Phase 2 Trial For Povorcitinib Sees Positive Trend In Hidradenitis Suppurativa Treatment

Joslyn Kirby, MD, MS, MEd

New findings from a phase 2 study—presented at the European Academy of Dermatology and Venerology (EADV) 2022 Congress this week—showed trends toward efficacy for the JAK1-selective inhibitor povorcitinib as a treatment for hidradenitis suppurativa (HS), depending on dosage.

The study team, led by Joslyn S. Kirby, MD, MS, MEd, and Martin M. Okun, MD, PhD, worked to “evaluate the efficacy and safety results of povorcitinib in a randomized, placebo-controlled, phase 2 dose-ranging study of povorcitinib over 16 weeks of treatment.”

Research and Methods

Many inflammatory conditions such as HS are affected by a dysregulation of the JANUS kinase (JAK)/ signal transducer and activator of transcription (STAT) pathway. Kirby and colleagues found that in 2 previous phase 2 studies on HS, povorcitinib—an oral JAK1-selective, small molecule inhibitor—showed proof of concept after 8 weeks of treatment without serious adverse events (AEs).

The investigators used a randomized, placebo-controlled study over the course of 16 weeks, during which the primary endpoint would be to change from baseline in abscess and inflammatory nodule (AN) count, and to achieve HS Clinical Response (HiSCR or HiSCR75). Eligible patients were men and women diagnosed with HS ≥3 months prior to screening.

The researchers randomized the patients to be given 1 of 3 povorcitinib treatments or a placebo once per day over 16 weeks of double-blind study. They included all randomized participants in the intent-to-treat (ITT) population. In week 16, they made comparisons in the ITT population that were analyzed through logistic regression including stratification factors, treatment group, and geographic area.

Study Results

The median age range for participants was 36 years, just over 75 percent of the study participants were female, and 81.8% were from North America. Additionally, 70.3% of participants were reported as White, 24.4% were reported as Black, and 2.9% were reported as Asian.

The investigators found that at baseline, almost 70% of patients were Hurley stage II (disease severity) and 23% were reported as Hurley stage III. By week 16, they found that patients treated with povorcitinib achieved noticeably greater decreases in their baseline AN count.

The researchers also found that, by week 16, a larger percentage of participants with povorcitinib achieved HiSCR versus the placebo arm, and similar findings were true of achieving HiSCR75.

“Results from this phase 2 study of povorcitinib in patients with HS suggest a trend toward dose-dependent efficacy between 15 mg and the higher doses, with no evidence for increased risk of serious toxicity at higher doses,” they wrote.

This study, “Efficacy and Safety of the Janus Kinase 1 Inhibitor Povorcitinib (INCB054707) in Patients With Hidradenitis Suppurativa: Results From a Randomized, Placebo-Controlled, Phase 2 Dose-Ranging Study,” was presented at EADV 2022.