missions and your sponsoring institution. “By and large, you want to go with a large organization that’s been doing ongoing work,” Dr. Albert said.

Volunteer work teaches you about the breadth of humanist endeavors across the world, he noted. “The people that you deal with are very grateful for your help. Whether you’re successful or not, they’re still very appreciative of the efforts that you’re making to help.”

Dr. Albert and Dr. Gore had no disclosures. Dr. Annapureddy has done consulting for GlaxoSmithKline. Ms. Barnes had no disclosures.

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

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Ustekinumab’s ‘Egregious’ Medicare Part B and D Pricing Differences Led to Federal Intervention

Article Type
Changed
Fri, 08/30/2024 - 14:48

 

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

 

 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

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A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

 

 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

 

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

 

 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

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Patients With Immune-Mediated Inflammatory Diseases, Type 2 Diabetes Reap GLP-1 Receptor Agonist Benefits, Too

Article Type
Changed
Fri, 08/23/2024 - 12:40

 

TOPLINE:

Compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are associated with a lower risk for all-cause mortality and major adverse cardiovascular events (MACE) in patients with immune-mediated inflammatory diseases (IMIDs) and type 2 diabetes (T2D).

METHODOLOGY:

  • GLP-1 RAs reduce the risk for all-cause mortality, cardiovascular mortality, and stroke in patients with diabetes. However, previous trials have excluded those with IMIDs, leaving a gap in understanding the cardioprotective effects of GLP-1 RAs in this population.
  • Researchers conducted a population-based cohort study to assess if patients with an IMID derive greater benefits from GLP-1 RAs than DPP-4 inhibitors.
  • They used administrative health data from British Columbia, Canada, to include 10,855 patients with IMIDs (rheumatoid arthritis, psoriatic disease, ankylosing spondylitis, inflammatory bowel disease, or systemic autoimmune rheumatic disease) and T2D who initiated either GLP-1 RA (n = 3570) or DPP-4 inhibitor (n = 7285).
  • The mean follow-up was 1.46 and 1.88 years in the GLP-1 RA and DPP-4 inhibitor cohorts, respectively.
  • The primary outcome was all-cause mortality, and the secondary outcome was MACE, including cardiovascular death, myocardial infarction, and ischemic stroke.

TAKEAWAY:

  • The risk for all-cause mortality was 52% lower in patients who initiated GLP-1 RAs than in those who initiated DPP-4 inhibitors (weighted hazard ratio [HR], 0.48; 95% CI, 0.31-0.75).
  • Additionally, patients initiating DPP-4 inhibitors.
  • In the subgroup of patients with GLP-1 RAs had a significantly lower risk for MACE (weighted HR, 0.66; 95% CI, 0.50-0.88), particularly myocardial infarction (weighted HR, 0.62; 95% CI, 0.40-0.96), than those initiating rheumatoid arthritis and T2D, those who initiated GLP-1 RAs had a 55% lower risk for all-cause mortality and 61% lower risk for MACE than those who initiated DPP-4 inhibitors.

IN PRACTICE:

“This corresponds to nine fewer deaths and 11 fewer MACE per 1000 person-years, respectively, supporting the hypothesis that these agents have a cardioprotective effect in this high-risk population,” the authors wrote.

SOURCE:

This study was led by Derin Karacabeyli, MD, Division of Rheumatology, Department of Medicine, University of British Columbia, Vancouver, Canada, and was published online on August 8, 2024, in PLOS ONE.

LIMITATIONS:

The study’s dependence on administrative health data might have resulted in incomplete capture of comorbidities, particularly obesity. The mean follow-up period was relatively short, which might have limited the long-term applicability of these findings. The accuracy of the case definitions for IMIDs and T2D, according to International Classification of Diseases codes, could not be fully ascertained.

DISCLOSURES:

The study was supported by grants from the Canadian Institutes of Health Research. Two authors declared receiving research support, consulting fees, or participating in advisory boards outside the submitted work.

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

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TOPLINE:

Compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are associated with a lower risk for all-cause mortality and major adverse cardiovascular events (MACE) in patients with immune-mediated inflammatory diseases (IMIDs) and type 2 diabetes (T2D).

METHODOLOGY:

  • GLP-1 RAs reduce the risk for all-cause mortality, cardiovascular mortality, and stroke in patients with diabetes. However, previous trials have excluded those with IMIDs, leaving a gap in understanding the cardioprotective effects of GLP-1 RAs in this population.
  • Researchers conducted a population-based cohort study to assess if patients with an IMID derive greater benefits from GLP-1 RAs than DPP-4 inhibitors.
  • They used administrative health data from British Columbia, Canada, to include 10,855 patients with IMIDs (rheumatoid arthritis, psoriatic disease, ankylosing spondylitis, inflammatory bowel disease, or systemic autoimmune rheumatic disease) and T2D who initiated either GLP-1 RA (n = 3570) or DPP-4 inhibitor (n = 7285).
  • The mean follow-up was 1.46 and 1.88 years in the GLP-1 RA and DPP-4 inhibitor cohorts, respectively.
  • The primary outcome was all-cause mortality, and the secondary outcome was MACE, including cardiovascular death, myocardial infarction, and ischemic stroke.

