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Osteoporosis remains highly prevalent in patients with RA
Key clinical point: The prevalence for osteoporosis continues to remain high in patients with rheumatoid arthritis (RA) despite significant advances in diagnostic methods, prevention, and treatment.
Major finding: Overall, osteoporosis was highly prevalent in patients with RA (prevalence, 27.6%; 95% CI, 23.9%-31.3%), with the prevalence being the highest in studies during 2011-2015 (36.2%; 95% CI, 24.5%-47.8%), followed by 2016-2021 (27.1%; 95% CI, 20.7%-33.4%), and before 2010 (21.6%; 95% CI, 15.8%-27.4%).
Study details: Findings are from a systematic review and meta-analysis of 57 studies including 227,812 patients with RA, of which 64,290 reported osteoporosis.
Disclosures: This study was funded by Arak University of Medical Sciences. The authors declared no conflicts of interest.
Source: Moshayedi S et al. The prevalence of osteoporosis in rheumatoid arthritis patient: A systematic review and meta-analysis. Sci Rep. 2022;12(1):15844 (Sep 23). Doi: 10.1038/s41598-022-20016-x.
Key clinical point: The prevalence for osteoporosis continues to remain high in patients with rheumatoid arthritis (RA) despite significant advances in diagnostic methods, prevention, and treatment.
Major finding: Overall, osteoporosis was highly prevalent in patients with RA (prevalence, 27.6%; 95% CI, 23.9%-31.3%), with the prevalence being the highest in studies during 2011-2015 (36.2%; 95% CI, 24.5%-47.8%), followed by 2016-2021 (27.1%; 95% CI, 20.7%-33.4%), and before 2010 (21.6%; 95% CI, 15.8%-27.4%).
Study details: Findings are from a systematic review and meta-analysis of 57 studies including 227,812 patients with RA, of which 64,290 reported osteoporosis.
Disclosures: This study was funded by Arak University of Medical Sciences. The authors declared no conflicts of interest.
Source: Moshayedi S et al. The prevalence of osteoporosis in rheumatoid arthritis patient: A systematic review and meta-analysis. Sci Rep. 2022;12(1):15844 (Sep 23). Doi: 10.1038/s41598-022-20016-x.
Key clinical point: The prevalence for osteoporosis continues to remain high in patients with rheumatoid arthritis (RA) despite significant advances in diagnostic methods, prevention, and treatment.
Major finding: Overall, osteoporosis was highly prevalent in patients with RA (prevalence, 27.6%; 95% CI, 23.9%-31.3%), with the prevalence being the highest in studies during 2011-2015 (36.2%; 95% CI, 24.5%-47.8%), followed by 2016-2021 (27.1%; 95% CI, 20.7%-33.4%), and before 2010 (21.6%; 95% CI, 15.8%-27.4%).
Study details: Findings are from a systematic review and meta-analysis of 57 studies including 227,812 patients with RA, of which 64,290 reported osteoporosis.
Disclosures: This study was funded by Arak University of Medical Sciences. The authors declared no conflicts of interest.
Source: Moshayedi S et al. The prevalence of osteoporosis in rheumatoid arthritis patient: A systematic review and meta-analysis. Sci Rep. 2022;12(1):15844 (Sep 23). Doi: 10.1038/s41598-022-20016-x.
RA: High serum IFNβ levels predict early relapse after bDMARD withdrawal
Key clinical point: Serum levels of interferon beta (IFNβ) may distinguish early from late relapse after biologic disease-modifying antirheumatic drug (bDMARD) withdrawal in patients with rheumatoid arthritis (RA).
Major finding: Patients with serum IFNβ levels of 3.38 vs. <3.38 in log2 had a significantly lower probability of sustained remission during the first 6 months of bDMARD withdrawal (log-rank test, P = .0177). Serum IFNβ levels of 3.38 in log2 at the time of bDMARD withdrawal predicted early vs. late relapse in patients with highly probable relapses (area under the curve, 0.833) and patients with lower IFNβ levels (<3.38 in log2) were able to safely discontinue bDMARD.
Study details: This prospective study included 40 patients with RA who maintained clinical remission with bDMARDs for >12 months, of which 26 relapsed at some point after bDMARD withdrawal.
Disclosures: This study was partially supported by unlimited research fund from Chugai Pharm, Eisai, and Mitsubishi-Tanabe provided to S Minota. The authors declared no conflicts of interest.
Source: Sakashita E et al. Serum level of IFNβ distinguishes early from late relapses after biologics withdrawal in rheumatoid arthritis. Sci Rep. 2022;12(1):16547 (Oct 3). Doi: 10.1038/s41598-022-21160-0.
Key clinical point: Serum levels of interferon beta (IFNβ) may distinguish early from late relapse after biologic disease-modifying antirheumatic drug (bDMARD) withdrawal in patients with rheumatoid arthritis (RA).
Major finding: Patients with serum IFNβ levels of 3.38 vs. <3.38 in log2 had a significantly lower probability of sustained remission during the first 6 months of bDMARD withdrawal (log-rank test, P = .0177). Serum IFNβ levels of 3.38 in log2 at the time of bDMARD withdrawal predicted early vs. late relapse in patients with highly probable relapses (area under the curve, 0.833) and patients with lower IFNβ levels (<3.38 in log2) were able to safely discontinue bDMARD.
