Dr Loftus presented a late-breaking abstract at the ACG Scientific Meeting October 25 presenting results from a maintenance trial of upadacitinib in the treatment of Crohn disease.

Edward Loftus, MD, is a professor of medicine at the Mayo Clinic in Rochester, Minnesota.

TRANSCRIPT:

Hi, I'm Ed Loftus. I'm a professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota, and I just gave a late breaking abstract presentation on the use of upadacitinib in patients with moderate to severe Crohn's disease. I presented the 52-week maintenance study, which was using doses of 15 or 30 milligrams of upadacitinib in patients who had responded to 45 milligrams in the induction studies. So in order for patients to enter this maintenance study, they had to have responded in the induction studies, and that was defined as a 30% reduction in stool frequency or abdominal pain score from baseline. And then they were randomized to either placebo, 15 milligrams or 30 milligrams of upadacitinib, which if you recall, is a selective JAK1 inhibitor. And then at the end of 52 weeks, they were reassessed and the coprimary endpoints were clinical remission and endoscopic response.

Clinical remission was defined in the U.S. as CDAI score of less than 150 points, and in Europe as a stool frequency score of less than 2.8, an abdominal pain score of less than 1. An endoscopic response was defined as an SES-CD reduction of at least 50%. So the primary endpoint was met, whether you define clinical remission by the U.S. or the European guidelines, as well as the endoscopic coprimary endpoint, and the deltas were fairly impressive for a Crohn's trial. And so we're seeing deltas anywhere from 25 to 35% roughly. And then the secondary endpoints were also met, including clinical response, maintenance of clinical remission amongst those who had achieved remission at the end of induction, and also steroid-free remission. The safety, it was well tolerated.

There were no new signals compared to what's known with the class of medications. In most cases, the type of adverse event was numerically lower in the upadacitinib-treated patients compared to placebo. One notable exception being zoster. In the higher dose of upadacitinib, there were 7 cases per 100 person years of zoster, which is again, similar to what we've seen in other JAK trials, notably the tofacitinib trials. There were no deaths in the trial. There were 3 malignancies. There was 1 thrombosis episode. There were no MACE events. So in summary, upadacitinib was effective and safe in this group of patients where it was actually a fairly refractory group of patients. Recall that three-quarters of the patients in this trial had failed a biologic therapy and yet it was still effective. So looking forward to hearing more about this drug in the coming months to years, and you'll be seeing more data, I'm sure.