MDedge Rheumatology

Many people with rheumatoid arthritis (RA) have concomitant hand osteoarthritis (OA). This Swiss cohort study by Lechtenboehmer et al¹ using a longitudinal registry of RA patients examined characteristics of RA patients who had progression of radiographic hand OA. Of over 1,300 patients who had radiographic distal interphalangeal (DIP) OA at baseline, a substantial fraction had progression of OA with osteophyte formation, joint space narrowing, and subchondral sclerosis. In subgroup analysis, biologic disease-modifying antirheumatic drug (bDMARD) use was associated with osteophyte formation, while of nearly 900 patients without radiographic OA at baseline, bDMARD use was not associated with development of DIP OA. While the authors postulate that this may be due to osteoanabolic effects of bDMARDs, in this real-world analysis the association does not imply a causative role for bDMARDs as additional confounders may exist and the onset/timing of progression is unknown. Still, the association deserves attention in controlled and long-term studies.

Another condition known to affect older adults is sarcopenia; in addition to aging, poor nutrition, lack of exercise, and autoimmune disease are thought to contribute to sarcopenia. RA is associated with an increased risk of sarcopenia. A cross-sectional study of cohort of Japanese women by Minamino et al.² of RA examines the potential relationship between 25-OH vitamin D levels and sarcopenia. Participants were over the age of 60 and not taking vitamin D supplements. Low vitamin D levels, as well as age, 28-Joint RA Disease Activity Score (DAS-28), and health assessment questionnaire disability index (HAQ), were associated with the prevalence of severe sarcopenia, including the separate components of muscle mass, physical performance, and strength. Although this does not prove causation, the known decrease in vitamin D receptors in muscle nuclei with aging lends pathophysiologic support to vitamin D’s role in sarcopenia. Whether this plays a larger role in RA-related sarcopenia also remains to be seen.

Several recent studies have expanded our awareness of respiratory illness and exposure outside of cigarette smoking as potentially associated with RA risk. This single-center case control study by Kronzer et al³ looked at respiratory disease diagnosis (based on ICD10 code) at least two years prior to RA diagnosis. Acute and chronic sinusitis, as well as pharyngitis, were associated with increased risk of RA, even adjusting for the known risk of smoking, raising the possibility of a role for the upper respiratory mucosa in RA pathogenesis. Whether this association is a sign of immune dysregulation instead or a result of other respiratory exposures is a question that should be further investigated given this growing body of evidence of respiratory involvement in RA pathogenesis.

In terms of other factors that influence the development of autoimmune disease, there is evidence of the involvement of the gut microbiome in RA pathogenesis, as well as public interest in the possibility of an optimal diet, such as the “Mediterranean diet” for control of arthritis symptoms. The recent Swedish crossover Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study by Turesson Wadell et al⁴ examined effects of a “typical” and “anti-inflammatory” diet with whole grains, fruits, nuts, legumes, fatty fish, and probiotics in patients with RA. Prior work suggested that the anti-inflammatory diet was associated with lower RA disease activity and inflammatory markers. Only 44 patients completed the 10 week study, perhaps contributing to the lack of differences seen in functional measures, pain, fatigue, and morning stiffness at the end of the intervention. Changes in medications may have masked dietary effects in this small study and a longer study period may be necessary to assess effects. Given the lack of evidence in this area, further research is of course needed, but this study represents an initial attempt at rigorous examination and could be suggested to interested and motivated patients as generally safe.

References

1. Lechtenboehmer CA et al. Increased radiographic progression of distal hand osteoarthritis occurring during biologic DMARD monotherapy for concomitant rheumatoid arthritis. Arthritis Res Ther. 2021;23:267 (Oct 26).
2. Minamino H et al. Serum vitamin D status inversely associates with a prevalence of severe sarcopenia among female patients with rheumatoid arthritis. Sci Rep. 2021;11:20485 (Oct 14).
3. Kronzer VL et al. Association of sinusitis and upper respiratory tract diseases with incident rheumatoid arthritis: A case-control study. J Rheumatol 2021(Oct 15).
4. Turesson Wadell A et al. Effects on health-related quality of life in the randomized, controlled crossover trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis). PLoS One. 2021(Oct 14).

