Top-line Results from a third Phase 3 trial of Pfizer's abrocitinib for moderate to severe atopic dermatitis showed improvements in skin clearance, disease extent and severity, and itch. JADE COMPARE (B7451029) met its co-primary efficacy endpoints. The Phase 3 study evaluated the safety and efficacy of abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in adults with moderate to severe atopic dermatitis who were also on background topical therapy. The study also included an active control arm, dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo.
“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.”
These data, along with other results from other pivotal trials, MONO-1 and MONO-2, will support filings with regulatory bodies, starting with the FDA planned for later this year.
Results showed that the percentage of patients achieving each co-primary efficacy endpoint at Week 12 was statistically superior with both doses of abrocitinib than with placebo. Superiority to placebo with both doses was maintained at Week 16. Dupilumab, the active control on these primary endpoints, demonstrated superiority to placebo at Week 12 and Week 16.
As a key secondary endpoint, the percentage of patients who had a clinically significant reduction in itch by Week 2 of treatment was statistically superior for the 200mg abrocitinib dose compared to dupilumab and numerically higher, but not statistically significantly higher, for the 100mg abrocitinib dose compared to dupilumab.
The safety profile seen with abrocitinib was consistent with previous studies. Safety results showed that a larger percentage of patients receiving abrocitinib 200mg experienced adverse events (61.9%) than in other treatment arms. The percentages of patients experiencing adverse events were similar for placebo (53.4%), abrocitinib 100mg (50.8%), and dupilumab (50%). The percentage of patients experiencing serious adverse events and adverse events leading to study discontinuation were similar across the placebo (3.8% each), abrocitinib 100mg (2.5% each), abrocitinib 200mg (0.9% and 4.4%, respectively), and dupilumab (0.8% and 3.3%, respectively) treatment arms.