The panel navigates unmet needs surrounding the vitiligo treatment landscape.
Jeffrey D. Dunn, PharmD, MBA: How would you define the unmet need, given what we have and this disease state?
David Rosmarin, MD: There’s a great unmet need for patients right now. There are no FDA-approved treatments for a reason. It’s a hard disease to treat. Part of the reason is that it takes only an overactive immune system to destroy the pigment cells and cause the disease, but to treat a patient or to get the pigment back, we often view it as a 2-step process. One is telling the immune system to calm down so the environment is more hospitable. But also those pigment cells have to migrate back into those depigmented white patches. Those are some of the big challenges. It isn’t enough sometimes to tell the immune system to calm down. You need that second step, which is what light treatment can often do. Or you wait with time, and it can naturally progress on its own.
Some of the unmet needs are having a treatment that works rapidly, effectively, safely, and conveniently. There are those main areas that we can improve on in all aspects. Some of our treatments with phototherapy don’t work for everybody. Calcineurin inhibitors certainly don’t work for everybody, nor do corticosteroids. It takes a long time for patients to repigment. It isn’t a several-week process, as Dr King said. It takes months. We need to give it time. The rapidity is important.
The ultimate efficacy and the safety matter. Some of our treatments, such as oral corticosteroids or topical corticosteroids, can have long-term effects. Oral JAK inhibitors can have their adverse effects as well. We need to take that into consideration. We’re lacking tools to adequately measure changes that are meaningful to patients. I wish we had better tools. Dr Epstein, I have a question based on what you said. The primary end point for a lot of these vitiligo studies is the face. The secondary end points are the whole body. Do you think that end point is going to affect the way payers view coverage of these new vitiligo treatments?
David Epstein, MD, MBA: I don’t think there’s a definite yes or no answer to that. It’s going to depend on what the data actually look like, and then how the KOLs [key opinion leaders] are picking this up and converting it into the real world, because the secondary end points are typically less important to the payers than the primary end points. That’s an unanswered question right now.
Jeffrey D. Dunn, PharmD, MBA: I’ll build on that. Personally, I don’t know if it matters if somebody is a primary or secondary by definition. If they’re clinically relevant and they’re powered appropriately, the data are good. The data will help. I still think maybe [we should look at] the policies. Some of the discussion we’ve had to this point is that if there are data on the trunk, then we have to look at that. If the policy is too dated, is it because we don’t have data there or because we’re antiquatedly thinking that we can cover that up by somebody wearing a shirt and they can’t cover the face?
Transcript edited for clarity.