ATLANTA, GA—Dupilumab demonstrated sustained efficacy in improving skin lesions and pruritus and improved the quality of life among patients with atopic dermatitis, reported Professor Mette Deleuran, Aarhus University Hospital, Aarhus, Denmark, at the 2017 AAAAI Annual Meeting.
Dupilumab, a fully human monoclonal antibody, binds specifically to the interleukin (IL)-4 receptor alpha subunit and inhibits both IL-4 and IL-13. To assess long-term safety and efficacy data of dupilumab in adults with moderate-to-severe atopic dermatitis, a team of researchers presented a first-step analysis from an ongoing Phase 3, long-term, multi-center, open-label trial. The study (NCT01949311) evaluated subcutaneous dupilumab 200mg or 300mg given weekly up to 3 years in adults with moderate-to-severe atopic dermatitis. Study outcomes included safety and Week 52 efficacy data relative to baseline of the parent study.
Of the 1,491 patients treated, 106 withdrew from treatment and 459 were included in the Week 52 analysis. Duration-adjusted analyses found 420.3 adverse events per 100 patient-years, 8.5 serious adverse events per 100 person-years, and 27 treatment discontinuations due to adverse events were reported; no deaths were reported.
The most common adverse events were nasopharyngitis (20.5%), upper respiratory tract infection (9.5%), and exacerbation of atopic dermatitis (8.2%). All etiologies of conjunctivitis adverse events were seen in 10.7% of patients where most were reported mild or moderate.
Week 52 analyses found 393.2 adverse events per 100 person-years, 7.6 serious adverse events per 100 person-years, and 15 treatment discontinuations due to adverse events. The most common adverse events were nasopharyngitis (29.2%), upper respiratory tract infection (8.3%), and headache (10.7%).
Nearly half of patients (48.6%) had an Investigator’s Global Assessment 0-1 and 75.4% of patients achieved ≥75% reductions in Eczema Area and Severity Index (EASI-75). At Week 52, the mean EASI score improved by 89.23%. Further, the peak pruritus Numerical Rating Scores (NRS) improved by 62.24%, which were calculated based on observed values. Study authors further reported that change in Dermatology Life Quality Index (DLQI) score at Week 48 was -11.3 points down to 2.9.
Efficacy did not vary between patients who were not exposed or patients with interrupted/continuous transitions from parent studies.
Overall, dupilumab “showed sustained efficacy in reducing signs and symptoms improving skin lesions and pruritus,” concluded Prof. Deleuran. “This study did not identify major safety concerns associated with the use of dupilumab in moderate-to-severe atopic dermatitis in this patient population.”