Incyte reports 54-week Phase 3 STOP-HS data showing durable efficacy, symptom improvement, and manageable safety of povorcitinib in moderate to severe hidradenitis suppurativa.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Incyte has reported 54-week data from its pivotal Phase 3 STOP-HS clinical program, demonstrating sustained efficacy and a consistent safety profile for povorcitinib in adults with moderate to severe Hidradenitis Suppurativa (HS). The data were presented as a late-breaking session at the American Academy of Dermatology Annual Meeting 2026, highlighting long-term outcomes for the oral JAK1 inhibitor.
Povorcitinib (INCB54707), an oral selective JAK1 inhibitor, had previously met the primary endpoint in both Phase 3 studies, STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836), achieving significant improvements in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12 compared with placebo at both 45 mg and 75 mg doses. Following this, patients entered a 42-week extension phase, during which those on active treatment continued their assigned doses while placebo participants were re-randomized to povorcitinib. After completing the study, participants transitioned either to the long-term extension study (STOP-HS LTE; NCT06212999) or to a 30-day safety follow-up phase.
At Week 54, povorcitinib demonstrated durable and clinically meaningful responses across both trials, with up to 71.4% of patients achieving HiSCR50. Higher response thresholds were also met, with up to 57% achieving HiSCR75 and up to 29% reaching complete response (HiSCR100). Consistent reductions were observed across all inflammatory lesion types, including abscesses, nodules, and draining tunnels, with complete lesion clearance (ANdT=0) reported in up to 20.2% of patients.
In addition to objective clinical improvements, patients reported meaningful benefits in symptoms and daily functioning. At Week 54, improvements in skin pain were observed in 40.5–46.8% of patients, while fatigue improved in 49.0–58.0%. Quality of life measures also improved substantially, with up to 64.7% of patients reporting better skin-related outcomes and up to 40.2% showing improvement in HS-specific quality of life.
Pablo J. Cagnoni, President and Global Head of Research and Development at Incyte, stated that the 54-week data show strong, sustained efficacy and a manageable safety profile for povorcitinib, supporting its potential as the first oral treatment option for HS, with regulatory progress underway in the U.S. and Europe.
The safety profile of povorcitinib over 54 weeks remained consistent with earlier findings. Treatment-emergent adverse events were reported in 76.2% to 83.4% of patients, with most events classified as mild to moderate, including acne, nasopharyngitis, and upper respiratory tract infections. Serious adverse events were infrequent, occurring in 3.7% to 6.4% of patients, and discontinuation rates were low. Events of special interest, including serious infections, malignancies, and thromboembolic events, were rare and occurred at low rates.
Based on these findings, regulatory submissions for povorcitinib are currently under review by the U.S. Food and Drug Administration and the European Medicines Agency. If approved, povorcitinib could become the first oral targeted therapy for moderate to severe HS, offering a convenient alternative to injectable biologics and potentially reshaping the treatment landscape.
Overall, the 54-week results reinforce povorcitinib’s potential to deliver durable disease control, symptom relief, and quality of life improvements, positioning it as a promising new option in a disease area with significant unmet need.
Reference
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting, 28 March 2026, Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting | Incyte
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS1), ClinicalTrials.gov ID NCT05620823, Study Details | NCT05620823 | A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa | ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) (STOP-HS2), ClinicalTrials.gov ID NCT05620836, Study Details | NCT05620836 | A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) | ClinicalTrials.gov
About the Writer
Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.