Psoriatic Arthritis ICYMI

Key clinical point: Patients with psoriatic arthritis (PsA) and obesity had ~50% lower likelihood of achieving minimal disease activity (MDA) or remission within a year of initiating treatment with biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD).

Major finding: Odds of achieving MDA (adjusted odds ratio [aOR] 0.45; 95% CI 0.24-0.82) and DAPSA-remission (aOR 0.42; 95% CI 0.21-0.85) were lower in the obese vs normal weight group within the first year; similarly, the overweight group had reduced odds of achieving DAPSA-remission (aOR 0.44; 95% CI 0.24-0.79).

Study details: Findings are from an observational cohort study including 774 adult patients with PsA who started their first b/tsDMARD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Vallejo-Yague E et al. Minimal disease activity and remission in patients with psoriatic arthritis with elevated body mass index: An observational cohort study in the Swiss Clinical Quality Management cohort. BMJ Open. 2022;12(9):e061474 (Sep 17). Doi: 10.1136/bmjopen-2022-061474

Key clinical point: Patients with psoriatic arthritis (PsA) and obesity had ~50% lower likelihood of achieving minimal disease activity (MDA) or remission within a year of initiating treatment with biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD).

Major finding: Odds of achieving MDA (adjusted odds ratio [aOR] 0.45; 95% CI 0.24-0.82) and DAPSA-remission (aOR 0.42; 95% CI 0.21-0.85) were lower in the obese vs normal weight group within the first year; similarly, the overweight group had reduced odds of achieving DAPSA-remission (aOR 0.44; 95% CI 0.24-0.79).

Study details: Findings are from an observational cohort study including 774 adult patients with PsA who started their first b/tsDMARD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Vallejo-Yague E et al. Minimal disease activity and remission in patients with psoriatic arthritis with elevated body mass index: An observational cohort study in the Swiss Clinical Quality Management cohort. BMJ Open. 2022;12(9):e061474 (Sep 17). Doi: 10.1136/bmjopen-2022-061474

Key clinical point: Patients with psoriatic arthritis (PsA) and obesity had ~50% lower likelihood of achieving minimal disease activity (MDA) or remission within a year of initiating treatment with biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD).

Major finding: Odds of achieving MDA (adjusted odds ratio [aOR] 0.45; 95% CI 0.24-0.82) and DAPSA-remission (aOR 0.42; 95% CI 0.21-0.85) were lower in the obese vs normal weight group within the first year; similarly, the overweight group had reduced odds of achieving DAPSA-remission (aOR 0.44; 95% CI 0.24-0.79).

Study details: Findings are from an observational cohort study including 774 adult patients with PsA who started their first b/tsDMARD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Vallejo-Yague E et al. Minimal disease activity and remission in patients with psoriatic arthritis with elevated body mass index: An observational cohort study in the Swiss Clinical Quality Management cohort. BMJ Open. 2022;12(9):e061474 (Sep 17). Doi: 10.1136/bmjopen-2022-061474

Key clinical point: Preliminary results from this real-world study demonstrated efficacy of interleukin (IL)-23 inhibitors in patients with psoriatic arthritis (PsA).

Major finding: A substantial proportion of patients with PsA receiving either of the IL-23 inhibitors achieved complete (40.9%) or partial (36.4%) remission compared with only 18.2% of patients who demonstrated no improvement. A higher proportion of patients receiving guselkumab achieved remission or partial remission (38.5% and 46.1%, respectively) than treatment failure (15.4%), with similar outcomes being observed with risankizumab.

Study details: Findings are from a retrospective, observational study including 80 patients with psoriasis who received guselkumab, tildrakizumab, or risankizumab, of which 27.5% of patients had PsA.

Disclosures: This study did not receive any funding. The authors declared serving as consultants, paid speakers, and/or advisors and/or receiving speaking fees or grants from several sources.

Source: Elgaard CDB et al. Guselkumab, tildrakizumab and risankizumab in real-world setting: Drug survival and effectiveness in the treatment of psoriasis and psoriatic arthritis. J Dermatolog Treat. 2022;1-24 (Oct 6). Doi: 10.1080/09546634.2022.2133531.

Key clinical point: Preliminary results from this real-world study demonstrated efficacy of interleukin (IL)-23 inhibitors in patients with psoriatic arthritis (PsA).

Major finding: A substantial proportion of patients with PsA receiving either of the IL-23 inhibitors achieved complete (40.9%) or partial (36.4%) remission compared with only 18.2% of patients who demonstrated no improvement. A higher proportion of patients receiving guselkumab achieved remission or partial remission (38.5% and 46.1%, respectively) than treatment failure (15.4%), with similar outcomes being observed with risankizumab.

Study details: Findings are from a retrospective, observational study including 80 patients with psoriasis who received guselkumab, tildrakizumab, or risankizumab, of which 27.5% of patients had PsA.

Disclosures: This study did not receive any funding. The authors declared serving as consultants, paid speakers, and/or advisors and/or receiving speaking fees or grants from several sources.

Source: Elgaard CDB et al. Guselkumab, tildrakizumab and risankizumab in real-world setting: Drug survival and effectiveness in the treatment of psoriasis and psoriatic arthritis. J Dermatolog Treat. 2022;1-24 (Oct 6). Doi: 10.1080/09546634.2022.2133531.

Key clinical point: Preliminary results from this real-world study demonstrated efficacy of interleukin (IL)-23 inhibitors in patients with psoriatic arthritis (PsA).

Major finding: A substantial proportion of patients with PsA receiving either of the IL-23 inhibitors achieved complete (40.9%) or partial (36.4%) remission compared with only 18.2% of patients who demonstrated no improvement. A higher proportion of patients receiving guselkumab achieved remission or partial remission (38.5% and 46.1%, respectively) than treatment failure (15.4%), with similar outcomes being observed with risankizumab.

Study details: Findings are from a retrospective, observational study including 80 patients with psoriasis who received guselkumab, tildrakizumab, or risankizumab, of which 27.5% of patients had PsA.

Disclosures: This study did not receive any funding. The authors declared serving as consultants, paid speakers, and/or advisors and/or receiving speaking fees or grants from several sources.

Source: Elgaard CDB et al. Guselkumab, tildrakizumab and risankizumab in real-world setting: Drug survival and effectiveness in the treatment of psoriasis and psoriatic arthritis. J Dermatolog Treat. 2022;1-24 (Oct 6). Doi: 10.1080/09546634.2022.2133531.

Key clinical point: Guselkumab demonstrated promising efficacy and was well tolerated in a real-world population of patients with psoriatic arthritis (PsA) and psoriasis.

Major finding: Before starting guselkumab, 48% of patients had moderate/high disease activity in PsA (DAPSA). In this subgroup, the mean DAPSA score reduced from 29 to 20, 16, and 14 at weeks 12, 24, and 52, respectively (P < .0001). Only 2.2% of patients reported mild adverse events.