Many people with rheumatoid arthritis (RA) have concomitant hand osteoarthritis (OA). This Swiss cohort study by Lechtenboehmer et al¹ using a longitudinal registry of RA patients examined characteristics of RA patients who had progression of radiographic hand OA. Of over 1,300 patients who had radiographic distal interphalangeal (DIP) OA at baseline, a substantial fraction had progression of OA with osteophyte formation, joint space narrowing, and subchondral sclerosis. In subgroup analysis, biologic disease-modifying antirheumatic drug (bDMARD) use was associated with osteophyte formation, while of nearly 900 patients without radiographic OA at baseline, bDMARD use was not associated with development of DIP OA. While the authors postulate that this may be due to osteoanabolic effects of bDMARDs, in this real-world analysis the association does not imply a causative role for bDMARDs as additional confounders may exist and the onset/timing of progression is unknown. Still, the association deserves attention in controlled and long-term studies.

Another condition known to affect older adults is sarcopenia; in addition to aging, poor nutrition, lack of exercise, and autoimmune disease are thought to contribute to sarcopenia. RA is associated with an increased risk of sarcopenia. A cross-sectional study of cohort of Japanese women by Minamino et al.² of RA examines the potential relationship between 25-OH vitamin D levels and sarcopenia. Participants were over the age of 60 and not taking vitamin D supplements. Low vitamin D levels, as well as age, 28-Joint RA Disease Activity Score (DAS-28), and health assessment questionnaire disability index (HAQ), were associated with the prevalence of severe sarcopenia, including the separate components of muscle mass, physical performance, and strength. Although this does not prove causation, the known decrease in vitamin D receptors in muscle nuclei with aging lends pathophysiologic support to vitamin D’s role in sarcopenia. Whether this plays a larger role in RA-related sarcopenia also remains to be seen.

Several recent studies have expanded our awareness of respiratory illness and exposure outside of cigarette smoking as potentially associated with RA risk. This single-center case control study by Kronzer et al³ looked at respiratory disease diagnosis (based on ICD10 code) at least two years prior to RA diagnosis. Acute and chronic sinusitis, as well as pharyngitis, were associated with increased risk of RA, even adjusting for the known risk of smoking, raising the possibility of a role for the upper respiratory mucosa in RA pathogenesis. Whether this association is a sign of immune dysregulation instead or a result of other respiratory exposures is a question that should be further investigated given this growing body of evidence of respiratory involvement in RA pathogenesis.

In terms of other factors that influence the development of autoimmune disease, there is evidence of the involvement of the gut microbiome in RA pathogenesis, as well as public interest in the possibility of an optimal diet, such as the “Mediterranean diet” for control of arthritis symptoms. The recent Swedish crossover Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study by Turesson Wadell et al⁴ examined effects of a “typical” and “anti-inflammatory” diet with whole grains, fruits, nuts, legumes, fatty fish, and probiotics in patients with RA. Prior work suggested that the anti-inflammatory diet was associated with lower RA disease activity and inflammatory markers. Only 44 patients completed the 10 week study, perhaps contributing to the lack of differences seen in functional measures, pain, fatigue, and morning stiffness at the end of the intervention. Changes in medications may have masked dietary effects in this small study and a longer study period may be necessary to assess effects. Given the lack of evidence in this area, further research is of course needed, but this study represents an initial attempt at rigorous examination and could be suggested to interested and motivated patients as generally safe.

References

1. Lechtenboehmer CA et al. Increased radiographic progression of distal hand osteoarthritis occurring during biologic DMARD monotherapy for concomitant rheumatoid arthritis. Arthritis Res Ther. 2021;23:267 (Oct 26).
2. Minamino H et al. Serum vitamin D status inversely associates with a prevalence of severe sarcopenia among female patients with rheumatoid arthritis. Sci Rep. 2021;11:20485 (Oct 14).
3. Kronzer VL et al. Association of sinusitis and upper respiratory tract diseases with incident rheumatoid arthritis: A case-control study. J Rheumatol 2021(Oct 15).
4. Turesson Wadell A et al. Effects on health-related quality of life in the randomized, controlled crossover trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis). PLoS One. 2021(Oct 14).

