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Patients with moderate to severe atopic dermatitis (AD) who responded to prior dupilumab sustained most of the clinical benefits when treatment was switched to abrocitinib, according to study results published in the Journal of the American Academy of Dermatology. Some patients who did not respond to dupilumab did see clinical benefit with abrocitinib, and researchers said the safety profile remained unchanged from previous studies.
Moderate to severe AD unresponsive to topical agents has few treatment options.
Researchers sought to evaluate results from adults with moderate to severe AD who are treated with abrocitinib after being treated with dupilumab.
To accomplish this, they conducted a phase 3 extension JADE EXTEND (ClinicalTrials.gov Identifier: NCT03422822) that included patients with moderate to severe AD from the dupilumab double-blind, placebo-controlled phase 3 JADE COMPARE who received abrocitinib 200 mg or 100 mg once-daily in the extension. Of the 223 patients in JADE COMPARE, 203 participated in JADE EXTEND creating a possible nonresponse bias. Of the 203 participants, 70 were randomly assigned to receive abrocitinib 200 mg and 122 were randomly assigned to receive abrocitinib 100 mg, and the remaining 11 were also randomly assigned into 1 or the other treatment cohorts but did not complete the treatment, adding to the possibility of bias.
More than 90% of patients who received either dose of abrocitinib for 12 weeks after responding to dupilumab saw at least 75% improvement in eczema area and severity index (EASI-75). More than 80% of these patients saw a 4-point or greater improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4). Among the dupilumab nonresponders, EASI-75 was reached with abrocitinib 200 mg (80%) and 100 mg (67.7%), and these patients saw PP-NRS4 in 77.3% (200 mg) and 37.8% (100 mg). Nasopharyngitis, nausea, acne, and headache were the most common adverse events for patients treated with abrocitinib, and nearly half of all patients treated with abrocitinib saw at least 1 adverse event, though very few patients reported serious or severe adverse events.
Study limitations include the study design being a short-term retrospective analysis, background concomitant topical therapy varied from JADE COMPARE to JADE EXTEND creating inconsistent placebo effect results, and JADE EXTEND did not have placebo control.
Researchers concluded that, “Efficacy and safety profile of abrocitinib in JADE EXTEND supports the role of abrocitinib as a treatment for patients with moderate-to-severe AD, regardless of prior dupilumab response status.”
Disclosure: This research was supported by Pfizer Inc. Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Reference
Shi VY, Bhutani T, Fonacier L, et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol. Published online April 16, 2022. doi:10.1016/j.jaad.2022.04.009
