Bruce Sands, MD, on the QUASAR Study of Guselkumab in Ulcerative Colitis

Dr Sands reviews a phase 2 study of guselkumab that showed very promising results.

Bruce Sands, MD, is the Dr. Burrill B. Crohn Professor of Medicine and chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mt Sinai in New York, New York.

TRANSCRIPT:

My name is Bruce Sands. I'm the chief of GI at Mount Sinai in New York and I'm here to tell you about results of an analysis from the QUASAR study that I presented at the ACG in Charlotte this year. The QUASAR study is a phase II study looking at guselkumab, which is an anti-IL-23 antibody for the treatment of moderately to severely active ulcerative colitis. The induction phase of this study was already reported out earlier this year and this explored 2 doses of guselkumab, 200 milligrams IV every 4 weeks, or 400 milligrams IV every 4 weeks times 3, compared to placebo with a primary outcome at week 12. The analysis that was presented at ACG looked at the patients who didn't respond at week 12 and filed them out for an additional 12 weeks of subcutaneous dosing, to see if more patients could be brought into response.

At the end of week 12 induction, you had about 60% of patients who were in clinical response at that time point, but among the other 40% of patients, who then were able to continue on guselkumab, 200 milligrams subcutaneously every 4 weeks, half of the remaining 40% of patients were brought into clinical response by week 24. So in sum total, if you added up the patients who responded by week 12 and the additional patients who responded to prolonged treatment with subcutaneous dosing from week 12 to week 24, you had approximately 80% of patients, who at 6 months, were really in clinical response. I think this is important information for when we might use this agent clinically, because patients do want to know by when should I respond and by what point in time, if I haven't responded, should I not prolong my dosing?

This would suggest that there is additional incremental benefit for patients who haven't responded by week 12 and who are patient enough to give it 12 more weeks. So this is an interesting result. I think this agent, guselkumab, which is a very safe agent and seems to be effective in phase II in ulcerative colitis, will be important to look at in phase III. Thanks very much.