Presentation (CTI)

OBJECTIVES: Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease characterized by painful nodules, abscesses, and scarring in intertriginous regions. Despite three FDA-approved therapies, high patient dissatisfaction and suboptimal response rates signal a persistent unmet need. This study maps the current approved landscape and late-stage pipeline for moderate-to-severe HS.
METHODS: A targeted literature review and ClinicalTrials.gov search through mid-2026 identified approved and Phase 2b/3 pipeline therapies. Key endpoints included HiSCR50/75/90/100, skin pain NRS, IHS4, and DLQI, synthesized narratively across mechanism of action, route of administration, and depth of response.
RESULTS: Three approved monoclonal antibodies, adalimumab (TNF-α), secukinumab (IL-17A), and bimekizumab (IL-17A/F) form the current standard of care, yet real-world dissatisfaction persists. The late-stage pipeline introduces eight molecules across six mechanisms. Povorcitinib (Incyte), an oral JAK1 inhibitor, met primary endpoints in both Phase 3 STOP-HS trials, with nearly 60% patients achieving HiSCR50 at Week 24. Upadacitinib (AbbVie), a second oral JAK1 inhibitor, is in Phase 3 for patients who have failed anti-TNF therapy. Sonelokimab (MoonLake), a trivalent IL-17A/F nanobody, achieved HiSCR75 in 62% and HiSCR100 in 32% at Week 40 in the Phase 3 VELA trials. Izokibep (ACELYRIN), an IL-17A inhibitor, achieved HiSCR50 in 50% versus 32% on placebo at Week 16 in Phase 3. Lutikizumab (AbbVie), a dual IL-1α/β antagonist, advanced to Phase 3 following positive Phase 2 data in anti-TNF inadequate responders. Remibrutinib (Novartis), an oral BTK inhibitor, is in Phase 3 with primary completion estimated in 2027. Spesolimab (Boehringer Ingelheim) completed Phase 3 in March 2025, with results awaited. Tulisokibart (MSD), an anti-TL1A antibody, is in Phase 2b with primary completion estimated in November 2026.
CONCLUSIONS: The HS landscape is rapidly diversifying across oral and biologic modalities. In the absence of head-to-head data, indirect treatment comparisons, long-term durability evidence, and patient-reported outcomes will be pivotal for HTA submissions and formulary decision-making.