Ustekinumab Shows Efficacy as Maintenance Therapy in Ulcerative Colitis Study
Phase 3 trial evaluated ustekinumab as a maintenance treatment in adult patients with moderate-to-severe ulcerative colitis.
New results from a phase 3 study demonstrate the potential of ustekinumab (Stelara) in helping patients with moderate-to-severe ulcerative colitis (UC) achieve and maintain clinical remission.
Compared with placebo, a significantly greater proportion of patients with moderate-to-severe ulcerative colitis (UC) who received ustekinumab were in clinical remission at 1 year, according to the study.
The UNIFI trial evaluated the safety and efficacy of ustekinumab induction and maintenance dosing for the treatment of moderate-to-severe UC in adults who demonstrated an inadequate response to or were unable to tolerate conventional or biologic therapies. According to the data, 44% of patients receiving ustekinumab subcutaneous injections every 8 weeks (q8w) and 38% receiving ustekinumab subcutaneous injections every 12 weeks achieved clinical remission at week 44. Twenty-four percent of patients who received placebo achieved clinical remission.
Additional study results at 1 year include:
- 71% of patients receiving ustekinumab q8w and 68% of patients receiving ustekinumab q12w maintained clinical response, compared with 44% of patients receiving placebo (both p>0.001).
- 51% of patients receiving ustekinumab q8w and 44% of patients receiving ustekinumab q12w achieved endoscopic improvement, compared with 29% of patients receiving placebo (p>0.001 and p=0.002, respectively).
- 42% of patients receiving ustekinumab q8w and 38% of patients receiving ustekinumab q12w were in clinical remission and were corticosteroid-free, compared with 23% of patients receiving placebo (p<0.001 and p=0.002, respectively).
“Ulcerative colitis is a disruptive, lifelong and potentially debilitating inflammatory bowel disease; however, it is a condition where remission is possible,” lead study investigator Willian Sandborn, MD, chief of the division of gastroenterology and professor of medicine at University of California, San Diego, said in a statement. “The data suggest the potential of ustekinumab as an effective therapy for helping people living with ulcerative colitis achieve remission, as well as providing other meaningful outcomes, including response, histo-endoscopic improvement and corticosteroid-free remission.”
In the UNIFI induction study, which evaluated the effects of ustekinumab on histo-endoscopic mucosal healing (HEMH), patients achieved higher rates of endoscopic improvement, histologic improvement, and the combined endpoint of HEMH versus placebo, 8 weeks after a single intravenous induction dose of ustekinumab. This is the first phase 3 study to report a combined histo-endoscopic endpoint in patients with UC, according to Janssen.
Ustekinumab is currently approved for the treatment of severe plaque psoriasis, active psoriatic arthritis, and Crohn disease.
UC affects nearly 907,000 individuals in the United States, with approximately 38,000 new cases diagnosed every year. The UNIFI maintenance data further support the use of ustekinumab as a potential new therapy option for patients with UC.
New phase 3 Stelara (ustekinumab) data show positive results as maintenance therapy in adults with moderate to severe ulcerative colitis [news release]. Janssen. https://www.janssen.com/new-phase-3-stelara-ustekinumab-data-show-positive-results-maintenance-therapy-adults-moderate. Accessed March 13, 2019.