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Simulating real-world abrocitinib use in atopic dermatitis: results from JADE REAL
Raj Chovatiya1,2, Matthew Zirwas3,4,5, Melinda J Gooderham6,7,8
1Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA.
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.
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