Pfizer announces Phase 3 clinical results of abrocitinib, a new-generation oral JAK1 inhibitor

Pfizer recently announced that the complete results of the Phase 3 JADE COMPARE study (NCT03720470) evaluating the once-daily oral JAK1 inhibitor abrocitinib in the treatment of moderate to severe atopic dermatitis (AD) have been published in the international medical journal New England Medicine Magazine (NEJM).

Currently, the New Drug Application (NDA) for abrocitinib (100mg, 200mg) for the treatment of moderate to severe AD patients aged ≥12 years is undergoing priority review by the US FDA, and the review result is expected to be obtained in April 2021.

Abrocitinib is an oral small molecule that can selectively inhibit Janus kinase 1 (JAK1).

Atopic dermatitis (AD) is a chronic skin disease characterized by skin inflammation and skin barrier defects.

In multiple clinical trials, abrocitinib has a strong effect in relieving the symptoms and signs of AD, including rapid relief of itching.

The regulatory application for abrocitinib is based on data from the robust Phase 3 JADE global clinical development project.

——JADE MONO-1 and JADE MONO-2: These two studies evaluated the efficacy and safety of two doses (100mg and 200mg, once a day) of abrocitinib monotherapy and placebo.

--JADE COMPARE: This study evaluated the efficacy and safety of two doses (100mg and 200mg, once a day) of abrocitinib and placebo in patients receiving background topical therapy.

JADE COMPARE is a randomized, double-blind, double-dummy, placebo-controlled, parallel group, multi-center phase 3 study.

The common primary endpoints of the study are: (1) The Investigator’s Global Assessment (IGA) response at the 12th week of treatment, defined as the IGA (score range: 0-4) with a score of 0 (complete skin lesion removal) or 1 (skin lesion Almost completely cleared) and improved by ≥2 points compared with baseline detection; (2) Eczema area and severity index -75 (EASI-75) response at the 12th week of treatment, defined as EASI (scoring range: 0-72) ) The score is improved by ≥75% compared with the baseline detection.

The study reached the common primary endpoint at week 12: the proportion of patients with both doses of abrocitinib in each primary efficacy endpoint was better than placebo.

The specific data of the primary endpoint are: (1) In the 200mg abrocitinib group, 100mg abrocitinib group, dupilumab group, and placebo group, 48.

In terms of key secondary endpoints, the 200-mg dose (rather than the 100-mg dose) abroctinib was better than dupilumab in the pruritus response in the second week.

Conclusion: In this trial, the signs and symptoms of moderate to severe atopic dermatitis were significantly reduced compared with placebo at a dose of 200 mg or 100 mg abrocitinib once a day during the 12th and 16th weeks of treatment.

Original source: Results from Pfizer's Phase 3 Jade Compare Study of Abrocitinib in Moderate to Severe Atopi