Dr Rubin discusses the results of the maintenance component of the QUASAR study of guselkumab, an IL-23/p19 inhibitor, in the treatment of ulcerative colitis, which he presented at Digestive Disease Week.

David Rubin, MD, is the Joseph B Kirsner Professor In Medicine, chief of Gastroenterology, Hepatology and Nutrition, and director of the Inflammatory Bowel Disease Center at the University of Chicago School of Medicine.

TRANSCRIPT:

Hi, it's Dr. David Rubin from the University of Chicago. I'm at DDW 2024 in Washington, DC, and I just presented the maintenance results of the phase 3 guselkumab study for moderate to severe ulcerative colitis. Guselkumab is an anti-IL-23/p19 antibody that also binds to the CD64 receptor on cells that make IL-23. It has demonstrated in prior study results the effectiveness at induction of response and remission.

The study I presented today were the phase 3 randomized results of patients who had received IV guselkumab dosing for induction, had responded to it, and then were followed out for 44 weeks in maintenance. The primary endpoint was clinical remission at week 44. Patients were randomized to 2 different doses of guselkumab in this maintenance study or to placebo, but all patients who entered the maintenance study had received guselkumab and responded to it in induction.

So the 3 arms were guselkumab 200 milligrams delivered every 4 weeks subcutaneously, guselkumab 100 milligrams delivered every 8 weeks subcutaneously, or a placebo arm which again were patients who had received guselkumab in the induction study but then had that drug withdrawn and then they continued on with placebo.

At week 44, both doses of guselkumab were superior to placebo at achieving that primary endpoint of clinical remission. The 200 milligrams every 4 weeks achieved that endpoint in 50% of the patients, and the 100 milligrams every 8 weeks achieved it in 45% of the patients. Both were statistically superior to the placebo-guselkumab withdrawal arm.

Looking at additional end points of interest, they included the usual secondary outcomes, all of which were met and hit by the guselkumab-treated patients compared to those placebo patients. And of interest, included very nice results with endoscopic response defined by a Mayo score of 0 or 1, as well as the endoscopic remission of a Mayo score of 0, —which is a stringent definition where essentially the bowel is completely healed—of 34% in both treatment arms.

This therapy was safe and well tolerated. The adverse event profile was similar to what had been seen in induction and is known about this particular therapy. Very safe, not an increased risk of other obvious adverse events. The most common adverse events that we see would be exacerbation of the ulcerative colitis, which as expected occurred more often in the patients who received placebo.

So this is a very nice and positive study for both doses of guselkumab that were studied in maintenance. And it's expected that this therapy will be an option for patients as it gets its approval from the FDA in the future. Thank you for your attention.