- Methotrexate (MTX) fails to maintain steroid-free response or remission after MTX induction therapy in patients with ulcerative colitis (UC), according to a randomized, placebo-controlled trial.
Why this matters
- Clinicians may advise discontinuing MTX after a successful induction period.
- Randomized, double-blinded, placebo-controlled trial of maintenance subcutaneous MTX (n=44; 25 mg/week) or placebo (n=40; 25 mg/week) for 32 additional weeks, after a successful 16-week open-label induction period of MTX (n=179; 25 mg/week) with steroid taper.
- Funding: NIH; Crohn's and Colitis Foundation.
- 51% of 179 patients achieved response or remission during the 16-week induction period.
- Over the maintenance period, 60% of responders in the placebo group (24/40) and 66% of responders in the MTX group (29/44) had a relapse and discontinued therapy (P=.71).
- At week 48, 30% (12/40) of placebo recipients and 27% (12/44) of the MTX recipients were in steroid-free clinical remission without the need for additional therapies such as steroids, immunosuppressants, or biologics (P=.91).
- There were no new safety problems linked to MTX.
- Small sample sizes.
- Because of power considerations, an MTX benefit of 10%-15% cannot be excluded.