Ustekinumab Results in Symptomatic Remission for Ulcerative Colitis Patients

Bruce E. Sands, MD

New data shows the majority of adult patients with moderate to severely active ulcerative colitis who initially respond to ustekinumab (STELARA) presented sustained symptomatic remission rates at week 152.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the new data from the long-term extension of the phase 3 UNIFI study showing 55.2% of adult patients achieved this response.

The Trial

The UNIFI trial is designed to evaluate the safety and efficacy of ustekinumab induction and maintenance dosing in ulcerative colitis patients who demonstrated an inadequate response to or were unable to tolerate convention treatment such as corticosteroids or immunomodulators or biologic therapies, including 1 or more TNF blockers or vedolizumab.

In addition, 96.4% (n = 185) of the patients in symptomatic remission at week 152 were corticosteroid-free.

The intent-to-treat portion of the study included 348 patients who achieved clinical response at maintenance baseline that were randomized to ustekinumab 90 mg every 8 weeks or every 12 weeks.

Overall, 55.2% of patients were in symptomatic remission at week 152.

For the 248 patients randomized to ustekinumab 90 mg every 8 weeks or 12 weeks at maintenance baseline and treated in the long-term extension, 67.6% of participants achieved symptomatic remission at week 152 and 76.4% of patients in clinical remission at week 44 were in symptomatic remission at week 152.

Safety

The safety evaluation for the 588 person trial included 1281.6 patient-years of follow-up in the treatment arm, compared to 425 patient-years of follow-up in the placebo group. There were 235.81 adverse events in the ustekinumab group, compared to 204.48 adverse events in the placebo arm.

The rate of serious adverse events was 7.73 in the treatment arm and 7.53 for patients taking the placebo, while there were 2,34 serious infections following ustekinumab compared to 2.35 for placebo.

There were no new safety signals observed.

"Despite recent substantial therapeutic gains, many patients living with ulcerative colitis still struggle to find lasting relief from their disease symptoms, especially without the use of steroids that can be associated with debilitating side effects when used long-term," said Bruce E. Sands, M.D., M.S., Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology) at the Icahn Institute for Medicine at Mount Sinai, in a statement. "The LTE of the UNIFI study underscores the importance of studying therapies long-term, with results showing ustekinumab as both an effective and enduring treatment option for patients living with moderately to severely active ulcerative colitis."

The new data was presented during the 16th Congress of the European Crohn’s and Colitis Organization.