Ryan Haumschild, PharmD, MS, MBA: You raise interesting points between some patients who are first responders or responders and patients who do not respond. As we take a look at the treatment of these patients, Dr Lebwohl, how do you view a patient and identify a non-responder earlier, and how can this data be used in real evidence to change treatment like this? specific patient earlier, so that they respond to therapy sooner and don’t have the same kind of delay compared to their other patient cohorts? In other words, how to leverage real world evidence and the DME [electronic medical record] data to identify non-responders and potentially change treatment pathways for them? Is this something you are looking at? Do you see this as the future of treatment in this patient population?
Mark Lebwohl, MD: I think it plays a very important role in having a defined decision point, when do we change, when do we know a drug won’t work? And often the time that has been chosen is 4 weeks. But for other drugs, it’s 3 or 4 months. A fast drug like ixekizumab did a study where they showed if you didn’t achieve a 50% reduction in PASI [Psoriasis Area and Severity Index] score at week 4, there is a reasonable chance that you will never reach the endpoint you are looking for at week 12 or 16. Week 4 is an important time for some medications. IL-23 [interleukin-23] blockers are slower on average. I can tell you that I’ve had patients, a doctor, come and say, “Well, nothing is working. I have tried all organic products, nothing works. The IL-23 blockers were out, and I encouraged her, and warned her up front, that they’re slow. Now some of the IL-23 blockers including tildrakizumab also looked at week 4 as an endpoint and said if I remember the data correctly if you got at least 38% improvement of the PASI score at week 4, there was a good chance that you would end up getting a PASI 75, which is a very good end point, a very good result. I think I remember these numbers correctly; Maybe I’m wrong. Tildrakizumab is a much slower treatment than most of the other treatments we have. But like I said, it peaks at 7 months.
Now I have had another one of the IL-23 blockers that we used for this doctor. And I said to him, “Look, you have to wait until at least week 16.” And sure enough, she came back to week 4 and she said, “It’s not working.” She came back to week 12, “It’s not working.” At week 16, she was completely gone. I think there will be different patients who will have different results. There are a number of companies that are actually looking to identify genetic markers to predict which [patient] will respond to which treatment at which time. There is a company called Madera that is studying this. There are currently several genetics companies in the field of dermatology that have been very successful, for example, in predicting which melanoma will spread. They have the technology to help us find the genetic markers that tell us, “OK, if a patient has that genetic profile, you might want to use a different drug because they’re less likely to respond to different drugs. “
So, I hope that one day we will have this kind of personalized medicine approach. But at the moment, we don’t have it. And right now, we’re treating patients with whatever drug we think is best for them based on their overall picture. Then at some point you have to make a decision, do they respond or not? For some drugs it can be 4 weeks. I think for more drugs it’s week 12 or week 16.
Ryan Haumschild, PharmD, MS, MBA: It was a great story that you shared about that coworker, and such a difference between week 4 and week 17, and seeing a kind of ‘I told you so’ moment there when you got them. consider uniquely.
This transcript has been edited for clarity.