Study details: Findings are from a multicenter, retrospective, observational study including 90 patients with PsA and concomitant psoriasis who started treatment with guselkumab.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Rocamora V et al. Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group. Dermatol Ther. 2022 (Sep 29). Doi: 10.1111/dth.15865

Key clinical point: Guselkumab demonstrated promising efficacy and was well tolerated in a real-world population of patients with psoriatic arthritis (PsA) and psoriasis.

Major finding: Before starting guselkumab, 48% of patients had moderate/high disease activity in PsA (DAPSA). In this subgroup, the mean DAPSA score reduced from 29 to 20, 16, and 14 at weeks 12, 24, and 52, respectively (P < .0001). Only 2.2% of patients reported mild adverse events.

Study details: Findings are from a multicenter, retrospective, observational study including 90 patients with PsA and concomitant psoriasis who started treatment with guselkumab.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Rocamora V et al. Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group. Dermatol Ther. 2022 (Sep 29). Doi: 10.1111/dth.15865

Key clinical point: Guselkumab demonstrated promising efficacy and was well tolerated in a real-world population of patients with psoriatic arthritis (PsA) and psoriasis.

Major finding: Before starting guselkumab, 48% of patients had moderate/high disease activity in PsA (DAPSA). In this subgroup, the mean DAPSA score reduced from 29 to 20, 16, and 14 at weeks 12, 24, and 52, respectively (P < .0001). Only 2.2% of patients reported mild adverse events.

Study details: Findings are from a multicenter, retrospective, observational study including 90 patients with PsA and concomitant psoriasis who started treatment with guselkumab.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Rocamora V et al. Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group. Dermatol Ther. 2022 (Sep 29). Doi: 10.1111/dth.15865

Key clinical point: Inflammatory bowel disease (IBD), particularly Crohn's disease, is a causal risk factor for psoriatic arthritis (PsA).

Major finding: Genetically predicted IBD was associated with a higher risk for PsA (pooled odds ratio [OR] 1.11; P = .003) with the risk being majorly mediated by Crohn’s disease (OR 1.12; P = .002) and not ulcerative colitis (P = .70).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 12,882 patients with IBD and 21,770 matched-controls and 5621 patients with psoriasis and 2063 patients with PsA who were compared with 252,323 controls.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Freuer D et al. Association between inflammatory bowel disease and both psoriasis and psoriatic arthritis: A bidirectional 2-sample mendelian randomization study. JAMA Dermatol. 2022 (Sep 14). Doi: 10.1001/jamadermatol.2022.3682

Key clinical point: Inflammatory bowel disease (IBD), particularly Crohn's disease, is a causal risk factor for psoriatic arthritis (PsA).

Major finding: Genetically predicted IBD was associated with a higher risk for PsA (pooled odds ratio [OR] 1.11; P = .003) with the risk being majorly mediated by Crohn’s disease (OR 1.12; P = .002) and not ulcerative colitis (P = .70).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 12,882 patients with IBD and 21,770 matched-controls and 5621 patients with psoriasis and 2063 patients with PsA who were compared with 252,323 controls.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Freuer D et al. Association between inflammatory bowel disease and both psoriasis and psoriatic arthritis: A bidirectional 2-sample mendelian randomization study. JAMA Dermatol. 2022 (Sep 14). Doi: 10.1001/jamadermatol.2022.3682

Key clinical point: Inflammatory bowel disease (IBD), particularly Crohn's disease, is a causal risk factor for psoriatic arthritis (PsA).

Major finding: Genetically predicted IBD was associated with a higher risk for PsA (pooled odds ratio [OR] 1.11; P = .003) with the risk being majorly mediated by Crohn’s disease (OR 1.12; P = .002) and not ulcerative colitis (P = .70).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 12,882 patients with IBD and 21,770 matched-controls and 5621 patients with psoriasis and 2063 patients with PsA who were compared with 252,323 controls.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Freuer D et al. Association between inflammatory bowel disease and both psoriasis and psoriatic arthritis: A bidirectional 2-sample mendelian randomization study. JAMA Dermatol. 2022 (Sep 14). Doi: 10.1001/jamadermatol.2022.3682

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

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

Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.

Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.

In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.

The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).

Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).

Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).

Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).

More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.

However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).

“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.

The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
 

Mechanisms driving sex differences remain unclear

“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.

The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.

Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.

The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.

Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.

Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.

In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.

The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).

Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).

Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).

Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).

More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.

However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).

“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.

The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
 

Mechanisms driving sex differences remain unclear

“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.

The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.

Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.

The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.

Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.

Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.

In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.

The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).

Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).

Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).

Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).

More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.

However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).

“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.

The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
 

Mechanisms driving sex differences remain unclear

“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.

The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.

Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.

The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib (Olumiant) may pose no greater risk than does adalimumab (Humira and biosimilars) for major adverse cardiovascular events (MACEs) or venous thromboembolism (VTE) on the basis of a nationwide cohort study.

The French data, which included almost 16,000 patients with rheumatoid arthritis, revealed similar safety across subgroups, including older patients with at least one preexisting cardiovascular risk factor, reported lead author Léa Hoisnard, MD, of Henri Mondor Hospital, Paris, and colleagues.

These findings arrive 1 year after the U.S. Food and Drug Administration imposed class-wide boxed warnings on three Janus kinase (JAK) inhibitors, citing increased risks for both cancer and serious cardiac events detected by the open-label, randomized ORAL Surveillance postmarketing trial, which compared tofacitinib against adalimumab and etanercept.

More recently, the observational STAR-RA study, relying upon private insurance and Medicare claims in the United States, found no significant increase in cardiovascular events among patients taking tofacitinib, adding some uncertainty to the conversation.

“In this context, observational studies of unselected populations outside of North America are still needed to assess other JAK inhibitor agents,” Dr. Hoisnard and colleagues write in Annals of the Rheumatic Diseases.

Their retrospective study included 8,481 patients who received baricitinib or tofacitinib, and 7,354 patients who received adalimumab. Almost all patients in the tofacitinib group received 5 mg twice daily instead of 10 mg twice daily (99.4% vs. 0.6%), so cardiovascular safety was assessed only for the 5-mg dose. Baricitinib was prescribed at 4-mg and 2-mg doses (79.5% vs. 20.5%), allowing inclusion of both dose levels. The investigators accounted for a range of covariates, including concurrent therapy, comorbidities, and other patient characteristics.

Median follow-up durations were 440 days in the JAK inhibitor group and 344 days in the adalimumab group. The JAK inhibitor group had numerically more MACEs than did the adalimumab group, but the difference in risk was not statistically significant (54 vs. 35 MACEs; weighted hazard ratio, 1.0; 95% confidence interval, 0.7-1.5; P = .99). Similarly, more patients taking JAK inhibitors had VTEs, but relative risk was, again, not significant (75 vs. 32 VTEs; HRw, 1.1; 95% CI, 0.7-1.6; P = .63).

