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NEW YORK (Reuters Health) Dec 17 - Patients with moderately active systemic lupus erythematosus (SLE) can significantly benefit from methotrexate with folic acid, according to researchers with the Canadian Network for Improved Outcomes in SLE.
The participants in the double-blind, randomized, placebo-controlled study were, on average, able to decrease their prednisone dose and experienced a slight reduction in disease activity, the researchers report in the December 15th issue of Arthritis & Rheumatism.
Dr. Paul R. Fortin of Toronto Western Research Institute told Reuters Health that compared with the one previous similar trial, his group's study was larger, longer and more strictly blinded. He also noted both studies showed a beneficial effect of methotrexate versus placebo.
Study participants were already receiving a stable dose of NSAIDs, prednisone or antimalarial drugs. Patients were excluded if their lupus manifestation was severe enough to require azathioprine or cyclophosphamide.
Sixty of 86 participants completed the 12-month study. All participants received an escalating dose of either methotrexate (starting with 7.5 mg/week) or placebo, plus 2.5 mg/day of folic acid.
Monthly follow-up visit were conducted for 1 year, during which an independent, blinded assessor scored the patients' symptoms.
Compared with patients in the placebo group, patients in the methotrexate group reduced their average daily dose of prednisone during the trial by about 22%. This decrease, of about 1.33 mg/day, constituted a statistically significant (p = 0.013) steroid-sparing effect.
Of 19 methotrexate patients not taking prednisone at baseline, only 1 was taking it at 12 months. Of the 23 patients initially not on prednisone in the placebo group, 6 (26.1%) were taking it at the study's finish.
Across the 12 monthly assessments, the mean Systemic Lupus Activity Measure (SLAM-R) score in the methotrexate group was 0.86 points lower (p = 0.039) than the score in the placebo group. At baseline, SLE disease activity was the same in both groups.
The methotrexate group had a higher risk of adverse gastrointestinal or mood disorder events. Seven (17.1%) participants taking methotrexate had to decrease their dose because of gastrointestinal events, compared with only one (2.2%) in the placebo group (p = 0.02).
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