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Prediction, Management of Sjögren-Related Lymphomas Gain Ground With New Studies

Article Type
Changed
Thu, 09/05/2024 - 15:09

Hematologists and rheumatologists may be able to adopt a more aggressive approach for managing low-grade marginal lymphoma in Sjögren disease, particularly mucosa-associated lymphoid tissue (MALT) lymphoma, based on recent findings that confirmed a key early biomarker and found that a systemic treatment strategy reduced Sjögren disease activity and the risk for lymphoma relapse.

Two European studies published in The Lancet Rheumatology — one a case-control study reporting that rheumatoid factor (RF) was an early and strong predictor of Sjögren disease–related MALT lymphoma and the other a retrospective study that found a combination of chemotherapy and anti-CD20 therapy with rituximab as a first-line treatment for lymphoma was more effective than localized treatment or watch-and-wait approach in minimizing autoimmune activity and treating the lymphoma — potentially shed new light on strategies to manage Sjögren disease–related lymphoma.

A commentary accompanying the studies noted that 5%-10% of patients with Sjögren disease will develop non-Hodgkin B-cell lymphoma, with marginal lymphoma the most common type of low-grade lymphoma. The commentary, led by Suzanne Arends, MD, a rheumatologist at the University of Groningen in Groningen, the Netherlands, found the studies “clinically relevant” but stated that the lack of consistent definitions between the two studies along with their retrospective nature prevent any “definitive conclusions.”
 

High Lymphoma Risk in Sjögren Disease

“It is the autoimmune disease in which the risk of lymphoma is the highest, a 10- to 20-fold increase of the risk of lymphoma in this disease,” Xavier Mariette, MD, PhD, co-senior author of the retrospective treatment study, said of Sjögren disease.

These lymphomas are predominantly the marginal zone type, specifically MALT occurring in the salivary glands, the same site of the autoimmune disease, said Dr. Mariette, who is the head of Rheumatology and professor at Université Paris-Saclay and Hôpital Bicêtre. Autoimmune B cells become lymphomatous. “So there is a continuity between autoimmunity and lymphoma genesis,” Dr. Mariette told this news organization. Typically, hematologists do not treat the lymphoma if it doesn’t migrate beyond the salivary glands, he said.

Dr. Xavier Mariette


Dr. Mariette said his group’s findings make the case for a more aggressive treatment.

“When patients got the systemic treatment, there was a decreased risk of flare of the autoimmune disease of Sjögren’s, but there was no effect on the lymphoma formation,” Dr. Mariette said. “And when these patients have combined therapy, immunotherapy plus chemotherapy, compared to single immunotherapy, they did have improvement of the lymphoma progression-free survival.”

Their multicenter study enrolled 106 patients with Sjögren disease who developed lymphoma, 64% (n = 68) of whom had MALT, 13% (n = 14) of whom had other marginal zone subtypes, and the same percentage with diffuse large B-cell lymphoma. With a median follow-up of 7 years, 32 patients with marginal zone subtypes who had combination chemotherapy and anti-CD20 therapy had a 64% greater chance of lymphoma progression-free survival than 18 of their counterparts who received anti-CD20 monotherapy. Overall, outcomes for Sjögren disease systemic activity or survival were no different between the combination therapy and monotherapy arms.

Patients who had a systemic approach had a 57% reduced risk for new Sjögren disease activity compared with those who had first-line surgery or radiation (16%, n = 13) or underwent watch and wait (23%, n = 19).

The study strengthens the argument for a systemic treatment approach over localized therapy “because patients with Sjögren’s have a higher degree of development of MALT lymphoma of the salivary glands,” Juan Pablo Alderuccio, MD, a hematologist and lymphoma clinical site disease group leader at the Sylvester Comprehensive Cancer Center at the University of Miami Health Systems, Miami, Florida, told this news organization.

Dr. Juan Pablo Alderuccio


“We already knew that the combination of chemotherapy with rituximab usually achieves a better outcome,” Dr. Alderuccio added, citing a 2017 clinical trial that found combined chemotherapy with chlorambucil plus rituximab improved progression-free survival compared with either therapy alone. The latest retrospective study from France reinforces that, he said.

“The study also shows it’s very important to consider treatment-related specificities — to select the most appropriate treatment for these patients,” Dr. Alderuccio added.
 

 

 

RF Biomarker

The case-control study by researchers in Italy and Greece included 80 patients with Sjögren-related MALT lymphoma matched to controls with Sjögren disease who did not have lymphoma.

“We showed that rheumatoid factor positivity at the time of Sjögren’s disease diagnosis serves as the most reliable and temporally distant independent predictor of MALT lymphoma development,” lead author Andreas Goules, MD, a pathophysiologist at the National and Kapodistrian University of Athens, Athens, Greece, told this news organization.

Dr. Andreas Goules


He added that the study found that specific biomarkers in addition to RF positivity were signs of a high risk for MALT lymphoma and a more advanced stage of Sjögren disease–related lymphomagenesis. They included high systemic disease activity, measured as a European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index ≥ 5, and specific B-cell manifestations, such as cryoglobulinemia, salivary gland enlargement, hypocomplementemia, and palpable purpura.

“Ideally, all patients should be evaluated at the time of diagnosis for the presence of RF and undergo a minor salivary gland biopsy to exclude an underlying ongoing lymphoproliferative process,” Dr. Goules said.

RF-positive patients with Sjögren disease require a closer follow-up to identify an advanced stage of lymphoma development, he added.

“It is well known that Sjögren’s disease is characterized by an increased mortality rate, compared to the general population, mainly due to the related lymphomas,” Dr. Goules added. “Thus, the early diagnosis of MALT lymphoma, which is associated with a better prognosis, is expected to improve the overall clinical outcome of Sjögren’s disease patients.”

Rheumatologists and hematologists should employ a similar strategy for Sjögren disease–related large B-cell lymphomas, he said.

“The pathogenetic mechanisms of these two lymphoma types are vastly different, so it wouldn’t be surprising if an entirely different risk factor emerges,” Dr. Goules said. “However, given the rarity of diffuse large B-cell lymphomas, much larger multinational cohorts will be necessary to obtain clinically and pathogenetically meaningful results.”

Alan Baer, MD, a rheumatologist and founder of the Sjögren’s Disease Clinic at Johns Hopkins University in Baltimore, noted Dr. Goules and colleagues are not the first to identify RF, along with a host of other clinical and laboratory findings, as a risk factor for lymphoma in patients with Sjögren disease. “The current study validates rheumatoid factor as an independent risk factor present at a time that is temporally distant from the time of lymphoma diagnosis,” he said.

Dr. Alan Baer


However, he cautioned that RF alone isn’t highly predictive of Sjögren-related lymphoma. Up to 60% of patients with Sjögren disease are positive for RF at the time of the diagnosis, Dr. Baer said.

“Thus, the finding of rheumatoid factor alone does not necessarily mandate closer surveillance of this group of patients, with the potential for more frequent clinical exams, imaging, and laboratory testing,” he said. “Such an approach has the risk of subjecting patients to unnecessary testing, including invasive procedures.” 

More detailed findings, such as if a certain RF level was more predictive of lymphoma or whether other features in combination with RF heightened the risk, would be helpful, he said.
 

 

 

What Future Studies Should Look At

The studies call for further research into biomarkers for Sjögren disease–related lymphoma and treatment of the disease, both Dr. Mariette and Dr. Goules said.

Dr. Goules said a multicenter prospective study is needed to measure RF positivity and RF titers over time and determine whether higher levels mean an increased risk for lymphoma development or a shorter time interval until lymphoma onset. “Such a study requires a large number of RF-positive Sjögren’s disease patients who would be followed up for a long period of time,” Dr. Goules said.

To further evaluate treatment approaches for Sjögren disease–related lymphoma, Dr. Mariette said, a prospective study should compare the watch-and-wait approach with combination chemotherapy and anti-CD20 therapy. “It would be difficult to run because the primary endpoint would be lymphoma progression–free survival, and the secondary would be Sjögren’s relapse and mortality, but it would take a lot of time,” he said.

He added, “It’s a reason why this retrospective study is important. Maybe if we had another retrospective study reaching the same conclusion, I think it would be very, very strong evidence.”

Funding for the case-control study came from the European Commission–Horizon 2020 program. The retrospective treatment study had no outside funding. Dr. Mariette disclosed financial relationships with AstraZeneca, Bristol-Myers Squibb, Galapagos, GlaxoSmithKline, Novartis, and Pfizer. Dr. Alderuccio, Dr. Goules, and Dr. Baer had no relevant relationships to disclose.