Many people with rheumatoid arthritis (RA) have concomitant hand osteoarthritis (OA). This Swiss cohort study by Lechtenboehmer et al¹ using a longitudinal registry of RA patients examined characteristics of RA patients who had progression of radiographic hand OA. Of over 1,300 patients who had radiographic distal interphalangeal (DIP) OA at baseline, a substantial fraction had progression of OA with osteophyte formation, joint space narrowing, and subchondral sclerosis. In subgroup analysis, biologic disease-modifying antirheumatic drug (bDMARD) use was associated with osteophyte formation, while of nearly 900 patients without radiographic OA at baseline, bDMARD use was not associated with development of DIP OA. While the authors postulate that this may be due to osteoanabolic effects of bDMARDs, in this real-world analysis the association does not imply a causative role for bDMARDs as additional confounders may exist and the onset/timing of progression is unknown. Still, the association deserves attention in controlled and long-term studies.

Another condition known to affect older adults is sarcopenia; in addition to aging, poor nutrition, lack of exercise, and autoimmune disease are thought to contribute to sarcopenia. RA is associated with an increased risk of sarcopenia. A cross-sectional study of cohort of Japanese women by Minamino et al.² of RA examines the potential relationship between 25-OH vitamin D levels and sarcopenia. Participants were over the age of 60 and not taking vitamin D supplements. Low vitamin D levels, as well as age, 28-Joint RA Disease Activity Score (DAS-28), and health assessment questionnaire disability index (HAQ), were associated with the prevalence of severe sarcopenia, including the separate components of muscle mass, physical performance, and strength. Although this does not prove causation, the known decrease in vitamin D receptors in muscle nuclei with aging lends pathophysiologic support to vitamin D’s role in sarcopenia. Whether this plays a larger role in RA-related sarcopenia also remains to be seen.

Several recent studies have expanded our awareness of respiratory illness and exposure outside of cigarette smoking as potentially associated with RA risk. This single-center case control study by Kronzer et al³ looked at respiratory disease diagnosis (based on ICD10 code) at least two years prior to RA diagnosis. Acute and chronic sinusitis, as well as pharyngitis, were associated with increased risk of RA, even adjusting for the known risk of smoking, raising the possibility of a role for the upper respiratory mucosa in RA pathogenesis. Whether this association is a sign of immune dysregulation instead or a result of other respiratory exposures is a question that should be further investigated given this growing body of evidence of respiratory involvement in RA pathogenesis.

In terms of other factors that influence the development of autoimmune disease, there is evidence of the involvement of the gut microbiome in RA pathogenesis, as well as public interest in the possibility of an optimal diet, such as the “Mediterranean diet” for control of arthritis symptoms. The recent Swedish crossover Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study by Turesson Wadell et al⁴ examined effects of a “typical” and “anti-inflammatory” diet with whole grains, fruits, nuts, legumes, fatty fish, and probiotics in patients with RA. Prior work suggested that the anti-inflammatory diet was associated with lower RA disease activity and inflammatory markers. Only 44 patients completed the 10 week study, perhaps contributing to the lack of differences seen in functional measures, pain, fatigue, and morning stiffness at the end of the intervention. Changes in medications may have masked dietary effects in this small study and a longer study period may be necessary to assess effects. Given the lack of evidence in this area, further research is of course needed, but this study represents an initial attempt at rigorous examination and could be suggested to interested and motivated patients as generally safe.

References

1. Lechtenboehmer CA et al. Increased radiographic progression of distal hand osteoarthritis occurring during biologic DMARD monotherapy for concomitant rheumatoid arthritis. Arthritis Res Ther. 2021;23:267 (Oct 26).
2. Minamino H et al. Serum vitamin D status inversely associates with a prevalence of severe sarcopenia among female patients with rheumatoid arthritis. Sci Rep. 2021;11:20485 (Oct 14).
3. Kronzer VL et al. Association of sinusitis and upper respiratory tract diseases with incident rheumatoid arthritis: A case-control study. J Rheumatol 2021(Oct 15).
4. Turesson Wadell A et al. Effects on health-related quality of life in the randomized, controlled crossover trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis). PLoS One. 2021(Oct 14).