Study details: This prospective study included 40 patients with RA who maintained clinical remission with bDMARDs for >12 months, of which 26 relapsed at some point after bDMARD withdrawal.
Disclosures: This study was partially supported by unlimited research fund from Chugai Pharm, Eisai, and Mitsubishi-Tanabe provided to S Minota. The authors declared no conflicts of interest.
Source: Sakashita E et al. Serum level of IFNβ distinguishes early from late relapses after biologics withdrawal in rheumatoid arthritis. Sci Rep. 2022;12(1):16547 (Oct 3). Doi: 10.1038/s41598-022-21160-0.
Key clinical point: Serum levels of interferon beta (IFNβ) may distinguish early from late relapse after biologic disease-modifying antirheumatic drug (bDMARD) withdrawal in patients with rheumatoid arthritis (RA).
Major finding: Patients with serum IFNβ levels of 3.38 vs. <3.38 in log2 had a significantly lower probability of sustained remission during the first 6 months of bDMARD withdrawal (log-rank test, P = .0177). Serum IFNβ levels of 3.38 in log2 at the time of bDMARD withdrawal predicted early vs. late relapse in patients with highly probable relapses (area under the curve, 0.833) and patients with lower IFNβ levels (<3.38 in log2) were able to safely discontinue bDMARD.
Study details: This prospective study included 40 patients with RA who maintained clinical remission with bDMARDs for >12 months, of which 26 relapsed at some point after bDMARD withdrawal.
Disclosures: This study was partially supported by unlimited research fund from Chugai Pharm, Eisai, and Mitsubishi-Tanabe provided to S Minota. The authors declared no conflicts of interest.
Source: Sakashita E et al. Serum level of IFNβ distinguishes early from late relapses after biologics withdrawal in rheumatoid arthritis. Sci Rep. 2022;12(1):16547 (Oct 3). Doi: 10.1038/s41598-022-21160-0.
Patients with RA remain at higher risk for SARS-CoV-2 infection and severe outcomes
Key clinical point: Patients with rheumatoid arthritis (RA) vs. general population remain at a higher risk for SARS-CoV-2 infection and its severe outcomes; although COVID-19 vaccination has reduced severe outcomes, the risk for breakthrough infections is higher among patients with RA, supporting recent recommendations for booster COVID-19 vaccination.
Major finding: Unvaccinated patients with RA vs. general population were at an increased risk for SARS-CoV-2 infection (adjusted hazard ratio [aHR] 1.11; 95% CI 1.00-1.24), COVID-19 hospitalization (aHR 1.62; 95% CI 1.34-1.96), and COVID-19 death (aHR 1.88; 95% CI 1.37-2.60). COVID-19 vaccination reduced disease severity but not the risk for breakthrough infection in patients with RA vs. general population over 9 months of follow-up (aHR1.10; 95% CI, 1.00-1.20).
Study details: Findings are from 2 cohort studies including patients with RA (unvaccinated n = 15,901; vaccinated n = 14,330) and non-RA individuals from general population (unvaccinated n = 1,558,423; vaccinated n = 1,208,659).
Disclosures: This study was supported by the National Institutes of Health and other sources. ZS Wallace declared receiving research support and consulting fees from various sources unrelated to this work.
Source: Li H et al. Risk of COVID-19 among unvaccinated and vaccinated patients with rheumatoid arthritis: A general population study. Arthritis Care Res (Hoboken). 2022 (Sep 26). Doi: 10.1002/acr.25028
Key clinical point: Patients with rheumatoid arthritis (RA) vs. general population remain at a higher risk for SARS-CoV-2 infection and its severe outcomes; although COVID-19 vaccination has reduced severe outcomes, the risk for breakthrough infections is higher among patients with RA, supporting recent recommendations for booster COVID-19 vaccination.
Major finding: Unvaccinated patients with RA vs. general population were at an increased risk for SARS-CoV-2 infection (adjusted hazard ratio [aHR] 1.11; 95% CI 1.00-1.24), COVID-19 hospitalization (aHR 1.62; 95% CI 1.34-1.96), and COVID-19 death (aHR 1.88; 95% CI 1.37-2.60). COVID-19 vaccination reduced disease severity but not the risk for breakthrough infection in patients with RA vs. general population over 9 months of follow-up (aHR1.10; 95% CI, 1.00-1.20).
Study details: Findings are from 2 cohort studies including patients with RA (unvaccinated n = 15,901; vaccinated n = 14,330) and non-RA individuals from general population (unvaccinated n = 1,558,423; vaccinated n = 1,208,659).
Disclosures: This study was supported by the National Institutes of Health and other sources. ZS Wallace declared receiving research support and consulting fees from various sources unrelated to this work.
Source: Li H et al. Risk of COVID-19 among unvaccinated and vaccinated patients with rheumatoid arthritis: A general population study. Arthritis Care Res (Hoboken). 2022 (Sep 26). Doi: 10.1002/acr.25028
Key clinical point: Patients with rheumatoid arthritis (RA) vs. general population remain at a higher risk for SARS-CoV-2 infection and its severe outcomes; although COVID-19 vaccination has reduced severe outcomes, the risk for breakthrough infections is higher among patients with RA, supporting recent recommendations for booster COVID-19 vaccination.