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

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Hematologists and rheumatologists may be able to adopt a more aggressive approach for managing low-grade marginal lymphoma in Sjögren disease, particularly mucosa-associated lymphoid tissue (MALT) lymphoma, based on recent findings that confirmed a key early biomarker and found that a systemic treatment strategy reduced Sjögren disease activity and the risk for lymphoma relapse.

Two European studies published in The Lancet Rheumatology — one a case-control study reporting that rheumatoid factor (RF) was an early and strong predictor of Sjögren disease–related MALT lymphoma and the other a retrospective study that found a combination of chemotherapy and anti-CD20 therapy with rituximab as a first-line treatment for lymphoma was more effective than localized treatment or watch-and-wait approach in minimizing autoimmune activity and treating the lymphoma — potentially shed new light on strategies to manage Sjögren disease–related lymphoma.

A commentary accompanying the studies noted that 5%-10% of patients with Sjögren disease will develop non-Hodgkin B-cell lymphoma, with marginal lymphoma the most common type of low-grade lymphoma. The commentary, led by Suzanne Arends, MD, a rheumatologist at the University of Groningen in Groningen, the Netherlands, found the studies “clinically relevant” but stated that the lack of consistent definitions between the two studies along with their retrospective nature prevent any “definitive conclusions.”
 

High Lymphoma Risk in Sjögren Disease

“It is the autoimmune disease in which the risk of lymphoma is the highest, a 10- to 20-fold increase of the risk of lymphoma in this disease,” Xavier Mariette, MD, PhD, co-senior author of the retrospective treatment study, said of Sjögren disease.

These lymphomas are predominantly the marginal zone type, specifically MALT occurring in the salivary glands, the same site of the autoimmune disease, said Dr. Mariette, who is the head of Rheumatology and professor at Université Paris-Saclay and Hôpital Bicêtre. Autoimmune B cells become lymphomatous. “So there is a continuity between autoimmunity and lymphoma genesis,” Dr. Mariette told this news organization. Typically, hematologists do not treat the lymphoma if it doesn’t migrate beyond the salivary glands, he said.

Dr. Xavier Mariette


Dr. Mariette said his group’s findings make the case for a more aggressive treatment.

“When patients got the systemic treatment, there was a decreased risk of flare of the autoimmune disease of Sjögren’s, but there was no effect on the lymphoma formation,” Dr. Mariette said. “And when these patients have combined therapy, immunotherapy plus chemotherapy, compared to single immunotherapy, they did have improvement of the lymphoma progression-free survival.”

Their multicenter study enrolled 106 patients with Sjögren disease who developed lymphoma, 64% (n = 68) of whom had MALT, 13% (n = 14) of whom had other marginal zone subtypes, and the same percentage with diffuse large B-cell lymphoma. With a median follow-up of 7 years, 32 patients with marginal zone subtypes who had combination chemotherapy and anti-CD20 therapy had a 64% greater chance of lymphoma progression-free survival than 18 of their counterparts who received anti-CD20 monotherapy. Overall, outcomes for Sjögren disease systemic activity or survival were no different between the combination therapy and monotherapy arms.

Patients who had a systemic approach had a 57% reduced risk for new Sjögren disease activity compared with those who had first-line surgery or radiation (16%, n = 13) or underwent watch and wait (23%, n = 19).

The study strengthens the argument for a systemic treatment approach over localized therapy “because patients with Sjögren’s have a higher degree of development of MALT lymphoma of the salivary glands,” Juan Pablo Alderuccio, MD, a hematologist and lymphoma clinical site disease group leader at the Sylvester Comprehensive Cancer Center at the University of Miami Health Systems, Miami, Florida, told this news organization.

Dr. Juan Pablo Alderuccio


“We already knew that the combination of chemotherapy with rituximab usually achieves a better outcome,” Dr. Alderuccio added, citing a 2017 clinical trial that found combined chemotherapy with chlorambucil plus rituximab improved progression-free survival compared with either therapy alone. The latest retrospective study from France reinforces that, he said.

“The study also shows it’s very important to consider treatment-related specificities — to select the most appropriate treatment for these patients,” Dr. Alderuccio added.
 

 

 

RF Biomarker

The case-control study by researchers in Italy and Greece included 80 patients with Sjögren-related MALT lymphoma matched to controls with Sjögren disease who did not have lymphoma.

“We showed that rheumatoid factor positivity at the time of Sjögren’s disease diagnosis serves as the most reliable and temporally distant independent predictor of MALT lymphoma development,” lead author Andreas Goules, MD, a pathophysiologist at the National and Kapodistrian University of Athens, Athens, Greece, told this news organization.

Dr. Andreas Goules


He added that the study found that specific biomarkers in addition to RF positivity were signs of a high risk for MALT lymphoma and a more advanced stage of Sjögren disease–related lymphomagenesis. They included high systemic disease activity, measured as a European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index ≥ 5, and specific B-cell manifestations, such as cryoglobulinemia, salivary gland enlargement, hypocomplementemia, and palpable purpura.

“Ideally, all patients should be evaluated at the time of diagnosis for the presence of RF and undergo a minor salivary gland biopsy to exclude an underlying ongoing lymphoproliferative process,” Dr. Goules said.

RF-positive patients with Sjögren disease require a closer follow-up to identify an advanced stage of lymphoma development, he added.

“It is well known that Sjögren’s disease is characterized by an increased mortality rate, compared to the general population, mainly due to the related lymphomas,” Dr. Goules added. “Thus, the early diagnosis of MALT lymphoma, which is associated with a better prognosis, is expected to improve the overall clinical outcome of Sjögren’s disease patients.”

Rheumatologists and hematologists should employ a similar strategy for Sjögren disease–related large B-cell lymphomas, he said.

“The pathogenetic mechanisms of these two lymphoma types are vastly different, so it wouldn’t be surprising if an entirely different risk factor emerges,” Dr. Goules said. “However, given the rarity of diffuse large B-cell lymphomas, much larger multinational cohorts will be necessary to obtain clinically and pathogenetically meaningful results.”

Alan Baer, MD, a rheumatologist and founder of the Sjögren’s Disease Clinic at Johns Hopkins University in Baltimore, noted Dr. Goules and colleagues are not the first to identify RF, along with a host of other clinical and laboratory findings, as a risk factor for lymphoma in patients with Sjögren disease. “The current study validates rheumatoid factor as an independent risk factor present at a time that is temporally distant from the time of lymphoma diagnosis,” he said.

Dr. Alan Baer


However, he cautioned that RF alone isn’t highly predictive of Sjögren-related lymphoma. Up to 60% of patients with Sjögren disease are positive for RF at the time of the diagnosis, Dr. Baer said.

“Thus, the finding of rheumatoid factor alone does not necessarily mandate closer surveillance of this group of patients, with the potential for more frequent clinical exams, imaging, and laboratory testing,” he said. “Such an approach has the risk of subjecting patients to unnecessary testing, including invasive procedures.” 

More detailed findings, such as if a certain RF level was more predictive of lymphoma or whether other features in combination with RF heightened the risk, would be helpful, he said.
 

 

 

What Future Studies Should Look At

The studies call for further research into biomarkers for Sjögren disease–related lymphoma and treatment of the disease, both Dr. Mariette and Dr. Goules said.

Dr. Goules said a multicenter prospective study is needed to measure RF positivity and RF titers over time and determine whether higher levels mean an increased risk for lymphoma development or a shorter time interval until lymphoma onset. “Such a study requires a large number of RF-positive Sjögren’s disease patients who would be followed up for a long period of time,” Dr. Goules said.

To further evaluate treatment approaches for Sjögren disease–related lymphoma, Dr. Mariette said, a prospective study should compare the watch-and-wait approach with combination chemotherapy and anti-CD20 therapy. “It would be difficult to run because the primary endpoint would be lymphoma progression–free survival, and the secondary would be Sjögren’s relapse and mortality, but it would take a lot of time,” he said.

He added, “It’s a reason why this retrospective study is important. Maybe if we had another retrospective study reaching the same conclusion, I think it would be very, very strong evidence.”

Funding for the case-control study came from the European Commission–Horizon 2020 program. The retrospective treatment study had no outside funding. Dr. Mariette disclosed financial relationships with AstraZeneca, Bristol-Myers Squibb, Galapagos, GlaxoSmithKline, Novartis, and Pfizer. Dr. Alderuccio, Dr. Goules, and Dr. Baer had no relevant relationships to disclose.

