Positive topline results were announced from the phase 3 JADE TEEN study evaluating abrocitinib (Pfizer), a Janus Kinase (JAK) inhibitor, in patients aged 12 to <18 years with moderate to severe atopic dermatitis who were also on background topical therapy.
The randomized, double-blind, parallel-group study compared the efficacy and safety of abrocitinib to placebo in 285 patients aged 12 to <18 years. Patients were randomized to receive abrocitinib 100mg, 200mg or placebo orally once daily for 12 weeks while on background topical therapy.
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.
Results showed that a statistically significantly higher percentage of patients treated with abrocitinib met the co-primary end points compared with placebo. Moreover, a statistically significantly greater proportion of patients treated with the 200mg dose achieved a ≥4 point reduction in itch severity at weeks 2, 4, and 12, as measured by the Peak Pruritus Numerical Rating Scale (PP-NRS). With regard to safety, abrocitinib demonstrated a profile consistent with that seen in previous studies.
“For children and adolescents, these findings build on the positive results of our companion phase 3 monotherapy trials that included patients 12 years and older,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.
The Food and Drug Administration (FDA) previously granted Breakthrough Therapy designation to abrocitinib for the treatment of moderate to severe atopic dermatitis.
For more information visit pfizer.com.
This article originally appeared on MPR