These findings were consistent for all subgroups, including patients aged 50 years or older and patients aged 65 years or older, although the investigators noted that statistical power was lacking for subgroup analyses.
 

Findings from Echo ORAL Surveillance

“I think the baricitinib data are important,” Kevin Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health & Science University, Portland, told this news organization. “There’s no difference between 2 mg and 4 mg [dose levels] in this analysis. And there doesn’t really seem to be a difference between baricitinib and tofacitinib. Most of the results are pretty consistent with ORAL Surveillance, which was a randomized, controlled trial.”

Dr. Winthrop, who has been active in JAK inhibitor clinical trials, recently coauthored an article in Nature Reviews Rheumatology encouraging clinicians to remember that the cardiovascular risks of JAK inhibitors are relative to adalimumab, and safety should be framed within the context of risk-to-benefit ratios.

He and his coauthor also called into question the FDA’s “better to be safe than sorry” approach, which resulted in boxed warnings across all JAK inhibitors, despite differences in target specificity.

“There are pros and cons of taking that approach,” Dr. Winthrop said in an interview. “The FDA might ultimately be right. Certainly, these drugs appear similar for some types of events, like herpes zoster, for example. But whether they’re similar with regard to malignancy or cardiovascular events, I don’t think we know.”

Dr. Winthrop noted that deucravacitinib was recently approved for psoriasis sans boxed warning, suggesting inconsistency in the FDA’s approach. The agent headlines as a “TYK2 inhibitor,” but TYK2 is a member of the JAK family.

“I don’t know why the FDA decided to treat them differently,” Dr. Winthrop said.

Boxed warnings encourage caution, lock treatment sequence

Michael Thakor, MD, of Arthritis & Rheumatology Clinic of Northern Colorado, Fort Collins, supports the boxed warnings because they encourage caution and transparency.

“It forces you to have that discussion with your patient, which may take some time, but it’s actually a very good thing,” Dr. Thakor said in an interview. “Some patients will say, ‘Oh my gosh, I don’t want to take that drug.’ But most patients, considering the level of risk that you’re talking about, are actually okay going ahead with the medication.”

If these risks aren’t discussed, he noted, patient trust may falter.

“They’re going to go online, and they’re going to be reading about it,” Dr. Thakor said. “And then they tend to get more spooked. They also may question your advice from then on, if you’re not telling them the possible risk.”

Reflecting on the present study, Dr. Thakor said that the findings initially appeared reassuring, but he became concerned about the lack of power and how adverse events trended higher in the JAK inhibitor group, particularly for VTEs, most of which occurred with baricitinib. This latter finding is challenging to interpret, however, because the 4-mg dose is not used in the United States, he added.

Dr. Thakor described how JAK inhibitors once seemed poised to assume a frontline role in RA until the boxed warnings came out. These safety concerns don’t take JAK inhibitors off the table, he said, but they do keep the class further down the treatment sequence, and the present data don’t alter this picture in daily practice.

“If I had a patient who was over the age of 50 with at least one cardiovascular risk factor, I might have a little bit of concern, but if they need their RA treated, I would definitely discuss the possibility of using a JAK inhibitor,” Dr. Thakor said. “If the patient is comfortable with it, then I would feel comfortable going ahead.”

The investigators disclosed no outside funding or conflicts of interest. Dr. Winthrop disclosed relationships with AbbVie, AstraZeneca, Bristol-Myers Squibb, and others. Dr. Thakor disclosed no conflicts of interest.

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

Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib (Olumiant) may pose no greater risk than does adalimumab (Humira and biosimilars) for major adverse cardiovascular events (MACEs) or venous thromboembolism (VTE) on the basis of a nationwide cohort study.

The French data, which included almost 16,000 patients with rheumatoid arthritis, revealed similar safety across subgroups, including older patients with at least one preexisting cardiovascular risk factor, reported lead author Léa Hoisnard, MD, of Henri Mondor Hospital, Paris, and colleagues.

These findings arrive 1 year after the U.S. Food and Drug Administration imposed class-wide boxed warnings on three Janus kinase (JAK) inhibitors, citing increased risks for both cancer and serious cardiac events detected by the open-label, randomized ORAL Surveillance postmarketing trial, which compared tofacitinib against adalimumab and etanercept.

More recently, the observational STAR-RA study, relying upon private insurance and Medicare claims in the United States, found no significant increase in cardiovascular events among patients taking tofacitinib, adding some uncertainty to the conversation.

“In this context, observational studies of unselected populations outside of North America are still needed to assess other JAK inhibitor agents,” Dr. Hoisnard and colleagues write in Annals of the Rheumatic Diseases.

Their retrospective study included 8,481 patients who received baricitinib or tofacitinib, and 7,354 patients who received adalimumab. Almost all patients in the tofacitinib group received 5 mg twice daily instead of 10 mg twice daily (99.4% vs. 0.6%), so cardiovascular safety was assessed only for the 5-mg dose. Baricitinib was prescribed at 4-mg and 2-mg doses (79.5% vs. 20.5%), allowing inclusion of both dose levels. The investigators accounted for a range of covariates, including concurrent therapy, comorbidities, and other patient characteristics.

Median follow-up durations were 440 days in the JAK inhibitor group and 344 days in the adalimumab group. The JAK inhibitor group had numerically more MACEs than did the adalimumab group, but the difference in risk was not statistically significant (54 vs. 35 MACEs; weighted hazard ratio, 1.0; 95% confidence interval, 0.7-1.5; P = .99). Similarly, more patients taking JAK inhibitors had VTEs, but relative risk was, again, not significant (75 vs. 32 VTEs; HRw, 1.1; 95% CI, 0.7-1.6; P = .63).

These findings were consistent for all subgroups, including patients aged 50 years or older and patients aged 65 years or older, although the investigators noted that statistical power was lacking for subgroup analyses.
 

Findings from Echo ORAL Surveillance

“I think the baricitinib data are important,” Kevin Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health & Science University, Portland, told this news organization. “There’s no difference between 2 mg and 4 mg [dose levels] in this analysis. And there doesn’t really seem to be a difference between baricitinib and tofacitinib. Most of the results are pretty consistent with ORAL Surveillance, which was a randomized, controlled trial.”

Dr. Winthrop, who has been active in JAK inhibitor clinical trials, recently coauthored an article in Nature Reviews Rheumatology encouraging clinicians to remember that the cardiovascular risks of JAK inhibitors are relative to adalimumab, and safety should be framed within the context of risk-to-benefit ratios.

He and his coauthor also called into question the FDA’s “better to be safe than sorry” approach, which resulted in boxed warnings across all JAK inhibitors, despite differences in target specificity.

“There are pros and cons of taking that approach,” Dr. Winthrop said in an interview. “The FDA might ultimately be right. Certainly, these drugs appear similar for some types of events, like herpes zoster, for example. But whether they’re similar with regard to malignancy or cardiovascular events, I don’t think we know.”