Major finding: Unvaccinated patients with RA vs. general population were at an increased risk for SARS-CoV-2 infection (adjusted hazard ratio [aHR] 1.11; 95% CI 1.00-1.24), COVID-19 hospitalization (aHR 1.62; 95% CI 1.34-1.96), and COVID-19 death (aHR 1.88; 95% CI 1.37-2.60). COVID-19 vaccination reduced disease severity but not the risk for breakthrough infection in patients with RA vs. general population over 9 months of follow-up (aHR1.10; 95% CI, 1.00-1.20).
Study details: Findings are from 2 cohort studies including patients with RA (unvaccinated n = 15,901; vaccinated n = 14,330) and non-RA individuals from general population (unvaccinated n = 1,558,423; vaccinated n = 1,208,659).
Disclosures: This study was supported by the National Institutes of Health and other sources. ZS Wallace declared receiving research support and consulting fees from various sources unrelated to this work.
Source: Li H et al. Risk of COVID-19 among unvaccinated and vaccinated patients with rheumatoid arthritis: A general population study. Arthritis Care Res (Hoboken). 2022 (Sep 26). Doi: 10.1002/acr.25028
Smoking worsens disease outcomes in RA
Key clinical point: Smoking worsened disease activity and health-related quality of life at 1 year in patients with rheumatoid arthritis (RA), with effects being persistent at 3 years and early smoking cessation vs. continued smoking being associated with improved disease activity.
Major finding: At 1 year, current smokers vs. non-smokers were at a higher risk for a swollen joint number above the median (odds ratio [OR] 1.7; P = .001) and 36-Item Short-Form Health Survey physical (OR 1.5; P = .006) and mental (OR 1.4; P = .03) scores below the median, with effects being persistent at 3 years. Patients who stopped vs. continued smoking within 1 year reported a lower swollen joint number (P = .002).
Study details: Findings are from a population-based case-control study including 1531 patients with newly diagnosed RA who were followed-up for 3 years, of which 376 patients were current smokers.
Disclosures: This study was supported by grants from the Swedish Medical Research Council and other sources. The authors declared no conflicts of interest.
Source: Alfredsson L et al. Influence of smoking on disease activity and quality of life in patients with rheumatoid arthritis: Results from a Swedish case-control study with longitudinal follow-up. Arthritis Care Res (Hoboken). 2022 (Sep 23). Doi: 10.1002/acr.25026
Key clinical point: Smoking worsened disease activity and health-related quality of life at 1 year in patients with rheumatoid arthritis (RA), with effects being persistent at 3 years and early smoking cessation vs. continued smoking being associated with improved disease activity.
Major finding: At 1 year, current smokers vs. non-smokers were at a higher risk for a swollen joint number above the median (odds ratio [OR] 1.7; P = .001) and 36-Item Short-Form Health Survey physical (OR 1.5; P = .006) and mental (OR 1.4; P = .03) scores below the median, with effects being persistent at 3 years. Patients who stopped vs. continued smoking within 1 year reported a lower swollen joint number (P = .002).
Study details: Findings are from a population-based case-control study including 1531 patients with newly diagnosed RA who were followed-up for 3 years, of which 376 patients were current smokers.
Disclosures: This study was supported by grants from the Swedish Medical Research Council and other sources. The authors declared no conflicts of interest.
Source: Alfredsson L et al. Influence of smoking on disease activity and quality of life in patients with rheumatoid arthritis: Results from a Swedish case-control study with longitudinal follow-up. Arthritis Care Res (Hoboken). 2022 (Sep 23). Doi: 10.1002/acr.25026
Key clinical point: Smoking worsened disease activity and health-related quality of life at 1 year in patients with rheumatoid arthritis (RA), with effects being persistent at 3 years and early smoking cessation vs. continued smoking being associated with improved disease activity.
Major finding: At 1 year, current smokers vs. non-smokers were at a higher risk for a swollen joint number above the median (odds ratio [OR] 1.7; P = .001) and 36-Item Short-Form Health Survey physical (OR 1.5; P = .006) and mental (OR 1.4; P = .03) scores below the median, with effects being persistent at 3 years. Patients who stopped vs. continued smoking within 1 year reported a lower swollen joint number (P = .002).
Study details: Findings are from a population-based case-control study including 1531 patients with newly diagnosed RA who were followed-up for 3 years, of which 376 patients were current smokers.
Disclosures: This study was supported by grants from the Swedish Medical Research Council and other sources. The authors declared no conflicts of interest.
Source: Alfredsson L et al. Influence of smoking on disease activity and quality of life in patients with rheumatoid arthritis: Results from a Swedish case-control study with longitudinal follow-up. Arthritis Care Res (Hoboken). 2022 (Sep 23). Doi: 10.1002/acr.25026
Suboptimal early RA management predicts difficult-to-treat RA
Key clinical point: Failure to initiate methotrexate within 3 months and discontinue glucocorticoids within 6 months during early disease management were associated with difficult-to-treat rheumatoid arthritis (D2T-RA).
Major finding: A significantly lower proportion of patients with D2T-RA had adequate methotrexate treatment duration vs. those with non-D2T-RA (70.8% v. 85.5%; P = .022). Additionally, a significantly higher proportion of patients with D2T-RA vs non-D2T-RA continued glucocorticoids beyond 6 months (70.8% vs 33.8%; P < .001), with a delay of <3 months vs >12 months in methotrexate treatment (odds ratio [OR] 0.3; P = .031) and failure to discontinue glucocorticoids (OR 4.6; P < .001) being significantly associated with D2T-RA.
