The Food and Drug Administration (FDA) has expanded the approval of Cibinqo® (abrocitinib) to include patients 12 to less than 18 years of age with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of other therapies is inadvisable. Previously, the treatment was approved only for adults 18 years of age and older.
The approval was based on data from previous studies that included 124 adolescent patients, as well as the phase 3 JADE TEEN study (ClinicalTrials.gov Identifier: NCT03796676), which compared the efficacy and safety of abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, to placebo in 285 patients 12 to less than 18 years of age with moderate to severe atopic dermatitis. Patients were randomly assigned to receive abrocitinib 100mg, 200mg or placebo orally once daily for 12 weeks while on background topical therapy.
The coprimary end points were the proportion of patients who achieved an Investigator’s Global Assessment (IGA) of clear (0) or almost clear (1) and a ≥2 point reduction from baseline at week 12; and the proportion of patients who achieved ≥75% change from baseline in the Eczema Area and Severity Index (EASI75) score at week 12.
Results from JADE TEEN showed that 39% and 46% of patients treated with abrocitinib 100mg and 200mg, respectively, achieved an IGA 0 or 1 response compared with 24% of patients treated with placebo. At week 12, 71% and 64% of patients treated with abrocitinib 100mg and 200mg, respectively, achieved an EASI-75 response compared with 41% of patients treated with placebo.
Additionally, a greater proportion of patients treated with abrocitinib 100mg and 200mg achieved at least a 4-point decrease from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) score at week 2 compared with placebo (13% and 25% vs 8%, respectively).
“As an efficacious once-daily pill, we believe that Cibinqo offers an important new treatment option for adolescents burdened by uncontrolled symptoms of atopic dermatitis,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “Encouraged by an increasing uptake in the adult population, we look forward to bringing this important new oral medicine to adolescents who have yet to find relief from this inflammatory skin condition with current options.”
The safety profile of abrocitinib in adolescents was consistent with that seen in previous studies in the adult population. Cibinqo carries a Boxed Warning regarding the potential for serious infection, malignancy, major adverse cardiovascular events, thrombosis, and death associated with JAK inhibitors. The treatment is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Cibinqo is supplied as 50mg, 100mg, and 200mg tablets.
- FDA approves Pfizer’s supplemental New Drug Application for Cibinqo® (abrocitinib). News release. Pfizer. Accessed February 10, 2023. https://www.businesswire.com/news/home/20230210005281/en/FDA-Approves-Pfizers-Supplemental-New-Drug-Application-for-CIBINQO%C2%AE-abrocitinib.
- Cibinqo. Package insert. Pfizer; 2023. Accessed February 10, 2023. https://labeling.pfizer.com/ShowLabeling.aspx?id=16652.
This article originally appeared on MPR