TAKEAWAY:

  • The risk for all-cause mortality was 52% lower in patients who initiated GLP-1 RAs than in those who initiated DPP-4 inhibitors (weighted hazard ratio [HR], 0.48; 95% CI, 0.31-0.75).
  • Additionally, patients initiating DPP-4 inhibitors.
  • In the subgroup of patients with GLP-1 RAs had a significantly lower risk for MACE (weighted HR, 0.66; 95% CI, 0.50-0.88), particularly myocardial infarction (weighted HR, 0.62; 95% CI, 0.40-0.96), than those initiating rheumatoid arthritis and T2D, those who initiated GLP-1 RAs had a 55% lower risk for all-cause mortality and 61% lower risk for MACE than those who initiated DPP-4 inhibitors.

IN PRACTICE:

“This corresponds to nine fewer deaths and 11 fewer MACE per 1000 person-years, respectively, supporting the hypothesis that these agents have a cardioprotective effect in this high-risk population,” the authors wrote.

SOURCE:

This study was led by Derin Karacabeyli, MD, Division of Rheumatology, Department of Medicine, University of British Columbia, Vancouver, Canada, and was published online on August 8, 2024, in PLOS ONE.

LIMITATIONS:

The study’s dependence on administrative health data might have resulted in incomplete capture of comorbidities, particularly obesity. The mean follow-up period was relatively short, which might have limited the long-term applicability of these findings. The accuracy of the case definitions for IMIDs and T2D, according to International Classification of Diseases codes, could not be fully ascertained.

DISCLOSURES:

The study was supported by grants from the Canadian Institutes of Health Research. Two authors declared receiving research support, consulting fees, or participating in advisory boards outside the submitted work.

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

 

TOPLINE:

Compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are associated with a lower risk for all-cause mortality and major adverse cardiovascular events (MACE) in patients with immune-mediated inflammatory diseases (IMIDs) and type 2 diabetes (T2D).

METHODOLOGY:

  • GLP-1 RAs reduce the risk for all-cause mortality, cardiovascular mortality, and stroke in patients with diabetes. However, previous trials have excluded those with IMIDs, leaving a gap in understanding the cardioprotective effects of GLP-1 RAs in this population.
  • Researchers conducted a population-based cohort study to assess if patients with an IMID derive greater benefits from GLP-1 RAs than DPP-4 inhibitors.
  • They used administrative health data from British Columbia, Canada, to include 10,855 patients with IMIDs (rheumatoid arthritis, psoriatic disease, ankylosing spondylitis, inflammatory bowel disease, or systemic autoimmune rheumatic disease) and T2D who initiated either GLP-1 RA (n = 3570) or DPP-4 inhibitor (n = 7285).
  • The mean follow-up was 1.46 and 1.88 years in the GLP-1 RA and DPP-4 inhibitor cohorts, respectively.
  • The primary outcome was all-cause mortality, and the secondary outcome was MACE, including cardiovascular death, myocardial infarction, and ischemic stroke.

TAKEAWAY:

  • The risk for all-cause mortality was 52% lower in patients who initiated GLP-1 RAs than in those who initiated DPP-4 inhibitors (weighted hazard ratio [HR], 0.48; 95% CI, 0.31-0.75).
  • Additionally, patients initiating DPP-4 inhibitors.
  • In the subgroup of patients with GLP-1 RAs had a significantly lower risk for MACE (weighted HR, 0.66; 95% CI, 0.50-0.88), particularly myocardial infarction (weighted HR, 0.62; 95% CI, 0.40-0.96), than those initiating rheumatoid arthritis and T2D, those who initiated GLP-1 RAs had a 55% lower risk for all-cause mortality and 61% lower risk for MACE than those who initiated DPP-4 inhibitors.

IN PRACTICE:

“This corresponds to nine fewer deaths and 11 fewer MACE per 1000 person-years, respectively, supporting the hypothesis that these agents have a cardioprotective effect in this high-risk population,” the authors wrote.

SOURCE:

This study was led by Derin Karacabeyli, MD, Division of Rheumatology, Department of Medicine, University of British Columbia, Vancouver, Canada, and was published online on August 8, 2024, in PLOS ONE.