Study details: Findings are from a retrospective cohort study including 48 patients with D2T-RA and 145 patients with non-D2T-RA.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Giollo A et al. Early characterisation of difficult-to-treat rheumatoid arthritis by suboptimal initial management A multicentre cohort study. Rheumatology (Oxford). 2022 (Oct 3). Doi: 10.1093/rheumatology/keac563
Key clinical point: Failure to initiate methotrexate within 3 months and discontinue glucocorticoids within 6 months during early disease management were associated with difficult-to-treat rheumatoid arthritis (D2T-RA).
Major finding: A significantly lower proportion of patients with D2T-RA had adequate methotrexate treatment duration vs. those with non-D2T-RA (70.8% v. 85.5%; P = .022). Additionally, a significantly higher proportion of patients with D2T-RA vs non-D2T-RA continued glucocorticoids beyond 6 months (70.8% vs 33.8%; P < .001), with a delay of <3 months vs >12 months in methotrexate treatment (odds ratio [OR] 0.3; P = .031) and failure to discontinue glucocorticoids (OR 4.6; P < .001) being significantly associated with D2T-RA.
Study details: Findings are from a retrospective cohort study including 48 patients with D2T-RA and 145 patients with non-D2T-RA.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Giollo A et al. Early characterisation of difficult-to-treat rheumatoid arthritis by suboptimal initial management A multicentre cohort study. Rheumatology (Oxford). 2022 (Oct 3). Doi: 10.1093/rheumatology/keac563
Key clinical point: Failure to initiate methotrexate within 3 months and discontinue glucocorticoids within 6 months during early disease management were associated with difficult-to-treat rheumatoid arthritis (D2T-RA).
Major finding: A significantly lower proportion of patients with D2T-RA had adequate methotrexate treatment duration vs. those with non-D2T-RA (70.8% v. 85.5%; P = .022). Additionally, a significantly higher proportion of patients with D2T-RA vs non-D2T-RA continued glucocorticoids beyond 6 months (70.8% vs 33.8%; P < .001), with a delay of <3 months vs >12 months in methotrexate treatment (odds ratio [OR] 0.3; P = .031) and failure to discontinue glucocorticoids (OR 4.6; P < .001) being significantly associated with D2T-RA.
Study details: Findings are from a retrospective cohort study including 48 patients with D2T-RA and 145 patients with non-D2T-RA.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Giollo A et al. Early characterisation of difficult-to-treat rheumatoid arthritis by suboptimal initial management A multicentre cohort study. Rheumatology (Oxford). 2022 (Oct 3). Doi: 10.1093/rheumatology/keac563
RA: Increased risk for VTE with JAK inhibitors
Key clinical point: Patients with rheumatoid arthritis (RA) treated with Janus kinase (JAK) vs tumor necrosis factor (TNF) inhibitors were at a higher risk for venous thromboembolism (VTE), particularly pulmonary embolism.
Major finding: Patients treated with JAK vs TNF inhibitors were at a 73% higher risk for VTE (adjusted hazard ratio [aHR] 1.73; 95% CI 1.24-2.42), with the higher risk appearing to be confined to pulmonary embolism (aHR 3.21; 95% CI 2.11-4.88) rather than deep vein thrombosis.
Study details: Findings are from a prospective, register-based, active comparator study including 85,722 patients with RA, of which 27,610 patients initiated biologic/targeted synthetic disease-modifying antirheumatic drugs and were matched with 91,207 healthy controls.
Disclosures: This study was funded by Swedish Research Council, the Swedish Heart Lung Foundation, and other sources. Karolinska Institutet has or has had research agreements with various sources for safety monitoring of biologics through ARTIS/Swedish Biologics Register.
Source: Molander V et al. Venous thromboembolism with JAK inhibitors and other immune-modulatory drugs: A Swedish comparative safety study among patients with rheumatoid arthritis. Ann Rheum Dis. 2022 (Sep 23). Doi: 10.1136/ard-2022-223050
Key clinical point: Patients with rheumatoid arthritis (RA) treated with Janus kinase (JAK) vs tumor necrosis factor (TNF) inhibitors were at a higher risk for venous thromboembolism (VTE), particularly pulmonary embolism.
Major finding: Patients treated with JAK vs TNF inhibitors were at a 73% higher risk for VTE (adjusted hazard ratio [aHR] 1.73; 95% CI 1.24-2.42), with the higher risk appearing to be confined to pulmonary embolism (aHR 3.21; 95% CI 2.11-4.88) rather than deep vein thrombosis.
Study details: Findings are from a prospective, register-based, active comparator study including 85,722 patients with RA, of which 27,610 patients initiated biologic/targeted synthetic disease-modifying antirheumatic drugs and were matched with 91,207 healthy controls.
Disclosures: This study was funded by Swedish Research Council, the Swedish Heart Lung Foundation, and other sources. Karolinska Institutet has or has had research agreements with various sources for safety monitoring of biologics through ARTIS/Swedish Biologics Register.
Source: Molander V et al. Venous thromboembolism with JAK inhibitors and other immune-modulatory drugs: A Swedish comparative safety study among patients with rheumatoid arthritis. Ann Rheum Dis. 2022 (Sep 23). Doi: 10.1136/ard-2022-223050
Key clinical point: Patients with rheumatoid arthritis (RA) treated with Janus kinase (JAK) vs tumor necrosis factor (TNF) inhibitors were at a higher risk for venous thromboembolism (VTE), particularly pulmonary embolism.