Research published in November has provided us with insights on the impact of psoriatic arthritis (PsA) as well as treatment outcomes. Although PsA often affects women of child-bearing age, data on pregnancy outcomes in PsA is scarce. To evaluate pregnancy outcomes in patients with severe PsA, Remaeus et al¹ conducted a Swedish nationwide register-based cohort study of births from Jul 1 2007 to Dec 31 2017. A total of 921 PsA- pregnancies and 9210 non-PsA-pregnancies (matched on maternal age, year, and parity) were identified. Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (surrogate for disease severity- preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36). Thus, pregnant women with PsA, particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes and therefore should be counselled appropriately.

Depression is a well-known comorbidity of PsA. However, little is known about the impact of the COVID-19 pandemic on the prevalence of depressive symptoms in PsA patients. Engelbrecht et al² evaluated 89 patients with PsA participating in the German multicenter RheumaDatenRhePort registry. Symptoms of depression were assessed using the Patient Health Questionnaire-2 (PHQ-2). The majority of patients scored <2 on the PHQ-2 indicating that they did not have depressive symptoms during (85.39%) and prior to (83.15%) the pandemic. The prevalence of depressive symptoms was not significantly different before and during the pandemic, irrespective of disease activity. Thus, contrary to expectations, the COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with PsA.

With regard to longer-term treatment efficacy and safety of recently approved advanced therapies for PsA, McInnes et al reported 2-year results from the from the Phase-3 DISCOVER-2 trial that included 739 biologic-naive patients with active PsA. At week 100, ACR20 response was achieved by 76%, 74%, and 68% of patients who initially were randomized to receive guselkumab every 4 weeks, every 8 weeks, or placebo, respectively, indicating a durable response. No new safety signals were identified. The 56-week efficacy and safety results from SELECT-PsA 1 trial with upadacitinib reported by McInnes et al^4,5 showed that of 1705 patients randomized, 1419 (83.2%) completed 56 weeks of treatment. A higher proportion of patients achieved ACR20 response with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Safety, especially risk of infection, remains a significant concern when treating patients with biologics, especially tumor necrosis factor inhibitors (TNFi). Patients with rheumatoid arthritis (RA) are known to have a higher risk of infection, but data are scarce regarding the risk of serious infections in patients with PsA treated with TNFi and the comparative risk of infection in TNFi-treated RA patients versus patients with PsA. Using data from 1,352 and 1,007 patients with RA and PsA, respectively, followed in the prospective multi-center NORwegian-Disease Modifying Anti-Rheumatic Drug (NOR-DMARD) registry, Christensen et al report that patients with PsA vs. RA had a lower risk of contracting serious infections (adjusted hazard ratio 0.65; P = .025).

References

1. Remaeus K et al. Pregnancy outcomes in women with psoriatic arthritis with respect to presence and timing of antirheumatic treatment. Arthritis Rheumatol. 2021(Oct 20).
2. Englbrecht M et al. Prevalence of depressive symptoms in patients with psoriatic arthritis: have numbers changed during the COVID-19 pandemic? Front Med (Lausanne). 2021(Nov 1);8:74826
3. McInnes IB et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through 2 years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2021(Nov 1).
4. McInnes IB et al. Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study.  RMD Open. 2021;7:e001838 (Oct 18).
5. Christensen IE et al. Serious infections in patients with rheumatoid arthritis and psoriatic arthritis treated with tumour necrosis factor inhibitors: data from register linkage of the NOR-DMARD study. Ann Rheum Dis. 2021(Oct 8). Correction: Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study. RMD Open. 2021 Nov;7(3):e001838corr1.

Research published in November has provided us with insights on the impact of psoriatic arthritis (PsA) as well as treatment outcomes. Although PsA often affects women of child-bearing age, data on pregnancy outcomes in PsA is scarce. To evaluate pregnancy outcomes in patients with severe PsA, Remaeus et al¹ conducted a Swedish nationwide register-based cohort study of births from Jul 1 2007 to Dec 31 2017. A total of 921 PsA- pregnancies and 9210 non-PsA-pregnancies (matched on maternal age, year, and parity) were identified. Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (surrogate for disease severity- preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36). Thus, pregnant women with PsA, particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes and therefore should be counselled appropriately.

