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54-week STOP-HS data show clinically meaningful improvements in pain, fatigue, and quality of life in one-third to two-thirds of patients.
The 54-week STOP-HS data for povorcitinib in moderate-to-severe hidradenitis suppurativa (HS) showed not only deepening inflammatory response but also broad and sustained improvements across patient-reported outcomes.1,2
These findings were presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting held in Denver, Colorado, from March 27-31, by Martina L. Porter, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston.
HCPLive spoke with Porter about the STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836) trials, identically designed global phase 3 trials with a combined enrollment of 1,227 adults with moderate-to-severe HS, randomized 1:1:1 to povorcitinib 75 mg once daily, 45 mg once daily, or placebo for 12 weeks, followed by a 42-week blinded extension through week 54. Mean disease duration was 10.3 years (SD, 9.4), mean AN count was 12.0 (SD, 8.8), and 75.5% had at least 1 draining tunnel at baseline.1,2
At week 12, HiSCR50 was achieved by 40.2% (45 mg) and 40.6% (75 mg) of patients versus 29.7% for placebo in STOP-HS1 (P <.025), and by 42.3% in both dose arms versus 28.6% for placebo in STOP-HS2 (P <.01). Responses deepened substantially through week 54, with HiSCR50 rates of 60.2% to 61.9% in STOP-HS1 and 57.3% to 67.5% in STOP-HS2 in patients on continuous povorcitinib. Up to 29.0% of patients achieved HiSCR100 at week 54, and complete clearance of all inflammatory lesions was documented in 16.1% to 20.2% of patients across both studies.1,2
The patient-reported outcome battery at week 54 included skin pain assessed by numerical rating scale, the Dermatology Life Quality Index (DLQI), the HS-specific quality-of-life instrument HiSQoL, and the FACIT-F fatigue scale — the last of which Porter noted is more commonly deployed in rheumatologic trials but is highly applicable to HS given the significant systemic burden of the disease. Rather than reporting aggregate total scores, the analysis focused on the proportion of patients achieving validated thresholds for clinically meaningful improvement on each measure. Across the 4 instruments, between approximately one-third and two-thirds of patients achieved these thresholds: ≥3-point decreases in skin pain NRS were reached by 40.5% to 58.0% of eligible patients, ≥4-point improvements in FACIT-F by 40.5% to 49.0%, ≥4-point decreases in DLQI by 59.4% to 64.7%, and ≥21-point decreases in HiSQoL total score by 33.7% to 40.2%. Porter emphasized that these measures continued to improve across the full 54-week observation period, consistent with the inflammatory response trajectory.1,2
She offered important context for interpreting these gains relative to other dermatologic diseases. In psoriasis or atopic dermatitis, achieving PASI 100 or EASI 100 means skin can return to a visually normal state. In HS, the inflammatory targets — abscesses, nodules, and draining tunnels — can respond to therapy while patients remain left with significant residual scarring and hyperpigmentation, particularly in darker skin tones, which are disproportionately represented in the HS patient population. This means that even when inflammatory control is achieved, quality-of-life measures may not reach zero, and clinicians should counsel patients accordingly: the goal of anti-inflammatory therapy is halting progression and eliminating drainage, not reversing structural damage already present. Porter characterized this counseling as central to appropriate patient expectations — that freedom from drainage, the ability to wear clothing, travel, work, and exercise without fear of a flare represents meaningful therapeutic success even when discoloration and scarring persist.
On treatment positioning, Porter described povorcitinib's potential role as potentially first-line pending FDA approval, with efficacy in the biologic-experienced population — 37.2% of trial participants, a higher proportion than in prior phase 3 HS programs — providing reassurance for a treatment landscape where many patients will arrive having already failed a TNF-α or IL-17 inhibitor. She also described emerging clinical phenotype patterns from her practice that she presented independently of the STOP-HS data: patients with very severe disease predominantly affecting the groin and buttocks with extensive tunneling, as well as patients with high nodule burden but relatively few draining tunnels, both appear to achieve particularly high clearance rates on JAK inhibitors in her clinical experience. She framed these as observational signals that warrant prospective investigation and may ultimately guide which patients are directed toward JAK inhibition versus biologics as initial therapy — a precision-medicine framework the field has not yet been able to operationalize systematically
Safety through week 54 was consistent with the known JAK1 inhibitor class profile, with acne (16.4%–21.1%), nasopharyngitis (9.4%–13.6%), and upper respiratory tract infection (9.1%–12.2%) as the most common treatment-emergent adverse events. Serious treatment-emergent adverse events occurred in 3.7% to 6.4% of patients across arms; no malignancies excluding non-melanoma skin cancer were reported and MACE was observed in 1 patient (0.3%) in STOP-HS2.1,2
“In the ideal dream world down the line is that what we really want to know for all these medications, because we're not looking at 90% of patients get 90% better. You know, we really need some markers, whether they're blood markers or clinical markers or demographic features, that help us really determine,” Porter said.
Relevant disclosures for Porter include Abbvie, Bristol Myers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, UCB, Trifecta Clinical, Incyte, and Anaptys Bio.