Major finding: Patients treated with JAK vs TNF inhibitors were at a 73% higher risk for VTE (adjusted hazard ratio [aHR] 1.73; 95% CI 1.24-2.42), with the higher risk appearing to be confined to pulmonary embolism (aHR 3.21; 95% CI 2.11-4.88) rather than deep vein thrombosis.
Study details: Findings are from a prospective, register-based, active comparator study including 85,722 patients with RA, of which 27,610 patients initiated biologic/targeted synthetic disease-modifying antirheumatic drugs and were matched with 91,207 healthy controls.
Disclosures: This study was funded by Swedish Research Council, the Swedish Heart Lung Foundation, and other sources. Karolinska Institutet has or has had research agreements with various sources for safety monitoring of biologics through ARTIS/Swedish Biologics Register.
Source: Molander V et al. Venous thromboembolism with JAK inhibitors and other immune-modulatory drugs: A Swedish comparative safety study among patients with rheumatoid arthritis. Ann Rheum Dis. 2022 (Sep 23). Doi: 10.1136/ard-2022-223050
Withdrawing methotrexate increased disease activity without affecting remission rates in RA patients at target
Key clinical point: Withdrawal of methotrexate slightly worsened disease activity without affecting remission rates in patients with rheumatoid arthritis (RA) at target who were treated with the combination of biologic disease-modifying antirheumatic drugs (bDMARD)/targeted synthetic DMARD (tsDMARD) and methotrexate.
Major finding: Withdrawing methotrexate vs maintaining combination therapy increased the disease activity score of 28-joints by 0.20 (95% CI 0.09-0.32) and decreased the proportion of patients achieving low disease activity (risk ratio [RR] 0.88; 95% CI 0.80-0.97); however, the remission rates remained unaffected (RR 0.90; 95% CI 0.81-1.01).
Study details: Findings are from a systematic review and meta-analysis of six randomized controlled trials including 1430 patients with RA at target who were treated with bDMARD or tsDMARD+methotrexate combination therapy, of which 734 withdrew and 696 continued methotrexate.
Disclosures: This study was supported by West China Hospital, Sichuan University. The authors declared no conflicts of interest.
Source: Wang X et al. Withdrawal of MTX in rheumatoid arthritis patients on bDMARD/tsDMARD plus methotrexate at target: A systematic review and meta-analysis. Rheumatology (Oxford). 2022 (Sep 20). Doi: 10.1093/rheumatology/keac515
Key clinical point: Withdrawal of methotrexate slightly worsened disease activity without affecting remission rates in patients with rheumatoid arthritis (RA) at target who were treated with the combination of biologic disease-modifying antirheumatic drugs (bDMARD)/targeted synthetic DMARD (tsDMARD) and methotrexate.
Major finding: Withdrawing methotrexate vs maintaining combination therapy increased the disease activity score of 28-joints by 0.20 (95% CI 0.09-0.32) and decreased the proportion of patients achieving low disease activity (risk ratio [RR] 0.88; 95% CI 0.80-0.97); however, the remission rates remained unaffected (RR 0.90; 95% CI 0.81-1.01).
Study details: Findings are from a systematic review and meta-analysis of six randomized controlled trials including 1430 patients with RA at target who were treated with bDMARD or tsDMARD+methotrexate combination therapy, of which 734 withdrew and 696 continued methotrexate.
Disclosures: This study was supported by West China Hospital, Sichuan University. The authors declared no conflicts of interest.
Source: Wang X et al. Withdrawal of MTX in rheumatoid arthritis patients on bDMARD/tsDMARD plus methotrexate at target: A systematic review and meta-analysis. Rheumatology (Oxford). 2022 (Sep 20). Doi: 10.1093/rheumatology/keac515
Key clinical point: Withdrawal of methotrexate slightly worsened disease activity without affecting remission rates in patients with rheumatoid arthritis (RA) at target who were treated with the combination of biologic disease-modifying antirheumatic drugs (bDMARD)/targeted synthetic DMARD (tsDMARD) and methotrexate.
Major finding: Withdrawing methotrexate vs maintaining combination therapy increased the disease activity score of 28-joints by 0.20 (95% CI 0.09-0.32) and decreased the proportion of patients achieving low disease activity (risk ratio [RR] 0.88; 95% CI 0.80-0.97); however, the remission rates remained unaffected (RR 0.90; 95% CI 0.81-1.01).
Study details: Findings are from a systematic review and meta-analysis of six randomized controlled trials including 1430 patients with RA at target who were treated with bDMARD or tsDMARD+methotrexate combination therapy, of which 734 withdrew and 696 continued methotrexate.
Disclosures: This study was supported by West China Hospital, Sichuan University. The authors declared no conflicts of interest.
Source: Wang X et al. Withdrawal of MTX in rheumatoid arthritis patients on bDMARD/tsDMARD plus methotrexate at target: A systematic review and meta-analysis. Rheumatology (Oxford). 2022 (Sep 20). Doi: 10.1093/rheumatology/keac515
RA in remission: Subclinical inflammation lower with cs/bDMARDs combination vs. monotherapy
Key clinical point: Ultrasound-detected subclinical inflammation of tendons and joints was better controlled in patients with rheumatoid arthritis (RA) in clinical remission who received the combination therapy of conventional synthetic and biologic disease-modifying antirheumatic drugs (csDMARD+bDMARD) vs csDMARD or bDMARD monotherapy.
