Methotrexate for induction of remission in refractory Crohn's disease

摘要: Background Although corticosteroids are effective for induction of remission Crohn's disease, many patients relapse when steroids withdrawn or become steroid dependent. Furthermore, exhibit significant adverse effects. The success methotrexate as a treatment rheumatoid arthritis led to its evaluation in with refractory disease. Methotrexate has been studied disease and the principal alternative azathioprine 6-mercaptopurine therapy. This systematic review is an update previously published Cochrane reviews. Objectives primary objective was assess efficacy safety active presence absence concomitant Search methods We searched MEDLINE, EMBASE, CENTRAL IBD/FBD group specialized register from inception June 9, 2014 relevant studies. Conference proceedings reference lists were also identify additional Selection criteria Randomized controlled trials compared placebo comparator adult (> 17 years) considered inclusion. Data collection analysis outcome failure enter withdraw steroids. Secondary outcomes included events, withdrawal due serious events quality life. calculated relative risk (RR) 95% confidence intervals (95% CI) each outcome. analyzed on intention-to-treat basis. bias tool used methodological GRADE approach overall evidence supporting Main results Seven studies (495 patients) included. Four rated low bias. Three high open label single-blind designs. seven differed respect participants, intervention, extent that meta-analysis be inappropriate. analyses indicated very most sparse data inadequate blinding. small which employed dose oral showed no statistically difference induce between 6-mercaptopurine. For study using 15 mg/week 33% (5/15) failed 11% (2/18) (RR 3.00, CI 0.68 13.31). 12.5 81% (21/26) 77% (20/26) 1.05, 0.79 1.39). had arm, 59% (19/32) 1.36, 0.97 1.92). methotrexate, 20% (3/15) 6% 3.20, 0.37 27.49). 5-ASA arm found significantly more likely than patients. Twenty per cent 86% (6/7) 0.23, 0.08 0.67). One higher intravenous (25 mg/week) azathioprine. Forty-four (12/27) 37% 1.20, 0.63 2.29). Two combination infliximab monotherapy. utilized (20 5 weeks then switched mg/week). Forty-five (5/11) 62% 0.73, 0.31 1.69). other assessing therapy subcutaneous (maximum 25 Twenty-four (15/63) 22% (14/63) 1.07, 0.57 2.03). A large placebo-controlled intramuscularly benefit placebo. Sixty-one 0.75, 0.61 0.93; number needed treat, NNT=5). Withdrawals common this study. Seventeen withdrew 2% 8.00, 1.09 58.51). incidence (63%, 17/27) (26%, 7/27) one 2.42, 1.21 4.89). No differences withdrawals reported any Common nausea vomiting, abdominal pain, diarrhea, skin rash headache. Authors' conclusions There single randomized trial suggests intramuscular provides complete Lower does not appear provide comparator. However, these further may justified. Comparative drugs such would require randomization numbers addition over However relatively research determine role conjunction biological therapies.