Safety of the Methotrexate-leflunomide Combination in Rheumatoid Arthritis: Results of a Multicentric, Registry-based, Cohort Study (Biobadabrasil).

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To evaluate the safety of the methotrexate (MTX)-leflunomide (LEF) combination in rheumatoid arthritis (RA), comparing it with other therapeutic schemes involving conventional synthetic (cs-) and biologic (b-) disease modifying anti-rheumatic drugs (DMARDs) or JAK inhibitors (JAKi).RA patients starting the first treatment course with a csDMARD (without previous use of biologic or JAKi) or first bDMARD/JAKi were followed-up in a registry-based, multicentric cohort study in Brazil (BiobadaBrasil). The primary outcome was the incidence of serious adverse events (SAEs); secondary outcomes included serious infections. Multivariate Cox proportional hazards models and propensity score matched analysis (PSMA) were used for statistical comparisons.In total, 1671 patients (5349 patient-years [PY]) were enrolled; 452 patients (1537 PY) received MTX plus LEF. The overall incidence of SAEs was 5.6/100 PY. The hazard of SAEs for MTX plus LEF was not higher than for MTX or LEF (adjusted hazard ratio: 1.00, 95% CI, 0.76 to 1.31, P=0.984). The MTX-LEF combo presented a lower hazard of SAEs (0.56, 0.36 to 0.88, P=0.011) and infectious SAEs (0.48, 0.25 to 0.94, P=0.031) than bDMARDs/JAKi with MTX or LEF. MTX plus LEF presented lower hazard of SAEs than MTX plus SSZ (0.33, 0.16 to 0.65, P=0.002). Analysis using PSMA confirmed the results obtained with traditional multivariate Cox analysis.In our study, MTX plus LEF presented a relatively good overall safety profile in comparison to MTX plus SSZ and schemes involving advanced therapies in RA.

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Authors: Markus Bredemeier, Roberto Ranza, Adriana Maria Kakehasi, Aline Ranzolin, Inês Guimarães da Silveira, Ana Cristina de Medeiros Ribeiro, David Cezar Titton, André Luiz Shinji Hayata, Hellen Mary Silveira Carvalho, Bárbara Stadler Kahlow, Vander Fernandes, Paulo Louzada, Manoel Barros Bértolo, Ângela Luzia Branco Pinto Duarte, José Caetano Macieira, José Roberto Silva Miranda, Geraldo da Rocha Castelar Pinheiro, Reginaldo Botelho Teodoro, Marcelo de Medeiros Pinheiro, Valéria Valim, Ivânio Alves Pereira, Maria de Fátima Lobato da Cunha Sauma, Gláucio Ricardo Werner de Castro, Laurindo Ferreira da Rocha, Sâmia Araujo de Sousa Studart, Morgana Ohira Gazzeta, Leticia Guimarães da Silveira, Cristiano Michelini Lupo, Ieda Maria Magalhães Laurindo