Low dose methotrexate in seronegative spondyloarthro pathy: result of a double blind, placebo controlled trial

Abstract

Objective: To evaluate the efficacy of methotrexate in patients with seronegative spondyloarthropathy (SSA) in a prospective, randomized, double-blind, placebo-controlled trial. Patients and Methods: 36 patients with SSA who fulfilled the European Spondyloarthropathy Study Group criteria were randomized to receive either weekly oral Methotrexate (MTX) 7.5 mg/week or placebo. Disease activity parameters were measured at baseline 2,4 and 6 months. Primary outcome variables included, physician's assessment of disease activity, patient assessment of assessment of disease activity, duration of early morning stiffness, pain on a visual analog scale, and tender and swollen joint counts. Other measures were modified-Schober’s tests, chest expansion, enthesitis site counts, erythrocyte sedimentation rate (ESR) and average daily Indomethacin (NSAID) dose. Results: 50% of patients in both the groups of 18 patients each showed an over-all improvement. There was a significant reduction in the dose of NSAID required for pain relief in the MTX group (p<0.05). Conclusion: Methotrexate at 7.5 mg weekly oral dose is ineffective as a slow acting, anti rheumatic drug (SAARD) in SSA except that it reduced the NSAID requirement. It has an NSAID sparing effect.