TY - JOUR T1 - Efficacy of methotrexate in ankylosing spondylitis: a randomized, double blind, placebo controlled trial. JF - The Journal of Rheumatology JO - J Rheumatol SP - 1568 LP - 1574 VL - 31 IS - 8 AU - Laura Gonzalez-Lopez AU - Araceli Garcia-Gonzalez AU - Monica Vazquez-Del-Mercado AU - Jose F Muñoz-Valle AU - Jorge I Gamez-Nava Y1 - 2004/08/01 UR - http://www.jrheum.org/content/31/8/1568.abstract N2 - OBJECTIVE: To evaluate the efficacy and safety of methotrexate (MTX) compared with placebo in patients with active ankylosing spondylitis (AS). METHODS: This 24 week, double bind, randomized, placebo controlled trial compared the response between MTX 7.5 mg/week or placebo in patients with active AS. The primary outcome measure was a composite index of improvement in 5 of the following scales: severity of morning stiffness, physical well being, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), the Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S), and physician and patient global assessment of disease activity. RESULTS: Seventeen patients received MTX and 18 placebo. In the intention-to-treat analysis at 24 weeks, 53% of patients in the MTX group had a treatment response, compared with 17% in the placebo group (p = 0.03). We observed significant improvements with MTX in physical well being (p = 0.009), BASDAI (p = 0.02), BASFI (p = 0.02), physician global assessment (p < 0.001), patient global assessment (p = 0.03), and HAQ-S (p = 0.02). In the adjusted analysis only MTX determined the improvement in the primary outcome. At the end of the trial, one patient with MTX withdrew due to a lack of compliance, and one with placebo due to a lack of efficacy. We did not observe significant differences in rates of side effects between the 2 groups. CONCLUSION: MTX is safe and effective for patients with AS. Longterm studies are needed to evaluate the permanence of its benefit. ER -