VIDEO: Stelara induces remission, response ‘reassuring for our patients’ with IBD
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In a Healio video exclusive, Maria T. Abreu, MD, outlined long-term data presented at the European Crohn’s and Colitis Congress on the use of Stelara among patients with inflammatory bowel disease.
Results from the UNIFI study (n = 205 patients) showed ustekinumab (Stelara, Janssen) induced clinical response (80%), modified Mayo score response (79.5%), endoscopic improvement (67.3%) and clinical remission (58%). Further, among 171 patients who continued onto long-term extension, 95.9% achieved clinical response, 95.3% achieved modified Mayo score response, 80.7% showed endoscopic improvement and 69.9% achieved clinical remission at week 200.
“For those of us that take care of IBD patients, we know that one of the issues that we have had with biologics is that, at least for some of the anti-TNFs, there is a loss of effect over time that can be very impactful for patients,” Abreu, director of the Crohn’s and Colitis Center at the University of Miami, said. “In this study, as far as I know, it is the longest study that has ever been done of a biologic where patients were continued on maintenance medication and actually continued to report on their clinical remission rates.”
Additional pooled safety data from 2,575 patients with IBD showed a similar rate of adverse events compared with placebo through 5 years in Crohn’s disease and 4 years in UC.
She said: “What the studies very clearly show is that, for those patients that entered in remission in these UNIFI studies, for the next several years, they continue to do very well, and they continue to have endoscopic response that I think is very reassuring for our patients.”
References:
- Atreya R, et al. Guselkumab, an IL-23p19 subunit–specific monoclonal antibody, binds CD64 myeloid cells and potently neutralizes IL-23 produced from the same cells. Presented at: European Crohn’s and Colitis Organization; March 1-4; 2023; Copenhagen, Denmark.
- Danese S, et al. Efficacy of ustekinumab for ulcerative colitis through 4 years: Final clinical and endoscopy outcomes from the UNIFI long-term extension. Presented at: European Crohn’s and Colitis Organization; March 1-4; 2023; Copenhagen, Denmark.
- Ghosh S, et al. Safety of ustekinumab in IBD: Final pooled long-term safety analysis through 5 years in CD and 4 years in UC. Presented at: European Crohn’s and Colitis Organization; March 1-4; 2023; Copenhagen, Denmark.
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