Objective: To assess the efficacy and toxicity profile of methotrexate (MTX) as the initial second-line disease modifying anti-rheumatic drug (DMARD) in rheumatoid arthritis (RA).
Methods: This was an observational retrospective cohort study comparing 28 patients who were treated with MTX as the first DMARD (MTX cases) and 55 matched patients treated with MTX after other DMARDs (MTX controls).
Results: The follow-up time was identical in the two groups: 19.4 +/- 14 months (2-56) for the MTX cases and 21.8 +/- 15.3 months (3-87) for MTX controls (NS). MTX efficacy was the same in the two groups, except for a higher incidence of remission in the MTX cases (8/28, 28.6% versus 5/55, 9.1%, p = 0.028). The toxicity profiles, frequencies, and reasons for MTX withdrawals were similar in the two groups.
Conclusion: The results obtained in this study suggest a benefit from MTX prescribed as an initial second-line agent in the treatment of RA, but studies involving a larger number of patients are needed.