Methotrexate in chronic active ulcerative colitis: a double-blind, randomized, Israeli multicenter trial

Area of Science:

• Gastroenterology
• Clinical Pharmacology
• Immunosuppressive Therapy

Background:

• Previous uncontrolled studies suggested methotrexate efficacy in ulcerative colitis.
• Chronic steroid-dependent ulcerative colitis poses a significant treatment challenge.

Purpose of the Study:

• To evaluate the effectiveness of oral methotrexate in chronic steroid-dependent ulcerative colitis.
• To compare methotrexate versus placebo in a randomized, double-blind, multicenter trial.

Main Methods:

• Sixty-seven patients with active ulcerative colitis were enrolled.
• Participants received either 12.5 mg oral methotrexate or placebo weekly for 9 months.
• Inclusion criteria included steroid/immunosuppressive use and a Mayo Clinic score >= 7.

Main Results:

• No significant difference in the proportion of patients achieving remission (46.7% methotrexate vs. 48.6% placebo).
• Similar time to first remission and relapse rates between methotrexate and placebo groups.
• Mean scores, steroid dosage, and laboratory results were comparable across groups.

Conclusions:

• Weekly oral methotrexate (12.5 mg) was not superior to placebo for ulcerative colitis remission.
• Methotrexate did not demonstrate benefit in induction or maintenance of remission in this patient population.