In the long-term extension of the UNIFI trial, ustekinumab demonstrated continued efficacy and safety of the IL 12/23 inhibitor among patients with moderate to severe ulcerative colitis (UC) throughout 3 years, Maria Abreu, MD, said in presenting an abstract at the American College of Gastroenterology (ACG) scientific meeting on October 26.

Dr Abreu is a professor of medicine, microbiology, and immunology, and director of the Crohn's & Colitis Center at the University of Miami Miller School of Medicine.

Because loss of response over time to anti-tumor necrosis factor (TNF) agents remains an issue in the management of both UC and Crohn disease, Dr Abreu and colleagues set out to determine if patients lost or sustained response to ustekinumab.

The 3-year UNIFI long-term extension included patients who had responded to ustekinumab during the original trial, were re-randomized during the maintenance phase, and continued to show response to the drug. During the extension, participants continued to receive 90 mg every 8 weeks and included those who had previously been exposed to biologics as well as biologic naïve patients.

At the end of the 3-year extension, 70% of patients were still in symptomatic remission with a Mayo rectal bleeding score of 0. Among biologic-naïve patients, the rate of symptomatic remission was approximately 80%. Approximately 60% of the participants were biologic-exposed, Dr Abreu noted.

Virtually all patients remained in steroid-free remission, as well, with only 2 patients requiring additional treatment with corticosteroids, Dr Abreu said.

Both C-reactive protein and fecal calprotectin levels showed a rapid drop among patients treated with ustekinumab in the original UNIFI trial, she explained. These values continued to improve during the trial and then showed consistent levels over the following 3 years.

--Rebecca Mashaw

Abreu, M. Efficacy of ustekinumab for ulcerative colitis in patients through 3 years: UNIFI long-term extension. Presented at American College of Gastroenterology Scientific Meeting. October 26, 2021.