LIMITATIONS:

The study’s dependence on administrative health data might have resulted in incomplete capture of comorbidities, particularly obesity. The mean follow-up period was relatively short, which might have limited the long-term applicability of these findings. The accuracy of the case definitions for IMIDs and T2D, according to International Classification of Diseases codes, could not be fully ascertained.

DISCLOSURES:

The study was supported by grants from the Canadian Institutes of Health Research. Two authors declared receiving research support, consulting fees, or participating in advisory boards outside the submitted work.

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

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Tendon Damage, Tenosynovitis Common But Not Limiting or Painful in Hand Osteoarthritis

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Changed
Thu, 08/22/2024 - 16:09

 

TOPLINE: 

Ultrasonography reveals tendon involvement in nearly 70% of the patients with hand osteoarthritis (OA), with no significant impact on hand function or pain. Tendon damage was more frequent in the flexor tendons, while tenosynovitis was more common in the extensor tendons.

METHODOLOGY:

  • Tendon damage is commonly associated with radiographic damage in rheumatoid arthritis and is a typical finding in psoriatic arthritis; however, data on tendon involvement in hand OA are scarce.
  • Researchers assessed tendon involvement, its impact on pain and hand function, and its association with radiographic features in hand OA.
  • They conducted a cross-sectional, monocenter observational study including 86 patients with hand OA (mean age, 65.9 years; 87.2% women) and 23 age- and sex-matched control individuals without bony enlargement and hand pain at a tertiary center of rheumatic and musculoskeletal disease in Vienna.
  • Clinical examination and ultrasonography were used to assess the extensor and flexor tendons of both hands for tenosynovitis and tendon damage.
  • Participants completed the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) questionnaire and the Moberg pickup test for the assessment of hand function, stiffness, and pain.

TAKEAWAY:

  • Ultrasonography identified tendon involvement in a higher proportion of patients with hand OA than in control individuals (69.8% vs 8.7%; P < .01).
  • In patients with hand OA, the flexor tendons were more commonly affected by tendon damage than the extensor tendons (2.1% vs 0.9%; P = .03), whereas tenosynovitis was more prevalent in the extensor tendons than in the flexor tendons (8.0% vs 0.6%; P < .001).
  • No significant association was found between tendon involvement and hand function or self-reported pain.
  • The sensitivity and specificity of clinical evaluation in identifying tendon involvement were 14.5% and 83.8%, respectively.

IN PRACTICE:

“Physicians treating patients with hand OA should keep the high prevalence of tendon involvement in mind,” the authors wrote. “In case of clinical suspicion, a sonographic examination should be performed. If tenosynovitis or tendon damage is detected, treatment may be tailored accordingly.”

SOURCE:

The study, led by Irina Gessl, MD, Department of Internal Medicine III, Medical University of Vienna in Austria, was published online on August 7, 2024, in Rheumatology.

LIMITATIONS: 

The study lacked a standardized clinical examination and a preferred method for detecting tenosynovitis and tendon damage. The lack of a separate evaluation of clinical tenderness in individual joints may have hindered a more comprehensive assessment of pain. The M-SACRAH questionnaire is validated for assessing the overall hand function in patients with hand OA and rheumatoid arthritis but not tendon involvement.

DISCLOSURES:

The Medical Scientific Fund of the Mayor of the City of Vienna supported the study. Some authors reported receiving personal fees, grants, royalties, or licenses and being part of speakers bureau for various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

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TOPLINE: 

Ultrasonography reveals tendon involvement in nearly 70% of the patients with hand osteoarthritis (OA), with no significant impact on hand function or pain. Tendon damage was more frequent in the flexor tendons, while tenosynovitis was more common in the extensor tendons.

METHODOLOGY:

  • Tendon damage is commonly associated with radiographic damage in rheumatoid arthritis and is a typical finding in psoriatic arthritis; however, data on tendon involvement in hand OA are scarce.
  • Researchers assessed tendon involvement, its impact on pain and hand function, and its association with radiographic features in hand OA.
  • They conducted a cross-sectional, monocenter observational study including 86 patients with hand OA (mean age, 65.9 years; 87.2% women) and 23 age- and sex-matched control individuals without bony enlargement and hand pain at a tertiary center of rheumatic and musculoskeletal disease in Vienna.
  • Clinical examination and ultrasonography were used to assess the extensor and flexor tendons of both hands for tenosynovitis and tendon damage.
  • Participants completed the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) questionnaire and the Moberg pickup test for the assessment of hand function, stiffness, and pain.

