Methotrexate for induction of remission in refractory Crohn's disease

ArticleinCochrane database of systematic reviews (Online) 12(12):CD003459 · December 2012with24 Reads
Impact Factor: 6.03 · DOI: 10.1002/14651858.CD003459.pub3 · Source: PubMed


    Although corticosteroids are effective for induction of remission of Crohn's disease, many patients relapse when steroids are withdrawn or become steroid dependent. Furthermore, corticosteroids exhibit significant side effects. Methotrexate is an immunosuppressive drug that is used to treat active treatment resistant Crohn's disease. This review includes seven randomized trials with a total of 495 participants. There is evidence from one large study which suggests that methotrexate (25 mg/week) injected intramuscularly for 16 weeks among patients with active treatment resistant Crohn's disease may provide a benefit for induction of remission and complete withdrawal from steroids. This reduction in steroid use could reduce steroid-induced side effects for people with chronic Crohn's disease. Although side effects are more common with high dose methotrexate therapy, no serious side effects have been observed. Common side effects associated with methotrexate therapy include nausea and vomiting, abdominal pain, diarrhea, skin rash and headache. Studies comparing lower dose oral methotrexate (12.5 to 15 mg/week) to placebo (e.g. sugar pill) or other active drugs (e.g. azathioprine or 6-mercaptopurine) indicate that lower dose oral methotrexate does not appear to provide any benefit for treatment of active treatment resistant Crohn's disease. However, these trials were small in size and further studies of oral methotrexate may be justified. Two studies looked at the combination of methotrexate and infliximab (a biological drug) compared to infliximab therapy alone. These studies indicated that the addition of methotrexate to infliximab therapy does not appear to provide any additional benefit over infiximab. However these studies were relatively small and further research is needed to determine the role of methotrexate when used in conjunction with infliximab or other biological therapies.