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The combination of oral abrocitinib
and topical therapy is effective and shows good tolerability in adolescents
having moderate-to-severe atopic dermatitis.
In atopic dermatitis patients, once-daily oral abrocitinib plus topical therapy demonstrated higher efficacy with an acceptable safety profile when compared to placebo plus topical therapy. Researchers undertook this phase 3, double-blind, placebo-controlled, randomized clinical trial (JADE TEEN) to examine the efficacy and safety of the combination of oral abrocitinib and topical therapy to treat atopic dermatitis.
Participants had an unsatisfactory response to four consecutive weeks or longer of medicated topical medication, or they had a requirement for systemic therapy for atopic dermatitis. The recruited subjects (n=285, age 12 to 17 years) were randomized to receive oral abrocitinib (100 or 200 mg) or placebo for 12 weeks combined with medicated topical treatment. Analysis of data was conducted after study completion.
The coprimary outcomes were attainment of (i) an Investigator's Global Assessment (IGA) response of almost clear or clear with an improvement of two or more grades from the baseline, and (ii) a 75% or higher improvement in Eczema Area and Severity Index (EASI-75) response from the baseline. A four-point or higher improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) at 12th week was the key secondary outcome. Monitoring of side effects was also done.
At week 12, considerably more patients treated with abrocitinib (100 or 200 mg) vs placebo attained an IGA response of 0/1, EASI-75, and PP-NRS4. In addition, herpes-linked adverse events were infrequent, while nausea was noted to be more common with abrocitinib therapy. The percentage of subjects with treatment-emergent side effects and serious adverse events are shown in table 1:
Thus, the combination of
abrocitinib and topical therapy substantially improves the signs and symptoms
of atopic dermatitis, with improvements in the patient's quality of life.
JAMA Dermatology
Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial
Lawrence F Eichenfield et al.
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