Dr. Winthrop noted that deucravacitinib was recently approved for psoriasis sans boxed warning, suggesting inconsistency in the FDA’s approach. The agent headlines as a “TYK2 inhibitor,” but TYK2 is a member of the JAK family.

“I don’t know why the FDA decided to treat them differently,” Dr. Winthrop said.

Boxed warnings encourage caution, lock treatment sequence

Michael Thakor, MD, of Arthritis & Rheumatology Clinic of Northern Colorado, Fort Collins, supports the boxed warnings because they encourage caution and transparency.

“It forces you to have that discussion with your patient, which may take some time, but it’s actually a very good thing,” Dr. Thakor said in an interview. “Some patients will say, ‘Oh my gosh, I don’t want to take that drug.’ But most patients, considering the level of risk that you’re talking about, are actually okay going ahead with the medication.”

If these risks aren’t discussed, he noted, patient trust may falter.

“They’re going to go online, and they’re going to be reading about it,” Dr. Thakor said. “And then they tend to get more spooked. They also may question your advice from then on, if you’re not telling them the possible risk.”

Reflecting on the present study, Dr. Thakor said that the findings initially appeared reassuring, but he became concerned about the lack of power and how adverse events trended higher in the JAK inhibitor group, particularly for VTEs, most of which occurred with baricitinib. This latter finding is challenging to interpret, however, because the 4-mg dose is not used in the United States, he added.

Dr. Thakor described how JAK inhibitors once seemed poised to assume a frontline role in RA until the boxed warnings came out. These safety concerns don’t take JAK inhibitors off the table, he said, but they do keep the class further down the treatment sequence, and the present data don’t alter this picture in daily practice.

“If I had a patient who was over the age of 50 with at least one cardiovascular risk factor, I might have a little bit of concern, but if they need their RA treated, I would definitely discuss the possibility of using a JAK inhibitor,” Dr. Thakor said. “If the patient is comfortable with it, then I would feel comfortable going ahead.”

The investigators disclosed no outside funding or conflicts of interest. Dr. Winthrop disclosed relationships with AbbVie, AstraZeneca, Bristol-Myers Squibb, and others. Dr. Thakor disclosed no conflicts of interest.

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

Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib (Olumiant) may pose no greater risk than does adalimumab (Humira and biosimilars) for major adverse cardiovascular events (MACEs) or venous thromboembolism (VTE) on the basis of a nationwide cohort study.

The French data, which included almost 16,000 patients with rheumatoid arthritis, revealed similar safety across subgroups, including older patients with at least one preexisting cardiovascular risk factor, reported lead author Léa Hoisnard, MD, of Henri Mondor Hospital, Paris, and colleagues.

These findings arrive 1 year after the U.S. Food and Drug Administration imposed class-wide boxed warnings on three Janus kinase (JAK) inhibitors, citing increased risks for both cancer and serious cardiac events detected by the open-label, randomized ORAL Surveillance postmarketing trial, which compared tofacitinib against adalimumab and etanercept.

More recently, the observational STAR-RA study, relying upon private insurance and Medicare claims in the United States, found no significant increase in cardiovascular events among patients taking tofacitinib, adding some uncertainty to the conversation.

“In this context, observational studies of unselected populations outside of North America are still needed to assess other JAK inhibitor agents,” Dr. Hoisnard and colleagues write in Annals of the Rheumatic Diseases.

Their retrospective study included 8,481 patients who received baricitinib or tofacitinib, and 7,354 patients who received adalimumab. Almost all patients in the tofacitinib group received 5 mg twice daily instead of 10 mg twice daily (99.4% vs. 0.6%), so cardiovascular safety was assessed only for the 5-mg dose. Baricitinib was prescribed at 4-mg and 2-mg doses (79.5% vs. 20.5%), allowing inclusion of both dose levels. The investigators accounted for a range of covariates, including concurrent therapy, comorbidities, and other patient characteristics.

Median follow-up durations were 440 days in the JAK inhibitor group and 344 days in the adalimumab group. The JAK inhibitor group had numerically more MACEs than did the adalimumab group, but the difference in risk was not statistically significant (54 vs. 35 MACEs; weighted hazard ratio, 1.0; 95% confidence interval, 0.7-1.5; P = .99). Similarly, more patients taking JAK inhibitors had VTEs, but relative risk was, again, not significant (75 vs. 32 VTEs; HRw, 1.1; 95% CI, 0.7-1.6; P = .63).

These findings were consistent for all subgroups, including patients aged 50 years or older and patients aged 65 years or older, although the investigators noted that statistical power was lacking for subgroup analyses.
 

Findings from Echo ORAL Surveillance

“I think the baricitinib data are important,” Kevin Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health & Science University, Portland, told this news organization. “There’s no difference between 2 mg and 4 mg [dose levels] in this analysis. And there doesn’t really seem to be a difference between baricitinib and tofacitinib. Most of the results are pretty consistent with ORAL Surveillance, which was a randomized, controlled trial.”

Dr. Winthrop, who has been active in JAK inhibitor clinical trials, recently coauthored an article in Nature Reviews Rheumatology encouraging clinicians to remember that the cardiovascular risks of JAK inhibitors are relative to adalimumab, and safety should be framed within the context of risk-to-benefit ratios.

He and his coauthor also called into question the FDA’s “better to be safe than sorry” approach, which resulted in boxed warnings across all JAK inhibitors, despite differences in target specificity.

“There are pros and cons of taking that approach,” Dr. Winthrop said in an interview. “The FDA might ultimately be right. Certainly, these drugs appear similar for some types of events, like herpes zoster, for example. But whether they’re similar with regard to malignancy or cardiovascular events, I don’t think we know.”

Dr. Winthrop noted that deucravacitinib was recently approved for psoriasis sans boxed warning, suggesting inconsistency in the FDA’s approach. The agent headlines as a “TYK2 inhibitor,” but TYK2 is a member of the JAK family.

“I don’t know why the FDA decided to treat them differently,” Dr. Winthrop said.

Boxed warnings encourage caution, lock treatment sequence

Michael Thakor, MD, of Arthritis & Rheumatology Clinic of Northern Colorado, Fort Collins, supports the boxed warnings because they encourage caution and transparency.

“It forces you to have that discussion with your patient, which may take some time, but it’s actually a very good thing,” Dr. Thakor said in an interview. “Some patients will say, ‘Oh my gosh, I don’t want to take that drug.’ But most patients, considering the level of risk that you’re talking about, are actually okay going ahead with the medication.”

If these risks aren’t discussed, he noted, patient trust may falter.

“They’re going to go online, and they’re going to be reading about it,” Dr. Thakor said. “And then they tend to get more spooked. They also may question your advice from then on, if you’re not telling them the possible risk.”

Reflecting on the present study, Dr. Thakor said that the findings initially appeared reassuring, but he became concerned about the lack of power and how adverse events trended higher in the JAK inhibitor group, particularly for VTEs, most of which occurred with baricitinib. This latter finding is challenging to interpret, however, because the 4-mg dose is not used in the United States, he added.

