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Methotrexate Fails to Prevent Relapse in Patients With UC
LAS VEGAS — While methotrexate combined with a steroid taper was effective for inducing steroid-free response and remission in patients with active ulcerative colitis, the immunosuppressant was not superior to placebo for maintaining remission in these patients, according to late-breaking results from the MERIT-UC study presented at the Crohn’s & Colitis Congress.
“Parenteral methotrexate (MTX) administered as 25-mg once a week is an effective therapy for induction and maintenance of remission for Crohn’s disease,” James Lewis, MD, professor of medicine and epidemiology at University of Pennsylvania, said during his presentation. “There have been numerous uncontrolled retrospective studies suggesting its efficacy in ulcerative colitis as well. The METEOR trial studied methotrexate 25-mg once a week as induction therapy for ulcerative colitis, and demonstrated a higher percentage of patients achieving steroid-free clinical remission when compared to placebo, but not mucosal healing. MERIT-UC is the first prospective controlled randomized double-blind trial comparing parenteral methotrexate at 25-mg a week vs. placebo to investigate the efficacy of methotrexate in maintaining methotrexate-induced response or remission.”
Lewis and colleagues recruited 179 patients with moderate-to-severe active UC at multiple centers, who received 25-mg per week subcutaneous MTX with a 12-week steroid taper in a 16-week open label induction period. At week 16, 51% responded and were able to stop taking steroids, and 30% achieved remission.
Then investigators randomly assigned 84 of the responders to receive a maintenance dose of MTX or placebo for an additional 32 weeks. All patients received 2.4 g mesalamine per day.
Relapse occurred in 63% of the placebo arm and in 66% of the treatment arm, which was statistically comparable. At week 48, 12/40 (30%) patients on placebo and 12/44 (27.3%) patients on MTX were in steroid-free clinical remission
Lewis and colleagues noted they observed no new safety signals.
“Parenteral methotrexate at a dose of 25 mg per week induced steroid-free response and remission in a substantial proportion of patients with active UC, but was not superior to placebo in preventing relapse of disease,” Lewis said. “Thus, albeit the suggestion of efficacy of methotrexate in inducing steroid-free remission, methotrexate does not appear to represent a therapeutic option for maintenance of remission in patients with ulcerative colitis.” – by Adam Leitenberger
Reference:
Herfarth H, et al. Abstract 29. Presented at: Crohn’s & Colitis Congress; Jan. 19-20, 2018; Las Vegas, NV.
Disclosures: Lewis reports financial relationships with Merck, Janssen, Takeda, Pfizer, Lilly, Gilead, Johnson and Johnson, Samsung Bioepis, AbbVie and Dark Canyon Laboratories. Please see the full abstract for all other authors’ relevant financial disclosures.
Editor's note: This article was updated on Jan. 24 with additional information from the presenter.