A 24-Week Real-World Study of Upadacitinib in Moderate-to-Severe Hidradenitis Suppurativa

Hidradenitis suppurativa is a chronic, recurrent inflammatory skin disease characterized by painful inflammatory nodules, abscesses, draining tunnels, and scarring. Patients with moderate-to-severe disease may experience inadequate responses, intolerance, or loss of response to conventional systemic therapies and biologic agents. This prospective, open-label, single-arm, real-world study will evaluate the effectiveness, safety, patient-reported outcomes, and treatment persistence of upadacitinib in 50 adults with moderate-to-severe hidradenitis suppurativa over 24 weeks. Participants will receive oral upadacitinib in routine clinical practice. A starting dose of 15 mg once daily is recommended. The dose may be increased to 30 mg once daily based on disease severity, treatment response, safety findings, drug accessibility, and shared decision-making between the investigator and the participant. Effectiveness assessments will include the Hidradenitis Suppurativa Clinical Response, abscess and inflammatory nodule count, International Hidradenitis Suppurativa Severity Score System, pain and pruritus numerical rating scales, Dermatology Life Quality Index, disease flares, rescue treatments, and surgical interventions. Safety assessments will include adverse events, serious adverse events, laboratory abnormalities, infections, thromboembolic events, major adverse cardiovascular events, hepatic abnormalities, lipid abnormalities, and cytopenias.

Inclusion Criteria: 1. Male or female participants aged 18 years or older. 2. Diagnosis of moderate-to-severe hidradenitis suppurativa confirmed by a dermatologist, generally corresponding to Hurley stage II or III, or active hidradenitis suppurativa considered by the investigator to require systemic treatment. 3. Presence of evaluable inflammatory lesions at baseline, allowing assessment of abscess and inflammatory nodule count, IHS4, pain NRS, pruritus NRS, and DLQI. 4. Considered by the investigator to be an appropriate candidate for treatment with upadacitinib in a real-world clinical setting. 5. Willing and able to comply with scheduled visits, laboratory testing, contraceptive requirements, and safety follow-up. 6. Able to understand the real-world and exploratory nature of the study and that upadacitinib is an investigational and off-label treatment for hidradenitis suppurativa. 7. Willing to provide written informed consent. Exclusion Criteria: 1. A condition requiring urgent treatment, inpatient antimicrobial treatment, extensive surgery, or another emergency intervention that, in the investigator's judgment, makes participation inappropriate. 2. Active serious infection, active tuberculosis, uncontrolled chronic or recurrent infection, or another condition associated with an unacceptable risk of immunosuppression. 3. Screening results indicating hepatitis B, hepatitis C, human immunodeficiency virus infection, tuberculosis, or another infection risk that requires postponement of immunomodulatory treatment and makes participation inappropriate. 4. Clinically significant cytopenia, severe hepatic or renal impairment, or another laboratory abnormality that makes treatment with upadacitinib inappropriate. 5. Previous venous thromboembolism, a serious major adverse cardiovascular event, active malignancy, or another condition for which the investigator considers the risk of a Janus kinase inhibitor unacceptable. 6. Pregnancy, breastfeeding, or plans to become pregnant during the study. 7. A participant of childbearing potential who is unable or unwilling to use effective contraception during the study. 8. Known serious hypersensitivity or contraindication to upadacitinib or any component of the formulation. 9. Recent participation in another interventional clinical study or another condition that may interfere with the evaluation of effectiveness or safety. 10. Any unacceptable safety risk or inability to obtain key effectiveness or safety data, as determined by the investigator.