Real-World Implications of Novel Crohn’s Disease Therapies

David P. Hudesman, MD: Dr Afzali, let's talk about the real world. What you're seeing in your practice and real-world evidence and how are you using these agents? Is the data that you're seeing consistent with the clinical trial?

Anita Afzali, MD, MPH, MHCM, FACG, AGAF: Great question. The real world is our world. We're not living in another world unless you are. It's what do we see in actual clinical practice? And in actual clinical practice, we see the patient where several therapies have failed them. We see the patient that has extra intestinal manifestations. We've seen all of this, but I will say with the newer therapies in the pipeline - exactly as Miguel, you mentioned - I believe we have been able to finally identify a selected immunologic target with these pathways that is either related to the gut or the skin. And we kind can take that as a pathway that we know will be effective for our patients, both short-term clinical symptoms, intermediate biomarkers, and long term that endoscopic improvement and remission. This is consistent with the trials results. And what I have seen in practice weathers with an IL-12/23 or 23 antagonists, I'm seeing very similar results where I have patients over large referral centers, who are referred to me, several therapies have failed them, and they are getting a response, an early response, in fact. I thought I had to wait 6 months, 8 months, 10, a year. But I am still seeing an early clinical response and getting to the some of these additional endpoints. I feel that dosing matters, we need to get the dose right. The targets mattered, we figured out well, with the New England Journal, they identified those targets for us. The timing matter, but now maybe it's not as sensitive to timing, because in real world, we are seeing folks who have had an either delay in diagnosis or several therapies have not worked.

Transcript Edited for Clarity