Longer-term treatment with povorcitinib 75 mg resulted in sustained and durable efficacy across all treatment arms in a phase 2 study.

Longer-term treatment with povorcitinib 75 mg resulted in sustained and durable efficacy across all treatment arms in a phase 2 study of hidradenitis suppurativa (HS) patients.

Povorcitinib is an oral JAK1 inhibitor. These data were presented as an oral presentation at the 12th Conference of the European Hidradenitis Suppurativa Foundation, held from February 8 to 10, 2023, in Florence, Italy.

The study previously met its primary endpoint, demonstrating that at week 16 – the double-blind, placebo-controlled portion of the study – patients receiving povorcitinib once daily (QD) had significantly greater decreases from baseline in abscess and inflammatory nodule (AN) count versus placebo (least squares mean change, −2.5 [0.9], placebo vs −5.2 [0.9], P = .0277, povorcitinib 15 mg; −6.9 [0.9], P = .0006, povorcitinib 45 mg; −6.3 [0.9], P = .0021), povorcitinib 75 mg).

New results at week 52, which include the 36-week open-label extension period during which all patients received povorcitinib 75 mg QD, show that average efficacy was sustained for all treatment arms following the switch to povorcitinib 75 mg QD (mean change in AN count from day 1 baseline at week 52 was −5.7 [7.3], placebo→75 mg; −8.4 [5.6], 15→75 mg; −10.4 [14.6], 45→75 mg; and −5.4 [5.6], 75 mg). Importantly, povorcitinib also demonstrated durable efficacy at week 52 in high-threshold outcomes, as evidenced by 22% to 29% of patients achieving HS Clinical Response 100 (HiSCR100), which is defined as a 100% reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count.

Povorcitinib was generally well tolerated, and the safety profile was consistent with previously reported data. The most common treatment-emergent adverse events (TEAEs) at week 52 (n = 174) were COVID-19 (21.3%), acne (11.5%), upper respiratory tract infection (10.9%), headache (5.7%), nasopharyngitis (5.7%), urinary tract infection (5.7%), and increased blood creatine kinase (CK) (5.2%). In total, six patients (3.4%) experienced a TEAE that led to treatment discontinuation. No fatal TEAEs were observed.

“HS is a chronic, progressive, and debilitating condition for which there is no cure. We are encouraged by these phase 2 data and believe they reinforce the potential of povorcitinib to be a safe and efficacious treatment for HS that is tolerable with longer-term administration, even at the higher doses,” says Kurt Brown, MD, global program head, povorcitinib, and associate vice president, drug development, inflammation & autoImmunity, Incyte. “Despite the available treatments for HS, no uniformly effective therapy has been found, underscoring the need for additional options. We look forward to continuing to progress the development of povorcitinib through our ongoing phase 3 trial in patients with moderate to severe HS.”

Additional 52-week efficacy results include:

“Given the nature of HS, which presents with persistent, painful nodules and abscesses, this immune-mediated skin condition often has a severe impact on a patient’s quality of life,” says Joslyn Kirby, MD, MS, MEd, an associate professor and vice chair for education, department of dermatology at Penn State Health. “I am encouraged by these promising results suggesting that povorcitinib may be a favorable oral treatment option that could provide substantial relief from common HS symptoms for patients.”