Depression is a well-known comorbidity of PsA. However, little is known about the impact of the COVID-19 pandemic on the prevalence of depressive symptoms in PsA patients. Engelbrecht et al² evaluated 89 patients with PsA participating in the German multicenter RheumaDatenRhePort registry. Symptoms of depression were assessed using the Patient Health Questionnaire-2 (PHQ-2). The majority of patients scored <2 on the PHQ-2 indicating that they did not have depressive symptoms during (85.39%) and prior to (83.15%) the pandemic. The prevalence of depressive symptoms was not significantly different before and during the pandemic, irrespective of disease activity. Thus, contrary to expectations, the COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with PsA.

With regard to longer-term treatment efficacy and safety of recently approved advanced therapies for PsA, McInnes et al reported 2-year results from the from the Phase-3 DISCOVER-2 trial that included 739 biologic-naive patients with active PsA. At week 100, ACR20 response was achieved by 76%, 74%, and 68% of patients who initially were randomized to receive guselkumab every 4 weeks, every 8 weeks, or placebo, respectively, indicating a durable response. No new safety signals were identified. The 56-week efficacy and safety results from SELECT-PsA 1 trial with upadacitinib reported by McInnes et al^4,5 showed that of 1705 patients randomized, 1419 (83.2%) completed 56 weeks of treatment. A higher proportion of patients achieved ACR20 response with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Safety, especially risk of infection, remains a significant concern when treating patients with biologics, especially tumor necrosis factor inhibitors (TNFi). Patients with rheumatoid arthritis (RA) are known to have a higher risk of infection, but data are scarce regarding the risk of serious infections in patients with PsA treated with TNFi and the comparative risk of infection in TNFi-treated RA patients versus patients with PsA. Using data from 1,352 and 1,007 patients with RA and PsA, respectively, followed in the prospective multi-center NORwegian-Disease Modifying Anti-Rheumatic Drug (NOR-DMARD) registry, Christensen et al report that patients with PsA vs. RA had a lower risk of contracting serious infections (adjusted hazard ratio 0.65; P = .025).

References

1. Remaeus K et al. Pregnancy outcomes in women with psoriatic arthritis with respect to presence and timing of antirheumatic treatment. Arthritis Rheumatol. 2021(Oct 20).
2. Englbrecht M et al. Prevalence of depressive symptoms in patients with psoriatic arthritis: have numbers changed during the COVID-19 pandemic? Front Med (Lausanne). 2021(Nov 1);8:74826
3. McInnes IB et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through 2 years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2021(Nov 1).
4. McInnes IB et al. Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study.  RMD Open. 2021;7:e001838 (Oct 18).
5. Christensen IE et al. Serious infections in patients with rheumatoid arthritis and psoriatic arthritis treated with tumour necrosis factor inhibitors: data from register linkage of the NOR-DMARD study. Ann Rheum Dis. 2021(Oct 8). Correction: Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study. RMD Open. 2021 Nov;7(3):e001838corr1.

Research published in November has provided us with insights on the impact of psoriatic arthritis (PsA) as well as treatment outcomes. Although PsA often affects women of child-bearing age, data on pregnancy outcomes in PsA is scarce. To evaluate pregnancy outcomes in patients with severe PsA, Remaeus et al¹ conducted a Swedish nationwide register-based cohort study of births from Jul 1 2007 to Dec 31 2017. A total of 921 PsA- pregnancies and 9210 non-PsA-pregnancies (matched on maternal age, year, and parity) were identified. Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (surrogate for disease severity- preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36). Thus, pregnant women with PsA, particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes and therefore should be counselled appropriately.

Depression is a well-known comorbidity of PsA. However, little is known about the impact of the COVID-19 pandemic on the prevalence of depressive symptoms in PsA patients. Engelbrecht et al² evaluated 89 patients with PsA participating in the German multicenter RheumaDatenRhePort registry. Symptoms of depression were assessed using the Patient Health Questionnaire-2 (PHQ-2). The majority of patients scored <2 on the PHQ-2 indicating that they did not have depressive symptoms during (85.39%) and prior to (83.15%) the pandemic. The prevalence of depressive symptoms was not significantly different before and during the pandemic, irrespective of disease activity. Thus, contrary to expectations, the COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with PsA.

