Long-Term Safety of Abrocitinib in Moderate-to-Severe Atopic Dermatitis: Integrated Analysis by Age

Authors

Michael J. Cork, Sheffield Dermatology Research, IICD, University of Sheffield and Sheffield Children's Hospital, Sheffield, United Kingdom.
Mette Deleuran, Aarhus University Hospital, Aarhus, Denmark.
Bob Geng, UC San Diego School of Medicine, San Diego, California, USA.
Jonathan I. Silverberg, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia, USA.
Eric L. Simpson, Oregon Health & Science University, Portland, Oregon, USA.
Linda F. Stein Gold, Henry Ford Health System, Detroit, Michigan, USA.
Alan D. Irvine, Clinical Medicine, School of Medicine, Trinity College Dublin, Dublin, Ireland.
William Romero, Pfizer Ltd., Tadworth, Surrey, United Kingdom.
Hernan Valdez, Pfizer Inc., New York, New York, USA.
Haiyun Fan, Pfizer Inc., Collegeville, Pennsylvania, USA.
Justine Alderfer, Pfizer Inc., Collegeville, Pennsylvania, USA. Electronic address: justine.alderfer@pfizer.com.

Document Type

Journal Article

Publication Date

3-11-2025

Journal

The journal of allergy and clinical immunology. In practice

DOI

10.1016/j.jaip.2025.02.040

Keywords

JAK 1-selective inhibitor; age groups; herpes zoster; lymphopenia; major adverse cardiovascular events; thrombocytopenia; venous thromboembolism

Abstract

BACKGROUND: Abrocitinib has a manageable long-term safety profile for patients with moderate-to-severe atopic dermatitis. Identifying populations at higher risk of adverse events (AEs) will help optimize dose selection. OBJECTIVE: To evaluate abrocitinib long-term safety by age. METHODS: Data (September 25, 2021 cutoff) from JADE clinical trials were pooled in a consistent-dose cohort (patients who received the same abrocitinib dose throughout exposure) or a variable-dose cohort (patients who received abrocitinib 200 mg [12 weeks], were randomly assigned later to receive abrocitinib 200 mg, 100 mg, or placebo [up to 40 weeks], and assigned to receive abrocitinib 200 mg or 100 mg in the long-term study). Data were stratified post hoc by age at baseline (12 to <18 years, 18 to <40 years, 40 to <65 years, and ≥65 years). Incidence rates (IRs) of treatment-emergent AEs (TEAEs) of special interest were assessed. RESULTS: Analysis included 3802 patients (exposure: 5214 patient-years). IRs for serious AEs, TEAEs leading to study discontinuation, serious infections, herpes zoster, thrombocytopenia, lymphopenia, nonmelanoma skin cancer (NMSC), malignancies (excluding NMSC), major cardiovascular events, and venous thromboembolism were numerically higher in patients aged ≥65 years than in younger patients. Overall, adolescents had the lowest rates for TEAEs of special interest. CONCLUSIONS: Abrocitinib has a manageable long-term safety profile. TEAEs of special interest were lower in adolescents and higher in the ≥65-year age group. Risk of specific TEAEs was numerically higher in patients aged ≥65 years treated with abrocitinib 200 mg and underscores the importance of dose selection in older patients.

APA Citation

Cork, Michael J.; Deleuran, Mette; Geng, Bob; Silverberg, Jonathan I.; Simpson, Eric L.; Stein Gold, Linda F.; Irvine, Alan D.; Romero, William; Valdez, Hernan; Fan, Haiyun; and Alderfer, Justine, "Long-Term Safety of Abrocitinib in Moderate-to-Severe Atopic Dermatitis: Integrated Analysis by Age" (2025). GW Authored Works. Paper 6825.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/6825

Department

Dermatology