Targeting IL-17A offers a promising treatment perspective in hidradenitis suppurativa

In an ongoing phase 3 study, izokibep demonstrated efficacy in hidradenitis suppurativa (HS). After 12 weeks, one-third of participants treated with izokibep achieved Hidradenitis Suppurativa Clinical Response (HiSCR)75, in contrast with 21% in the placebo arm, thereby meeting the study endpoint.

“Hidradenitis is a horrible disease and we're constantly searching for new and improved therapies,” Dr Kim Papp (Probity Medical Research, ON, Canada) acknowledged [1]. He presented the 12-week results of an ongoing phase 3 trial (NCT05905783) on izokibep, a small protein that inhibits IL-17A.

The study assessed efficacy and safety in moderate-to-severe HS and randomised 258 participants (mean age of 37.3 years; 69% women) to weekly subcutaneous injections with 160 mg of izokibep or placebo over 16 weeks. The mean count of abscesses and nodules was 13.4, draining tunnels count 2.2, the Dermatology Life Quality Index (DLQI) was 11.9, and the disease duration was over 10 years.

A first statistically significant separation of the primary endpoint, an improvement of the HS clinical response by 75% (HiSCR75) curves was already seen at week 4. At week 12, 33% of participants in the izokibep arm reached HiSCR75 versus 21% on placebo (P<0.05) (see Figure). Only moments before his presentation, Dr Papp received the official results of HiSCR75 at week 16. “You will see it in the final publication, week 16: 38% izokibep and 20% placebo—spectacular results.”

Figure: Percentage of participants reaching the primary endpoint of HiSCR75 at week 12 [1]

HiSCR75, Hidradenitis suppurativa clinical response improvement by 75%; QW, once weekly.

The secondary endpoints HiSCR90 and HiSCR100 also favoured izokibep (25% vs 9%; P<0.001 and 22% vs 8%; P<0.01). Further ameliorations were found in patient-reported outcomes like DLQI and skin pain numeric rating scale (Skin Pain-NRS). Of note, half of the baseline Hurley stage II participants attained a count of 0, 1, or 2 for inflammatory lesions (P<0.01).

The interim rate of serious treatment-emergent adverse events was 0.8% on izokibep and 3.1% on placebo. The most common adverse events were injection-site reaction (65.1% vs 7.8%), headache (10.1% vs 9.3%), and nasopharyngitis (7.0% in both groups). No cases of candidiasis were seen in the izokibep arm.

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   1. Papp KA, et al. Efficacy and safety of izokibep, a novel IL-17A inhibitor, in moderate-to-severe hidradenitis suppurativa: Week 12 results from a randomized, double-blind, placebo-controlled, multicentre, phase 3 study. D1T01.2A, EADV Congress 2024, 25–28 September, Amsterdam, the Netherlands.

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Posted on 6 November 2024