Major finding: Grey-scale tenosynovitis (P = .025) and power Doppler (PD) tenosynovitis (P = .047) were better controlled with csDMARD+bDMARD than with csDMARD alone. csDMARD+bDMARD was also associated with better treatment results for PD synovitis vs csDMARD (P = .01) or bDMARD (P = .02) alone.
Study details: Findings are from a longitudinal analysis of the STARTER study including 256 patients with RA in clinical remission who received csDMARD alone, bDMARD alone, or csDMARD+bDMARD.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Parisi S et al. Relationship between the prevalence of subclinical tenosynovitis and treatment in patients with RA in clinical remission: STARTER study. Rheumatology (Oxford). 2022 (Sep 6). Doi: 10.1093/rheumatology/keac518
Key clinical point: Ultrasound-detected subclinical inflammation of tendons and joints was better controlled in patients with rheumatoid arthritis (RA) in clinical remission who received the combination therapy of conventional synthetic and biologic disease-modifying antirheumatic drugs (csDMARD+bDMARD) vs csDMARD or bDMARD monotherapy.
Major finding: Grey-scale tenosynovitis (P = .025) and power Doppler (PD) tenosynovitis (P = .047) were better controlled with csDMARD+bDMARD than with csDMARD alone. csDMARD+bDMARD was also associated with better treatment results for PD synovitis vs csDMARD (P = .01) or bDMARD (P = .02) alone.
Study details: Findings are from a longitudinal analysis of the STARTER study including 256 patients with RA in clinical remission who received csDMARD alone, bDMARD alone, or csDMARD+bDMARD.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Parisi S et al. Relationship between the prevalence of subclinical tenosynovitis and treatment in patients with RA in clinical remission: STARTER study. Rheumatology (Oxford). 2022 (Sep 6). Doi: 10.1093/rheumatology/keac518
Key clinical point: Ultrasound-detected subclinical inflammation of tendons and joints was better controlled in patients with rheumatoid arthritis (RA) in clinical remission who received the combination therapy of conventional synthetic and biologic disease-modifying antirheumatic drugs (csDMARD+bDMARD) vs csDMARD or bDMARD monotherapy.
Major finding: Grey-scale tenosynovitis (P = .025) and power Doppler (PD) tenosynovitis (P = .047) were better controlled with csDMARD+bDMARD than with csDMARD alone. csDMARD+bDMARD was also associated with better treatment results for PD synovitis vs csDMARD (P = .01) or bDMARD (P = .02) alone.
Study details: Findings are from a longitudinal analysis of the STARTER study including 256 patients with RA in clinical remission who received csDMARD alone, bDMARD alone, or csDMARD+bDMARD.
Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.
Source: Parisi S et al. Relationship between the prevalence of subclinical tenosynovitis and treatment in patients with RA in clinical remission: STARTER study. Rheumatology (Oxford). 2022 (Sep 6). Doi: 10.1093/rheumatology/keac518
Increased risk for severe COVID-19 in rheumatoid arthritis and its phenotypic subgroups
Key clinical point: Patients with rheumatoid arthritis (RA), including those across different phenotypic subgroups, were at an increased risk for severe COVID-19 compared with patients without RA, with a pronounced association being observed in patients with RA-associated interstitial lung disease (RA-ILD).
Major finding: Risk for severe COVID-19 was significantly higher in patients with RA vs. those without RA (adjusted hazard ratio [aHR], 1.75; P < .0001). Risk was persistent among the sub-group of patients who were seropositive (aHR, 1.97; P < .0001) or had erosive disease (aHR, 1.93; P < .0001) and most prominent among patients with RA-ILD (aHR, 2.50; P < .0001).
Study details: Findings are from a retrospective study of 582 patients with RA and 2,875 matched comparators without RA, all of whom had COVID-19.
Disclosures: This study did not receive any funding. Some authors reported receiving research support, consulting fees, and/or grants unrelated to this study from various sources.
Source: Figueroa-Parra G et al. Risk of severe COVID-19 outcomes associated with rheumatoid arthritis and phenotypic subgroups: A retrospective, comparative, multicentre cohort study. Lancet Rheumatol. 2022 (Sep 13). Doi: 10.1016/S2665-9913(22)00227-2.
Key clinical point: Patients with rheumatoid arthritis (RA), including those across different phenotypic subgroups, were at an increased risk for severe COVID-19 compared with patients without RA, with a pronounced association being observed in patients with RA-associated interstitial lung disease (RA-ILD).
Major finding: Risk for severe COVID-19 was significantly higher in patients with RA vs. those without RA (adjusted hazard ratio [aHR], 1.75; P < .0001). Risk was persistent among the sub-group of patients who were seropositive (aHR, 1.97; P < .0001) or had erosive disease (aHR, 1.93; P < .0001) and most prominent among patients with RA-ILD (aHR, 2.50; P < .0001).
Study details: Findings are from a retrospective study of 582 patients with RA and 2,875 matched comparators without RA, all of whom had COVID-19.
Disclosures: This study did not receive any funding. Some authors reported receiving research support, consulting fees, and/or grants unrelated to this study from various sources.