Dr. Thakor described how JAK inhibitors once seemed poised to assume a frontline role in RA until the boxed warnings came out. These safety concerns don’t take JAK inhibitors off the table, he said, but they do keep the class further down the treatment sequence, and the present data don’t alter this picture in daily practice.

“If I had a patient who was over the age of 50 with at least one cardiovascular risk factor, I might have a little bit of concern, but if they need their RA treated, I would definitely discuss the possibility of using a JAK inhibitor,” Dr. Thakor said. “If the patient is comfortable with it, then I would feel comfortable going ahead.”

The investigators disclosed no outside funding or conflicts of interest. Dr. Winthrop disclosed relationships with AbbVie, AstraZeneca, Bristol-Myers Squibb, and others. Dr. Thakor disclosed no conflicts of interest.

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

A commentary published across four dermatology journals in September urges dermatologists and their medical societies to “engage more meaningfully” on climate change issues, “moving beyond merely discussing skin-related impacts” and toward prioritizing both patient and planetary health.

Dermatologists must make emissions-saving changes in everyday practice, for instance, and the specialty must enlist key stakeholders in public health, nonprofits, and industry – that is, pharmaceutical and medical supply companies – in finding solutions to help mitigate and adapt to climate change, wrote Eva Rawlings Parker, MD, and Markus D. Boos, MD, PhD.

“We have an ethical imperative to act,” they wrote. “The time is now for dermatologists and our medical societies to collectively rise to meet this crisis.”

Their commentary was published online in the International Journal of Dermatology , Journal of the European Academy of Dermatology and Venereology, British Journal of Dermatology, and Pediatric Dermatology.

In an interview, Dr. Parker, assistant professor of dermatology at Vanderbilt University, Nashville, Tenn., said that she and Dr. Boos, associate professor in the division of dermatology and department of pediatrics at the University of Washington, Seattle, were motivated to write the editorial upon finding that dermatology was not represented among more than 230 medical journals that published an editorial in September 2021 calling for emergency action to limit global warming and protect health. In addition to the New England Journal of Medicine and The Lancet, the copublishing journals represented numerous specialties, from nursing and pediatrics, to cardiology, rheumatology, and gastroenterology.

The editorial was not published in any dermatology journals, Dr. Parker said. “It was incredibly disappointing for me along with many of my colleagues who advocate for climate action because we realized it was a missed opportunity for dermatology to align with other medical specialties and be on the forefront of leading climate action to protect health.”
 

‘A threat multiplier’

The impact of climate change on skin disease is “an incredibly important part of our conversation as dermatologists because many cutaneous diseases are climate sensitive and we’re often seeing the effects of climate change every day in our clinical practices,” Dr. Parker said.

In fact, the impact on skin disease needs to be explored much further through more robust research funding, so that dermatology can better understand not only the incidence and severity of climate-induced changes in skin diseases – including and beyond atopic dermatitis, acne, and psoriasis – but also the mechanisms and pathophysiology involved, she said.

However, the impacts are much broader, she and Dr. Boos, a pediatric dermatologist at Seattle Children’s Hospital, maintain in their commentary. “An essential concept to broker among dermatologists is that the impacts of climate change extend well beyond skin disease by also placing broad pressure” on infrastructure, the economy, financial markets, global supply chains, food and water insecurity, and more, they wrote, noting the deep inequities of climate change.

Climate change is a “threat multiplier for public health, equity, and health systems,” the commentary says. “The confluence of these climate-related pressures should sound alarm bells as they place enormous jeopardy on the practice of dermatology across all scales and regions.”

Health care is among the most carbon-intensive service sectors worldwide, contributing to almost 5% of greenhouse gas emissions globally, the commentary says. And nationally, of the estimated greenhouse gas emissions from the United States, the health care sector contributes 10%, Dr. Parker said in the interview, referring to a 2016 report.

In addition, according to a 2019 report, the United States is the top contributor to health care’s global climate footprint, contributing 27% of health care’s global emissions, Dr. Parker noted.

Petmal/iStock/Getty Images

In their commentary, she and Dr. Boos wrote that individually and practice wide, dermatologists can impact decarbonization through measures such as virtual attendance at medical meetings and greater utilization of telehealth services. Reductions in carbon emissions were demonstrated for virtual isotretinoin follow-up visits in a recent study, and these savings could be extrapolated to other routine follow-up visits for conditions such as rosacea, monitoring of biologics in patients with well-controlled disease, and postoperative wound checks, they said.

But when it comes to measures such as significantly reducing packaging and waste and “curating supply chains to make them more sustainable,” it is medical societies that have the “larger voice and broader relationship with the pharmaceutical industry” and with medical supply manufacturers and distributors, Dr. Parker explained in the interview, noting the potential for reducing the extensive amount of packaging used for drug samples.

Dr. Parker cochairs the American Academy of Dermatology’s Expert Resource Group for Climate Change and Environmental Issues, which was established several years ago, and Dr. Boos is a member of the group’s executive committee.


 

AAD actions

In its 2018 Position Statement on Climate and Health, the American Academy of Dermatology resolved to raise awareness of the effects of climate change on the skin and educate patients about this, and to “work with other medical societies in ongoing and future efforts to educate the public and mitigate the effects of climate change on global health.”

Asked about the commentary’s call for more collaboration with industry and other stakeholders – and the impact that organized dermatology can have on planetary health – Mark D. Kaufmann, MD, president of the AAD, said in an email that the AAD is “first and foremost an organization focused on providing gold-standard educational resources for dermatologists.”

The academy recognizes that “there are many dermatologic consequences of climate change that will increasingly affect our patients and challenge our membership,” and it has provided education on climate change in forums such as articles, podcasts, and sessions at AAD meetings, said Dr. Kaufmann, clinical professor in the department of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Regarding collaboration with other societies, he said that the AAD’s “focus to date has been on how to provide our members with educational resources to understand and prepare for how climate change may impact their practices and the dermatologic health of their patients,” he said.

The AAD has also sought to address its own carbon footprint and improve sustainability of its operations, including taking steps to reduce plastic and paper waste at its educational events, and to eliminate plastic waste associated with mailing resources like its member magazine, Dr. Kaufmann noted.

And in keeping with the Academy pledge – also articulated in the 2018 position statement – to support and facilitate dermatologists’ efforts to decrease their carbon footprint “in a cost effective (or cost-saving) manner,” Dr. Kaufmann said that the AAD has been offering a program called My Green Doctor as a free benefit of membership.
 

‘Be part of the solution’

In an interview, Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, said her practice did an audit of their surgical area and found ways to increase the use of paper-packaged gauze – and decrease use of gauze in hard plastic containers – and otherwise decrease the amount of disposables, all of which take “huge amounts of resources” to create.

In the process, “we found significant savings,” she said. “Little things can turn out, in the long run, to be big things.”