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

Hematologists and rheumatologists may be able to adopt a more aggressive approach for managing low-grade marginal lymphoma in Sjögren disease, particularly mucosa-associated lymphoid tissue (MALT) lymphoma, based on recent findings that confirmed a key early biomarker and found that a systemic treatment strategy reduced Sjögren disease activity and the risk for lymphoma relapse.

Two European studies published in The Lancet Rheumatology — one a case-control study reporting that rheumatoid factor (RF) was an early and strong predictor of Sjögren disease–related MALT lymphoma and the other a retrospective study that found a combination of chemotherapy and anti-CD20 therapy with rituximab as a first-line treatment for lymphoma was more effective than localized treatment or watch-and-wait approach in minimizing autoimmune activity and treating the lymphoma — potentially shed new light on strategies to manage Sjögren disease–related lymphoma.

A commentary accompanying the studies noted that 5%-10% of patients with Sjögren disease will develop non-Hodgkin B-cell lymphoma, with marginal lymphoma the most common type of low-grade lymphoma. The commentary, led by Suzanne Arends, MD, a rheumatologist at the University of Groningen in Groningen, the Netherlands, found the studies “clinically relevant” but stated that the lack of consistent definitions between the two studies along with their retrospective nature prevent any “definitive conclusions.”
 

High Lymphoma Risk in Sjögren Disease

“It is the autoimmune disease in which the risk of lymphoma is the highest, a 10- to 20-fold increase of the risk of lymphoma in this disease,” Xavier Mariette, MD, PhD, co-senior author of the retrospective treatment study, said of Sjögren disease.

These lymphomas are predominantly the marginal zone type, specifically MALT occurring in the salivary glands, the same site of the autoimmune disease, said Dr. Mariette, who is the head of Rheumatology and professor at Université Paris-Saclay and Hôpital Bicêtre. Autoimmune B cells become lymphomatous. “So there is a continuity between autoimmunity and lymphoma genesis,” Dr. Mariette told this news organization. Typically, hematologists do not treat the lymphoma if it doesn’t migrate beyond the salivary glands, he said.

Dr. Xavier Mariette


Dr. Mariette said his group’s findings make the case for a more aggressive treatment.

“When patients got the systemic treatment, there was a decreased risk of flare of the autoimmune disease of Sjögren’s, but there was no effect on the lymphoma formation,” Dr. Mariette said. “And when these patients have combined therapy, immunotherapy plus chemotherapy, compared to single immunotherapy, they did have improvement of the lymphoma progression-free survival.”

Their multicenter study enrolled 106 patients with Sjögren disease who developed lymphoma, 64% (n = 68) of whom had MALT, 13% (n = 14) of whom had other marginal zone subtypes, and the same percentage with diffuse large B-cell lymphoma. With a median follow-up of 7 years, 32 patients with marginal zone subtypes who had combination chemotherapy and anti-CD20 therapy had a 64% greater chance of lymphoma progression-free survival than 18 of their counterparts who received anti-CD20 monotherapy. Overall, outcomes for Sjögren disease systemic activity or survival were no different between the combination therapy and monotherapy arms.

Patients who had a systemic approach had a 57% reduced risk for new Sjögren disease activity compared with those who had first-line surgery or radiation (16%, n = 13) or underwent watch and wait (23%, n = 19).

The study strengthens the argument for a systemic treatment approach over localized therapy “because patients with Sjögren’s have a higher degree of development of MALT lymphoma of the salivary glands,” Juan Pablo Alderuccio, MD, a hematologist and lymphoma clinical site disease group leader at the Sylvester Comprehensive Cancer Center at the University of Miami Health Systems, Miami, Florida, told this news organization.

Dr. Juan Pablo Alderuccio


“We already knew that the combination of chemotherapy with rituximab usually achieves a better outcome,” Dr. Alderuccio added, citing a 2017 clinical trial that found combined chemotherapy with chlorambucil plus rituximab improved progression-free survival compared with either therapy alone. The latest retrospective study from France reinforces that, he said.

“The study also shows it’s very important to consider treatment-related specificities — to select the most appropriate treatment for these patients,” Dr. Alderuccio added.
 

 

 

RF Biomarker

The case-control study by researchers in Italy and Greece included 80 patients with Sjögren-related MALT lymphoma matched to controls with Sjögren disease who did not have lymphoma.

“We showed that rheumatoid factor positivity at the time of Sjögren’s disease diagnosis serves as the most reliable and temporally distant independent predictor of MALT lymphoma development,” lead author Andreas Goules, MD, a pathophysiologist at the National and Kapodistrian University of Athens, Athens, Greece, told this news organization.

Dr. Andreas Goules


He added that the study found that specific biomarkers in addition to RF positivity were signs of a high risk for MALT lymphoma and a more advanced stage of Sjögren disease–related lymphomagenesis. They included high systemic disease activity, measured as a European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index ≥ 5, and specific B-cell manifestations, such as cryoglobulinemia, salivary gland enlargement, hypocomplementemia, and palpable purpura.

“Ideally, all patients should be evaluated at the time of diagnosis for the presence of RF and undergo a minor salivary gland biopsy to exclude an underlying ongoing lymphoproliferative process,” Dr. Goules said.

RF-positive patients with Sjögren disease require a closer follow-up to identify an advanced stage of lymphoma development, he added.

“It is well known that Sjögren’s disease is characterized by an increased mortality rate, compared to the general population, mainly due to the related lymphomas,” Dr. Goules added. “Thus, the early diagnosis of MALT lymphoma, which is associated with a better prognosis, is expected to improve the overall clinical outcome of Sjögren’s disease patients.”

Rheumatologists and hematologists should employ a similar strategy for Sjögren disease–related large B-cell lymphomas, he said.

“The pathogenetic mechanisms of these two lymphoma types are vastly different, so it wouldn’t be surprising if an entirely different risk factor emerges,” Dr. Goules said. “However, given the rarity of diffuse large B-cell lymphomas, much larger multinational cohorts will be necessary to obtain clinically and pathogenetically meaningful results.”

Alan Baer, MD, a rheumatologist and founder of the Sjögren’s Disease Clinic at Johns Hopkins University in Baltimore, noted Dr. Goules and colleagues are not the first to identify RF, along with a host of other clinical and laboratory findings, as a risk factor for lymphoma in patients with Sjögren disease. “The current study validates rheumatoid factor as an independent risk factor present at a time that is temporally distant from the time of lymphoma diagnosis,” he said.

Dr. Alan Baer


However, he cautioned that RF alone isn’t highly predictive of Sjögren-related lymphoma. Up to 60% of patients with Sjögren disease are positive for RF at the time of the diagnosis, Dr. Baer said.

“Thus, the finding of rheumatoid factor alone does not necessarily mandate closer surveillance of this group of patients, with the potential for more frequent clinical exams, imaging, and laboratory testing,” he said. “Such an approach has the risk of subjecting patients to unnecessary testing, including invasive procedures.” 

More detailed findings, such as if a certain RF level was more predictive of lymphoma or whether other features in combination with RF heightened the risk, would be helpful, he said.
 

 

 

What Future Studies Should Look At

The studies call for further research into biomarkers for Sjögren disease–related lymphoma and treatment of the disease, both Dr. Mariette and Dr. Goules said.

Dr. Goules said a multicenter prospective study is needed to measure RF positivity and RF titers over time and determine whether higher levels mean an increased risk for lymphoma development or a shorter time interval until lymphoma onset. “Such a study requires a large number of RF-positive Sjögren’s disease patients who would be followed up for a long period of time,” Dr. Goules said.

To further evaluate treatment approaches for Sjögren disease–related lymphoma, Dr. Mariette said, a prospective study should compare the watch-and-wait approach with combination chemotherapy and anti-CD20 therapy. “It would be difficult to run because the primary endpoint would be lymphoma progression–free survival, and the secondary would be Sjögren’s relapse and mortality, but it would take a lot of time,” he said.

He added, “It’s a reason why this retrospective study is important. Maybe if we had another retrospective study reaching the same conclusion, I think it would be very, very strong evidence.”

Funding for the case-control study came from the European Commission–Horizon 2020 program. The retrospective treatment study had no outside funding. Dr. Mariette disclosed financial relationships with AstraZeneca, Bristol-Myers Squibb, Galapagos, GlaxoSmithKline, Novartis, and Pfizer. Dr. Alderuccio, Dr. Goules, and Dr. Baer had no relevant relationships to disclose.

