Methotrexate in Crohn's disease: Results of a randomized, double-blind, placebo-controlled trial

Sanjeev Arora, William Katkov, Jeffery Cooley, James Alan Kemp, David E. Johnston, Robert H. Schapiro, Daniel Podolsky

Research output: Contribution to journalArticlepeer-review

133 Scopus citations


BACKGROUND/AIMS: Immunosuppression with methotrexate may be useful in the treatment of Crohn's disease. We tested the efficacy of methotrexate in refractory Crohn's disease in a randomized, controlled trial. METHODOLOGY: Randomized, double-blind placebo-controlled trial of methotrexate in 33 patients with steroid-dependent Crohn's disease, 33% of whom had previously failed therapy with 6-mercaptopurine. Patients were given placebo or oral methotrexate 15 mg/week, or adjusted up to 22.5 mg/week, for up to 1 year or until treatment failure. Outcome was assessed by reduction in prednisone dosage, Crohn's Disease Activity Index, hospital admission, and laboratory parameters. RESULTS: Four patients were dropped from the study for non-compliance and one because of intercurrent illness, and 28 patients could be evaluated. Fewer methotrexate-treated patients (6/13 or 46%) had flares of Crohn's disease as compared to placebo-treated patients (12/15 or 80%), but this did not achieve statistical significance (p < 0.1). There was a non-significant trend toward an increased number of significant side effects in the methotrexate-treated patients (3/13 or 23%) as compared to the placebo-treated patients (0/15 or 0%) (p < 0.2). Laboratory indices of inflammation did not differ between the two groups. CONCLUSIONS: The methotrexate-treated group showed a trend toward fewer Crohn's disease flares, balanced by an increased number of significant side effects.

Original languageEnglish (US)
Pages (from-to)1724-1729
Number of pages6
Issue number27
StatePublished - 1999


  • Crohn's disease
  • Methotrexate

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology


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