Background: Dupilumab, a fully human anti-IL-4Rα mAb, inhibits signaling of IL-4/IL-13, key drivers of type 2/Th2-mediated diseases, such as AD/asthma.
Objectives: We report efficacy and safety of dupilumab in Korean patients (pts) with moderate-to-severe AD in a randomized, placebo (PBO)-controlled, multinational phase 3 trial (SOLO 2: NCT02277769).
Methods: Pts were randomized 1:1:1 to subcutaneous dupilumab 300mg every 2 weeks (wks; q2w), weekly (qw), or PBO qw, for 16 wks.
Results: 708 pts were randomized; 80 were Korean. In the Korean population, more dupilumab-treated pts achieved Investigator’s Global Assessment 0/1 vs PBO at Wk 16 (primary endpoint; q2w/qw vs PBO: 33.3%/33.3% vs 0.0%; both P=0.0018), ≥75% improvement in Eczema Area and Severity Index (29.6%/40.7% vs 7.7%; P=0.0764/P=0.0091) and peak pruritus numerical rating scale ≥4-point improvement from baseline at Wk 16 vs PBO (33.3%/34.6% vs 3.8%; P=0.0113/P=0.0109) (key secondary). Dupilumab also improved Patient Oriented Eczema Measure and Dermatology Life Quality Index vs PBO at Wk 16 (both P<0.01) (secondary). Adverse events (AEs) were reported in 12/27 (q2w) and 8/27 pts (qw) vs 17/26 pts (PBO), none were serious. AD was the most common AE, occurring less frequently in the dupilumab groups vs PBO (4/27 and 4/27 pts vs 16/26 pts).
Conclusion: The efficacy and acceptable safety profile of dupilumab in Korean pts were generally consistent with the overall study population.