Dupilumab significantly improved atopic dermatitis signs, symptoms and quality of life in Asian, black and white patients, according to a pooled analysis of three phase 3 trials.
“Trends in this analysis suggest that dupilumab 300 mg [weekly] may provide incremental benefits over the [every 2 weeks] regimen in black/African American patients; however, interpretation is limited by the small sample size of the black/African American cohort and variations in mean body weight between racial subgroups,” Andrew F. Alexis, MD, MPH, of the department of dermatology at Mount Sinai West in New York, and colleagues wrote.
LIBERTY AD SOLO 1 and SOLO 2 were identical in design and assessed dupilumab 300 mg weekly or every 2 weeks vs. placebo for 16 weeks. CHRONOS randomly assigned patients 3:1:3 to dupilumab 300 mg weekly, dupilumab 300 mg every 2 weeks or placebo, all with concomitant topical corticosteroids, for 52 weeks. A 600 mg loading dose was administered on day 1 in all three trials for patients who received dupilumab, while those on placebo received a double dose of placebo.
Most patients had a high disease burden, with a median atopic dermatitis duration of more than 20 years, mean baseline Eczema Area and Severity Index (EASI) score greater than 30 and mean baseline weekly Peak Pruritus Numerical Rating Scale (NRS) score greater than 7.
In white and Asian patients, both dupilumab regimens significantly improved signs of atopic dermatitis as measured by EASI and Investigator’s Global Assessment (IGA), symptoms as measured by Patient-Oriented Eczema Measure (POEM), Peak Pruritus NRS and European Quality of Life-5 Dimensions 3 level questionnaire, and quality of life as measured by Dermatology Life Quality Index (DLQI) compared with placebo at week 16 (P < .0001).
In black patients, both dupilumab regimens significantly improved EASI endpoints and mean change in Peak Pruritus NRS and DLQI. In these patients, only dupilumab 300 mg weekly showed significant improvement in mean percent change in Peak Pruritus NRS, POEM endpoints and proportions of patients achieving the IGA success endpoint, according to the researchers.
Dupilumab was well tolerated in all three trials with similar rates of treatment-emergent adverse events in all treatment groups.
“Filaggrin loss-of-function mutations, which lead to deficiency of the structural protein filaggrin and resulting skin barrier defects, have been identified as a major predisposing factor for the development of [atopic dermatitis] in Europeans and Asians,” Alexis and colleagues wrote. In patients of African descent, the association between filaggrin mutations and atopic dermatitis is unclear.
The researchers said the results support the relevance of moderating type 2 inflammation in atopic dermatitis by blocking interleukin-4 and IL-13 signaling in all racial subgroups. – by Abigail Sutton
Disclosures: Alexis reports he is an advisory board member/consultant for Almirall, Beiersdorf, BioPharmX, Celgene, Cipla, Dermavant, Dermira, Galderma, Leo Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, Trevi Therapeutics, Unilever and Valeant, and an investigator for Almirall, Bristol-Myers Squibb, Celgene, Galderma, Leo Pharma, Menlo Therapeutics, Novartis and RxL. Please see the study for all other authors’ relevant financial disclosures.