Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study.

Background: Janus kinase 1 inhibition may alleviate hidradenitis suppurativa (HS)-associated inflammation and improve symptoms.
Objective: To assess efficacy and safety of povorcitinib (selective oral Janus kinase 1 inhibitor) in HS.
Methods: This placebo-controlled phase 2 study randomized patients with HS 1:1:1:1 to receive povorcitinib 15, 45, or 75 mg or placebo for 16 weeks. Primary and key secondary end points were mean change from baseline in abscess and inflammatory nodule count and percentage of patients achieving HS Clinical Response at week 16.
Results: Of 209 patients randomized (15 mg, n = 52; 45 mg, n = 52; 75 mg, n = 53; placebo, n = 52), 83.3% completed the 16-week treatment. At week 16, povorcitinib significantly reduced abscess and inflammatory nodule count from baseline (least squares mean [SE] change: 15 mg, -5.2 [0.9], P = .0277; 45 mg, -6.9 [0.9], P = .0006; 75 mg, -6.3 [0.9], P = .0021) versus placebo (-2.5 [0.9]). More povorcitinib-treated patients achieved HS Clinical Response at week 16 (15 mg, 48.1%, P = .0445; 45 mg, 44.2%, P = .0998; 75 mg, 45.3%, P = .0829) versus placebo (28.8%). A total of 60.0% and 65.4% of povorcitinib- and placebo-treated patients had adverse events.
Limitations: Baseline lesion counts were mildly imbalanced between groups.
Conclusion: Povorcitinib demonstrated efficacy in HS, with no evidence of increased incidence of adverse events among doses.
Competing Interests: Conflicts of interest Dr Kirby has served as a speaker for AbbVie and as a consultant for AbbVie, Bayer, ChemoCentryx, Incyte Corporation, InflaRx, Janssen, Novartis, Pfizer, and UCB. Dr Okun is a consultant for AbbVie, Azora, Bluefin, Boehringer Ingelheim, ChemoCentryx, Incyte, InflaRx, Innovaderm, Novartis, Pfizer, and Vyne. Dr Alavi received honoraria as a consultant or advisory board participant from AbbVie, InflaRx, Incyte, Novartis, Boehringer Ingelheim, and UCB and received honoraria as an investigator for Boehringer Ingelheim and Processa. Dr Bechara has received honoraria for participation in advisory boards, in clinical trials, and/or as a speaker from AbbVie, AbbVie Deutschland, Boehringer Ingelheim, Incyte, Janssen-Cilag, MoonLake, Novartis, and UCB. Dr Zouboulis declares that none of the mentioned conflicts of interest had any influence on this manuscript. He reports consultancy/advisory board disease-relevant honoraria from Boehringer Ingelheim, Incyte, InflaRx, Janssen-Cilag, Novartis, Regeneron, Sanofi, UCB, and Viatris. He has received speaker fees from Almirall, Novartis, and UCB; is President of the EHSF eV, coordinator of the ALLOCATE Skin group of the ERN Skin and chair of the ARHS Task Force group of the EADV. He is Editor of the EADV News; is cocopyright holder of IHS4 on behalf of the EHSF eV. His employer has received disease-relevant grants from Boehringer Ingelheim, InflaRx, Novartis, and UCB for his participation as clinical investigator. Dr Bibeau was an employee of Incyte at the time of the study. Drs Brown, Santos, and Wang are employees and shareholders of Incyte. Dr Kimball’s institution has received grants from AbbVie, Admirx, AnaptysBio, Aristea, Bristol Myers Squibb, Eli Lilly, Incyte, Janssen, MoonLake, Novartis, Pfizer, Prometheus, UCB, and Sonoma Bio, fellowship funding from Janssen and AbbVie. She received consulting fees from AbbVie, Alumis, Bayer, Boehringer Ingelheim, Eli Lilly, Evommune, Janssen, MoonLake, Novartis, Pfizer, Priovant, Sonoma Bio, Sanofi, UCB, and Target RWE, and serves on the board of directors of Almirall. Dr Porter is a consultant and/or investigator for AbbVie, Acelyrin, Alumis, AnaptysBio, Aristea, Bayer, Bristol Myers Squibb, Eli Lilly, Incyte, Janssen, MoonLake, Novartis, Pfizer, Prometheus Laboratories, Regeneron, Sanofi, Trifecta Clinical, Sonoma Bio, and UCB.
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