The quality of evidence is downgraded by study limitations (lack of/unclear allocation concealment and blinding), and by imprecise results (few patients and outcome events).
A Cochrane review [Abstract] 1 included 8 studies with a total of 572 subjects. Five studies compared methotrexate with placebo, and 4 studies compared methotrexate with other DMARDs. The average age of subjects varied across studies from 26 to 52 years, and the average duration of psoriatic arthritis varied from 1 to 9 years. Doses of methotrexate varied from 7.5 mg to 25 mg orally per week, but most studies administered approximately 15 mg or less orally per week.
Methotrexate dose 15 mg orally or less per week improved disease response, measured by the proportion who responded to treatment according to Psoriatic Arthritis Response Criteria (PsARC) (RR 1.76, 95% CI 1.14 to 2.70; 1 study, n=221; NNTB=6, 95% CI 5 to 25) compared to placebo. Mean function, measured by the Health Assessment Questionnaire for Rheumatoid Arthritis (HAQ; scale 0 to 3; 0 meaning no functional impairment; minimum clinically important difference 0.22), was 1.0 points with placebo and 0.3 points better (95% 0.51 better to 0.09 better) with methotrexate; absolute improvement 10% (3% better to 17% better; 1 study, n=221). Mean disease activity as measured by the disease activity score (28 joints) with erythrocyte sedimentation rate (DAS28-ESR; scale of 0 to 10; lower score means lower disease activity; minimum clinically important difference unknown) was 3.8 points in the methotrexate group and 4.06 points in the placebo group (MD -0.26 points, 95% CI -0.65 to 0.13; 1 study, n=221). Three studies (n = 293) informed for serious adverse events (RR 0.26, 95% CI 0.03 to 2.26) and withdrawals due to adverse events (RR 1.32, 95% CI 0.51 to 3.42) between methotrexate and placebo. No study measured radiographic progression.
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