Waqqas Afif, MD, on Ustekinumab for Ulcerative Colitis

Dr Afif reviews the final results of a 4-year study on the safety and efficacy of ustekinumab among patients with ulcerative colitis.

Waqqas Afif, MD, is an associate professor in the Division of Experimental Medicine and Division of Gastroenterology at McGill University in Montreal, Quebec, Canada.

TRANSCRIPT:

Speaker 1:

Hi everyone, my name is Waqqas Afif. I'm a gastroenterologist at the McGill University Health Center in Montreal, Canada. I'm an associate professor of medicine in the Department of Medicine. I wanted to present some data that we spoke about at UEG, and the title of the abstract presentation was Efficacy and Safety for Ustekinumab in Ulcerative Colitis Through Four Years. And this was the final results from the 4-year maintenance study.

Just a little bit of background: the phase 3 results were presented a few years ago in the UNIFI study, which looked at the induction and maintenance of remission in patients with moderate to severe ulcerative colitis. In that study, patients were either randomized to placebo or every 8 weeks or 12 weeks, during maintenance therapy. And those patients that continued on ustekinumab did much better than those patients that were on placebo.

After completion of 1 year, the remission rate at week 44 was approximately 65%, and this was similar for every 8 weeks and every 12 weeks. And as you know, this medication is now approved for the use in patients with moderate to severe ulcerative colitis. We presented the data at UEG, showing the 4-year total data for this cohort of patients. So in terms of the patients that continued on after the 1-year maintenance, the majority of those patients, about 55%, continued to stay in remission. And most of those patients, 96% of those patients, were in corticosteroid-free remission. Patients that were bionaive, they were not exposed to previous biologic agents, had a higher rate of remission during that first year of study. So 72% of those patients were in remission at the end of week 44. And throughout the 4 years, that percentage remained quite high at 67%. And almost all of those patients were off of steroids.

These numbers were a little bit lower in patients that were bioexposed, but certainly this medication was still effective in patients, not only in bionaive patients, but also in bioexperienced patients. Most importantly in the study, there was no new safety signals that were identified throughout the 4-year study period, which is good news for our patients. And so in general, this medication is quite effective in keeping patients in remission. And most importantly, it does it in a very safe manner with no serious adverse events that were reported over the course of 4 years.