With regard to longer-term treatment efficacy and safety of recently approved advanced therapies for PsA, McInnes et al reported 2-year results from the from the Phase-3 DISCOVER-2 trial that included 739 biologic-naive patients with active PsA. At week 100, ACR20 response was achieved by 76%, 74%, and 68% of patients who initially were randomized to receive guselkumab every 4 weeks, every 8 weeks, or placebo, respectively, indicating a durable response. No new safety signals were identified. The 56-week efficacy and safety results from SELECT-PsA 1 trial with upadacitinib reported by McInnes et al^4,5 showed that of 1705 patients randomized, 1419 (83.2%) completed 56 weeks of treatment. A higher proportion of patients achieved ACR20 response with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Safety, especially risk of infection, remains a significant concern when treating patients with biologics, especially tumor necrosis factor inhibitors (TNFi). Patients with rheumatoid arthritis (RA) are known to have a higher risk of infection, but data are scarce regarding the risk of serious infections in patients with PsA treated with TNFi and the comparative risk of infection in TNFi-treated RA patients versus patients with PsA. Using data from 1,352 and 1,007 patients with RA and PsA, respectively, followed in the prospective multi-center NORwegian-Disease Modifying Anti-Rheumatic Drug (NOR-DMARD) registry, Christensen et al report that patients with PsA vs. RA had a lower risk of contracting serious infections (adjusted hazard ratio 0.65; P = .025).

References

1. Remaeus K et al. Pregnancy outcomes in women with psoriatic arthritis with respect to presence and timing of antirheumatic treatment. Arthritis Rheumatol. 2021(Oct 20).
2. Englbrecht M et al. Prevalence of depressive symptoms in patients with psoriatic arthritis: have numbers changed during the COVID-19 pandemic? Front Med (Lausanne). 2021(Nov 1);8:74826
3. McInnes IB et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through 2 years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2021(Nov 1).
4. McInnes IB et al. Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study.  RMD Open. 2021;7:e001838 (Oct 18).
5. Christensen IE et al. Serious infections in patients with rheumatoid arthritis and psoriatic arthritis treated with tumour necrosis factor inhibitors: data from register linkage of the NOR-DMARD study. Ann Rheum Dis. 2021(Oct 8). Correction: Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study. RMD Open. 2021 Nov;7(3):e001838corr1.

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Dr Joan Merrill, of the Oklahoma Medical Research Foundation in Oklahoma City, reviews updates on several treatment options for systemic lupus erythematosus that were presented at the 2021 ACR Convergence.  

Dr Merrill begins by sharing data from a phase 2 study in which she and her colleagues investigated the efficacy and safety data for iberdomide. The novel agent was associated with sustained clinical benefits in multiple measures of disease activity and was well tolerated through week 52.  

Next, she reports on a post-hoc analysis of the BLISS-LN trial that evaluated the effects of belimumab plus standard therapy on renal outcomes in patients with or without steroid pulses during induction therapy. The study found that belimumab improved kidney outcomes compared with placebo, regardless of whether steroid pulses were administered. However, it was also observed that prevention of lupus nephritis flares was more prominent in patients who received steroid pulses.  

Finally, Dr Merrill highlights a late-breaking poster that reported results from BLISS-BELIEVE, a study evaluating the efficacy and safety of belimumab plus rituximab. Although adding a single cycle of rituximab to belimumab did not improve disease control or remission, the study found that duration of disease control at week 52 and SLEDAI-2K reductions at week 104 were significantly greater in this group compared with the belimumab-plus-placebo group. However, there were also more serious infections reported in the belimumab-plus-rituximab group. 

--

Joan Merrill, MD, Professor, Department of Medicine, University of Oklahoma Health Sciences Center; Director of Clinical Projects, Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 

Joan Merrill, MD, has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Biogen 

Received research grant from: AstraZeneca 

Received income in an amount equal to or greater than $250 from: AbbVie; Amgen; AstraZeneca; Aurinia; Biogen; BMS; EMD Serono; Genentech; GSK; Janssen; Provention; RemeGen; Sanofi; UCB; Zenas 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Rheumatologist Stanley B. Cohen from UT Southwestern Medical School offers insight on key findings in rheumatoid arthritis (RA) presented at ACR 2021. 

