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Understanding Long-Term Safety, Efficacy, and Demographic Variances in Ruxolitinib Trials


Alexandra Golant, MD, explains why she is confident in the latest safety and efficacy data from ruxolitinib trials to treat pediatric patients with atopic dermatitis.

In this Dermatology Times Expert Perspectives series, 5 experts delve into the multifaceted aspects of pediatric atopic dermatitis care including demographic variances to long-term safety and efficacy, comparative analyses, key takeaways from recent research, personalized approaches, and future research directions. Discover clinical insights into the role of ruxolitinib (Opzelura) in addressing critical challenges and enhancing patient outcomes.

In this episode, Alexandra Golant, MD, assistant professor and residency program director at the Icahn School of Medicine at Mount Sinai in New York, New York, explains why she is confident in the latest safety and efficacy data from ruxolitinib trials to treat pediatric patients with atopic dermatitis.

Episode Transcript

Golant: The clinical trial programs for topical ruxolitinib (Opzelura), even in the pediatric population, included a diverse range of ethnicities. The data that I've seen hasn't shown data stratified by ethnicity, but the inclusion of these populations would suggest that the efficacy outcomes are applicable to a wide range of patient populations consistent with the diversity of patients that we see in our offices.
Looking at the trials of topical ruxolitinib in our pediatric patients, we see efficacy and safety data that is fortunately quite consistent with what we saw in the trials for our adult patients using this therapy for AD. We see high rates of skin clearance, looking at IGA success, EASI 75, patients that experienced very rapid itch reduction. We know that topical ruxolitinib is a topical JAK inhibitor, and the hallmark of our JAK inhibitors is speed, [and] its efficacy of onset, particularly for itch. What I love about using these agents is that translates into very rapid itch reduction in days, sometimes even shorter than days. Hours after using it, patients will report significant itch reduction. And that fortunately translated beautifully into our younger patient population as well. On the flip side of efficacy is always safety and we saw a very consistent safety profile for use of topical rucks in our pediatric patients.
We know that the medication even hopefully when approved for our younger patients will still have the same warning language, will still have that same boxed warning. It's the same drug, but the safety data would support very confident use in this patient population. The available data from the clinical trials looking at topical ruxolitinib in that pediatric under 12, that 2 to 12 population, shows really consistent safety profiles. The safety profile we see with topical ruxolitinib in that 2 to 12 age range pediatric patient population really was consistent with what we saw from the large phase 3 clinical trial programs from our patients 12 and up.
This included the primary study period as well as that long term safety follow up. So, no new signals, no new amplification of adverse events, really consistent with what we know true from its label today.
The available data gives me a lot of confidence for the use of this topical the way we traditionally use topicals, which is allowing patients to maintain,
to use this as needed over long periods of time. I have really no concerns from this data set, no new alarm bells relative to what we know about data from our adolescent or our adult population with AD.

Transcript edited for clarity

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