Abrocitinib Consistent in Atopic Dermatitis Clearance Outcomes in Adolescents and Adults

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Post hoc analysis data from JADE REGIMEN show continuous and reduced-dose regimens provided similar efficacy and safety outcomes in the 2 age groups.

Both continuous and reduced-dose regimens of abrocitinib provided similar efficacy and safety outcomes in adults and adolescents alike who initiated the drug for treatment of atopic dermatitis, according to new findings.

In post-hoc data presented at the Society of Dermatology Physician Assistants (SDPA) 2022 Annual Meeting in Miami, FL this week, a team of US investigators reported that a majority of adolescents and adults alike receiving open-label abrocitinib achieved skin clearance outcomes including Eczema Area Severity Index 75% (EASI 75) and Investigator’s Global Assessment (IGA) scores of 0 or 1.

Led by Prof. Carsten Flohr, head of pediatric and population-based dermatology research at St. John’s Institute of Dermatology in London, investigators conducted a post-hoc analysis of JADE REGIMEN, a phase 3 trial assessing Pfizer’s abrocitinib in patients ≥12 years old with moderate to severe atopic dermatitis. Patients in JADE REGIMEN who responded positively to a 12-week daily oral regimen of the therapy were randomized into a double-blind comparison of 200 mg or 100 mg abrocitinib, versus placebo, over 40 weeks.

The phase 3 trial additionally allowed for patients experiencing a disease-worsening flare to enter a 12-week rescue treatment regimen, including 200 mg abrocitinib plus topical therapy.

Flohr and colleagues sought to assess maintenance of response associated with continuous-dose or reduced-dose abrocitinib, or post-withdrawal reintroduction-dose abrocitinib.

Their patient population included 266 patients receiving 200 mg abrocitinib (47 adolescents; 219 adults), 265 receiving 100 mg abrocitinib (49 adolescents; 216 adults), and 267 receiving placebo (49 adolescents, 218 adults). Primary endpoint was a protocol-defined flare (loss of IGA response resulting in score of ≥2; loss of ≥50% of week 12 EASI response.

Regarding the efficacy of open-label 200 mg abrocitinib induction, investigators observed 59% of adolescent patients achieved both EASI 75 and IGA 0 or 1. Another 58% achieved Peak Pruritus Numerical Rating Scale scores of 4 (PP-NRS4). Adult patients with atopic dermatitis fared even better; 67% achieved both EASI-75 and IGA 0 or 1, and 71% achieved PP-NRS4.

However, adolescents treated with 200 mg abrocitinib were less likely to report a flare (15%) than adult patients on the same regimen (20%). Both adolescents and adults on 100 mg abrocitinib had a 43% probability of flare; patients on placebo in either age group had a ≥80% probability of flare.

Among patients to experience a flare during the rescue period of JADE REGIMEN, 29% and 25% of adolescents on abrocitinib 200 mg and 100 mg, respectively, recaptured EASI response; rates among adults in those treatment arms were 34% for each.

Regarding safety, abrocitinib 200 mg was associated with the greatest rate of treatment-emergent adverse events in both adolescents (68.1%) and adults (62.1%). However, serious adverse events with that treatment occurred in only 4.3% of adolescents and 5.0% of adults. The most common adverse events among each treatment arm and age group were nausea, acne, and herpes zoster infection.

“The efficacy and safety of abrocitinib induction and maintenance with continuous- or reduced-dose abrocitinib were similar between adults and adolescents,” investigators concluded. “More adults than adolescents achieved PP-NRS4 after induction.”

The study, “Efficacy and Safety of Abrocitinib Monotherapy in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE REGIMEN,” was presented at SDPA 2022.