Researchers determined there were no unique safety concerns in the study, which spanned 1000 patient years.
Abrocitinib demonstrated an acceptable long-term safety profile in adolescents with atopic dermatitis across 1000 patient years, according to late-breaking research presented at the Revolutionizing Atopic Dermatitis conference in Washington, DC.1
Researchers sought to evaluate and describe the updated long-term safety profile of the drug in adolescents through an ad-hoc analysis of the JADE clinical program, citing the study’s determination of abrocitinib as efficacious and safe in its researched population. Furthermore, they acknowledged the US Food and Drug Administration’s (FDA) recent expansion of abrocitinib’s indication, which now includes adolescents ages 12 to less than 18.
The analysis assessed data from participants (n=635) in the JADE clinical trials MONO-1, MONO-2, TEEN, REGIMEN, and extension trial, JADE EXTEND. Researchers began by pooling patient data into 2 separate cohorts: a consistent-dose cohort and a variable-dose cohort.
Patients in the consistent-dose cohort (n=490) received the same dose ofabrocitinib (either100 mg or 200 mg) throughout the entire duration of the above trials. Participants who did not meet JADE REGIMEN maintenance period inclusion criteria following 200 mg abrocitinib induction in the open-label period and 200 mgabrocitinib in JADE EXTEND.
The variable-dose cohort consisted of patients (n=145) who had been randomly assigned to the maintenance period of JADE REGIMEN following the induction period. These patients may have also subsequently participated in the JADE EXTEND trial.
Researchers collected several data points, including age, sex, race, disease duration, Eczema Area and Severity Index (EASI) score, Investigator’s Global Assessment (IGA) score, and history of prior therapy (systemic or topical). They also examined patients’ PY and exposure at 48 weeks, 96 weeks, and 144 weeks.
Adverse events occurred in 84% of patients receiving 200 mg of abrocitinib and in 76% of patients receiving 100 mg of the drug in the consistent-dose cohort.
“No meaningful dose-response relationship was observed for serious AEs, severe AEs, AEs leading to study discontinuation, or AEs of special interest, including serious infections, all herpes zoster infections, and opportunistic herpes zoster infections,” study authors wrote.
In the variable-dose cohort, 96% of patients experienced adverse events when exposed to either dose of abrocitinib.
“The IRs for serious AEs [adverse events], severe AEs, AEs leading to study discontinuation, and AEs of special interest in the variable-dose cohort were consistent with those in the consistent-dose cohort,” study authors wrote.
Additionally, no tuberculosis events, opportunistic infections, venous thromboembolism events, or events of nonmelanoma skin cancer, malignancies, major cardiovascular events, or deaths, were reported in either the consistent or variable- dose cohorts.
“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,” study authors wrote. “There were no unique safety concerns related to adolescents compared to the findings observed previously in the integrated safety analysis using the same data cut in which most patients were adults.”