Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial
Journal of the American Academy of Dermatology Sep 10, 2021
Blauvelt A, Silverberg JI, Lynde CW, et al. - Induction therapy with abrocitinib was effective; the majority of responders who continued abrocitinib did not flare. The rescue treatment of abrocitinib plus topical therapy successfully restored the response.
Patients with moderate-to-severe atopic dermatitis who responded to open-label abrocitinib 200 mg monotherapy for 12 weeks were randomly assigned in a 1:1:1 ratio to blinded abrocitinib (200 or 100 mg) or placebo for 40 weeks.
Patients who were having a flare were given rescue treatment (abrocitinib 200 mg plus topical therapy).
Seven hundred ninety-eight induction responders (64.7%) were chosen at random from a total of 1,233 patients.
During maintenance, the flare probability was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively.
With rescue treatment, 36.6%, 58.8%, and 81.6% of patients with flare in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo groups regained investigator global assessment 0/1 response, and 55.0%, 74.5%, and 91.8% regained eczema area and severity index response, respectively.
Adverse events occurred in 63.2% and 54.0% of patients receiving abrocitinib 200 and 100 mg, respectively, during maintenance.
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