Ustekinumab Demonstrates Sustained Clinical, Corticosteroid-free Remission at 4 Years in Adults with Moderate-to-Severe Ulcerative Colitis

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Adults with moderate-to-severe ulcerative colitis (UC) receiving ustekinumab (Stelara®; Janssen Pharmaceuticals) generally maintained clinical benefit through 4 years of follow-up, according to research presented at the United European Gastroenterology (UEG) Week 2022 congress held in-person in Vienna and virtually from October 8-11.

Final data from the long-term extension (LTE) of the phase III UNIFI study showed that among 348 patients who achieved clinical response to treatment with intravenous ustekinumab during induction, 64.9% were in symptomatic remission after 44 weeks. After 200 weeks, the 4-year mark, 55.2% were in symptomatic remission. The majority of patients (96.4%) were not receiving corticosteroids.

Among the 174 patients receiving ustekinumab as their first biologic for UC (biologic-naïve), 71.8% were in symptomatic remission after 44 weeks of maintenance and 67.2% were in remission at week 200.

A separate presentation of UNIFI LTE study data showed 79.1% of patients randomized to the ustekinumab cohort who received corticosteroids at maintenance baseline and were treated with ustekinumab in the LTE were no longer receiving corticosteroids by week 200.

“The final LTE results of the UNIFI study demonstrated that STELARA can be an effective long-term treatment option for patients living with moderately to severely active ulcerative colitis, including in patients who are biologic-naive,” said presenting study author Waqqas Afif, MD, associate professor, Department of Medicine, Division of Experimental Medicine and Division of Gastroenterology at McGill University Health Centre in Montreal, Canada, in a press release. “Importantly, the vast majority of patients who achieved remission in the study were able to eliminate the use of steroids, which can cause significant side effects and are not a long-term treatment solution for the disease.”

The UNIFI study was designed to evaluate the safety and efficacy of ustekinumab induction and maintenance dosing for the treatment of moderate-to-severe active UC in adults who demonstrated an inadequate response to or were unable to tolerate conventional or biologic therapies.