TAKEAWAY:

  • Ultrasonography identified tendon involvement in a higher proportion of patients with hand OA than in control individuals (69.8% vs 8.7%; P < .01).
  • In patients with hand OA, the flexor tendons were more commonly affected by tendon damage than the extensor tendons (2.1% vs 0.9%; P = .03), whereas tenosynovitis was more prevalent in the extensor tendons than in the flexor tendons (8.0% vs 0.6%; P < .001).
  • No significant association was found between tendon involvement and hand function or self-reported pain.
  • The sensitivity and specificity of clinical evaluation in identifying tendon involvement were 14.5% and 83.8%, respectively.

IN PRACTICE:

“Physicians treating patients with hand OA should keep the high prevalence of tendon involvement in mind,” the authors wrote. “In case of clinical suspicion, a sonographic examination should be performed. If tenosynovitis or tendon damage is detected, treatment may be tailored accordingly.”

SOURCE:

The study, led by Irina Gessl, MD, Department of Internal Medicine III, Medical University of Vienna in Austria, was published online on August 7, 2024, in Rheumatology.

LIMITATIONS: 

The study lacked a standardized clinical examination and a preferred method for detecting tenosynovitis and tendon damage. The lack of a separate evaluation of clinical tenderness in individual joints may have hindered a more comprehensive assessment of pain. The M-SACRAH questionnaire is validated for assessing the overall hand function in patients with hand OA and rheumatoid arthritis but not tendon involvement.

DISCLOSURES:

The Medical Scientific Fund of the Mayor of the City of Vienna supported the study. Some authors reported receiving personal fees, grants, royalties, or licenses and being part of speakers bureau for various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

 

TOPLINE: 

Ultrasonography reveals tendon involvement in nearly 70% of the patients with hand osteoarthritis (OA), with no significant impact on hand function or pain. Tendon damage was more frequent in the flexor tendons, while tenosynovitis was more common in the extensor tendons.

METHODOLOGY:

  • Tendon damage is commonly associated with radiographic damage in rheumatoid arthritis and is a typical finding in psoriatic arthritis; however, data on tendon involvement in hand OA are scarce.
  • Researchers assessed tendon involvement, its impact on pain and hand function, and its association with radiographic features in hand OA.
  • They conducted a cross-sectional, monocenter observational study including 86 patients with hand OA (mean age, 65.9 years; 87.2% women) and 23 age- and sex-matched control individuals without bony enlargement and hand pain at a tertiary center of rheumatic and musculoskeletal disease in Vienna.
  • Clinical examination and ultrasonography were used to assess the extensor and flexor tendons of both hands for tenosynovitis and tendon damage.
  • Participants completed the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) questionnaire and the Moberg pickup test for the assessment of hand function, stiffness, and pain.

TAKEAWAY:

  • Ultrasonography identified tendon involvement in a higher proportion of patients with hand OA than in control individuals (69.8% vs 8.7%; P < .01).
  • In patients with hand OA, the flexor tendons were more commonly affected by tendon damage than the extensor tendons (2.1% vs 0.9%; P = .03), whereas tenosynovitis was more prevalent in the extensor tendons than in the flexor tendons (8.0% vs 0.6%; P < .001).
  • No significant association was found between tendon involvement and hand function or self-reported pain.
  • The sensitivity and specificity of clinical evaluation in identifying tendon involvement were 14.5% and 83.8%, respectively.

IN PRACTICE:

“Physicians treating patients with hand OA should keep the high prevalence of tendon involvement in mind,” the authors wrote. “In case of clinical suspicion, a sonographic examination should be performed. If tenosynovitis or tendon damage is detected, treatment may be tailored accordingly.”

SOURCE:

The study, led by Irina Gessl, MD, Department of Internal Medicine III, Medical University of Vienna in Austria, was published online on August 7, 2024, in Rheumatology.

LIMITATIONS: 

The study lacked a standardized clinical examination and a preferred method for detecting tenosynovitis and tendon damage. The lack of a separate evaluation of clinical tenderness in individual joints may have hindered a more comprehensive assessment of pain. The M-SACRAH questionnaire is validated for assessing the overall hand function in patients with hand OA and rheumatoid arthritis but not tendon involvement.

DISCLOSURES:

The Medical Scientific Fund of the Mayor of the City of Vienna supported the study. Some authors reported receiving personal fees, grants, royalties, or licenses and being part of speakers bureau for various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

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Do You Have Patients With JAKne — JAK Inhibitor–Associated Acne? Here’s What to Know

Article Type
Changed
Fri, 08/23/2024 - 12:15

Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.

“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
 

What Is JAKne?

JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”

Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.

courtesy Brigham and Women&#039;s Hospital
Dr. Arash Mostaghimi

“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”

In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.

Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”

Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”

This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
 

How Do You Treat It?

“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.

“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”

Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)

courtesy Harvard Medical School
Dr. Janelle Nassim

In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.

If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.

“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”

Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.

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

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Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.

“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
 

What Is JAKne?

JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”

Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.

courtesy Brigham and Women&#039;s Hospital
Dr. Arash Mostaghimi

“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”

In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.

Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”

Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”

This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
 

How Do You Treat It?

“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.

“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”

Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)

courtesy Harvard Medical School
Dr. Janelle Nassim

In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.

If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.

“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”

Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.

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

Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.

“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
 

What Is JAKne?

JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”

Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.

courtesy Brigham and Women&#039;s Hospital
Dr. Arash Mostaghimi

“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”

In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.

Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”

Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”

This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
 

How Do You Treat It?

“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.

“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”

Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)

courtesy Harvard Medical School
Dr. Janelle Nassim

In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.

If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.

“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”

Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.

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

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Chronic Back Pain in Patients With Psoriasis, Uveitis, or Colitis: How Often Is It Axial Spondyloarthritis?

Article Type
Changed
Thu, 08/15/2024 - 15:06

 

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

  • Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
  • Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
  • Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
  • An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
  • The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

  • AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
  • Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
  • Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
  • In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

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

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TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

  • Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
  • Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
  • Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
  • An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
  • The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

  • AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
  • Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
  • Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
  • In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

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

 

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

  • Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
  • Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
  • Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
  • An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
  • The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

  • AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
  • Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
  • Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
  • In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

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

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Is SNRI Treatment of Fibromyalgia Working? Look at Sleep Patterns

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Tue, 08/13/2024 - 13:39

Not a morning person? For patients with fibromyalgia, the answer to that question could be a clue about their treatment response with a serotonin and norepinephrine reuptake inhibitor (SNRI), suggested a new cross-sectional study published in Rheumatology International.

Compared with patients who had 30% or more pain relief after 8 or more weeks on an SNRI (duloxetinevenlafaxine, or milnacipran), those with less pain relief reported rougher mornings and worse sleep overall. Morningness, morning affect, diurnal dysrhythmia, anytime wakeability, overall sleep quality, subjective sleep quality and disturbances, sleep medication use, and daytime dysfunction were all predictors of nonresponse to SNRI treatment.

“The observed chronobiological characteristics of patients resistant to SNRI treatment are important because they can be targeted with adjunctive circadian interventions, ie, morning light therapy, in order to normalize circadian rhythms and improve sleep, and in effect, overcome the resistance to treatment and alleviate [the] patient’s pain,” said study author Anna Julia Krupa, MD, a psychiatrist and research assistant in the Department of Affective Disorders at Jagiellonian University Medical College, Kraków, Poland.

Fibromyalgia symptoms like sleep disturbance, low mood, fatigue, stiffness, cognitive impairment, and anxiety are often interlinked in positive feedback loops, meaning that the presence of one symptom (ie, sleep problems or depression) exacerbates the other (ie, pain or anxiety), Dr. Krupa said. While SNRIs can reduce pain, anxiety, and depression, they don’t directly improve sleep. Sometimes, pain relief smooths out minor sleep problems, but not always.

“Therefore, if circadian rhythm disruptions and sleep problems are significant, they may constitute a factor which limits SNRI effects on pain in people with fibromyalgia,” Dr. Krupa said.

With 60 patients with fibromyalgia (30 responsive to treatment and 30 nonresponsive to treatment) and 30 healthy controls, this was a small study, noted Daniel G. Arkfeld, MD, DDS, a rheumatologist and associate professor of clinical medicine at Keck School of Medicine, University of Southern California, Los Angeles. However, “sleep is probably one of the most difficult things in fibromyalgia, and it definitely needs to be targeted.”

Decades of research suggest that important neurochemicals, like growth hormone, are released in deep sleep. “We know that sleep disturbances and time frame and release of neurochemicals [are] all super important in fibromyalgia,” he said.

Side effects of medication could be another factor at play here. As with any drug, the side effects of SNRIs vary widely from person to person, but palpitations, tremulousness, and insomnia are common, said Daniel J. Clauw, MD, professor of anesthesiology, internal medicine/rheumatology, and psychiatry and director of the Chronic Pain & Fatigue Research Center at the University of Michigan, Ann Arbor.

“SNRIs are often ‘activating’ because of the increase in norepinephrine,” Dr. Clauw said. “This is often helpful for symptoms such as fatigue and memory problems — but could worsen sleep.”

That’s why he always recommends that patients take an SNRI in the morning, not at night. Try that and the following tips to help patients with fibromyalgia sleep better and feel better, too.

Start with the basics. It’s worth reminding patients about the tried-and-true tips like going to bed and waking up at the same time every day and keeping your bedroom quiet and dark. “Patients should first try ‘sleep hygiene’ strategies,” said Dr. Clauw. “If that doesn’t help then cognitive-behavioral therapy (CBT) for insomnia can be very helpful.”