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

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Kidney Disease May Accelerate With Higher Rheumatoid Arthritis Disease Activity

Article Type
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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Stroke Risk from Atrial Fibrillation Rises in Presence of Rheumatoid Arthritis

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Tue, 09/10/2024 - 02:15

 

TOPLINE: 

Patients with both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

  • Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
  • They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
  • They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
  • The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
  • The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

  • At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
  • Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
  • Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

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 both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

  • Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
  • They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
  • They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
  • The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
  • The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

  • At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
  • Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
  • Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

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 both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

  • Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
  • They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
  • They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
  • The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
  • The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

  • At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
  • Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
  • Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

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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Teclistamab Promising as a Treatment of Last Resort for Refractory Autoimmune Diseases

Article Type
Changed
Thu, 09/05/2024 - 13:36

 

TOPLINE: 

Teclistamab, a T-cell engager that targets B-cell maturation antigen (BCMA), improved disease activity in four patients with refractory autoimmune conditions. In a separately published case report, teclistamab treatment induced remission in a patient with refractory systemic lupus erythematosus (SLE).

BACKGROUND: 

  • Chimeric antigen receptor (CAR) T cells or T-cell engagers against CD19 have been effective in small studies of patients with treatment-resistant autoimmune diseases.
  • Some patients have disease rooted in long-lived plasma cells that express BCMA but not CD19, making them resistant to CD19 CAR T-cell therapy.
  • Teclistamab acts on T cells through CD3 and targets plasmablasts and plasma cells through BCMA.

METHODOLOGY:

  • In one case series, researchers administered teclistamab subcutaneously to four patients with autoimmune diseases resistant to more than five immunosuppressants, including rituximab.
  • Patient 1 had systemic sclerosis, patient 2 had primary Sjögren disease, patient 3 had idiopathic inflammatory myositis, and patient 4 had rheumatoid arthritis.
  • Researchers incrementally increased teclistamab dosage in an inpatient setting: 0.06 mg/kg on day 1, 0.3 mg/kg on day 3, and 1.5 mg/kg on day 5. Patients 2, 3, and 4 received one maintenance dose of 1.5 mg/kg after 4 weeks, and patient 1 received a 1.5-mg/kg dose after 12 weeks.
  • In the single case report, the patient with SLE received a step-up dosage of teclistamab (0.06 mg/kg and 0.3 mg/kg) followed by 0.8 mg/kg on day 7. She received 1.5 mg/kg at weeks 2 and 5.

TAKEAWAY: 

  • Teclistamab therapy led to significant improvements in disease activity in all four patients, with notable reductions in skin disease, arthritis, and lung function scores.
  • Teclistamab therapy had a good safety profile, with no neurotoxicity or myelotoxicity and only lower-grade cytokine release syndrome reported.
  • Researchers observed seroconversion of PM-Scl-75, PM-Scl-100, rheumatoid factor, and autoantibodies against mutated citrullinated vimentin and lower levels of autoantibodies ANA, MDAS, SS-A/Ro, SS-B/La, and PL-7 after treatment.
  • In the separate case report, the patient reached complete drug-free remission by week 6, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000.
  • The level of anti–double-stranded DNA antibodies in the patient with SLE decreased rapidly, reaching normal range by week 5 and remaining undetectable through week 16.

IN PRACTICE:

“These data show that the targeting of the plasma-cell compartment by a BCMA-targeted T-cell engager is feasible in patients with autoimmune disease. Whether such therapy results in sustained clinical remission warrants further study,” write the authors of the four-patient case series.

SOURCE: 

Melanie Hagen, MD, Friedrich Alexander University Erlangen–Nuremberg, Germany, and colleagues reported their case series online in The New England Journal of Medicine. Tobias Alexander, MD, and colleagues at Charité–Universitätsmedizin Berlin, Germany, also described their single case report in The New England Journal of Medicine.

 

 

LIMITATIONS:

The small number of patients limits the generalizability of the findings. The short duration of follow-up may not capture long-term effects and potential late-onset adverse events. The lack of a control group makes it difficult to attribute improvements solely to teclistamab therapy.

DISCLOSURES:

The four-patient case series was supported by grants from the Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, and the European Union. The single case report was supported by grants from the Deutsche Forschungsgemeinschaft and the European Union. Several authors have disclosed financial relationships with pharmaceutical companies, including Janssen Biotech, which markets teclistamab.

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: 

Teclistamab, a T-cell engager that targets B-cell maturation antigen (BCMA), improved disease activity in four patients with refractory autoimmune conditions. In a separately published case report, teclistamab treatment induced remission in a patient with refractory systemic lupus erythematosus (SLE).

BACKGROUND: 

  • Chimeric antigen receptor (CAR) T cells or T-cell engagers against CD19 have been effective in small studies of patients with treatment-resistant autoimmune diseases.
  • Some patients have disease rooted in long-lived plasma cells that express BCMA but not CD19, making them resistant to CD19 CAR T-cell therapy.
  • Teclistamab acts on T cells through CD3 and targets plasmablasts and plasma cells through BCMA.

METHODOLOGY:

  • In one case series, researchers administered teclistamab subcutaneously to four patients with autoimmune diseases resistant to more than five immunosuppressants, including rituximab.
  • Patient 1 had systemic sclerosis, patient 2 had primary Sjögren disease, patient 3 had idiopathic inflammatory myositis, and patient 4 had rheumatoid arthritis.
  • Researchers incrementally increased teclistamab dosage in an inpatient setting: 0.06 mg/kg on day 1, 0.3 mg/kg on day 3, and 1.5 mg/kg on day 5. Patients 2, 3, and 4 received one maintenance dose of 1.5 mg/kg after 4 weeks, and patient 1 received a 1.5-mg/kg dose after 12 weeks.
  • In the single case report, the patient with SLE received a step-up dosage of teclistamab (0.06 mg/kg and 0.3 mg/kg) followed by 0.8 mg/kg on day 7. She received 1.5 mg/kg at weeks 2 and 5.

TAKEAWAY: 

  • Teclistamab therapy led to significant improvements in disease activity in all four patients, with notable reductions in skin disease, arthritis, and lung function scores.
  • Teclistamab therapy had a good safety profile, with no neurotoxicity or myelotoxicity and only lower-grade cytokine release syndrome reported.
  • Researchers observed seroconversion of PM-Scl-75, PM-Scl-100, rheumatoid factor, and autoantibodies against mutated citrullinated vimentin and lower levels of autoantibodies ANA, MDAS, SS-A/Ro, SS-B/La, and PL-7 after treatment.
  • In the separate case report, the patient reached complete drug-free remission by week 6, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000.
  • The level of anti–double-stranded DNA antibodies in the patient with SLE decreased rapidly, reaching normal range by week 5 and remaining undetectable through week 16.

IN PRACTICE:

“These data show that the targeting of the plasma-cell compartment by a BCMA-targeted T-cell engager is feasible in patients with autoimmune disease. Whether such therapy results in sustained clinical remission warrants further study,” write the authors of the four-patient case series.

SOURCE: 

Melanie Hagen, MD, Friedrich Alexander University Erlangen–Nuremberg, Germany, and colleagues reported their case series online in The New England Journal of Medicine. Tobias Alexander, MD, and colleagues at Charité–Universitätsmedizin Berlin, Germany, also described their single case report in The New England Journal of Medicine.

 

 

LIMITATIONS:

The small number of patients limits the generalizability of the findings. The short duration of follow-up may not capture long-term effects and potential late-onset adverse events. The lack of a control group makes it difficult to attribute improvements solely to teclistamab therapy.

DISCLOSURES:

The four-patient case series was supported by grants from the Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, and the European Union. The single case report was supported by grants from the Deutsche Forschungsgemeinschaft and the European Union. Several authors have disclosed financial relationships with pharmaceutical companies, including Janssen Biotech, which markets teclistamab.

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: 

Teclistamab, a T-cell engager that targets B-cell maturation antigen (BCMA), improved disease activity in four patients with refractory autoimmune conditions. In a separately published case report, teclistamab treatment induced remission in a patient with refractory systemic lupus erythematosus (SLE).

BACKGROUND: 

  • Chimeric antigen receptor (CAR) T cells or T-cell engagers against CD19 have been effective in small studies of patients with treatment-resistant autoimmune diseases.
  • Some patients have disease rooted in long-lived plasma cells that express BCMA but not CD19, making them resistant to CD19 CAR T-cell therapy.
  • Teclistamab acts on T cells through CD3 and targets plasmablasts and plasma cells through BCMA.

