Open AccessEfficacy of methotrexate in ulcerative colitis: Failure or promise
Author(s) -
Herfarth Hans H.,
Osterman Mark T.,
Isaacs Kim L.,
Lewis James D.,
Sands Bruce E.
Publication year - 2010
Publication title -
inflammatory bowel diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.932
H-Index - 146
eISSN - 1536-4844
pISSN - 1078-0998
DOI - 10.1002/ibd.21246
Subject(s) - medicine , methotrexate , ulcerative colitis , psoriasis , inflammatory bowel disease , rheumatoid arthritis , context (archaeology) , adverse effect , randomized controlled trial , infliximab , placebo , dosing , crohn's disease , gastroenterology , pharmacology , disease , dermatology , pathology , paleontology , alternative medicine , biology
Abstract Background: Low‐dose methotrexate is a widely used and efficacious therapy in chronic inflammatory disorders such as psoriasis and rheumatoid arthritis. Prospective randomized controlled trials have demonstrated the efficacy of parenteral methotrexate in Crohn's disease (CD). We performed a systematic review of the efficacy of methotrexate in ulcerative colitis (UC) and discuss the results in the context of the known pharmacokinetics and adverse events of methotrexate therapy in inflammatory bowel diseases and other inflammatory conditions. Materials and Methods: We performed a systematic review of the literature in Medline, Embase, and Web of Science. All publications describing patients with UC treated with methotrexate were included. Results: We identified 12 studies or retrospective case series and 5 meeting abstracts that met the inclusion criteria. Only 1 study reported a prospective randomized placebo‐controlled trial using methotrexate at a dose of 12.5 mg orally with no significant clinical benefit. However, the majority of uncontrolled retrospective analyses suggest a clinical response to methotrexate therapy in a range of 30%–80% when the drug is applied by parenteral route in doses between 20–25 mg. Conclusions: The only randomized controlled trial of methotrexate in UC employed oral dosing and doses lower than those shown to be effective in CD and did not demonstrate efficacy, whereas uncontrolled, retrospective studies using doses and routes of administration similar to those employed in CD suggest benefit. Well‐designed, prospective, placebo‐controlled trials of methotrexate in UC are needed. Inflamm Bowel Dis 2010