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

2021; The Journal of Rheumatology Publishing Company Limited; Volume: 48; Issue: 10 Linguagem: Inglês

10.3899/jrheum.201248

1499-2752

Markus Bredemeier, Roberto Ranza, Adriana María Kakehasi, Aline Ranzolin, Inês G. da Silveira, Ana Cristina de Medeiros Ribeiro, D. Titton, A. L. S. Hayata, Hellen M.S. Carvalho, Bárbara Stadler Kahlow, Vander Fernandes, Paulo Louzada‐Júnior, Manoel Barros Bértolo, Ângela L.B.P. Duarte, José Caetano Macieira, J. Miranda, Geraldo R.C. Pinheiro, Reginaldo Botelho Teodoro, Marcelo M. Pinheiro, Valéria Valim, Ivânio Alves Pereira, Maria F.L.C. Sauma, Gláucio R.W. de Castro, Laurindo F. da Rocha, Sâmia A.S. Studart, Morgana O. Gazzeta, Leticia G. da Silveira, Cristiano M. Lupo, Iêda Maria Magalhães Laurindo,

Autoimmune and Inflammatory Disorders Research

Objective. 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 antirheumatic drugs (DMARDs) or Janus kinase inhibitors (JAKi). Methods. Patients with RA starting a treatment course with a csDMARD (without previous use of bDMARD or JAKi) or their 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 matching analysis (PSMA) were used for statistical comparisons. Results. In total, 1671 patients (5349 patient-years [PY]) were enrolled; 452 patients (1537 PY) received MTX + LEF. The overall incidence of SAEs was 5.6 per 100 PY. The hazard of SAEs for MTX + LEF was not higher than for MTX or LEF (adjusted HR [aHR] 1.00, 95% CI 0.76–1.31, P = 0.98). MTX + LEF presented a lower hazard of SAEs (aHR 0.56, 95% CI 0.36–0.88, P = 0.01) and infectious SAEs (aHR 0.48, 95% CI 0.25–0.94, P = 0.03) than bDMARDs/JAKi with MTX or LEF. MTX + LEF presented lower hazard of SAEs than MTX + sulfasalazine (SSZ; aHR 0.33, 95% CI 0.16–0.65, P = 0.002). Analysis using PSMA confirmed the results obtained with traditional multivariate Cox analysis. Conclusion. In our study, MTX + LEF presented a relatively good overall safety profile in comparison to MTX + SSZ and schemes involving advanced therapies in RA.