METHODOLOGY:

  • In one case series, researchers administered teclistamab subcutaneously to four patients with autoimmune diseases resistant to more than five immunosuppressants, including rituximab.
  • Patient 1 had systemic sclerosis, patient 2 had primary Sjögren disease, patient 3 had idiopathic inflammatory myositis, and patient 4 had rheumatoid arthritis.
  • Researchers incrementally increased teclistamab dosage in an inpatient setting: 0.06 mg/kg on day 1, 0.3 mg/kg on day 3, and 1.5 mg/kg on day 5. Patients 2, 3, and 4 received one maintenance dose of 1.5 mg/kg after 4 weeks, and patient 1 received a 1.5-mg/kg dose after 12 weeks.
  • In the single case report, the patient with SLE received a step-up dosage of teclistamab (0.06 mg/kg and 0.3 mg/kg) followed by 0.8 mg/kg on day 7. She received 1.5 mg/kg at weeks 2 and 5.

TAKEAWAY: 

  • Teclistamab therapy led to significant improvements in disease activity in all four patients, with notable reductions in skin disease, arthritis, and lung function scores.
  • Teclistamab therapy had a good safety profile, with no neurotoxicity or myelotoxicity and only lower-grade cytokine release syndrome reported.
  • Researchers observed seroconversion of PM-Scl-75, PM-Scl-100, rheumatoid factor, and autoantibodies against mutated citrullinated vimentin and lower levels of autoantibodies ANA, MDAS, SS-A/Ro, SS-B/La, and PL-7 after treatment.
  • In the separate case report, the patient reached complete drug-free remission by week 6, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000.
  • The level of anti–double-stranded DNA antibodies in the patient with SLE decreased rapidly, reaching normal range by week 5 and remaining undetectable through week 16.

IN PRACTICE:

“These data show that the targeting of the plasma-cell compartment by a BCMA-targeted T-cell engager is feasible in patients with autoimmune disease. Whether such therapy results in sustained clinical remission warrants further study,” write the authors of the four-patient case series.

SOURCE: 

Melanie Hagen, MD, Friedrich Alexander University Erlangen–Nuremberg, Germany, and colleagues reported their case series online in The New England Journal of Medicine. Tobias Alexander, MD, and colleagues at Charité–Universitätsmedizin Berlin, Germany, also described their single case report in The New England Journal of Medicine.

 

 

LIMITATIONS:

The small number of patients limits the generalizability of the findings. The short duration of follow-up may not capture long-term effects and potential late-onset adverse events. The lack of a control group makes it difficult to attribute improvements solely to teclistamab therapy.

DISCLOSURES:

The four-patient case series was supported by grants from the Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, and the European Union. The single case report was supported by grants from the Deutsche Forschungsgemeinschaft and the European Union. Several authors have disclosed financial relationships with pharmaceutical companies, including Janssen Biotech, which markets teclistamab.

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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The Wellness Industry: Financially Toxic, Says Ethicist

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Changed
Wed, 09/04/2024 - 13:51

 



This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.

 



This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.

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Systemic Sclerosis Without Scleroderma Has Unique Severity, Prognosis

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Tue, 09/03/2024 - 12:42

 

TOPLINE:

Systemic sclerosis sine scleroderma (ssSSc) affects nearly 10% of patients with systemic sclerosis (SSc), with substantial internal organ involvement. Despite lacking skin fibrosis, patients with ssSSc are at a risk for interstitial lung disease, pulmonary arterial hypertension, and cardiac dysfunction.

METHODOLOGY:

  • Driven by a fatal case of ssSSc with cardiac involvement, researchers aimed to evaluate its prevalence, severity, and prognosis.
  • They conducted a systematic literature and qualitative synthesis of 35 studies on SSc cohorts from databases published between 1976 and 2023 that comprised data on the prevalence of SSc with or without organ involvement.
  • A total of 25,455 patients with SSc were included, with 2437 identified as having ssSSc.
  • Studies used various classification criteria for SSc, including the 1980 American Rheumatism Association criteria, 2001 LeRoy and Medsger criteria, and 2013 American College of Rheumatology/European League Against Rheumatism criteria, while ssSSc was classified on the basis of the definitions provided by Rodnan and Fennell and also Poormoghim.
  • The analysis focused on ssSSc prevalence, reclassification rates, and internal organ involvement, including interstitial lung disease, pulmonary arterial hypertension, scleroderma renal crisis, and cardiac dysfunction.

TAKEAWAY:

  • The overall mean prevalence of ssSSc was 9.6%, with a range of 0%-22.9% across different studies.
  • Reclassification rates of ssSSc into limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc) varied substantially, with some studies reporting rates as high as 27.8% over a 4-year follow-up period.
  • The mean frequency of internal organ involvement in patients with ssSSc was 46% for interstitial lung disease, 15% for pulmonary arterial hypertension, 5% for scleroderma renal crisis, and 26.5% for cardiac dysfunction — mainly diastolic dysfunction.
  • The survival rates in patients with ssSSc were similar to those with lcSSc and better than those with dcSSc.

IN PRACTICE:

“The results presented herein suggest a slightly more severe yet similar clinical picture of ssSSc compared to lcSSc [limited cutaneous SSc], while dcSSc [diffuse cutaneous SSc] remains the most severe disease form,” the authors wrote. “Although classification criteria should not impact appropriate management of patients, updated ssSSc subclassification criteria, which will take into account time from disease onset, should be considered,” they further added.

SOURCE:

The study was led by Anastasios Makris, MD, First Department of Propaedeutic & Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece. It was published online on August 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The variability in the classification criteria across different studies may affect the comparability of results. The included studies lacked data on cardiac MRI, restricting the identification of myocardial fibrosis patterns and characterization of cardiac disease activity.

DISCLOSURES:

The study did not receive any specific funding. Some authors disclosed having a consultancy relationship, serving as speakers, and receiving funding for research from multiple companies. One author reported having a patent and being a cofounder of CITUS AG.

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 appeared on Medscape.com.

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TOPLINE:

Systemic sclerosis sine scleroderma (ssSSc) affects nearly 10% of patients with systemic sclerosis (SSc), with substantial internal organ involvement. Despite lacking skin fibrosis, patients with ssSSc are at a risk for interstitial lung disease, pulmonary arterial hypertension, and cardiac dysfunction.

METHODOLOGY:

  • Driven by a fatal case of ssSSc with cardiac involvement, researchers aimed to evaluate its prevalence, severity, and prognosis.
  • They conducted a systematic literature and qualitative synthesis of 35 studies on SSc cohorts from databases published between 1976 and 2023 that comprised data on the prevalence of SSc with or without organ involvement.
  • A total of 25,455 patients with SSc were included, with 2437 identified as having ssSSc.
  • Studies used various classification criteria for SSc, including the 1980 American Rheumatism Association criteria, 2001 LeRoy and Medsger criteria, and 2013 American College of Rheumatology/European League Against Rheumatism criteria, while ssSSc was classified on the basis of the definitions provided by Rodnan and Fennell and also Poormoghim.
  • The analysis focused on ssSSc prevalence, reclassification rates, and internal organ involvement, including interstitial lung disease, pulmonary arterial hypertension, scleroderma renal crisis, and cardiac dysfunction.

TAKEAWAY:

  • The overall mean prevalence of ssSSc was 9.6%, with a range of 0%-22.9% across different studies.
  • Reclassification rates of ssSSc into limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc) varied substantially, with some studies reporting rates as high as 27.8% over a 4-year follow-up period.
  • The mean frequency of internal organ involvement in patients with ssSSc was 46% for interstitial lung disease, 15% for pulmonary arterial hypertension, 5% for scleroderma renal crisis, and 26.5% for cardiac dysfunction — mainly diastolic dysfunction.
  • The survival rates in patients with ssSSc were similar to those with lcSSc and better than those with dcSSc.

IN PRACTICE:

“The results presented herein suggest a slightly more severe yet similar clinical picture of ssSSc compared to lcSSc [limited cutaneous SSc], while dcSSc [diffuse cutaneous SSc] remains the most severe disease form,” the authors wrote. “Although classification criteria should not impact appropriate management of patients, updated ssSSc subclassification criteria, which will take into account time from disease onset, should be considered,” they further added.

SOURCE:

The study was led by Anastasios Makris, MD, First Department of Propaedeutic & Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece. It was published online on August 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The variability in the classification criteria across different studies may affect the comparability of results. The included studies lacked data on cardiac MRI, restricting the identification of myocardial fibrosis patterns and characterization of cardiac disease activity.

