Martina J. Porter, MD: New Findings on Efficacy, Safety of Ruxolitinib Cream Among Patients with HS

New phase 2 trial findings suggest that twice-daily ruxolitinib cream 1.5% (Opzelura) leads to positive outcomes among those with mild-to-moderate (Hurley stage 1 or 2) hidradenitis suppurativa (HS), with a substantially greater reduction in patients’ abscess and inflammatory nodules (AN) versus placebo.

These findings were released as late-breaking data at the 2024 American Academy of Dermatology (AAD) Conference in San Diego, with the research being presented by Martina J. Porter, MD, of Harvard Medical School. Porter spoke with HCPLive on the findings in a new interview.

“This is actually one of the first studies that we've done that was placebo-controlled for milder patients,” Porter said. “So most of the studies for HS now have only been done in the moderate-to-severe population. But there is a great need for some of these more mild patients, because they're actually the vast majority of HS patients overall.”

Study participants were randomized 1 to 1 to either receive 1.5% ruxolitinib cream twice-per-day or the vehicle cream. Subjects would apply the cream to their lesions that were present at baseline and then 1 centimeter around, so it was not for an entire anatomic area.

“The subjects were able to go to an extension period for an additional 16 weeks that's still ongoing,” Porter said. “But the main eligibility criteria were that they were adult patients who had to have HS for at least 3 months in the absence of AN count was in the milder range, so they needed to have between 3 and 10 lesions and they could not have any draining tunnels at any time during the study.”

Portr’s team also included criteria that participants either had to have itch or pain and an NRS score of 1 at baseline. She noted that the study involved a slightly younger population, with the average age being 29 and almost all being female.

“We did see at week 16, that there was a significantly greater number of patients who applied ruxolitinib cream and had a greater change in their AN count from baseline,” Porter said. “We even started to see this split as early as Week 8. Just in terms of some of the other secondary endpoints, we also looked at that AN count, the percentage of improvement, so we saw differences for AN50 and AN75, or 50% and 75% AN change.”

Porter referenced that the team had found 20.8% achieved AN90 and 20.8% achieved AN100), surpassing the reductions observed in the vehicle control arm. Nevertheless, she noted these percentages were not as large and not significant as the aforementioned AN50 and AN75 endpoints.

“So I think this is actually something that patients are very excited about, having a topical treatment option that could be effective for them,” Porter said. “ I really do see quite a few patients who don't need systemic therapy now and so this would really fill that gap for them. Obviously, this was more of a proof of concept, phase 2 study. So we need to validate the data and larger trials, but the fact is that it's pretty well tolerated and seems to have a good effect.”

Porter also highlighted the lack of serious treatment emergent adverse events observed with ruxolitinib cream in the study. She noted that the treatment overall appears to be very safe and well tolerated, as has been seen with other indications.

For further information on these late-breaking data, view the full interview segment above.

The quotes contained in this summary were edited for the purposes of clarity.