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2020-04-05| R&DTrials & Approvals

Pfizer’s Dupixent Rival Meets Endpoints in Atopic Dermatitis Trial

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

Last month, Pfizer announced that its oral Janus kinase inhibitor, abrocitinib met the co-primary efficacy endpoint in Phase III, JADE COMPARE trial for severe atopic dermatitis (AD). The JADE COMPARE trial evaluated abrocitinib in treating moderate to severe AD in comparison to placebo. Sanofi and Regeneron’s dupilumab (Dupixent), biological treatment by subcutaneous injection was used as a positive control. Dupixent had been approved for the treatment of moderate-to-severe AD since 2017 and has been one of the dominant contributors to Sanofi’s sales hitherto. Last year it received expanded approval for the drug to be used in adolescents with moderate-to-severe AD. With positive data emerging from the Phase III trial, Pfizer now plans to launch its Dupixent rival, abrocitinib with hopes of obtaining approval in 2020.

 

Disease & Drug Information

AD is a common, chronic, relapsing childhood dermatoses, characterized by inflammation of the skin. It affects up to 10% of adults and 20% of children worldwide. AD lesions cause itching, oozing/crusting, erythema (redness) and papulation (formulation of papules). Inhibition of Janus Kinase, JAK1 is considered to modulate multiple cytokines involved in the pathophysiology of AD, which includes interferon-gamma and interleukins such as IL-22, IL-13, IL-31, and IL-4. The JAK pathways are associated with over 50 cytokines and growth factors signaling and are thought to play important roles in inflammatory processes. Therefore, JAK inhibition could potentially provide relief patients linked with these conditions.

With years of research on these pathways, Pfizer has developed abrocitinib with an added IL-31 inhibition, compared to Dupixent which covers only IL-4 and IL-13. “IL-31, which is a key driver of itch, is one of the reasons why we see such rapid and profound effects on itch severity,” said Michael Vincent, senior vice president and CSO of Pfizer’s inflammation and immunology unit.

 

Abrocitinib vs. Dupixent Comparisons

The JADE COMPARE study was conducted in 837 participants and in the 20 weeks of treatment, they used non-medicated emollients at least twice a day and medicated topical therapy (such as PDE4 inhibitors, corticosteroids, and calcineurin) to treat active lesions. All participants were randomized into five different treatment arms that tested different doses of abrocitinib (100mg/200mg) or dupilumab (300mg) given with matching placebos from day 1 to week 16 followed by 100mg or 200mg of abrocitinib or placebo until week 20.

The clinical results showed that in comparison to the placebo, a higher percentage of patients treated with abrocitinib achieved the co-primary efficacy endpoint at week 12. 200mg of abrocitinib showed a significant reduction in itch by week 2 in comparison to the same dosage of dupilumab. However, a similar statistical significance was not observed with 100mg abrocitinib dose.

Patients experienced higher adverse events with 200mg abrocitinib (61.9%) than placebo (53.4%), 100mg abrocitinib (50.8%) and dupilumab (50%). In addition, the percentage of patients encountering serious adverse events leading to study discontinuation were similar across the placebo (3.8% each), 100mg abrocitinib (2.5% each), 200mg abrocitinib (0.9% and 4.4%, respectively), and dupilumab (0.8% and 3.3%, respectively) throughout all five treatment arms. 20.1% of participants receiving High dosage of abrocitinib also resulted in short-lasting nausea (20.1%), nasopharyngitis (11.7%) and headache (9.7%). Although the rate of serious effects was higher in the abrocitinib arms (3.2%) than the placebo group (1.9%), the rate of discontinuation was lower, 5.8% versus 9.1%.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: Kangstem Biotech Rethinks Strategy with New Stem Cell Drug against Atopic Dermatitis

References
  1. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_third_phase_3_trial_of_abrocitinib_for_moderate_to_severe_atopic_dermatitis_which_showed_improvements_in_skin_clearance_disease_extent_and_severity_and_itch
  2. http://www.news.sanofi.us/2017-03-28-Sanofi-and-Regeneron-Announce-FDA-Approval-of-Dupixent-R-dupilumab-the-First-Targeted-Biologic-Therapy-for-Adults-with-Moderate-to-Severe-Atopic-Dermatitis
  3. http://www.news.sanofi.us/2019-03-11-FDA-approves-Dupixent-R-dupilumab-for-moderate-to-severe-atopic-dermatitis-in-adolescents

 

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