An Open-Label, Single-Center Proof of Concept Study Evaluating the Efficacy and Safety of Tirzepatide for Moderate to Severe Hidradenitis Suppurativa.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory disease associated with obesity and metabolic dysregulation. Current therapies yield variable benefits and do not target metabolic drivers. Tirzepatide, a dual GLP-1/GIP receptor agonist, induces weight loss and exerts anti-inflammatory effects, offering a potential novel approach for the treatment of HS. OBJECTIVES: To evaluate the efficacy and safety of tirzepatide in adults with moderate-to-severe HS. METHODS: In this open-label, single-center, single-arm proof-of-concept study, 20 adults with moderate-to-severe HS (Physician's Global Assessment greater than or equal to 3; BMI greater than or equal to 27) received once-weekly tirzepatide, titrated to maximum tolerated dose, for 24 weeks, followed by an 8-week washout. The primary endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 24. Secondary endpoints included changes in PGA, Dermatology Life Quality Index (DLQI), pain visual analog scale (VAS), and Hospital Anxiety and Depression Scale (HADS). Analyses were conducted using an intention-to-treat approach. RESULTS: At week 24, 16 of 20 participants (80.0%; P<0.00001) achieved HiSCR. Improvements were also observed in DLQI, VAS, and PGA scores, with some benefits persisting through week 32. Treatment was well tolerated, with high adherence and favorable metabolic effects. LIMITATIONS: Single-center, open-label design, modest sample size. CONCLUSIONS: Tirzepatide demonstrated promising efficacy and tolerability in patients with moderate-to-severe HS and obesity. Larger randomized trials are warranted to confirm efficacy, durability, and safety. &nbsp.