A systematic review and meta-analysis showed that CBT for insomnia helped patients with fibromyalgia improve sleep quality, pain, anxiety, and depression compared with nonpharmacologic treatments. And if that doesn’t help? “If need be, they can try nonbenzodiazepine hypnotic drugs, eg, tricyclics or gabapentinoids taken at bedtime,” said Dr. Clauw.

Help them fall in love with exercise. A personalized approach to exercise can help patients with fibromyalgia feel better, suggested a study review in Clinical and Experimental Rheumatology. Exercise can also help reset the circadian clock. Morning activity helps night owls get on an earlier schedule, suggested a study review published in Physical Activity and Nutrition

Consider yoga, tai chi, or qigong.study review published in Seminars in Arthritis and Rheumatism suggested mind-body and combined exercises help improve sleep for people with fibromyalgia, while aerobic or strength training alone does not. One explanation is that mind-body exercises might do more than other types to tamp down sympathetic-excitatory overactivation in fibromyalgia, the researchers said. Use this handy guide from the European Pain Federation to help you start the exercise conversation.

Talk about sleep alongside other aspects of fibromyalgia. Psychoeducation for fibromyalgia often includes information about the distinction between acute and chronic pain, the nature of fibromyalgia syndrome, disease-contributing factors, safe and effective treatments, symptoms and characteristics, and coping strategies, according to a study review in the journal Behavioral Sciences. “As a psychiatrist and someone who often consults patients with fibromyalgia, I would also add the information about links between pain and mood, anxiety as well as sleep,” said Dr. Krupa.

Try morning light. Use light to shift circadian rhythms, suggested Dr. Krupa. People who struggle in the morning might benefit from 30-60 minutes of morning light therapy immediately after waking using a 10,000-lux light box or light glasses, as suggested by a study review from the University of Michigan.

Help them get off the night shift. “Fibromyalgia patients probably shouldn’t work the night shift and throw their circadian rhythm off,” said Dr. Arkfeld. Depending on a patient’s work and financial circumstances, a job change might not be possible, but consider writing a note to the patient’s employer asking them to switch the patient to the day shift. Dr. Arkfeld said this approach has worked for some of his patients.

Refer them for a sleep study. Many patients with fibromyalgia have obstructive sleep apnea or other sleep disorders that require additional intervention. “Sleep studies are important to kind of define the actual sleep problem that’s occurring as well, whether it’s the stage for interruption of sleep or sleep apnea or wakefulness,” said Dr. Arkfeld.

The study was funded by Jagiellonian University Medical College. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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Not a morning person? For patients with fibromyalgia, the answer to that question could be a clue about their treatment response with a serotonin and norepinephrine reuptake inhibitor (SNRI), suggested a new cross-sectional study published in Rheumatology International.

Compared with patients who had 30% or more pain relief after 8 or more weeks on an SNRI (duloxetinevenlafaxine, or milnacipran), those with less pain relief reported rougher mornings and worse sleep overall. Morningness, morning affect, diurnal dysrhythmia, anytime wakeability, overall sleep quality, subjective sleep quality and disturbances, sleep medication use, and daytime dysfunction were all predictors of nonresponse to SNRI treatment.

“The observed chronobiological characteristics of patients resistant to SNRI treatment are important because they can be targeted with adjunctive circadian interventions, ie, morning light therapy, in order to normalize circadian rhythms and improve sleep, and in effect, overcome the resistance to treatment and alleviate [the] patient’s pain,” said study author Anna Julia Krupa, MD, a psychiatrist and research assistant in the Department of Affective Disorders at Jagiellonian University Medical College, Kraków, Poland.

Fibromyalgia symptoms like sleep disturbance, low mood, fatigue, stiffness, cognitive impairment, and anxiety are often interlinked in positive feedback loops, meaning that the presence of one symptom (ie, sleep problems or depression) exacerbates the other (ie, pain or anxiety), Dr. Krupa said. While SNRIs can reduce pain, anxiety, and depression, they don’t directly improve sleep. Sometimes, pain relief smooths out minor sleep problems, but not always.

“Therefore, if circadian rhythm disruptions and sleep problems are significant, they may constitute a factor which limits SNRI effects on pain in people with fibromyalgia,” Dr. Krupa said.

With 60 patients with fibromyalgia (30 responsive to treatment and 30 nonresponsive to treatment) and 30 healthy controls, this was a small study, noted Daniel G. Arkfeld, MD, DDS, a rheumatologist and associate professor of clinical medicine at Keck School of Medicine, University of Southern California, Los Angeles. However, “sleep is probably one of the most difficult things in fibromyalgia, and it definitely needs to be targeted.”

Decades of research suggest that important neurochemicals, like growth hormone, are released in deep sleep. “We know that sleep disturbances and time frame and release of neurochemicals [are] all super important in fibromyalgia,” he said.

