Topical ruxolitinib shows promise in milder stages of hidradenitis suppurativa

In patients with milder hidradenitis suppurativa (HS), treatment with ruxolitinib cream led to significantly superior reductions in the abscess and inflammatory nodule (AN) count compared with vehicle application. The topical JAK inhibitor also led to more pronounced results in both HS Clinical Response (HiSCR) and International HS Severity Score System (IHS4).

With no approved treatment and unsatisfactory responses to standard therapies, treatments for patients with milder stages of HS are needed [1,2]. “There are no options for these patients,” Prof. Martina Porter (Beth Israel Deaconess Medical Center, MA, USA) underlined in her talk [1]. Treatment success with topical ruxolitinib in skin diseases like atopic dermatitis and vitiligo contributed to the rationale for investigating the compound for milder stages of HS.

In a 16-week phase 2 trial (NCT05635838), ruxolitinib 1.5% cream twice daily was compared with vehicle in 69 adult patients with Hurley stage 1 or 2. To be eligible, the AN count had to be 3–10 and the affected body surface area could not exceed 20%. Prof. Porter further explained that the participants did not apply the cream as a field therapy but only 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% vs vehicle 50%). Furthermore, a mean decrease in IHS4 was depicted by a delta of -4.46 on ruxolitinib compared with -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). However, treatment-related adverse events occurred in 11.8% and 11.4%, respectively. On ruxolitinib, nasopharyngitis and COVID-19 were the most common treatment-emergent adverse events, on vehicle this was nausea. There were no serious adverse events noted in the active treatment arm.

Relevant readings:

• Hidradenitis suppurativa treatment with secukinumab linked to low immunogenicity (AAD 2024)
• BTK signalling as a novel target in hidradenitis suppurativa treatment (AAD 2024)

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   1. Porter MJ, et al. Efficacy and safety of ruxolitinib cream in patients with hidradenitis suppurativa (Hurley Stage I and II): results from a randomised, double-blind, vehicle-controlled phase 2 study. LB2, 2024 AAD Annual Meeting, 8–12 March, San Diego, USA.
   2. Sabat R, et al. Nat Rev Dis Primers. 2020;6(1):18.

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Posted on 22 April 202417 May 2024