DISCLOSURES:

The study did not receive any specific funding. Some authors disclosed having a consultancy relationship, serving as speakers, and receiving funding for research from multiple companies. One author reported having a patent and being a cofounder of CITUS AG.

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 appeared on Medscape.com.

 

TOPLINE:

Systemic sclerosis sine scleroderma (ssSSc) affects nearly 10% of patients with systemic sclerosis (SSc), with substantial internal organ involvement. Despite lacking skin fibrosis, patients with ssSSc are at a risk for interstitial lung disease, pulmonary arterial hypertension, and cardiac dysfunction.

METHODOLOGY:

  • Driven by a fatal case of ssSSc with cardiac involvement, researchers aimed to evaluate its prevalence, severity, and prognosis.
  • They conducted a systematic literature and qualitative synthesis of 35 studies on SSc cohorts from databases published between 1976 and 2023 that comprised data on the prevalence of SSc with or without organ involvement.
  • A total of 25,455 patients with SSc were included, with 2437 identified as having ssSSc.
  • Studies used various classification criteria for SSc, including the 1980 American Rheumatism Association criteria, 2001 LeRoy and Medsger criteria, and 2013 American College of Rheumatology/European League Against Rheumatism criteria, while ssSSc was classified on the basis of the definitions provided by Rodnan and Fennell and also Poormoghim.
  • The analysis focused on ssSSc prevalence, reclassification rates, and internal organ involvement, including interstitial lung disease, pulmonary arterial hypertension, scleroderma renal crisis, and cardiac dysfunction.

TAKEAWAY:

  • The overall mean prevalence of ssSSc was 9.6%, with a range of 0%-22.9% across different studies.
  • Reclassification rates of ssSSc into limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc) varied substantially, with some studies reporting rates as high as 27.8% over a 4-year follow-up period.
  • The mean frequency of internal organ involvement in patients with ssSSc was 46% for interstitial lung disease, 15% for pulmonary arterial hypertension, 5% for scleroderma renal crisis, and 26.5% for cardiac dysfunction — mainly diastolic dysfunction.
  • The survival rates in patients with ssSSc were similar to those with lcSSc and better than those with dcSSc.

IN PRACTICE:

“The results presented herein suggest a slightly more severe yet similar clinical picture of ssSSc compared to lcSSc [limited cutaneous SSc], while dcSSc [diffuse cutaneous SSc] remains the most severe disease form,” the authors wrote. “Although classification criteria should not impact appropriate management of patients, updated ssSSc subclassification criteria, which will take into account time from disease onset, should be considered,” they further added.

SOURCE:

The study was led by Anastasios Makris, MD, First Department of Propaedeutic & Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece. It was published online on August 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The variability in the classification criteria across different studies may affect the comparability of results. The included studies lacked data on cardiac MRI, restricting the identification of myocardial fibrosis patterns and characterization of cardiac disease activity.

DISCLOSURES:

The study did not receive any specific funding. Some authors disclosed having a consultancy relationship, serving as speakers, and receiving funding for research from multiple companies. One author reported having a patent and being a cofounder of CITUS AG.

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 appeared on Medscape.com.

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

Article Type
Changed
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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More Than the Paycheck: Top Non-Salary Perks for Doctors

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Fri, 08/30/2024 - 13:44

Holly Wyatt, MD, had spent 20 years in UCHealth with no plans to leave. Her home, support system, and lifestyle were all rooted in Denver. But in 2020, The University of Alabama at Birmingham (UAB) made the endocrinologist an offer she couldn’t resist.

The pay increase and a bump to full professorship weren’t enough to lure her across the country. But then UAB sweetened the deal with fewer clinic hours and paid time to create. “I didn’t have to fit into the typical ‘see patients 5 days a week, bill this many dollars,’ ” she said.

With no minimum billable hours, she could spend her time on clinical trials, designing programs, and recording podcasts. “When they offered that, I said, ‘Ooh, that’s enticing.’ ”

After a couple of visits to the campus, she began the job transition.

Doctors are looking for more than base pay. For many physicians, like Dr. Wyatt, non-salary incentives carry a lot of weight in the recruitment and job-hunting process.

“Some of the usual suspects are CME [continuing medical education] budget, signing bonuses, relocation assistance, loan repayment programs, and housing allowances,” said Jake Jorgovan, partner at Alpha Apex Group, a physician recruiting firm in Denver.

Post pandemic, doctors are vying for other benefits, perks that support their interests, work-life balance, and financial stability. “We’ve come across offers like sabbatical opportunities, paid time for research or personal projects, and even concierge services that handle things like grocery shopping or pet care,” said Mr. Jorgovan.

Amid physician shortages, doctors have more bargaining power than ever.
 

Money Still Talks

Financial perks are still the premiere portion of a benefits package, according to Marc Adam, physician recruiter at MASC Medical, a medical recruitment firm in Fort Lauderdale, Florida.

New data from the medical staffing company AMN Healthcare reported that the average signing bonus for physicians is $31,103. The average relocation allowance is $11,000, and the average CME allowance is $4000.

“CME budget and loan repayment programs are big because they directly impact career advancement and financial well-being,” Mr. Jorgovan said. He said that given the high cost of medical training, loan repayment help, especially, has become a huge deciding factor for clinicians. Employers have historically been hesitant to offer these kinds of long-term benefits because of the financial commitment and planning involved, but that’s changing.

Mr. Adam said that short-term financial perks, like relocation assistance and signing bonuses, tend to be more important for younger doctors. They’re not yet financially established, so the relocation support and bonus funds have more impact as they take on a new role, he said.

Mid- and late-career doctors, on the other hand, are less beholden to these types of bonuses. Mr. Adam has recruited established doctors from across the country to Florida, and he said that the relocation allowance and singing bonus didn’t even rank in their top five priorities. Similarly, in Birmingham, Dr. Wyatt recently reread her offer letter from UAB and was surprised to find a relocation stipend that she never used. “I had no idea,” she said.
 

 

 

Vying for Time

Mid- and late-career doctors who have a better financial safety net tend to seek benefits that boost their quality of life.

One of Mr. Adam’s recent job-searching clients was unwilling to compromise on priorities like specific location and a 4-day workweek.

Four-day workweeks, flexible scheduling, and options for remote work are increasingly popular, especially since the pandemic. Some physicians, like those in primary care, are looking for dedicated charting hours — paid days or half-days set aside for updating the electronic medical records. Other doctors are negotiating multistate telehealth licensing paid by their employer and work-from-home telehealth hours.

“Work life has been slowly increasing over the 14 years I’ve been doing this. And post COVID, the employer’s willingness to be flexible with those types of accommodations increased,” said Mr. Adam.

Priya Jaisinghani, MD, an endocrinologist and obesity medicine specialist in her second year of practice, NYU Langone Health, New York City, said work-life balance can be a priority for young doctors, too. After training in New York during the pandemic, Dr. Jaisinghani was all too aware of the risk for burnout. So she negotiated a 4-day workweek when she took her first job out of fellowship in 2022. “I was able to prioritize work-life balance from the start,” she said.
 

Support for the Career You Want

When Dr. Jaisinghani signed her first contract in 2022 with NYU, her move from New Jersey to New York wasn’t far enough to warrant a relocation allowance. “There was a signing bonus, sure,” she said. But what really grabbed her attention were perks like mentorship, access to trainees, and autonomy.

Perks that support long-term growth — like CME allowance, teaching opportunities, or access to leadership tracks — are especially important to young doctors. “After dedicating so many years to medical training, you want to look for some degree of autonomy in building your practice,” she said. NYU offered her that kind of freedom and support.

On top of personal growth, young physicians are looking for perks that will allow them to build the practice they want for their patients,Dr. Jaisinghani told this news organization. A lot of young doctors don’t know that they can negotiate for schedule preferences, office space, their own exam room, and dedicated support staff. However, they can and should because these factors influence their daily work life and patient experience.

Experienced doctors are also looking for perks that support the career they want. Recruitment experts say that doctors tend to look for opportunities that accommodate their interests. One of Mr. Jorgovan’s recent clients took a position because it offered a generous CME budget and dedicated research hours. Similarly, Dr. Wyatt at UAB moved because her contract included paid time to create.

“It really comes down to the need for balance — being able to keep learning while also having time for personal life and family,” Mr. Jorgovan said.
 

Making and Meeting Demand

Thanks to the rising demand, doctors have more power than ever to negotiate the perks they want and need.

