Ustekinumab safe, effective over 5-year maintenance period
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Ustekinumab safely maintained a long-term clinical response and remission in patients with Crohn’s disease and ulcerative colitis, according to a presentation at the American College of Gastroenterology Virtual Annual Scientific Meeting.
“By way of background, ustekinumab (UST) is approved for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis,” William J. Sandborn, MD, University of California, San Diego, said. “UST induced and maintained remission in patients in the induction, maintenance and 3-year trials of the UNITI program.”
In the UNITI program, researchers randomly assigned patients to receive either 90 mg UST or placebo every day for 12 weeks, patients who failed to respond received an additional 90 mg dose of subcutaneous UST. Responsive patients moved on to the extension trial where they continued dosage through 5-years; placebo patients were discontinued following study unblinding. Researchers further studied patients through intention-to-treat analyses.
Study results showed an initial response in 60% of all patients with 34% of patients maintaining clinical remission at 5-years. Further analysis showed an initial response of 60% to 80% in the anti-TNF naive patient population and an initial response of 40% to 60% in the failure subgroup patient population; remission was maintained in 44.2% of patients and 21.4% of patients, respectively.
“This is the longest duration of the anti-IL 12/23 treatment reported in patients with inflammatory bowel disease,” Sandborn concluded. “About half of the patients who entered into the long-term extension program continued through the final dosing visit. Patients receiving subcutaneous use UCT maintain clinical response and remission through five years ... no new safety signals were observed.”
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Sandborn WJ, et al. Presentation 42. Presented at: The American College of Gastroenterology Annual Scientific Meeting (Virtual). Oct. 26-28, 2020.
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