Video
Adverse Events of Ruxolitinib in Vitiligo Trials
Author(s):
Heather Woolery-Lloyd, MD, discusses the adverse event profile of topical ruxolitinib for treatment of vitiligo, highlighting the well-tolerated nature of the drug.
Seemal Desai, MD: Let’s go back to the study. Let’s get back on task because I want to focus on the remainder of the data. Heather, talk about adverse events. Safety is so important. Talk to me a little about the TRuE-V1 and TRuE-V2 adverse event [AE] profile and anything you pull from that when you counsel your patient.
Heather Woolery-Lloyd, MD: The adverse event profile is great. I call myself a safety nerd. I really care about safety. To me, it’s just as important as efficacy. But in the TRuE-V1 and TRuE-V2 trials, the most common adverse events were application site acne and application site pruritus. Then there was nasopharyngitis. Those are at a rate of around 5% to 6%. It’s very well tolerated with topical ruxolitinib. I see similar things in my practice. I’ve never seen itching or any irritation, but application site acne can be seen, and it’s easy to treat with topical benzoyl peroxide, salicylic acid, or whatever you choose.
Seemal Desai, MD: That sounds great. I agree that the acne I’ve seen as a result of topical ruxolitinib in my patients with vitiligo hasn’t led to them wanting to stop the therapy. Patients with vitiligo are some of the most motivated patients we have the privilege of treating, and they want to continue their therapy. If I tell them up front, “You may get some acne-like bumps.” Call our office, and we’ll see you if you really need to. That usually hasn’t been an issue. Has that been everyone else’s experience?
Nada Elbuluk, MD: Yes.
Ted Lain, MD: A proxy that you can use for AE severity is the discontinuation rate due to treatment-related AEs.
Seemal Desai, MD: Good point.
Ted Lain, MD: I encourage individuals, when you’re talking to your reps or your MSLs [medical science liaisons], to ask about that 1 metric in particular, because that gives you an idea about how well tolerated this is. If individuals are dropping out due to AEs deemed to be treatment related by the investigator, then we have an issue. That number is extremely small in TRuE-V1, TRuE-V2, and the long-term extension.
Seemal Desai, MD: We need to remind everyone that this is meant for less than 10% BSA [body surface area]. In fact, some of us were at a meeting, and I said, “This isn’t your 1-pound jar of triamcinolone that you’re going to do wet wraps in for your bad eczema.” This is localized use. As this continues to evolve, hopefully there will be ways to do this on larger body surface areas. Does everyone agree with that approach? OK, perfect.
Transcript edited for clarity