Side effects of medication could be another factor at play here. As with any drug, the side effects of SNRIs vary widely from person to person, but palpitations, tremulousness, and insomnia are common, said Daniel J. Clauw, MD, professor of anesthesiology, internal medicine/rheumatology, and psychiatry and director of the Chronic Pain & Fatigue Research Center at the University of Michigan, Ann Arbor.

“SNRIs are often ‘activating’ because of the increase in norepinephrine,” Dr. Clauw said. “This is often helpful for symptoms such as fatigue and memory problems — but could worsen sleep.”

That’s why he always recommends that patients take an SNRI in the morning, not at night. Try that and the following tips to help patients with fibromyalgia sleep better and feel better, too.

Start with the basics. It’s worth reminding patients about the tried-and-true tips like going to bed and waking up at the same time every day and keeping your bedroom quiet and dark. “Patients should first try ‘sleep hygiene’ strategies,” said Dr. Clauw. “If that doesn’t help then cognitive-behavioral therapy (CBT) for insomnia can be very helpful.”

A systematic review and meta-analysis showed that CBT for insomnia helped patients with fibromyalgia improve sleep quality, pain, anxiety, and depression compared with nonpharmacologic treatments. And if that doesn’t help? “If need be, they can try nonbenzodiazepine hypnotic drugs, eg, tricyclics or gabapentinoids taken at bedtime,” said Dr. Clauw.

Help them fall in love with exercise. A personalized approach to exercise can help patients with fibromyalgia feel better, suggested a study review in Clinical and Experimental Rheumatology. Exercise can also help reset the circadian clock. Morning activity helps night owls get on an earlier schedule, suggested a study review published in Physical Activity and Nutrition

Consider yoga, tai chi, or qigong.study review published in Seminars in Arthritis and Rheumatism suggested mind-body and combined exercises help improve sleep for people with fibromyalgia, while aerobic or strength training alone does not. One explanation is that mind-body exercises might do more than other types to tamp down sympathetic-excitatory overactivation in fibromyalgia, the researchers said. Use this handy guide from the European Pain Federation to help you start the exercise conversation.

Talk about sleep alongside other aspects of fibromyalgia. Psychoeducation for fibromyalgia often includes information about the distinction between acute and chronic pain, the nature of fibromyalgia syndrome, disease-contributing factors, safe and effective treatments, symptoms and characteristics, and coping strategies, according to a study review in the journal Behavioral Sciences. “As a psychiatrist and someone who often consults patients with fibromyalgia, I would also add the information about links between pain and mood, anxiety as well as sleep,” said Dr. Krupa.

Try morning light. Use light to shift circadian rhythms, suggested Dr. Krupa. People who struggle in the morning might benefit from 30-60 minutes of morning light therapy immediately after waking using a 10,000-lux light box or light glasses, as suggested by a study review from the University of Michigan.

Help them get off the night shift. “Fibromyalgia patients probably shouldn’t work the night shift and throw their circadian rhythm off,” said Dr. Arkfeld. Depending on a patient’s work and financial circumstances, a job change might not be possible, but consider writing a note to the patient’s employer asking them to switch the patient to the day shift. Dr. Arkfeld said this approach has worked for some of his patients.

Refer them for a sleep study. Many patients with fibromyalgia have obstructive sleep apnea or other sleep disorders that require additional intervention. “Sleep studies are important to kind of define the actual sleep problem that’s occurring as well, whether it’s the stage for interruption of sleep or sleep apnea or wakefulness,” said Dr. Arkfeld.

The study was funded by Jagiellonian University Medical College. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Not a morning person? For patients with fibromyalgia, the answer to that question could be a clue about their treatment response with a serotonin and norepinephrine reuptake inhibitor (SNRI), suggested a new cross-sectional study published in Rheumatology International.

Compared with patients who had 30% or more pain relief after 8 or more weeks on an SNRI (duloxetinevenlafaxine, or milnacipran), those with less pain relief reported rougher mornings and worse sleep overall. Morningness, morning affect, diurnal dysrhythmia, anytime wakeability, overall sleep quality, subjective sleep quality and disturbances, sleep medication use, and daytime dysfunction were all predictors of nonresponse to SNRI treatment.

“The observed chronobiological characteristics of patients resistant to SNRI treatment are important because they can be targeted with adjunctive circadian interventions, ie, morning light therapy, in order to normalize circadian rhythms and improve sleep, and in effect, overcome the resistance to treatment and alleviate [the] patient’s pain,” said study author Anna Julia Krupa, MD, a psychiatrist and research assistant in the Department of Affective Disorders at Jagiellonian University Medical College, Kraków, Poland.