Source: Figueroa-Parra G et al. Risk of severe COVID-19 outcomes associated with rheumatoid arthritis and phenotypic subgroups: A retrospective, comparative, multicentre cohort study. Lancet Rheumatol. 2022 (Sep 13). Doi: 10.1016/S2665-9913(22)00227-2.
Key clinical point: Patients with rheumatoid arthritis (RA), including those across different phenotypic subgroups, were at an increased risk for severe COVID-19 compared with patients without RA, with a pronounced association being observed in patients with RA-associated interstitial lung disease (RA-ILD).
Major finding: Risk for severe COVID-19 was significantly higher in patients with RA vs. those without RA (adjusted hazard ratio [aHR], 1.75; P < .0001). Risk was persistent among the sub-group of patients who were seropositive (aHR, 1.97; P < .0001) or had erosive disease (aHR, 1.93; P < .0001) and most prominent among patients with RA-ILD (aHR, 2.50; P < .0001).
Study details: Findings are from a retrospective study of 582 patients with RA and 2,875 matched comparators without RA, all of whom had COVID-19.
Disclosures: This study did not receive any funding. Some authors reported receiving research support, consulting fees, and/or grants unrelated to this study from various sources.
Source: Figueroa-Parra G et al. Risk of severe COVID-19 outcomes associated with rheumatoid arthritis and phenotypic subgroups: A retrospective, comparative, multicentre cohort study. Lancet Rheumatol. 2022 (Sep 13). Doi: 10.1016/S2665-9913(22)00227-2.
FDA OKs teclistamab for relapsed/refractory multiple myeloma
The results made the case for “teclistamab as a monotherapy for eligible patients with heavily pretreated multiple myeloma, in need of new treatment options,” investigator Maria-Victoria Mateos, MD, PhD, a hematologist at the University Hospital of Salamanca (Spain) said in a June press release from drug maker Janssen/Johnson & Johnson.
The approval was based on the phase 1-2 single-arm MajesTEC-1 trial. The MajesTEC-1 findings, published in August in the New England Journal of Medicine, included 165 patients with relapsed or refractory multiple myeloma after at least three therapy lines – including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. These patients received a weekly subcutaneous 1.5 mg/kg injection of teclistamab after stepping up from 0.06 mg and 0.3 mg/kg doses.
According to the FDA announcement, the overall response rate was nearly 62%. And the estimated duration of response rate among responders was 90.6% at 6 months and 66.5% at 9 months.
The NEJM results also indicated that almost 40% of patients had a complete response to the therapy, over a median follow-up of 14.1 months. More than a quarter of patients (26.7%) had no minimal residual disease.
The study investigators concluded that “teclistamab resulted in a high rate of deep and durable response in patients with triple-class exposed relapsed or refractory multiple myeloma.”
In a press release, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, commented that “teclistamab is an important new treatment option for patients who have faced multiple relapses.”
The recommended dose for teclistamab is 0.06 mg/kg via subcutaneous injection on day 1, 0.3 mg/kg on day 4, and 1.5 mg/kg on day 7, followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.
The FDA noted, however, that the prescribing information for teclistamab comes with a Boxed warning for “life-threatening or fatal cytokine-release syndrome (CRS) and neurologic toxicity, including immune effector cell–associated neurotoxicity (ICANS).”
CRS was reported in 72.1% of patients (grade 3 in one patient but no grade 4 cases), neurologic toxicity in 57%, and ICANS in 6%. Other common adverse events in the NEJM report included neutropenia in 71% of subjects (grade 3 or 4 in 64%); anemia in 52% (grade 3 or 4 in 37%), and thrombocytopenia in 40% (grade 3 or 4 in 21%). Overall, 45% of patients developed grade 3 or 4 infections.
“Because of the risks of CRS and neurologic toxicity, including ICANS, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli REMS,” according to the FDA’s press release.
Teclistamab is a T-cell–bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen (BCMA) expressed on the surface of myeloma cells, activating T-cells to kill cancer cells that express the antigen.
Three BCMA-directed therapies are already on the market in the United States that carry teclistamab’s indication: the antibody-drug conjugate belantamab mafodotin (Blenrep) and two chimeric antigen receptor (CAR) T-cell therapies, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti).
The overall response rate is approximately 31% with belantamab mafodotin, 67% for idecabtagene vicleucel, and 83% for ciltacabtagene autoleucel.
Pfizer also has a bispecific BCMA-CD3–targeted antibody in development, elranatamab, for triple-class refractory multiple myeloma that is expected to compete with teclistamab.
MajesTEC-1 was funded by Janssen. Dr. Mateos is a paid speaker and consultant for the company.
A version of this article first appeared on Medscape.com.
The results made the case for “teclistamab as a monotherapy for eligible patients with heavily pretreated multiple myeloma, in need of new treatment options,” investigator Maria-Victoria Mateos, MD, PhD, a hematologist at the University Hospital of Salamanca (Spain) said in a June press release from drug maker Janssen/Johnson & Johnson.
The approval was based on the phase 1-2 single-arm MajesTEC-1 trial. The MajesTEC-1 findings, published in August in the New England Journal of Medicine, included 165 patients with relapsed or refractory multiple myeloma after at least three therapy lines – including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. These patients received a weekly subcutaneous 1.5 mg/kg injection of teclistamab after stepping up from 0.06 mg and 0.3 mg/kg doses.
According to the FDA announcement, the overall response rate was nearly 62%. And the estimated duration of response rate among responders was 90.6% at 6 months and 66.5% at 9 months.