Asked about the commentary, Dr. Maloney, who is involved in the AAD’s climate change resource group, said “the message is that yes, we need to be aware of the diseases affected by climate change. But our greater imperative is to be part of the solution and not part of the problem as far as doing things that affect climate change.”

Organized dermatology needs to broaden its advocacy, she said. “I don’t want us to stop advocating for things for our patients, but I do want us to start advocating for the world ... If we don’t try to [mitigate] climate change, we won’t have patients to advocate for.”

Dr. Parker, an associate editor of The Journal of Climate Change and Health, and Dr. Boos declared no conflicts of interest and no funding source for their commentary. Dr. Maloney said she has no conflicts of interest.

A commentary published across four dermatology journals in September urges dermatologists and their medical societies to “engage more meaningfully” on climate change issues, “moving beyond merely discussing skin-related impacts” and toward prioritizing both patient and planetary health.

Dermatologists must make emissions-saving changes in everyday practice, for instance, and the specialty must enlist key stakeholders in public health, nonprofits, and industry – that is, pharmaceutical and medical supply companies – in finding solutions to help mitigate and adapt to climate change, wrote Eva Rawlings Parker, MD, and Markus D. Boos, MD, PhD.

“We have an ethical imperative to act,” they wrote. “The time is now for dermatologists and our medical societies to collectively rise to meet this crisis.”

Their commentary was published online in the International Journal of Dermatology , Journal of the European Academy of Dermatology and Venereology, British Journal of Dermatology, and Pediatric Dermatology.

In an interview, Dr. Parker, assistant professor of dermatology at Vanderbilt University, Nashville, Tenn., said that she and Dr. Boos, associate professor in the division of dermatology and department of pediatrics at the University of Washington, Seattle, were motivated to write the editorial upon finding that dermatology was not represented among more than 230 medical journals that published an editorial in September 2021 calling for emergency action to limit global warming and protect health. In addition to the New England Journal of Medicine and The Lancet, the copublishing journals represented numerous specialties, from nursing and pediatrics, to cardiology, rheumatology, and gastroenterology.

The editorial was not published in any dermatology journals, Dr. Parker said. “It was incredibly disappointing for me along with many of my colleagues who advocate for climate action because we realized it was a missed opportunity for dermatology to align with other medical specialties and be on the forefront of leading climate action to protect health.”
 

‘A threat multiplier’

The impact of climate change on skin disease is “an incredibly important part of our conversation as dermatologists because many cutaneous diseases are climate sensitive and we’re often seeing the effects of climate change every day in our clinical practices,” Dr. Parker said.

In fact, the impact on skin disease needs to be explored much further through more robust research funding, so that dermatology can better understand not only the incidence and severity of climate-induced changes in skin diseases – including and beyond atopic dermatitis, acne, and psoriasis – but also the mechanisms and pathophysiology involved, she said.

However, the impacts are much broader, she and Dr. Boos, a pediatric dermatologist at Seattle Children’s Hospital, maintain in their commentary. “An essential concept to broker among dermatologists is that the impacts of climate change extend well beyond skin disease by also placing broad pressure” on infrastructure, the economy, financial markets, global supply chains, food and water insecurity, and more, they wrote, noting the deep inequities of climate change.

Climate change is a “threat multiplier for public health, equity, and health systems,” the commentary says. “The confluence of these climate-related pressures should sound alarm bells as they place enormous jeopardy on the practice of dermatology across all scales and regions.”

Health care is among the most carbon-intensive service sectors worldwide, contributing to almost 5% of greenhouse gas emissions globally, the commentary says. And nationally, of the estimated greenhouse gas emissions from the United States, the health care sector contributes 10%, Dr. Parker said in the interview, referring to a 2016 report.

In addition, according to a 2019 report, the United States is the top contributor to health care’s global climate footprint, contributing 27% of health care’s global emissions, Dr. Parker noted.

Petmal/iStock/Getty Images

In their commentary, she and Dr. Boos wrote that individually and practice wide, dermatologists can impact decarbonization through measures such as virtual attendance at medical meetings and greater utilization of telehealth services. Reductions in carbon emissions were demonstrated for virtual isotretinoin follow-up visits in a recent study, and these savings could be extrapolated to other routine follow-up visits for conditions such as rosacea, monitoring of biologics in patients with well-controlled disease, and postoperative wound checks, they said.

But when it comes to measures such as significantly reducing packaging and waste and “curating supply chains to make them more sustainable,” it is medical societies that have the “larger voice and broader relationship with the pharmaceutical industry” and with medical supply manufacturers and distributors, Dr. Parker explained in the interview, noting the potential for reducing the extensive amount of packaging used for drug samples.

Dr. Parker cochairs the American Academy of Dermatology’s Expert Resource Group for Climate Change and Environmental Issues, which was established several years ago, and Dr. Boos is a member of the group’s executive committee.


 

AAD actions

In its 2018 Position Statement on Climate and Health, the American Academy of Dermatology resolved to raise awareness of the effects of climate change on the skin and educate patients about this, and to “work with other medical societies in ongoing and future efforts to educate the public and mitigate the effects of climate change on global health.”

Asked about the commentary’s call for more collaboration with industry and other stakeholders – and the impact that organized dermatology can have on planetary health – Mark D. Kaufmann, MD, president of the AAD, said in an email that the AAD is “first and foremost an organization focused on providing gold-standard educational resources for dermatologists.”

The academy recognizes that “there are many dermatologic consequences of climate change that will increasingly affect our patients and challenge our membership,” and it has provided education on climate change in forums such as articles, podcasts, and sessions at AAD meetings, said Dr. Kaufmann, clinical professor in the department of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Regarding collaboration with other societies, he said that the AAD’s “focus to date has been on how to provide our members with educational resources to understand and prepare for how climate change may impact their practices and the dermatologic health of their patients,” he said.

The AAD has also sought to address its own carbon footprint and improve sustainability of its operations, including taking steps to reduce plastic and paper waste at its educational events, and to eliminate plastic waste associated with mailing resources like its member magazine, Dr. Kaufmann noted.

And in keeping with the Academy pledge – also articulated in the 2018 position statement – to support and facilitate dermatologists’ efforts to decrease their carbon footprint “in a cost effective (or cost-saving) manner,” Dr. Kaufmann said that the AAD has been offering a program called My Green Doctor as a free benefit of membership.
 

‘Be part of the solution’

In an interview, Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, said her practice did an audit of their surgical area and found ways to increase the use of paper-packaged gauze – and decrease use of gauze in hard plastic containers – and otherwise decrease the amount of disposables, all of which take “huge amounts of resources” to create.

In the process, “we found significant savings,” she said. “Little things can turn out, in the long run, to be big things.”

Asked about the commentary, Dr. Maloney, who is involved in the AAD’s climate change resource group, said “the message is that yes, we need to be aware of the diseases affected by climate change. But our greater imperative is to be part of the solution and not part of the problem as far as doing things that affect climate change.”

