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.
RCT Entities:
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.
Authors: J Braun; J Zochling; E Märker-Hermann; G Stucki; H Böhm; M Rudwaleit; H Zeidler; J Sieper Journal: Z Rheumatol Date: 2006-12 Impact factor: 1.372
Authors: J Zochling; D van der Heijde; R Burgos-Vargas; E Collantes; J C Davis; B Dijkmans; M Dougados; P Géher; R D Inman; M A Khan; T K Kvien; M Leirisalo-Repo; I Olivieri; K Pavelka; J Sieper; G Stucki; R D Sturrock; S van der Linden; D Wendling; H Böhm; B J van Royen; J Braun Journal: Ann Rheum Dis Date: 2005-08-26 Impact factor: 19.103
Authors: Hamid J Mohamed; Michael J Sorich; Stefan M Kowalski; Ross McKinnon; Susanna M Proudman; Leslie Cleland; Michael D Wiese Journal: Eur J Clin Pharmacol Date: 2015-02-18 Impact factor: 2.953
Authors: Sarah Ringold; Sheila T Angeles-Han; Timothy Beukelman; Daniel Lovell; Carlos A Cuello; Mara L Becker; Robert A Colbert; Brian M Feldman; Polly J Ferguson; Harry Gewanter; Jaime Guzman; Jennifer Horonjeff; Peter A Nigrovic; Michael J Ombrello; Murray H Passo; Matthew L Stoll; C Egla Rabinovich; Rayfel Schneider; Olha Halyabar; Kimberly Hays; Amit Aakash Shah; Nancy Sullivan; Ann Marie Szymanski; Marat Turgunbaev; Amy Turner; James Reston Journal: Arthritis Care Res (Hoboken) Date: 2019-04-25 Impact factor: 4.794