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Dermbits

What is the long-term safety and efficacy data of topical roflumilast? 

Psoriasis

You? Well, with any new medication, even topicals, which I think we have a bias that they are probably a little bit safer than a systemic agent. And I think that is largely true when we think about the absorption, but not 100% true. We know certain topical medicines can be very highly absorbed and really have similar effects to any systemic medicine, but with any new medicine, it takes time. Of course, we have trial data, and a lot of the trial data is a few weeks or a few months or maybe even a year to get safety data. But we know that with other medications, sometimes it truly takes years. And I think about topical calcium inhibitors as a good example of something that it really took more than a decade to get data out there. That, at least for me now I think is enough to say, boy, topical calcium inhibitors in this group of patients, in that particular example, with atopic dermatitis children, Dr. Pallor and others put together that beautiful study suggesting that there really isn't a measurable increased risk of cancer. And of course, that still persists in the black box warning. But it took a very long time. I'm happy to say that what we see so far with topical roflumalast and the fact that this medication has been available for a number of years as an oral medicine already, so that also kind of helps. We already know people taking it as a systemic drug, obviously not for these indications, but for other indications, pulmonary disease in particular, then we can see that the long term safety profile appears very reassuring. And then what we have from topical application in this patient population is also very reassuring. And I am quite empowered by the fact that it doesn't require lab monitoring, it doesn't have a black box warning. And in general, the safety and warnings are actually fairly compact. So that's kind of a refreshing change from some of the other more powerful agents. And we need both, right? I love having my more powerful tools in my toolbox, but oftentimes those more powerful tools come with them. They bring with them a number of safety issues that we have to navigate with the patients. And this is one that I think, in general, all the things that we've seen so far are extremely reassuring and suggest that this will not only get, hopefully, other indications for other disease conditions, but also even lower age ranges. Obviously, I don't know about that, but that's my hope. Hope, because when we see a safe medication that's very effective, I really hope we can use it in other instances because we truly have a lot of unmet needs. Bye.