The NEJM results also indicated that almost 40% of patients had a complete response to the therapy, over a median follow-up of 14.1 months. More than a quarter of patients (26.7%) had no minimal residual disease.
The study investigators concluded that “teclistamab resulted in a high rate of deep and durable response in patients with triple-class exposed relapsed or refractory multiple myeloma.”
In a press release, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, commented that “teclistamab is an important new treatment option for patients who have faced multiple relapses.”
The recommended dose for teclistamab is 0.06 mg/kg via subcutaneous injection on day 1, 0.3 mg/kg on day 4, and 1.5 mg/kg on day 7, followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.
The FDA noted, however, that the prescribing information for teclistamab comes with a Boxed warning for “life-threatening or fatal cytokine-release syndrome (CRS) and neurologic toxicity, including immune effector cell–associated neurotoxicity (ICANS).”
CRS was reported in 72.1% of patients (grade 3 in one patient but no grade 4 cases), neurologic toxicity in 57%, and ICANS in 6%. Other common adverse events in the NEJM report included neutropenia in 71% of subjects (grade 3 or 4 in 64%); anemia in 52% (grade 3 or 4 in 37%), and thrombocytopenia in 40% (grade 3 or 4 in 21%). Overall, 45% of patients developed grade 3 or 4 infections.
“Because of the risks of CRS and neurologic toxicity, including ICANS, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli REMS,” according to the FDA’s press release.
Teclistamab is a T-cell–bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen (BCMA) expressed on the surface of myeloma cells, activating T-cells to kill cancer cells that express the antigen.
Three BCMA-directed therapies are already on the market in the United States that carry teclistamab’s indication: the antibody-drug conjugate belantamab mafodotin (Blenrep) and two chimeric antigen receptor (CAR) T-cell therapies, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti).
The overall response rate is approximately 31% with belantamab mafodotin, 67% for idecabtagene vicleucel, and 83% for ciltacabtagene autoleucel.
Pfizer also has a bispecific BCMA-CD3–targeted antibody in development, elranatamab, for triple-class refractory multiple myeloma that is expected to compete with teclistamab.
MajesTEC-1 was funded by Janssen. Dr. Mateos is a paid speaker and consultant for the company.
A version of this article first appeared on Medscape.com.
The results made the case for “teclistamab as a monotherapy for eligible patients with heavily pretreated multiple myeloma, in need of new treatment options,” investigator Maria-Victoria Mateos, MD, PhD, a hematologist at the University Hospital of Salamanca (Spain) said in a June press release from drug maker Janssen/Johnson & Johnson.
The approval was based on the phase 1-2 single-arm MajesTEC-1 trial. The MajesTEC-1 findings, published in August in the New England Journal of Medicine, included 165 patients with relapsed or refractory multiple myeloma after at least three therapy lines – including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. These patients received a weekly subcutaneous 1.5 mg/kg injection of teclistamab after stepping up from 0.06 mg and 0.3 mg/kg doses.
According to the FDA announcement, the overall response rate was nearly 62%. And the estimated duration of response rate among responders was 90.6% at 6 months and 66.5% at 9 months.
The NEJM results also indicated that almost 40% of patients had a complete response to the therapy, over a median follow-up of 14.1 months. More than a quarter of patients (26.7%) had no minimal residual disease.
The study investigators concluded that “teclistamab resulted in a high rate of deep and durable response in patients with triple-class exposed relapsed or refractory multiple myeloma.”
In a press release, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, commented that “teclistamab is an important new treatment option for patients who have faced multiple relapses.”
The recommended dose for teclistamab is 0.06 mg/kg via subcutaneous injection on day 1, 0.3 mg/kg on day 4, and 1.5 mg/kg on day 7, followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.
The FDA noted, however, that the prescribing information for teclistamab comes with a Boxed warning for “life-threatening or fatal cytokine-release syndrome (CRS) and neurologic toxicity, including immune effector cell–associated neurotoxicity (ICANS).”
CRS was reported in 72.1% of patients (grade 3 in one patient but no grade 4 cases), neurologic toxicity in 57%, and ICANS in 6%. Other common adverse events in the NEJM report included neutropenia in 71% of subjects (grade 3 or 4 in 64%); anemia in 52% (grade 3 or 4 in 37%), and thrombocytopenia in 40% (grade 3 or 4 in 21%). Overall, 45% of patients developed grade 3 or 4 infections.
“Because of the risks of CRS and neurologic toxicity, including ICANS, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli REMS,” according to the FDA’s press release.
Teclistamab is a T-cell–bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen (BCMA) expressed on the surface of myeloma cells, activating T-cells to kill cancer cells that express the antigen.
Three BCMA-directed therapies are already on the market in the United States that carry teclistamab’s indication: the antibody-drug conjugate belantamab mafodotin (Blenrep) and two chimeric antigen receptor (CAR) T-cell therapies, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti).
The overall response rate is approximately 31% with belantamab mafodotin, 67% for idecabtagene vicleucel, and 83% for ciltacabtagene autoleucel.
Pfizer also has a bispecific BCMA-CD3–targeted antibody in development, elranatamab, for triple-class refractory multiple myeloma that is expected to compete with teclistamab.
MajesTEC-1 was funded by Janssen. Dr. Mateos is a paid speaker and consultant for the company.
A version of this article first appeared on Medscape.com.