Dr Martina Porter Shares Findings on Ruxolitinib Cream in Patients With HS

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Martina Porter, MD

At the American Academy of Dermatology Annual Meeting 2024, Martina Porter, MD, FAAD, vice chair of research, Department of Dermatology, Beth Israel Deaconess Medical Center, reinforced the efficacy and safety profile of twice-daily ruxolitinib (Opzelura) cream 1.5% for patients with mild to moderate hidradenitis suppurativa (HS), according to a phase 2 study (NCT05635838).

AJMC: Can you provide an overview of the late-breaking session you presented, "Efficacy and Safety of Ruxolitinib Cream in Patients With Hidradenitis Suppurativa (Hurley Stage I and II): Results From a Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study?"

Porter: I presented the efficacy and safety of ruxolitinib cream in patients with hidradenitis suppurativa or HS, who are early stage 1 and 2. This was a randomized double-blind vehicle-controlled phase 2 study. The study design was essentially a 16-week double-blind period where patients applied the cream twice daily and it was compared with vehicle. These are all adult patients who had HS for more than 3 months, their abscess and nodule count had to be between 3 and 10, and they couldn't have any draining nodules.

AJMC: What were your primary findings, and did anything surprise you?

Porter: The main outcome was a change from baseline and abscess and inflammatory nodule [AN] count through week 16. That was the primary end point. We also looked at percentage change in the AN counts and the highest score in the International Hidradenitis Suppurativa 4.

Nothing, I would say, is very surprising. The things that were great were that there actually was a statistically significant difference between the vehicle and the ruxolitinib cream, favoring the ruxolitinib cream, and we saw the changes as early as week 8 of the 16-week period. When we're looking at the proportion of patients who achieved a 50% or 75% improvement, there were significant changes as well between the vehicle and the cream. There was still a numerical difference in the 90% and 100% improvement, but less so.

AJMC: Can you discuss the safety profile of these findings and if there were any notable adverse events?

Porter: Overall, the ruxolitinib cream was very well tolerated in the first 16 weeks. There were no serious treatment-emergent adverse events [AE], and there were about 35 patients in each group. About 40% of patients had an AE, which is not surprising for a study of this length. But there was only 1 grade 3 or higher and serious AE, and that was in the vehicle group. It was a patient who had diabetic ketoacidosis.

AJMC: How do the results of this study contribute to our understanding of the potential role of ruxolitinib cream as a treatment option for mild to moderate HS compared with existing therapies?

Porter: I think the exciting part is that this is the very first study that we've done from an industry-funded standpoint that was a double-blind study for patients who had milder HS disease. And so, it's nice that we saw some statistically significant results. Things I think that are still to be determined is what type of end point we'll use for a trial like this, because patients overall are less severe and the end points we've always historically used are for patients who have moderate to severe disease.

But like I said, the promising things are this study was very popular among patients that are clearly looking for more treatment options, both topical and for people who have less severe disease.

AJMC: Given the lack of approved therapies for mild-to-moderate HS and the limitations of current standard of care, how do you envision ruxolitinib cream fitting into the treatment landscape for this condition, particularly in terms of patient quality of life and long-term management?

Porter: In general, you know that patients with HS who even have mild disease have very significant quality of life impairments. This trial was looking at monotherapy, so patients aren't allowed to be on any other treatments while they use the ruxolitinib cream. But my suspicion is that in clinical practice, this could be used as monotherapy for patients who have a milder disease, but it can also be used as adjunctive therapy for patients who have moderate-to-severe disease since we don't see those patients clearing up entirely with the available treatments that are out there right now or approved.