Organized dermatology needs to broaden its advocacy, she said. “I don’t want us to stop advocating for things for our patients, but I do want us to start advocating for the world ... If we don’t try to [mitigate] climate change, we won’t have patients to advocate for.”

Dr. Parker, an associate editor of The Journal of Climate Change and Health, and Dr. Boos declared no conflicts of interest and no funding source for their commentary. Dr. Maloney said she has no conflicts of interest.

A commentary published across four dermatology journals in September urges dermatologists and their medical societies to “engage more meaningfully” on climate change issues, “moving beyond merely discussing skin-related impacts” and toward prioritizing both patient and planetary health.

Dermatologists must make emissions-saving changes in everyday practice, for instance, and the specialty must enlist key stakeholders in public health, nonprofits, and industry – that is, pharmaceutical and medical supply companies – in finding solutions to help mitigate and adapt to climate change, wrote Eva Rawlings Parker, MD, and Markus D. Boos, MD, PhD.

“We have an ethical imperative to act,” they wrote. “The time is now for dermatologists and our medical societies to collectively rise to meet this crisis.”

Their commentary was published online in the International Journal of Dermatology , Journal of the European Academy of Dermatology and Venereology, British Journal of Dermatology, and Pediatric Dermatology.

In an interview, Dr. Parker, assistant professor of dermatology at Vanderbilt University, Nashville, Tenn., said that she and Dr. Boos, associate professor in the division of dermatology and department of pediatrics at the University of Washington, Seattle, were motivated to write the editorial upon finding that dermatology was not represented among more than 230 medical journals that published an editorial in September 2021 calling for emergency action to limit global warming and protect health. In addition to the New England Journal of Medicine and The Lancet, the copublishing journals represented numerous specialties, from nursing and pediatrics, to cardiology, rheumatology, and gastroenterology.

The editorial was not published in any dermatology journals, Dr. Parker said. “It was incredibly disappointing for me along with many of my colleagues who advocate for climate action because we realized it was a missed opportunity for dermatology to align with other medical specialties and be on the forefront of leading climate action to protect health.”
 

‘A threat multiplier’

The impact of climate change on skin disease is “an incredibly important part of our conversation as dermatologists because many cutaneous diseases are climate sensitive and we’re often seeing the effects of climate change every day in our clinical practices,” Dr. Parker said.

In fact, the impact on skin disease needs to be explored much further through more robust research funding, so that dermatology can better understand not only the incidence and severity of climate-induced changes in skin diseases – including and beyond atopic dermatitis, acne, and psoriasis – but also the mechanisms and pathophysiology involved, she said.

However, the impacts are much broader, she and Dr. Boos, a pediatric dermatologist at Seattle Children’s Hospital, maintain in their commentary. “An essential concept to broker among dermatologists is that the impacts of climate change extend well beyond skin disease by also placing broad pressure” on infrastructure, the economy, financial markets, global supply chains, food and water insecurity, and more, they wrote, noting the deep inequities of climate change.

Climate change is a “threat multiplier for public health, equity, and health systems,” the commentary says. “The confluence of these climate-related pressures should sound alarm bells as they place enormous jeopardy on the practice of dermatology across all scales and regions.”

Health care is among the most carbon-intensive service sectors worldwide, contributing to almost 5% of greenhouse gas emissions globally, the commentary says. And nationally, of the estimated greenhouse gas emissions from the United States, the health care sector contributes 10%, Dr. Parker said in the interview, referring to a 2016 report.

In addition, according to a 2019 report, the United States is the top contributor to health care’s global climate footprint, contributing 27% of health care’s global emissions, Dr. Parker noted.

Petmal/iStock/Getty Images

In their commentary, she and Dr. Boos wrote that individually and practice wide, dermatologists can impact decarbonization through measures such as virtual attendance at medical meetings and greater utilization of telehealth services. Reductions in carbon emissions were demonstrated for virtual isotretinoin follow-up visits in a recent study, and these savings could be extrapolated to other routine follow-up visits for conditions such as rosacea, monitoring of biologics in patients with well-controlled disease, and postoperative wound checks, they said.

But when it comes to measures such as significantly reducing packaging and waste and “curating supply chains to make them more sustainable,” it is medical societies that have the “larger voice and broader relationship with the pharmaceutical industry” and with medical supply manufacturers and distributors, Dr. Parker explained in the interview, noting the potential for reducing the extensive amount of packaging used for drug samples.

Dr. Parker cochairs the American Academy of Dermatology’s Expert Resource Group for Climate Change and Environmental Issues, which was established several years ago, and Dr. Boos is a member of the group’s executive committee.


 

AAD actions

In its 2018 Position Statement on Climate and Health, the American Academy of Dermatology resolved to raise awareness of the effects of climate change on the skin and educate patients about this, and to “work with other medical societies in ongoing and future efforts to educate the public and mitigate the effects of climate change on global health.”

Asked about the commentary’s call for more collaboration with industry and other stakeholders – and the impact that organized dermatology can have on planetary health – Mark D. Kaufmann, MD, president of the AAD, said in an email that the AAD is “first and foremost an organization focused on providing gold-standard educational resources for dermatologists.”

The academy recognizes that “there are many dermatologic consequences of climate change that will increasingly affect our patients and challenge our membership,” and it has provided education on climate change in forums such as articles, podcasts, and sessions at AAD meetings, said Dr. Kaufmann, clinical professor in the department of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Regarding collaboration with other societies, he said that the AAD’s “focus to date has been on how to provide our members with educational resources to understand and prepare for how climate change may impact their practices and the dermatologic health of their patients,” he said.

The AAD has also sought to address its own carbon footprint and improve sustainability of its operations, including taking steps to reduce plastic and paper waste at its educational events, and to eliminate plastic waste associated with mailing resources like its member magazine, Dr. Kaufmann noted.

And in keeping with the Academy pledge – also articulated in the 2018 position statement – to support and facilitate dermatologists’ efforts to decrease their carbon footprint “in a cost effective (or cost-saving) manner,” Dr. Kaufmann said that the AAD has been offering a program called My Green Doctor as a free benefit of membership.
 

‘Be part of the solution’

In an interview, Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, said her practice did an audit of their surgical area and found ways to increase the use of paper-packaged gauze – and decrease use of gauze in hard plastic containers – and otherwise decrease the amount of disposables, all of which take “huge amounts of resources” to create.

In the process, “we found significant savings,” she said. “Little things can turn out, in the long run, to be big things.”

Asked about the commentary, Dr. Maloney, who is involved in the AAD’s climate change resource group, said “the message is that yes, we need to be aware of the diseases affected by climate change. But our greater imperative is to be part of the solution and not part of the problem as far as doing things that affect climate change.”

Organized dermatology needs to broaden its advocacy, she said. “I don’t want us to stop advocating for things for our patients, but I do want us to start advocating for the world ... If we don’t try to [mitigate] climate change, we won’t have patients to advocate for.”

