Long-term safety and efficacy of open-label dupilumab in patients with moderate-to-severe atopic dermatitis

To provide additional long-term safety and efficacy data in adults with moderate-to-severe atopic dermatitis (AD). We present a first-step-analysis from an ongoing phase 3, multi-center, open-label trial (NCT01949311) of subcutaneous dupilumab, 300mg weekly up to 3 years, in adults with moderate-to-severe AD. Patients are eligible after participating in previous dupilumab trials (including unexposed/interrupted/continuous treatment between the previous and this study). Outcomes include safety and Week 52 (W52) efficacy relative to baseline of the parent study. 1491 patients (60% male, mean age[SD] 39.7[13.41]) were treated; 106 withdrew from treatment. Duration-adjusted analyses showed 420.4 adverse events (AEs)/100 patient-years (100PY), 8.5 serious AEs/100PY, 27 (1.8%) treatment discontinuations due to AEs, and no deaths; most common AEs (preferred term): nasopharyngitis (20.5%), upper respiratory tract infection (9.5%), exacerbation of AD (8.2%); conjunctivitis AEs (all etiologies) occurred in 10.7% of patients. W52 analyses (N=459, 399 completed/60 patients withdrew before W52) showed 393.2 AEs/100PY, 7.6 serious AEs/100PY and 15 (3.3%) discontinuations due to AEs; most common AEs: nasopharyngitis (29.2%), headache (10.7%), upper respiratory tract infection (8.3%). At W52, 48.6% patients had an Investigator’s Global Assessment 0-1 and 75.4% achieved ≥75% reductions in Eczema Area and Severity Index (missing values as non-responders for both outcomes); pruritus Numerical Rating Scale scores decreased by 62.24% (calculated based on observed values). Efficacy did not differ among unexposed patients or interrupted/continuous transitions from parent studies. In this long-term open-label study, dupilumab showed sustained efficacy in reducing signs and symptoms improving skin lesions and pruritus among AD patients without any major safety issues.