For ulcerative colitis, ustekinumab safe, effective through 4 years, industry study finds
Most patients who had symptomatic remission of their ulcerative colitis on the drug maintained it without corticosteroids, an extension of a randomized trial found.
Subcutaneous ustekinumab was safe and effective in patients with moderate to severe ulcerative colitis to maintain clinical and endoscopic outcomes through four years with no new safety signals, an industry-funded study found.
A long-term extension of a placebo-controlled trial, the study included patients who completed 44 weeks of maintenance treatment of ustekinumab, dosed every eight or 12 weeks. Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0 and was evaluated at each visit through week 200. C-reactive protein (CRP) and fecal calprotectin were assessed every three months through week 200. Endoscopic assessment was done at week 200. The study was supported by Janssen Research & Development, with results published Dec. 14 by the American Journal of Gastroenterology.
Of the 348 patients who received subcutaneous ustekinumab every eight or 12 weeks, 55.2% were in symptomatic remission at week 200. A greater proportion of biologic-naive patients (67.2% [117 of 174]) were in symptomatic remission versus those with a history of biologic failure (41.6% [67 of 161]). Among patients in symptomatic remission at week 200, 96.4% were also corticosteroid-free. Of the 171 patients with endoscopic evaluation at week 200, 81.6% (71 of 87) in the 12-week group and 79.8% (67 of 84) in the eight-week group had endoscopic improvement.
From weeks 156 to the final safety visit (up to week 220), no deaths, major adverse cardiovascular events, or tuberculosis occurred in patients receiving ustekinumab. Nasopharyngitis, worsening of ulcerative colitis, and upper respiratory tract infections were the most frequently reported adverse events.
“Due to the life-long nature of [ulcerative colitis], long-term treatment is often required to induce and maintain remission,” the study authors wrote. “Advances in biologic therapies have allowed a paradigm shift in treatment goals from controlling symptoms to endoscopic healing, thus improving long-term outcomes.”