Photo Credit: MD Babul Hosen

Phase 2 trial results show reductions in the abscesses and inflammatory nodule count were induced by topical treatment with ruxolitinib versus vehicle.

Significantly greater reductions in the abscesses and inflammatory nodule (AN) count were induced by topical treatment with ruxolitinib versus vehicle in a phase 2 trial. Also, the achievement of HS Clinical Response (HiSCR) and improvements in the International HS Severity Score System (IHS4) were more prominent on the JAK inhibitor.

Treatment success with topical ruxolitinib in skin diseases like atopic dermatitis and vitiligo contributed to the rationale to also investigate the compound for milder stages of hidradenitis suppurativa (HS), which currently lacks approved treatments [1]. Within a 16-week phase 2 trial (NCT05635838), ruxolitinib 1.5% cream twice daily was compared with vehicle in 69 enrolled adult Hurley stage 1 or 2 adult patients. To be eligible, the number of abscesses and inflammatory nodules (AN) had to be 3–10, and the affected body surface area could not exceed 20%. Martina Porter, MD, explained that the participants did not apply the cream as a field therapy; they only applied it on the lesions.

The study met its primary endpoint with a significantly greater change in least-square means of the AN count in the ruxolitinib arm (-3.61 vs -2.42 on vehicle; P<0.05). At week 16, a reduction of at least 50% in AN (AN50) was seen in 79.2% on ruxolitinib cream and 56.3% on vehicle. Proportions for reaching HiSCR were similar (ruxolitinib, 79.2%; vehicle, 50%). Furthermore, a mean decrease in IHS4 was depicted by a delta of -4.46 on ruxolitinib versus -2.66 on vehicle. This was also reflected by bigger drops on the scales for skin pain and itch for participants receiving the JAK inhibitor treatment.

The safety assessment revealed treatment-emergent adverse event rates of 38.2% (ruxolitinib) and 42.9% (vehicle). Treatment-related adverse events, however, occurred in 11.8% and 11.4%, respectively. On ruxolitinib, nasopharyngitis and COVID-19 were the most common adverse events; on vehicle, it was nausea. No serious adverse events were noted in the active treatment arm.

Medical writing support was provided by Karin Drooff, MPH.
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