Dr. Parker, an associate editor of The Journal of Climate Change and Health, and Dr. Boos declared no conflicts of interest and no funding source for their commentary. Dr. Maloney said she has no conflicts of interest.

Psoriasis is an immune-mediated chronic inflammatory disease characterized by well-demarcated, scaly, erythematous plaques. Those who present with the condition often have a family history, which supports recent research uncovering various genes implicated in its pathogenesis. The disease is also associated with other systemic complications, most notably cardiovascular disease.

Palmoplantar psoriasis is a unique manifestation of psoriasis appearing in an acral distribution, but can coexist with plaque psoriasis, which is commonly found on extensor surfaces. This condition is found in a small percentage of patients with psoriasis and presentation varies from hyperkeratotic plaques to pustular lesions. The pustular form is known as palmoplantar pustulosis and is within the spectrum of palmoplantar psoriasis.

Psoriasis is typically a clinical diagnosis and its severity can be measured using the Psoriasis Area and Severity Index. If biopsy is performed, the histology demonstrates parakeratosis, orthokeratosis, loss of the stratum granulosum, and dilated vasculature with an inflammatory cell infiltrate. The keratinocytes present with abnormal differentiation and hyperplasia, and the presence of foci of neutrophils known as “Munro’s microabscesses” in the stratum corneum serve as the hallmark of histological diagnosis. However, it is important to note that appearance can vary based on the stage of the lesion and the subtype of psoriasis present.

Palmoplantar psoriasis can be especially limiting and difficult to treat because of its distribution. Topical steroids, topical vitamin D analogues, and narrow band ultraviolet light therapy can be effective for less severe cases. Methotrexate, biologic treatments, and apremilast can be used for more extensive disease.

This patient is HLA-B27 positive and has uveitis. The presence of the HLA-B27 allele has been associated with inflammatory bowel disease, uveitis, psoriatic arthritis, and reactive arthritis. It has also been reported to be associated with pustular psoriasis. She responded well to topical steroids and vitamin D analogues.

This case and photo were submitted by Mr. Shapiro at Nova Southeastern University College of Osteopathic Medicine, Davie, Fla., and Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Psoriasis: Overview and Diagnosis, in “Evidence-Based Psoriasis. Updates in Clinical Dermatology.” (Cham, Switzerland: Springer International, 2018).

2. Merola JF et al. Dermatol Ther. 2018 May;31(3):e12589.

3. Chung J et al. J Am Acad Dermatol. 2014 Oct;71(4):623-32.

Psoriasis is an immune-mediated chronic inflammatory disease characterized by well-demarcated, scaly, erythematous plaques. Those who present with the condition often have a family history, which supports recent research uncovering various genes implicated in its pathogenesis. The disease is also associated with other systemic complications, most notably cardiovascular disease.

Palmoplantar psoriasis is a unique manifestation of psoriasis appearing in an acral distribution, but can coexist with plaque psoriasis, which is commonly found on extensor surfaces. This condition is found in a small percentage of patients with psoriasis and presentation varies from hyperkeratotic plaques to pustular lesions. The pustular form is known as palmoplantar pustulosis and is within the spectrum of palmoplantar psoriasis.

Psoriasis is typically a clinical diagnosis and its severity can be measured using the Psoriasis Area and Severity Index. If biopsy is performed, the histology demonstrates parakeratosis, orthokeratosis, loss of the stratum granulosum, and dilated vasculature with an inflammatory cell infiltrate. The keratinocytes present with abnormal differentiation and hyperplasia, and the presence of foci of neutrophils known as “Munro’s microabscesses” in the stratum corneum serve as the hallmark of histological diagnosis. However, it is important to note that appearance can vary based on the stage of the lesion and the subtype of psoriasis present.

Palmoplantar psoriasis can be especially limiting and difficult to treat because of its distribution. Topical steroids, topical vitamin D analogues, and narrow band ultraviolet light therapy can be effective for less severe cases. Methotrexate, biologic treatments, and apremilast can be used for more extensive disease.

This patient is HLA-B27 positive and has uveitis. The presence of the HLA-B27 allele has been associated with inflammatory bowel disease, uveitis, psoriatic arthritis, and reactive arthritis. It has also been reported to be associated with pustular psoriasis. She responded well to topical steroids and vitamin D analogues.

This case and photo were submitted by Mr. Shapiro at Nova Southeastern University College of Osteopathic Medicine, Davie, Fla., and Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Psoriasis: Overview and Diagnosis, in “Evidence-Based Psoriasis. Updates in Clinical Dermatology.” (Cham, Switzerland: Springer International, 2018).

2. Merola JF et al. Dermatol Ther. 2018 May;31(3):e12589.

3. Chung J et al. J Am Acad Dermatol. 2014 Oct;71(4):623-32.

Psoriasis is an immune-mediated chronic inflammatory disease characterized by well-demarcated, scaly, erythematous plaques. Those who present with the condition often have a family history, which supports recent research uncovering various genes implicated in its pathogenesis. The disease is also associated with other systemic complications, most notably cardiovascular disease.

Palmoplantar psoriasis is a unique manifestation of psoriasis appearing in an acral distribution, but can coexist with plaque psoriasis, which is commonly found on extensor surfaces. This condition is found in a small percentage of patients with psoriasis and presentation varies from hyperkeratotic plaques to pustular lesions. The pustular form is known as palmoplantar pustulosis and is within the spectrum of palmoplantar psoriasis.

Psoriasis is typically a clinical diagnosis and its severity can be measured using the Psoriasis Area and Severity Index. If biopsy is performed, the histology demonstrates parakeratosis, orthokeratosis, loss of the stratum granulosum, and dilated vasculature with an inflammatory cell infiltrate. The keratinocytes present with abnormal differentiation and hyperplasia, and the presence of foci of neutrophils known as “Munro’s microabscesses” in the stratum corneum serve as the hallmark of histological diagnosis. However, it is important to note that appearance can vary based on the stage of the lesion and the subtype of psoriasis present.

Palmoplantar psoriasis can be especially limiting and difficult to treat because of its distribution. Topical steroids, topical vitamin D analogues, and narrow band ultraviolet light therapy can be effective for less severe cases. Methotrexate, biologic treatments, and apremilast can be used for more extensive disease.

This patient is HLA-B27 positive and has uveitis. The presence of the HLA-B27 allele has been associated with inflammatory bowel disease, uveitis, psoriatic arthritis, and reactive arthritis. It has also been reported to be associated with pustular psoriasis. She responded well to topical steroids and vitamin D analogues.

This case and photo were submitted by Mr. Shapiro at Nova Southeastern University College of Osteopathic Medicine, Davie, Fla., and Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. Psoriasis: Overview and Diagnosis, in “Evidence-Based Psoriasis. Updates in Clinical Dermatology.” (Cham, Switzerland: Springer International, 2018).

2. Merola JF et al. Dermatol Ther. 2018 May;31(3):e12589.

3. Chung J et al. J Am Acad Dermatol. 2014 Oct;71(4):623-32.