Methotrexate only as good as placebo in preventing UC relapse
Parenteral methotrexate does not perform better than placebo in preventing relapses of ulcerative colitis (UC) in patients who have achieved steroid-free response during induction therapy, a recent study has found.
A total of 179 patients with active UC (Mayo score 6–12 with endoscopy subscore ≥2) despite previous conventional or biological therapy were enrolled in a 48-week trial. All patients received subcutaneous methotrexate (25 mg/week) for 4 weeks, with a 12-week steroid taper (open-label phase). At week 16, steroid-free responders were randomly assigned to groups given either continued methotrexate (25 mg/week) or placebo until week 48 (maintenance phase).
Response occurred in 91 (51 percent) patients at week 16, and 84 patients were included in the maintenance phase (methotrexate group, n=44; placebo group, n=40). During this period, relapse of UC was reported in 29 methotrexate-treated patients vs 24 patients who received placebo (66 percent vs 60 percent; p=0.75).
At week 48, the number of patients who were in steroid-free clinical remission without need for additional therapies was likewise similar between the methotrexate and placebo groups (27 percent vs 30 percent; p=0.86).
There were no new safety signals detected for methotrexate.
Available therapeutic options for induction and maintenance of remission for patients with active UC are limited. The fact that biologics are costly highlight a need for affordable, easy to administer therapies such as methotrexate. However, while there is a dose–response relationship observed for methotrexate in the treatment of rheumatoid arthritis, more studies are needed to investigate methotrexate prospectively in studies using higher doses and employing parenteral administration (subcutaneous or intramuscular) in patients with UC. [Inflamm Bowel Dis 2010;16:1421-1430]