First, Dr Cohen discusses a series of abstracts from the ORAL Surveillance trial. The study demonstrated that the incidence of major adverse cardiovascular events and malignancies was higher with tofacitinib than with tumor necrosis factor inhibitors, but only in certain patient subgroups. Next, he highlights a series of abstracts looking at the response to COVID vaccination in patients with autoimmune diseases, primarily RA. It was observed that many RA therapies blunt the response to COVID vaccines. 

Dr Cohen then discusses a study of the ability of abatacept to delay the development of RA. The study evaluated patients who received abatacept vs placebo for 6 months and were then followed up 1 year after treatment. After 12 months, close to 40% of people on placebo developed RA vs only 8% of those on abatacept.  

He then shares insight on a study that examined whether initial response to RA therapy could predict a patient's risk for refractory RA. The study found that patients for whom initial therapy was ineffective or difficult to tolerate were more likely to develop refractory RA.  

Dr Cohen closes his commentary by discussing a study on the effectiveness of cycling JAK inhibitors in patients with RA.  

--

Clinical Professor, Department of Internal Medicine, UT Southwestern Medical School; Director, Rheumatology Training Program, THR Presbyterian, Rheumatology Associates, Dallas, Texas 

Stanley B. Cohen, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

Received research grant from: Amgen; AbbVie; Pfizer; BMS; Genentech; Lilly 

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A new study has established guselkumab (Tremfya) as both a safe and effective treatment option for psoriatic arthritis (PsA) in patients who had previously responded poorly to tumor necrosis factor inhibitors (TNFis).

“While the positive guselkumab benefit-risk profile observed through week 24 was maintained through 1 year, real-world evidence will further inform long-term guselkumab persistence in TNFi-inadequate response patients,” writes Laura C. Coates, MBChB, PhD, of the University of Oxford (England), and her coauthors. The study was published in the Annals of the Rheumatic Diseases.

Previous studies indicated that the anti–interleukin-23p19 monoclonal antibody improved outcomes in patients with PsA, even after 1 year, but some uncertainty remained regarding the surprisingly similar level of effectiveness in biologic-naive and TNFi-treated patients. Guselkumab is approved for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.

Clarity on guselkumab’s effectiveness in certain patients

“In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,” Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the division of rheumatology at Northwestern University in Chicago, Illinois, said in an interview. “We didn’t really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.

“Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials,” said Dr. Ruderman, who was not involved in the study. “You can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

When asked about potential follow-up studies, Dr. Ruderman noted that “the missing piece of the puzzle is that we still really have no way to compare this to other biologics. The next step would be to ask, in a single trial, what happens if you give some people TNF inhibitors and some people guselkumab? Just to try to give us context. Is this equivalent? Is it less effective? More effective? Where does it fit? Without that information, rheumatologists may struggle to figure out who is the right person for this drug and how often should they use it.”

Study details

To assess the efficacy and safety of guselkumab in patients who had previously taken TNFis but stopped because of inefficacy or intolerance, the researchers launched a randomized, double-blind study called COSMOS at 84 European sites from March 2019 to November 2020. The study’s 285 patients – 52% of whom were women, with an average overall age of 49 – were assigned to two groups: guselkumab (n = 189) or placebo (n = 96). A total of 88% of all patients had used one TNFi prior; 12% had used two.

The guselkumab group received 100-mg injections at week 0, week 4, and then every 8 weeks through week 44; the placebo group received injections at weeks 0, 4, 12, and 20, followed by 100 mg of guselkumab at weeks 24, 28, 36, and 44. Patients with less than 5% improvement from baseline in both tender and swollen joint counts at week 16 qualified for early escape to “initiate or increase the dose of one permitted concomitant medication up to the maximum allowed dose at the physician’s discretion.” Ultimately, 88% of patients in the guselkumab arm and 83% of the placebo arm completed the study.

