- Parenteral methotrexate monotherapy failed to show improved efficacy vs placebo as a maintenance treatment in preventing relapse in patients with ulcerative colitis.
- No new safety signals for methotrexate were detected.
Why this matters
- Findings demonstrate that methotrexate monotherapy is not a therapeutic viable option for ulcerative colitis.
- MERIT-UC is a 48-week trial (induction period, 16 weeks; randomised, placebo-controlled maintenance period, 32 weeks) of 179 patients with active ulcerative colitis.
- During induction period, patients were given subcutaneous methotrexate (25 mg/week) and a 12-week steroid taper.
- At week 16, steroid-free responders were randomly allocated to either continue methotrexate (n=44) or were given placebo (n=40) until week 48.
- Funding: National Institute of Diabetes and Digestive Kidney Diseases.
- At week 16, 51% of patients achieved a steroid-free clinical response, of which 29% were in steroid-free clinical remission.
- At week 48, relapse-free survival without the need for additional therapies like steroids, immunosuppressants or biologics and remission did not differ between groups (P=.78).
- In patients who completed the 48-week visit, 30% vs 27% patients in placebo vs methotrexate group were in steroid-free remission without the need for additional therapies (P=.91).
- Adverse events were significantly higher in methotrexate vs placebo group (P=.03).
- No significant differences were observed in types of adverse events between groups, except a higher occurrence of nausea in methotrexate group.
- Trial powered to detect a 25% difference between placebo and methotrexate.
- Central reading of sigmoidoscopies not performed.