Unclear benefits of methotrexate highlighted for PsA patients
medwireNews: Findings from a systematic review suggest that methotrexate may offer some benefits for patients with psoriatic arthritis (PsA), but the quality of evidence is low.
As reported in The Cochrane Library, the review included eight randomized controlled trials, of which five compared methotrexate with placebo, and four investigated methotrexate in comparison with other DMARDs. Patients were aged an average of 26–52 years, and the majority of studies used a methotrexate dose of 15 mg/week.
Evidence from one placebo-controlled trial involving 221 participants suggested that methotrexate “might provide clinically meaningful benefit” in terms of treatment response and function, say Tom Wilsdon (Royal Adelaide Hospital and University of Adelaide, South Australia) and co-authors.
In this study, 37.6% of 109 patients treated with methotrexate responded to treatment according to psoriatic arthritis response criteria over 6 months, compared with 21.4% of 112 participants given placebo, equating to an absolute difference of 16% more responders with methotrexate. The average improvement in Health Assessment Questionnaire for Rheumatoid Arthritis function score was also 10% better with methotrexate than with placebo.
However, Wilsdon and team say that average disease activity scores did not significantly differ between the methotrexate and placebo groups, and caution that the evidence was judged to be of low quality due to bias and imprecision.
Safety results from three placebo-controlled studies including a total of 293 participants indicated that one methotrexate-treated patient and one placebo-treated patient experienced serious adverse events, and nine and seven patients, respectively, withdrew from the studies due to adverse events.
“Due to low event rates, we are uncertain if methotrexate results show increased risk of serious adverse events or withdrawals due to adverse events compared to placebo,” say the researchers.
When methotrexate was compared with other DMARDs, Wilsdon and colleagues found “very low-quality evidence” indicating that the efficacy of methotrexate may be comparable to leflunomide 20 mg/day, and better than ciclosporin A 3–5 mg/kg per day. For example, a similar number of patients treated with methotrexate versus leflunomide achieved an ACR50 response at 6 months in one study, while two studies demonstrated that methotrexate treatment was associated with lower tender joint counts than ciclosporin A.
Given the low quality of these studies, “we do not believe they provide clinically meaningful information, and we do believe they should be interpreted and applied with extreme caution,” stress the researchers.
They note that at present, “[w]ith the exception of leflunomide, head-to-head data are inadequate to inform comparison [of methotrexate] versus other DMARDs, including biologic DMARDs.”
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