The existing physician shortage — driven by retiring doctors and an aging patient population — was only exacerbated by the pandemic. Now, a number of new market entries are further increasing competition for talent, according to AMN Healthcare’s report. Retail clinics, urgent care, telehealth companies, and private equity firms compete for the same doctors, driving up salaries and doctor bargaining power.

“Physicians were always in the driver’s seat, and their bargaining power has only increased,” Mr. Adam said. Healthcare systems, once reticent about flexible working arrangements or loan repayment, are reconsidering.

Even young doctors have more negotiating power than they realize, but they might need help. “It’s underrated to get a contracts lawyer as a young doctor, but I think it’s smart,” Dr. Jaisinghani said. They’re often more familiar with salaries in the area, flexibility options, and potential benefits, none of which doctors are taught in training, she said.

Mr. Adam said that the pandemic opened employers’ eyes to the fact that doctors have the bargaining power. There’s a stark need for their talent and a lot of public support for their service. So hiring managers are listening and are ready to offer “creative benefits to accommodate the market demand,” he said.

In her new position at UAB, Dr. Wyatt said that money will always matter. “When your salary is low, bumping that salary will make you happier.” But after a certain point, she said, other things become more important — like your time, the work you do, and the people you work with. Her perks at UAB offer more than money can. “I get up in the morning, and I’m excited — [the work] excites me,” she said.

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

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Holly Wyatt, MD, had spent 20 years in UCHealth with no plans to leave. Her home, support system, and lifestyle were all rooted in Denver. But in 2020, The University of Alabama at Birmingham (UAB) made the endocrinologist an offer she couldn’t resist.

The pay increase and a bump to full professorship weren’t enough to lure her across the country. But then UAB sweetened the deal with fewer clinic hours and paid time to create. “I didn’t have to fit into the typical ‘see patients 5 days a week, bill this many dollars,’ ” she said.

With no minimum billable hours, she could spend her time on clinical trials, designing programs, and recording podcasts. “When they offered that, I said, ‘Ooh, that’s enticing.’ ”

After a couple of visits to the campus, she began the job transition.

Doctors are looking for more than base pay. For many physicians, like Dr. Wyatt, non-salary incentives carry a lot of weight in the recruitment and job-hunting process.

“Some of the usual suspects are CME [continuing medical education] budget, signing bonuses, relocation assistance, loan repayment programs, and housing allowances,” said Jake Jorgovan, partner at Alpha Apex Group, a physician recruiting firm in Denver.

Post pandemic, doctors are vying for other benefits, perks that support their interests, work-life balance, and financial stability. “We’ve come across offers like sabbatical opportunities, paid time for research or personal projects, and even concierge services that handle things like grocery shopping or pet care,” said Mr. Jorgovan.

Amid physician shortages, doctors have more bargaining power than ever.
 

Money Still Talks

Financial perks are still the premiere portion of a benefits package, according to Marc Adam, physician recruiter at MASC Medical, a medical recruitment firm in Fort Lauderdale, Florida.

New data from the medical staffing company AMN Healthcare reported that the average signing bonus for physicians is $31,103. The average relocation allowance is $11,000, and the average CME allowance is $4000.

“CME budget and loan repayment programs are big because they directly impact career advancement and financial well-being,” Mr. Jorgovan said. He said that given the high cost of medical training, loan repayment help, especially, has become a huge deciding factor for clinicians. Employers have historically been hesitant to offer these kinds of long-term benefits because of the financial commitment and planning involved, but that’s changing.

Mr. Adam said that short-term financial perks, like relocation assistance and signing bonuses, tend to be more important for younger doctors. They’re not yet financially established, so the relocation support and bonus funds have more impact as they take on a new role, he said.

Mid- and late-career doctors, on the other hand, are less beholden to these types of bonuses. Mr. Adam has recruited established doctors from across the country to Florida, and he said that the relocation allowance and singing bonus didn’t even rank in their top five priorities. Similarly, in Birmingham, Dr. Wyatt recently reread her offer letter from UAB and was surprised to find a relocation stipend that she never used. “I had no idea,” she said.
 

 

 

Vying for Time

Mid- and late-career doctors who have a better financial safety net tend to seek benefits that boost their quality of life.

One of Mr. Adam’s recent job-searching clients was unwilling to compromise on priorities like specific location and a 4-day workweek.

Four-day workweeks, flexible scheduling, and options for remote work are increasingly popular, especially since the pandemic. Some physicians, like those in primary care, are looking for dedicated charting hours — paid days or half-days set aside for updating the electronic medical records. Other doctors are negotiating multistate telehealth licensing paid by their employer and work-from-home telehealth hours.

“Work life has been slowly increasing over the 14 years I’ve been doing this. And post COVID, the employer’s willingness to be flexible with those types of accommodations increased,” said Mr. Adam.

Priya Jaisinghani, MD, an endocrinologist and obesity medicine specialist in her second year of practice, NYU Langone Health, New York City, said work-life balance can be a priority for young doctors, too. After training in New York during the pandemic, Dr. Jaisinghani was all too aware of the risk for burnout. So she negotiated a 4-day workweek when she took her first job out of fellowship in 2022. “I was able to prioritize work-life balance from the start,” she said.
 

Support for the Career You Want

When Dr. Jaisinghani signed her first contract in 2022 with NYU, her move from New Jersey to New York wasn’t far enough to warrant a relocation allowance. “There was a signing bonus, sure,” she said. But what really grabbed her attention were perks like mentorship, access to trainees, and autonomy.

Perks that support long-term growth — like CME allowance, teaching opportunities, or access to leadership tracks — are especially important to young doctors. “After dedicating so many years to medical training, you want to look for some degree of autonomy in building your practice,” she said. NYU offered her that kind of freedom and support.

On top of personal growth, young physicians are looking for perks that will allow them to build the practice they want for their patients,Dr. Jaisinghani told this news organization. A lot of young doctors don’t know that they can negotiate for schedule preferences, office space, their own exam room, and dedicated support staff. However, they can and should because these factors influence their daily work life and patient experience.

Experienced doctors are also looking for perks that support the career they want. Recruitment experts say that doctors tend to look for opportunities that accommodate their interests. One of Mr. Jorgovan’s recent clients took a position because it offered a generous CME budget and dedicated research hours. Similarly, Dr. Wyatt at UAB moved because her contract included paid time to create.

“It really comes down to the need for balance — being able to keep learning while also having time for personal life and family,” Mr. Jorgovan said.
 

Making and Meeting Demand

Thanks to the rising demand, doctors have more power than ever to negotiate the perks they want and need.

The existing physician shortage — driven by retiring doctors and an aging patient population — was only exacerbated by the pandemic. Now, a number of new market entries are further increasing competition for talent, according to AMN Healthcare’s report. Retail clinics, urgent care, telehealth companies, and private equity firms compete for the same doctors, driving up salaries and doctor bargaining power.

“Physicians were always in the driver’s seat, and their bargaining power has only increased,” Mr. Adam said. Healthcare systems, once reticent about flexible working arrangements or loan repayment, are reconsidering.

Even young doctors have more negotiating power than they realize, but they might need help. “It’s underrated to get a contracts lawyer as a young doctor, but I think it’s smart,” Dr. Jaisinghani said. They’re often more familiar with salaries in the area, flexibility options, and potential benefits, none of which doctors are taught in training, she said.

Mr. Adam said that the pandemic opened employers’ eyes to the fact that doctors have the bargaining power. There’s a stark need for their talent and a lot of public support for their service. So hiring managers are listening and are ready to offer “creative benefits to accommodate the market demand,” he said.

In her new position at UAB, Dr. Wyatt said that money will always matter. “When your salary is low, bumping that salary will make you happier.” But after a certain point, she said, other things become more important — like your time, the work you do, and the people you work with. Her perks at UAB offer more than money can. “I get up in the morning, and I’m excited — [the work] excites me,” she said.

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

Holly Wyatt, MD, had spent 20 years in UCHealth with no plans to leave. Her home, support system, and lifestyle were all rooted in Denver. But in 2020, The University of Alabama at Birmingham (UAB) made the endocrinologist an offer she couldn’t resist.

The pay increase and a bump to full professorship weren’t enough to lure her across the country. But then UAB sweetened the deal with fewer clinic hours and paid time to create. “I didn’t have to fit into the typical ‘see patients 5 days a week, bill this many dollars,’ ” she said.

With no minimum billable hours, she could spend her time on clinical trials, designing programs, and recording podcasts. “When they offered that, I said, ‘Ooh, that’s enticing.’ ”

After a couple of visits to the campus, she began the job transition.

