Safety of the Methotrexate–leflunomide Combination in Rheumatoid Arthritis: Results of a Multicentric, Registry-based, Cohort Study (BiobadaBrasil)
| Autor: | José Caetano Macieira, André Luiz Shinji Hayata, Ana Cristina de Medeiros Ribeiro, Paulo Roberto Louzada, Reginaldo Botelho Teodoro, Vander Fernandes, Hellen M.S. Carvalho, Manoel Barros Bertolo, Ângela Luzia Branco Pinto Duarte, Marcelo de Medeiros Pinheiro, Roberto Ranza, Adriana Maria Kakehasi, Bárbara Stadler Kahlow, Ivânio Alves Pereira, Aline Ranzolin, Markus Bredemeier, Cristiano Michelini Lupo, Maria de Fátima Lobato da Cunha Sauma, Laurindo Ferreira da Rocha, Letícia Guimarães da Silveira, David C. Titton, Gláucio Ricardo Werner de Castro, Ieda Maria Magalhães Laurindo, Morgana Ohira Gazzeta, Valeria Valim, Inês Guimarães da Silveira, S. Studart, Geraldo da Rocha Castelar Pinheiro, José Roberto Silva Miranda |
|---|---|
| Rok vydání: | 2022 |
| Předmět: |
Oncology
medicine.medical_specialty Immunology Arthritis Rheumatoid Cohort Studies Rheumatology Sulfasalazine Internal medicine Medicine Humans Immunology and Allergy Registries Adverse effect Leflunomide business.industry Proportional hazards model Incidence (epidemiology) Isoxazoles medicine.disease Methotrexate Rheumatoid arthritis Drug Therapy Combination business medicine.drug Cohort study |
| Zdroj: | The Journal of Rheumatology. 49:122-122 |
| ISSN: | 1499-2752 0315-162X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|