Brian Feagan, MD, shares takeaways from his ACG presentation of phase 2 data on risankizumab for the treatment of Crohn's disease.
In an interview with MD Magazine® at ACG 2019, Brian Feagan, MD, professor of medicine at the University of Western Ontario, and presenting author of a study on risankizumab for the treatment of Crohn's disease, discusses the key findings and next steps for this line of research.
MD Magazine®: What is the current treatment landscape for Crohn’s disease, including current gaps in treatment?
Feagan: The current landscape of therapy in Crohn's disease has moved away from step care. Currently, we focus on patients who are high risk and treat them with highly effective therapy earlier in the course of the disease. That's quite a departure from the incremental approach, which we've used for many years.
MD Magazine®: Can you summarize the key findings of the study on risankizumab?
Feagan: Risankizumab is a monoclonal antibody directed against Interleukin 23, which is a cytokine that has pronounced pro-inflammatory effects in inflammatory bowel disease (IBD), and in certain rheumatic diseases, specifically ankylosing spondylitis and psoriatic arthritis. It's also a highly effective therapy for psoriasis. This study was a phase 2 study that was conducted 2 years ago in global locations, and the study was a dose-finding study that compared a low dose of risankizumab 200 mg given intravenously on 3 occasions during the induction phase of the trial to 600 mg, a high dose, to placebo. The overall end point was remission as defined by CDAI scores. However, there was also some extensive endoscopic assessments. And what we demonstrated in the trial was that the drug was effective for inducing remission, and there was a dose response. So the 600 mg dose was highly effective compared to 200 mg and placebo And, moreover, there was a striking endoscopic improvement such that the rates of endoscopic remission were substantially greater than placebo.
Now at this year’s ACG, we've updated a secondary analysis from that study, looking at rapidity of response. In the study we used CDAI scores by week to compare the 600 mg, 200 mg, and placebo assignments. What was demonstrated is the drug had a relatively rapid onset of action, with statistically significant changes being demonstrated at 2 weeks with the 600 mg dose been most effective.
MD Magazine®: What is next in this line of research?
Feagan: There's great interest in IL-23 as next generation monoclonal antibodies, both in ulcerative colitis and Crohn's disease. There are several agents under evaluation. And, moreover, several of these drugs have now made it to market approval in psoriasis therapy so their safety and efficacy is excellent in that condition. In fact, they've transformed the field and they really have achieved psoriasis induction rates of 90%, which is unheard of. So, obviously, we’re very interested in both ulcerative colitis and Crohn's disease and there are phase 3 studies underway with many agents right now.
The poster, “Early Symptom Improvement With Risankizumab Treatment in Patients With Moderately to Severely Active Crohn’s Disease: Analysis From a Phase 2 Study,” was presented Tuesday, October 29, 2019, at the American College of Gastroenterology Annual Scientific Meeting (ACG 2019) in San Antonio, Texas.