乌鸦传媒

At the American Academy of Dermatology (AAD) annual meeting, eleven abstracts highlighted new data on bimekizumab for the treatment of adults with moderate to severe plaque psoriasis, including a late-breaking oral platform presentation.

乌鸦传媒 brought together three expert leaders in the field: moderator , of the Oregon Medical Research Center in Portland, is joined by , of the University of Pennsylvania in Philadelphia, and , of Case Western Reserve University in Cleveland, for a virtual roundtable discussion. This second of four exclusive episodes focuses on the use of bimekizumab, as well as the incidence of oral candidiasis and inflammatory bowel disease (IBD) with interleukin (IL)-17 blockers.

Following is a transcript of their remarks:

Blauvelt: Hello, everyone. My name is Dr. Andy Blauvelt. I'm a dermatologist from Portland, Oregon, at the Oregon Medical Research Center. I'm happy to be joined today by two of my friends and colleagues, Dr. Joel Gelfand from University of Pennsylvania, and Dr. Neil Korman from Case Western Reserve University.

I'm gonna switch now to a new drug that's likely to be approved by the FDA any day now. It's called bimekizumab. It's a new biologic. It blocks IL-17A and IL-17F, and at the AAD meeting we saw for the first time the year 2 efficacy and safety, so this drug extended out now over 2 years of use.

And as sort of expected from the 1-year results that have been published before, the drug works really well. It stays working well. There's no fall off from year 1 to year 2. And in particular, in my view, the [Psoriasis Area and Severity Index] PASI 100 numbers for this drug are the highest that we have seen to date. We're in the 70% range of PASI 100 with bimekizumab. And it really is maintained over the course of 2 years.

What we do see with this drug, though, is about 15% or so of patients with oral candidiasis, or thrush, which we had seen with other IL-17 blockers, but really not to this degree. And then rare incidences of IBD as well, which we have seen with IL-17 blockers. So, for me, I'm very impressed by this new biologic. I think it's setting a new standard, although it's not markedly different from what's on the market. It's incrementally better, I think. But I'm curious to hear from you guys, what you think the impact of bimekizumab would be, or maybe the incidence of thrush at 15% -- do you think that's gonna affect the use of this new drug? So, Neil, can you comment first?

Korman: Sure. So, certainly at 15% incidence of oral candidiasis, none of which is a big deal. And I think if I remember correctly, there might have been one person in the whole study that chose to discontinue because of it. So, it's really not a big deal. And certainly we all have experience with the other two IL-17 blockers that only block [IL-17]A, that they caused the same thing, they cause candidiasis, probably at a lower level -- maybe 3%, 5%. So, to me, it wouldn't make a difference to me. I've got probably a dozen, 15, 20 patients who are sitting, waiting for this drug to come on the market so that I can get them on it, since they failed the other 11 biologics that are currently on the market.

I'm very excited by it and it won't scare me. But I would encourage our colleagues to not be scared by it either. If you have the nerve to use Diflucan, fluconazole to treat oral candidiasis, this is a great drug. And people do really, really well with it. And the candidiasis to me is a non-issue.

Gelfand: I think the way we have to think about it as clinicians is to make sure the patients know what to look out for. And they need to know to talk to us, their dermatologist that prescribe them, when these things come up. Because what I see in my clinical practice is that, the patients may develop one of these problems and they don't bring it to our attention. They go back to their primary doctor who may not be able to recognize thrush. They go see an ENT, they get a biopsy, all this stuff done that could just be easily dealt with in one in-basket message. It's a very straightforward thing. But sometimes the more primary care teams or other specialists may not be as comfortable identifying thrush as we are as dermatologists. So, it's an important thing to keep in mind when you counsel patients.

Blauvelt: Hey, Joel, can you give us your take on the IBD story with IL-17 blockers? We've seen new-onset disease, we've seen exacerbations. What do you think of the numbers? What do you tell your patients?

Gelfand: Inflammatory bowel disease itself is statistically rare. The incidence is quite low. And the extra risk from IL-17 inhibitors is pretty small as well. And so, as an individual clinician, we're unlikely to see many cases in our practice, even if you're treating a lot of patients. In some of the large-scale, sort of, epidemiological studies, it's hard to show an association because you need thousands and thousands of patients to really make this type of estimate here. But I do think it's something to keep in mind as a clinician.

Inflammatory bowel disease is such an emotional condition for people when that occurs. And so, for my patients who have a very strong family history of inflammatory bowel disease, for example, I may try and shift them away from that medication class, unless they have a strong indication, they have arthritis, or they're not doing well with other agents. So, patients need to be aware of it. They need to know what to look out for. And they should be reassured to know that's pretty unlikely to occur.

Blauvelt: Okay. That's kind of my take on it too. So, I mentioned it, but I talk about it being rare.

Watch episode one of this discussion: Cardiovascular Risk in Patients With Psoriasis

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