At 24 weeks, more than 44% of the guselkumab group achieved a 20% or greater improvement in American College of Rheumatology criteria (ACR20), compared with just under 20% of the placebo group, a difference of nearly 25% (95% confidence interval, 14.1%-35.2%; multiplicity-adjusted P < .001). At 48 weeks, nearly 58% of the guselkumab group had achieved ACR20; of the 51 patients in the placebo arm who started taking guselkumab at week 24, 55% achieved ACR20 by week 48.

Through 24 weeks, 80 patients in the guselkumab group (42%) and 46 patients in the placebo group (48%) experienced adverse events; only 3.7% and 3.1% developed serious adverse events, respectively. The most common adverse events in the guselkumab group at that point included nasopharyngitis (5%) and upper respiratory tract infection (4%), which occurred at a similar frequency (5% and 3%) in the placebo group.

The authors acknowledge their study’s limitations, including imbalances in baseline characteristics such as gender and weight, as well as the COSMOS study being restricted to European patients and thus potentially limiting diversity. In addition, while the COVID-19 pandemic may have increased major protocol deviations near the end of the study, the authors note that “most were related to timing of study visits and did not impact efficacy.”

The study was funded by Janssen, and six authors reported being employees of the company. The authors also acknowledge numerous potential conflicts of interest, including receiving consulting fees and research grants from various pharmaceutical companies, including Janssen. Dr. Ruderman is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Janssen and served on the data safety monitoring committee for two other phase 3 guselkumab trials.

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

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images

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

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images

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

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images

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

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

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

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

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

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

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

COVID-19’s relentless toll on the clinical workforce inspired four doctors to draft an action plan to stem the exits and help colleagues preserve their physical and mental health.

Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.

“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.

The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.

“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”

Among the other action items are:

• Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
• Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
• Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
• Encourage clinicians to use vacation time; leaders should model this.
• Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.

The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine

Action items intended to be easily achievable, low cost

Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.

She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.

“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.

Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.

“It’s not just about a hug or a piece of pizza,” she said.

Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.

“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”

Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.

“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.

Favorable reactions to list

Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”

Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.

Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.

“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
 

Outside expert: Not all items may be easy to implement

Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.

The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.

According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.

“Most of these things are hard and we need to be in it for the long run,” she said.

The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
 

Related research

A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.

The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.

Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.

The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”

Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.

COVID-19’s relentless toll on the clinical workforce inspired four doctors to draft an action plan to stem the exits and help colleagues preserve their physical and mental health.

Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.

“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.

The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.

“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”

Among the other action items are:

• Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
• Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
• Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
• Encourage clinicians to use vacation time; leaders should model this.
• Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.

The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine

Action items intended to be easily achievable, low cost

Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.

She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.

“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.

Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.

“It’s not just about a hug or a piece of pizza,” she said.

Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.

“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”

Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.

“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.

Favorable reactions to list

Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”

Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.

Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.

“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
 

Outside expert: Not all items may be easy to implement

Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.

The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.

According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.

“Most of these things are hard and we need to be in it for the long run,” she said.

The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
 

Related research

A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.

The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.

Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.

The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”

Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.

COVID-19’s relentless toll on the clinical workforce inspired four doctors to draft an action plan to stem the exits and help colleagues preserve their physical and mental health.

Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.

“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.

The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.

“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”

Among the other action items are:

• Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
• Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
• Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
• Encourage clinicians to use vacation time; leaders should model this.
• Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.

The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine

Action items intended to be easily achievable, low cost

Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.

She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.

“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.

Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.

“It’s not just about a hug or a piece of pizza,” she said.

Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.

“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”

Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.

“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.

Favorable reactions to list

Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”

Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.

Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.

“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
 

Outside expert: Not all items may be easy to implement

Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.

The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.

According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.

“Most of these things are hard and we need to be in it for the long run,” she said.

The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
 

Related research

A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.

The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.

Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.

The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”

Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.

A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.

The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before.  He sought testing on Nov. 24.  His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health.  The man was fully vaccinated, the department said.

He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.

“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”

The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.

This breaking news story will be updated.

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

A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.

The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before.  He sought testing on Nov. 24.  His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health.  The man was fully vaccinated, the department said.

He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.

“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”

The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.

This breaking news story will be updated.

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

A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.

The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before.  He sought testing on Nov. 24.  His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health.  The man was fully vaccinated, the department said.

He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.

“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”

The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.

This breaking news story will be updated.

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