Dr. Cross discusses his presentation on how advances in anticytokine therapy are broadening options for treatment of inflammatory bowel disease.

Raymond Cross, MD, is professor of medicine and director of the IBD Program at the University of Maryland.

TRANSCRIPT:

Thank you for joining us at our symposium, "Advances in Anti-Cytokine Therapy -- The Current and Potential Roles of IL-12/23 and IL-23 Inhibitors in IBD." My name is Raymond Cross. I'm a professor of medicine and director of the Inflammatory Bowel Disease Program at the University of Maryland.

Over the next few minutes, I want to give you some of the key takeaway points from my presentation. In my presentation, we reviewed the efficacy of ustekinumab for Crohn's disease and ulcerative colitis from the pivotal trials that led to regulatory approval of the drug.

Clearly, ustekinumab is an effective agent, not only in reducing symptoms and need for steroids but also resulting in reasonable rates of mucosal healing for both UC and Crohn's disease. You also saw some long-term data which is very encouraging, showing the durability of response, again, for both disease states.

It seems like with this drug, because of the superior PK and the design of the drug, that once you get a patient into remission with this agent, they tend to stay there over the long haul, and the remission that is induced tends to be one that is steroid-free.

A couple other newer areas that we haven't looked at before is looking at comparative effectiveness. As a practicing gastroenterologist, one of our major questions is, how do you position these therapies, and how do you sequence them?

I showed 1 study that is a prospective cohort study showing that ustekinumab seems to have a better efficacy than vedolizumab for Crohn's disease. That's only one study, but it is a comparative effectiveness cohort.

The other is in the patients who are post-op, who've been exposed to anti-TNFs—can you use a drug like ustekinumab to prevent postoperative recurrence? The short answer from this small trial is yes. It does seem to have reasonable efficacy to prevent postoperative Crohn's.

Lastly, we went over the results of the STARDUST trial. The STARDUST trial looked at patients treated with standard dosing of ustekinumab who then had an endoscopy at week 16. For patients that did not have significant improvement in endoscopy, they then had dose optimization.

Now, they did start with q12-week dosing, but they were able to escalate all the way down to q4 weeks. They made subsequent adjustments based on symptoms and biomarkers. Surprisingly, at the end of the year, they did not find it that treat-to-target group did better than the conventionally managed group as far as looking at endoscopic response, which is a bit surprising. I'm not sure how that's going to impact clinical practice, but I think it speaks to the PK of this drug being designed very well that for most patients 90 milligrams every 8 weeks is sufficient dosing. Going to 6 weeks and 4 weeks for most people isn't going to improve outcomes, but more to come on that.

Again, I'd like to thank you for joining us in our symposium, and I hope to see you next time.