Four-Year Efficacy and Safety Data of Ustekinumab Use in Ulcerative Colitis - Episode 3
David P. Hudesman, MD, reviews long-term extension study data for the corticosteroid-sparing effects of ustekinumab on ulcerative colitis as presented at ACG 2022.
David P. Hudesman, MD: One interesting study that was presented at the ACG [American College of Gastroenterology] conference in Charlotte, North Carolina, in 2022, was by Dr Maria Abreu et al. It was Corticosteroid-Sparing Effects of Ustekinumab for Ulcerative Colitis Through 4 Years. This trial looked at the UNIFI trial, a registration trial for ustekinumab use in moderate to severe ulcerative colitis; for patients who received and responded to an IV [intravenous] induction of ustekinumab. Over 500 patients who responded were then followed up out to 4 years, or 200 weeks. This specific abstract was looking at the steroid-sparing capabilities of ustekinumab. This is extremely important. We talk about patients going into remission, but we want them in remission feeling well off of steroids.
For our patients with ulcerative colitis, when we are looking at long-term outcomes, we want them to be feeling better, have a good response, and be in remission. We want them to be in remission off of steroids. This is what this study looked at. They took patients who responded to IV ustekinumab…over 500 patients who went into the maintenance phase of the unified trial. Now, they are following these patients out 4 years. Out of the patients who made it into the long-term extension, just under 50% were on steroids at the time. Now when you follow these patients out 4 years, just under 80% of patients were feeling great at week 200, 4 years later off of steroids. If you went back and you looked at patients who were in remission, feeling perfect at the end of maintenance, and at the end of the long-term extension at week 44, over 95% of them were off of steroids. That really shows that ustekinumab is a good long-term agent, and a good steroid-sparing agent.
Transcript Edited for Clarity