Positive topline results were announced from the phase 3 JADE COMPARE trial of abrocitinib (Pfizer), a Janus Kinase (JAK) inhibitor, for the treatment of moderate to severe atopic dermatitis.
The multicenter, double-blind, placebo-controlled trial compared the efficacy and safety of abrocitinib with placebo and dupilumab in 837 adults with moderate to severe atopic dermatitis for 20 weeks. Patients were randomized to 1 of 5 treatment arms: abrocitinib 100mg or 200mg orally once daily, dupilumab 300mg subcutaneous injection every 2 weeks (600mg loading dose at baseline), or placebo (oral or injectable).
The co-primary 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 their Eczema Area and Severity Index (EASI75) score at Week 12. Key secondary end points included the proportion of patients achieving the IGA and EASI75 measures at Week 16; and achieving a ≥4 point reduction in itch severity from baseline measured with the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 2.
Results showed that a statistically superior proportion of patients treated with abrocitinib (100mg and 200mg) met both co-primary end points compared with placebo at Week 12, and maintained superiority at Week 16. Dupilumab also demonstrated superiority to placebo at Weeks 12 and 16. Additionally, the abrocitinib 200mg arm had a statistically superior reduction in itch by Week 2 compared with dupilumab.
The safety profile of abrocitinib was consistent with previous studies. Patients treated with abrocitinib 200mg experienced greater adverse events (61.9%) compared with abrocitinib 100mg (50.8%), dupilumab (50%), and placebo (53.4%).
Full study data will be submitted for presentation at a future scientific meeting and publication in a medical journal.
“It was helpful to study abrocitinib in combination with topical therapies to provide data relevant to the real-world setting,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “The addition of an active control was also important to better understand the significance of this potential new medicine and we’re encouraged by the positive data from this trial.”
The Food and Drug Administration (FDA) previously granted Breakthrough Therapy designation to abrocitinib in February 2018. The Company plans to submit abrocitinib for regulatory review in 2020 using data from JADE COMPARE, JADE MONO-1 and JADE MONO-2.
For more information visit pfizer.com.