Simulating real-world abrocitinib use in atopic dermatitis: results from JADE REAL

BACKGROUND: JADE REAL was a global, prospective, multicenter, open-label expanded access protocol study that integrated the rigorous follow-up, safety, and efficacy assessments of a clinical trial with dosing flexibility and ability to use concomitant topical therapies to simulate real-world management of atopic dermatitis (AD). OBJECTIVE: The study aimed to provide access to abrocitinib for patients with moderate-to-severe AD without adequate treatments available. METHODS: Eligible patients received abrocitinib 100 mg or 200 mg once daily per investigator's discretion. Dose could be adjusted during treatment. Safety and exploratory efficacy endpoints were assessed. RESULTS: Of 312 patients, 120 (38.5%) and 192 (61.5%) received an initial dose of abrocitinib 100 mg and 200 mg, respectively. TEAEs were reported in 78.2% of patients. TEAEs led to dose change in 39 patients (12.5%); 12 (3.8%) had a dose escalation and 27 (8.7%) had a dose reduction. Rapid improvements in AD severity progressed up to 72 weeks among observed patients. CONCLUSION: Most patients continued their initial dose of abrocitinib. TEAEs accounted for a minority of documented dose reductions; instead, investigators may have determined that the patients' disease could be maintained at a lower dose. These findings support clinical decision-making around dose selection and modification. TRIAL REGISTRATION: NCT04564755.