Methotrexate and Leflunomide Combo is Safe in Rheumatoid Arthritis Treatment

According to a study, methotrexate (MTX) plus leflunomide (LEF) has a comparatively acceptable overall safety profile when compared to MTX and sulfasalazine (SSZ) and advanced therapy options in rheumatoid arthritis (RA).

Methotrexate and Leflunomide Combo is Safe in Rheumatoid Arthritis Treatment
Photo: Doctor Holding a Clipboard with Diagnosis of Rheumatoid Arthritis | InStyleHealth


A group of researchers assessed the safety of MTX plus LEF in RA and compared it to other treatment options such as disease-modifying antirheumatic medications (DMARDs), Janus kinase (JAK) inhibitors, or Janus kinase (JAK) inhibitors. In a registry-based, multi-centric cohort research in Brazil, they tracked RA patients on a treatment course with a csDMARD (without prior use of a bDMARD or JAK inhibitor) or their first bDMARD/JAK inhibitor.

The primary and secondary outcomes were the occurrence of serious adverse events and serious infections, respectively. Multivariate Cox proportional hazards models and propensity-score matching analysis were used to make statistical comparisons (PSMA).

The study comprised a total of 1,671 patients (5,349 patient-years), with 452 (1,537 patient-years) receiving the MTX–LEF combination. Overall, there were 5.6 major adverse events per 100 patient-years.

When compared to MTX or LEF alone, the risk of major adverse events was not increased (adjusted hazard ratio [AHR], 1.00, 95 percent confidence interval [CI], 0.76–1.31; p=0.98). MTX with LEF had a lower risk of serious adverse events (AHR, 0.56, 95 percent CI, 0.36–0.88; p=0.01) and infectious serious adverse events (AHR, 0.48, 95 percent CI, 0.25–0.94; p=0.03) than bDMARDs or JAK inhibitors with MTX or LEF (AHR, 0.48, 95 percent CI, 0.25–0.94; p=0.03) than bDMARDs

Additionally, when compared to MTX plus SSZ, the MTX–LEF combination had a lower risk of major adverse events (AHR, 0.33, 95 percent CI, 0.16–0.65; p=0.002).

PSMA supported the results of the standard multivariate Cox analysis.

 

Source: J Rheumatol 2021;48:1519-1527

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