NEW YORK (Reuters) –in a phase-3 study.
The JADE TEEN study was conducted in the Asia-Pacific region, Europe and North America andin JAMA Dermatology. Dr. Gary Chan of Pfizer and colleagues randomly assigned 285 adolescents with moderate-to-severe AD to treatment with once-daily oral abrocitinib, 200 mg or 100 mg, or placebo in combination with topical therapy, for 12 weeks.
The median age was 15; about half of participants were boys; 56% were white and 33% Asian. All had an inadequate response to four consecutive weeks or longer of topical therapy or a need for AD systemic therapy.
Coprimary end points were achieving an Investigator’s Global Assessment (IGA) response of clear (0) or almost clear (1), with improvement of 2 or more grades from baseline (IGA 0/1), and 75% or greater improvement from baseline in the Eczema Area and Severity Index (EASI-75) response at week 12.
At week 12, more patients treated with abrocitinib (200 mg or 100 mg) versus placebo achieved an IGA response of 0/1 (46.2% and 41.6%, respectively, vs. 24.5%); EASI-75 (72% and 68.5% vs. 41.5%); and improvement in the Peak Pruritus Numerical Rating Scale (55.4% and 52.6% vs. 29.8%).
Adverse events were reported by 62.8% of those taking 200 mg abrocitinib; 56.8% in the 100 mg group; and 52.1% of those on placebo. Nausea was more common with abrocitinib 200 mg (18.1%) and 100 mg (7.4%). Most nausea events were mild; however, there were two severe cases in the abrocitinib 200 mg group, one of which led to discontinuation of the study drug.
Herpes-related adverse events were infrequent. Rates of serious adverse events were 1.1%, 0, and 2.1% in the 200 mg, 100 mg and placebo groups, respectively.
On July 21, the FDA notified Pfizer that it will not meet the Prescription Drug User Fee Act (PDUFA) goal dates for the New Drug Application for abrocitinib for this indication and extended the deadline. Pfizer spokesperson Steve Danehy told Reuters Health by email, “In addition to continuing our phase 3 clinical program for abrocitinib, which includes an ongoing head-to-head trial with dupilumab ... we are continuing to work with regulatory bodies around the world to bring this new option to patients. We have an understanding of the potential safety signals to watch for, and if approved, we are committed to working with physicians to educate them on the safety profile of abrocitinib, including support in identifying patients at the most risk for serious, treatment-related adverse reactions.”
The study was sponsored by Pfizer. Five coauthors were employees during the study and many of the others received funds from the company.
Reuters Health Information © 2021