Doctors are looking for more than base pay. For many physicians, like Dr. Wyatt, non-salary incentives carry a lot of weight in the recruitment and job-hunting process.

“Some of the usual suspects are CME [continuing medical education] budget, signing bonuses, relocation assistance, loan repayment programs, and housing allowances,” said Jake Jorgovan, partner at Alpha Apex Group, a physician recruiting firm in Denver.

Post pandemic, doctors are vying for other benefits, perks that support their interests, work-life balance, and financial stability. “We’ve come across offers like sabbatical opportunities, paid time for research or personal projects, and even concierge services that handle things like grocery shopping or pet care,” said Mr. Jorgovan.

Amid physician shortages, doctors have more bargaining power than ever.
 

Money Still Talks

Financial perks are still the premiere portion of a benefits package, according to Marc Adam, physician recruiter at MASC Medical, a medical recruitment firm in Fort Lauderdale, Florida.

New data from the medical staffing company AMN Healthcare reported that the average signing bonus for physicians is $31,103. The average relocation allowance is $11,000, and the average CME allowance is $4000.

“CME budget and loan repayment programs are big because they directly impact career advancement and financial well-being,” Mr. Jorgovan said. He said that given the high cost of medical training, loan repayment help, especially, has become a huge deciding factor for clinicians. Employers have historically been hesitant to offer these kinds of long-term benefits because of the financial commitment and planning involved, but that’s changing.

Mr. Adam said that short-term financial perks, like relocation assistance and signing bonuses, tend to be more important for younger doctors. They’re not yet financially established, so the relocation support and bonus funds have more impact as they take on a new role, he said.

Mid- and late-career doctors, on the other hand, are less beholden to these types of bonuses. Mr. Adam has recruited established doctors from across the country to Florida, and he said that the relocation allowance and singing bonus didn’t even rank in their top five priorities. Similarly, in Birmingham, Dr. Wyatt recently reread her offer letter from UAB and was surprised to find a relocation stipend that she never used. “I had no idea,” she said.
 

 

 

Vying for Time

Mid- and late-career doctors who have a better financial safety net tend to seek benefits that boost their quality of life.

One of Mr. Adam’s recent job-searching clients was unwilling to compromise on priorities like specific location and a 4-day workweek.

Four-day workweeks, flexible scheduling, and options for remote work are increasingly popular, especially since the pandemic. Some physicians, like those in primary care, are looking for dedicated charting hours — paid days or half-days set aside for updating the electronic medical records. Other doctors are negotiating multistate telehealth licensing paid by their employer and work-from-home telehealth hours.

“Work life has been slowly increasing over the 14 years I’ve been doing this. And post COVID, the employer’s willingness to be flexible with those types of accommodations increased,” said Mr. Adam.

Priya Jaisinghani, MD, an endocrinologist and obesity medicine specialist in her second year of practice, NYU Langone Health, New York City, said work-life balance can be a priority for young doctors, too. After training in New York during the pandemic, Dr. Jaisinghani was all too aware of the risk for burnout. So she negotiated a 4-day workweek when she took her first job out of fellowship in 2022. “I was able to prioritize work-life balance from the start,” she said.
 

Support for the Career You Want

When Dr. Jaisinghani signed her first contract in 2022 with NYU, her move from New Jersey to New York wasn’t far enough to warrant a relocation allowance. “There was a signing bonus, sure,” she said. But what really grabbed her attention were perks like mentorship, access to trainees, and autonomy.

Perks that support long-term growth — like CME allowance, teaching opportunities, or access to leadership tracks — are especially important to young doctors. “After dedicating so many years to medical training, you want to look for some degree of autonomy in building your practice,” she said. NYU offered her that kind of freedom and support.

On top of personal growth, young physicians are looking for perks that will allow them to build the practice they want for their patients,Dr. Jaisinghani told this news organization. A lot of young doctors don’t know that they can negotiate for schedule preferences, office space, their own exam room, and dedicated support staff. However, they can and should because these factors influence their daily work life and patient experience.

Experienced doctors are also looking for perks that support the career they want. Recruitment experts say that doctors tend to look for opportunities that accommodate their interests. One of Mr. Jorgovan’s recent clients took a position because it offered a generous CME budget and dedicated research hours. Similarly, Dr. Wyatt at UAB moved because her contract included paid time to create.

“It really comes down to the need for balance — being able to keep learning while also having time for personal life and family,” Mr. Jorgovan said.
 

Making and Meeting Demand

Thanks to the rising demand, doctors have more power than ever to negotiate the perks they want and need.

The existing physician shortage — driven by retiring doctors and an aging patient population — was only exacerbated by the pandemic. Now, a number of new market entries are further increasing competition for talent, according to AMN Healthcare’s report. Retail clinics, urgent care, telehealth companies, and private equity firms compete for the same doctors, driving up salaries and doctor bargaining power.

“Physicians were always in the driver’s seat, and their bargaining power has only increased,” Mr. Adam said. Healthcare systems, once reticent about flexible working arrangements or loan repayment, are reconsidering.

Even young doctors have more negotiating power than they realize, but they might need help. “It’s underrated to get a contracts lawyer as a young doctor, but I think it’s smart,” Dr. Jaisinghani said. They’re often more familiar with salaries in the area, flexibility options, and potential benefits, none of which doctors are taught in training, she said.

Mr. Adam said that the pandemic opened employers’ eyes to the fact that doctors have the bargaining power. There’s a stark need for their talent and a lot of public support for their service. So hiring managers are listening and are ready to offer “creative benefits to accommodate the market demand,” he said.

In her new position at UAB, Dr. Wyatt said that money will always matter. “When your salary is low, bumping that salary will make you happier.” But after a certain point, she said, other things become more important — like your time, the work you do, and the people you work with. Her perks at UAB offer more than money can. “I get up in the morning, and I’m excited — [the work] excites me,” she said.

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

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Seated Doctors Better Satisfy Patients, Communication

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Fri, 08/30/2024 - 12:37

Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

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

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Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

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

Sitting at a patient’s bedside is one of the behaviors associated with better doctor-patient communication, patient satisfaction, and trust. During a busy day of consultations, however, it can be difficult for healthcare professionals to sit regularly with patients. Previous studies have revealed that hospital doctors sit during one out of every five meetings with patients.

recent US study evaluated the impact of the practitioner’s seated position next to the patient on the quality of the doctor-patient interaction in an internal medicine department. This research involved a sample of 51 doctors (average age, 35 years; 51% men) and analyzed 125 clinical interviews (n = 125 patients; average age, 53 years; 55% men). Participants were not informed of the real objective of the study. The patient’s perception of medical care was also solicited.

The experimental protocol involved two distinct configurations. Either the chair was positioned near the bed (within 90 cm) before the doctor arrived or it remained visible in its usual place. Each meeting with a patient was randomized according to the chair location (intervention group: n = 60; control group: n = 65).

The primary criterion was the doctor’s binary decision to sit or not at a given moment during a meeting with a patient. Secondary criteria included patient satisfaction, time spent in the room, and the perception of time spent in the room by doctors and patients.

The chair’s location had no effect on the average duration of the interview, whether actual or estimated. When a chair was placed near the bed, the doctor sat in more than six out of 10 cases (63%), compared with fewer than one case out of 10 (8%) when the chair was less easily accessible (odds ratio, 20.7; 95% CI, 7.2-59.4; P < .001).

The chair arrangement did not lead to a significant difference in the average duration of presence in the room (10.6 min for both groups). Likewise, no notable difference was observed regarding the subjective estimation of this duration from the practitioners’ point of view (9.4 min vs 9.8 min) or from the patients’ point of view (13.1 min vs 13.5 min).

In the group in which the doctor sat to converse, patient satisfaction was significantly higher, with an overall difference of 3.9% (P = .02). Patients felt that the information provided was better (72% vs 52%; P =.03), and their confidence in the proposed care was also higher (58% vs 35%; P = .01). On the other hand, no significant difference appeared between the two groups regarding the information retained by the patient (doctor’s name and reason for hospitalization) or the doctor’s behavior.

The study authors acknowledged the study’s methodological limitations, which included a sample size that was lower than initially projected and the restriction to a single hospital setting. In addition, they noted that all patients were housed in individual rooms, which could be a source of bias. Despite these reservations, they suggested that even minimal environmental changes, such as the thoughtful placement of a chair, can significantly affect patients’ perceptions of the quality of care provided.
 

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

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