Fibromyalgia symptoms like sleep disturbance, low mood, fatigue, stiffness, cognitive impairment, and anxiety are often interlinked in positive feedback loops, meaning that the presence of one symptom (ie, sleep problems or depression) exacerbates the other (ie, pain or anxiety), Dr. Krupa said. While SNRIs can reduce pain, anxiety, and depression, they don’t directly improve sleep. Sometimes, pain relief smooths out minor sleep problems, but not always.

“Therefore, if circadian rhythm disruptions and sleep problems are significant, they may constitute a factor which limits SNRI effects on pain in people with fibromyalgia,” Dr. Krupa said.

With 60 patients with fibromyalgia (30 responsive to treatment and 30 nonresponsive to treatment) and 30 healthy controls, this was a small study, noted Daniel G. Arkfeld, MD, DDS, a rheumatologist and associate professor of clinical medicine at Keck School of Medicine, University of Southern California, Los Angeles. However, “sleep is probably one of the most difficult things in fibromyalgia, and it definitely needs to be targeted.”

Decades of research suggest that important neurochemicals, like growth hormone, are released in deep sleep. “We know that sleep disturbances and time frame and release of neurochemicals [are] all super important in fibromyalgia,” he said.

Side effects of medication could be another factor at play here. As with any drug, the side effects of SNRIs vary widely from person to person, but palpitations, tremulousness, and insomnia are common, said Daniel J. Clauw, MD, professor of anesthesiology, internal medicine/rheumatology, and psychiatry and director of the Chronic Pain & Fatigue Research Center at the University of Michigan, Ann Arbor.

“SNRIs are often ‘activating’ because of the increase in norepinephrine,” Dr. Clauw said. “This is often helpful for symptoms such as fatigue and memory problems — but could worsen sleep.”

That’s why he always recommends that patients take an SNRI in the morning, not at night. Try that and the following tips to help patients with fibromyalgia sleep better and feel better, too.

Start with the basics. It’s worth reminding patients about the tried-and-true tips like going to bed and waking up at the same time every day and keeping your bedroom quiet and dark. “Patients should first try ‘sleep hygiene’ strategies,” said Dr. Clauw. “If that doesn’t help then cognitive-behavioral therapy (CBT) for insomnia can be very helpful.”

A systematic review and meta-analysis showed that CBT for insomnia helped patients with fibromyalgia improve sleep quality, pain, anxiety, and depression compared with nonpharmacologic treatments. And if that doesn’t help? “If need be, they can try nonbenzodiazepine hypnotic drugs, eg, tricyclics or gabapentinoids taken at bedtime,” said Dr. Clauw.

Help them fall in love with exercise. A personalized approach to exercise can help patients with fibromyalgia feel better, suggested a study review in Clinical and Experimental Rheumatology. Exercise can also help reset the circadian clock. Morning activity helps night owls get on an earlier schedule, suggested a study review published in Physical Activity and Nutrition

Consider yoga, tai chi, or qigong.study review published in Seminars in Arthritis and Rheumatism suggested mind-body and combined exercises help improve sleep for people with fibromyalgia, while aerobic or strength training alone does not. One explanation is that mind-body exercises might do more than other types to tamp down sympathetic-excitatory overactivation in fibromyalgia, the researchers said. Use this handy guide from the European Pain Federation to help you start the exercise conversation.

Talk about sleep alongside other aspects of fibromyalgia. Psychoeducation for fibromyalgia often includes information about the distinction between acute and chronic pain, the nature of fibromyalgia syndrome, disease-contributing factors, safe and effective treatments, symptoms and characteristics, and coping strategies, according to a study review in the journal Behavioral Sciences. “As a psychiatrist and someone who often consults patients with fibromyalgia, I would also add the information about links between pain and mood, anxiety as well as sleep,” said Dr. Krupa.

Try morning light. Use light to shift circadian rhythms, suggested Dr. Krupa. People who struggle in the morning might benefit from 30-60 minutes of morning light therapy immediately after waking using a 10,000-lux light box or light glasses, as suggested by a study review from the University of Michigan.

Help them get off the night shift. “Fibromyalgia patients probably shouldn’t work the night shift and throw their circadian rhythm off,” said Dr. Arkfeld. Depending on a patient’s work and financial circumstances, a job change might not be possible, but consider writing a note to the patient’s employer asking them to switch the patient to the day shift. Dr. Arkfeld said this approach has worked for some of his patients.

Refer them for a sleep study. Many patients with fibromyalgia have obstructive sleep apnea or other sleep disorders that require additional intervention. “Sleep studies are important to kind of define the actual sleep problem that’s occurring as well, whether it’s the stage for interruption of sleep or sleep apnea or wakefulness,” said Dr. Arkfeld.

The study was funded by Jagiellonian University Medical College. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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