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.