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Abstract

Efficacy of methotrexate in ankylosing spondylitis: a randomized, double blind, placebo controlled trial.

Laura Gonzalez-Lopez, Araceli Garcia-Gonzalez, Monica Vazquez-Del-Mercado, Jose F Muñoz-Valle and Jorge I Gamez-Nava
The Journal of Rheumatology August 2004, 31 (8) 1568-1574;
Laura Gonzalez-Lopez
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Araceli Garcia-Gonzalez
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Monica Vazquez-Del-Mercado
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Jose F Muñoz-Valle
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Jorge I Gamez-Nava
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Abstract

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.

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The Journal of Rheumatology
Vol. 31, Issue 8
1 Aug 2004
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Efficacy of methotrexate in ankylosing spondylitis: a randomized, double blind, placebo controlled trial.
Laura Gonzalez-Lopez, Araceli Garcia-Gonzalez, Monica Vazquez-Del-Mercado, Jose F Muñoz-Valle, Jorge I Gamez-Nava
The Journal of Rheumatology Aug 2004, 31 (8) 1568-1574;

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Efficacy of methotrexate in ankylosing spondylitis: a randomized, double blind, placebo controlled trial.
Laura Gonzalez-Lopez, Araceli Garcia-Gonzalez, Monica Vazquez-Del-Mercado, Jose F Muñoz-Valle, Jorge I Gamez-Nava
The Journal of Rheumatology Aug 2004, 31 (8) 1568-1574;
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