Integrated Safety Analysis of Abrocitinib in 635 Adolescent Patients With Moderate-To-Severe Atopic Dermatitis With Over 1000 Patient-Years of Exposure

Main Article Content

Amy Paller
Lawrence Eichenfield
Jonathan Silverberg
Michael Cork
Christine Bangert
Alan Irvine
Stephan Weidinger
Sebastien Barbarot
Haiyun Fan
Justine Alderfer
Herwig Koppensteiner
Kanti Chittuluru




Introduction: Abrocitinib, an oral, once-daily, Janus kinase 1–selective inhibitor, was efficacious and well tolerated in adolescent patients with moderate-to-severe atopic dermatitis (AD) exposed for approximately 1 year of treatment. Here, we describe the updated long-term integrated safety profile of abrocitinib in adolescent patients in the JADE clinical program.
Methods: A total of 635 adolescent patients (12 to <18 years; exposure: 1011.4 patient-years [PY]) were pooled for safety analysis from the phase 3 JADE clinical trials MONO-1 (NCT03349060), MONO-2 (NCT03575871), TEEN (NCT03796676), and REGIMEN (NCT03627767) and subsequently enrolled in the ongoing phase 3 extension trial JADE EXTEND (NCT03422822; data cutoff: September 25, 2021). Incidence rates (IRs; number of unique patients with events/100 PY) of severe adverse events (SAEs) and AEs of special interest were assessed.
Results: Of the total 635 adolescents, 490 received the same abrocitinib dose throughout exposure (730.6 PY); 289 received abrocitinib 200 mg (424.5 PY) and 201 received abrocitinib 100 mg (306.1 PY). Duration of exposure was ≥96 weeks in 38% and 37%, and ≥144 weeks in 8% and 4% of patients who received abrocitinib 200 mg or 100 mg, respectively. In the 200-mg and 100-mg arms, AEs occurred in 243 (84%) and 153 (76%) patients; 8% (IR [95% CI], 5.87 [3.76-8.74]) and 9% (5.87 [3.48-9.27]) experienced SAEs, and 10% (6.96 [4.69-9.93]) and 8% (5.13 [2.93-8.33]) discontinued the study due to AEs, respectively. IRs of AEs of special interest were 1.84 (95% CI, 0.79-3.62) and 1.28 (0.35-3.27) for serious infection, 2.11 (0.97-4.01) and 1.62 (0.53-3.77) for all herpes zoster (HZ) infections, and 0.69 (0.14-2.03) and 0.32 (0.01-1.77) for opportunistic HZ infections in the 200-mg and 100-mg arms, respectively. One patient (aged 16 years) in the 200-mg arm had a nonfatal venous thromboembolism event (pulmonary embolism; IR, 0.23 [95% CI, 0.01-1.28]); patient had a family history of pulmonary embolism. There were no events of nonmelanoma skin cancer or other malignancies, tuberculosis, or other opportunistic infections (excluding HZ), major adverse cardiovascular events, or deaths.
Conclusions: In this integrated safety analysis using the September 2021 data cut from the ongoing JADE EXTEND trial, abrocitinib had an acceptable long-term safety profile in adolescents with moderate-to-severe AD.


1. Cibinqo (abrocitinib). Prescribing information. Pfizer Labs; January 2022.

2. Paller A et al. Integrated Analysis of Abrocitinib for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis From the Phase 3
Clinical Trial Program. Presented at the 2022 AAD Annual Meeting; March 25-29, 2022; Boston, Massachusetts.

3. Simpson EL et al. Integrated Safety Analysis of Abrocitinib in 3802 Patients With Moderate-To-Severe Atopic Dermatitis With Over 5000 Patient-
Years of Exposure. Presented at the 2023 AAD Annual Meeting; March 17–21, 2023; New Orleans, Louisiana.

Most read articles by the same author(s)

1 2 3 4 5 6 7 > >>