Results from Pfizer’s Phase 3 Jade Compare Study of Abrocitinib in Moderate to Severe Atopic Dermatitis Published in New England Journal of Medicine
New York, March 24, 2021 — Pfizer Inc. (NYSE: PFE) today announced the publication of complete results from the JADE COMPARE study of investigational oral, once-daily, Janus kinase 1 (JAK1) inhibitor, abrocitinib in The New England Journal of Medicine (NEJM). The study evaluated the safety and efficacy of two doses of abrocitinib, 100mg and 200mg, versus placebo in adults with moderate to severe atopic dermatitis who were on background topical therapy. The study included an active control arm where patients were treated with dupilumab, a biologic treatment administered by subcutaneous injection. Both doses of abrocitinib met the co-primary study endpoints. The manuscript was published in the March 25, 2021 issue of NEJM.
For additional information about the JADE COMPARE study, please visit https://www.clinicaltrials.gov.
Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.i,ii Lesions of AD are characterized by erythema (skin turning red or purple depending on normal skin color), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting.ii,iii
AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.iii,iv
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Pfizer Disclosure Notice
The information contained in this release is as of March 24, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a product candidate, abrocitinib, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other jurisdictions for any potential indication for abrocitinib; whether and when the applications for abrocitinib pending with the FDA and EMA may be approved and whether and when any such other applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether abrocitinib will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of abrocitinib; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
[i] Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.
[ii] Bieber T. Atopic dermatitis. Dermatology. 2012;1(3):203-217.
[iii] Oszukowska M, Michalak I, Gutfreund K, et al. Role of primary and secondary prevention in atopic dermatitis. Postep Derm Alergol. 2015:32(6):409-420.
[iv] Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16.