Four-Year Efficacy and Safety Data of Ustekinumab Use in Ulcerative Colitis - Episode 2
David P. Hudesman, MD, reviews data presented at the ACG 2022 Annual Scientific Meeting on the safety and efficacy of ustekinumab for ulcerative colitis treatment.
David P. Hudesman, MD: Another important point with maintenance therapy for ulcerative colitis and something we discuss with our patients is durability. Obviously, we want our patients to feel better and go into remission quickly, but we also want them to stay that way for a long period of time. Unfortunately, with many of our therapies, over time patients are more likely to lose response. However, with some of our newer biologic therapies like ustekinumab, an IL-12/23 inhibitor based on both dosing and low immunogenicity rates, we have seen better durability. I’d like to discuss a study that was presented at our ACG [American College of Gastroenterology] conference this year in Charlotte, North Carolina. The study was entitled Efficacy and Safety of Ustekinumab for Ulcerative Colitis Through 4 Years. The final results were from the UNIFI long-term extension study. This was by Dr Sands et al. The UNIFI trial was the registration trial for ustekinumab in moderate to severe ulcerative colitis patients. After intravenous induction, they took all responders—over 500 patients who responded—and followed these patients out for 4 years to look at both efficacy and safety. They analyzed this in 2 different ways. 1) The non-responder imputation method; 4 years later, you are not going to have every patient still in the study. A patient could have still been doing well, but if they didn’t have those follow-up visits through 4 years, they would count as a failure, they lost response. 2) Just observed cases; at the end of 4 years, whoever followed up at that last visit, to learn how they were doing. What you saw was impressive long-term remission rates in these patients. This is at week 200 on ustekinumab. The durability, was well over 50%, closer to 60%. If we look, they are further broken into bio-naive patients or patients who were exposed. This is another important part. If you looked at patients who were naive to biologics, this was their first line. They were more likely to have those long-term remission rates at week 200 at 4 years with almost 70% versus lower if you were experienced to biologics in the past; that was about 40%. There was also 1 other way they broke down this data. They looked at patients, so the way you got into long-term maintenance is you needed a response. But if you looked at patients who were actually in remission, who were feeling perfect during maintenance, and followed those patients out for 4 years, whether you are bio-naive or bio-exposed, those patients did extremely well in over 80% of observed cases. Putting this all together really shows some good durability data for use to ustekinumab in ulcerative colitis, both in the bio-naive and bio exposed patients.
This long-term extension trial for ustekinumab in ulcerative colitis is an important study, and now we have so many therapeutic options for our ulcerative colitis patients. We have to decide what therapy for what patient. If we start treatment early, I think many of our therapies will work. The other factor we are looking at besides efficacy is safety. We know this class, these IL-12/23 inhibitors and selective IL-23 inhibitors, are very safe agents. We talk about onset of action, how quickly they work. But again, I think what this study really drives home is the durability. Now, it’s something we can talk to our patients about and say, “This is a drug that will get you well, there’s a good chance it’s going to get you well up-front, and you’ll continue to feel well down the road 4 years later.”
Transcript Edited for Clarity