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.
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