In phase 3 dupilumab (DPL) trials, the overall severity of 4 signs of atopic dermatitis (AD), erythema, infiltration/papulation, excoriation lichenification, was assessed globally through the investigator-assessed Global Individual Signs Score (GISS; range 0–12). Here, the effects of DPL on AD signs as measured by GISS in phase 3 trials are reported (LIBERTY AD: SOLO 1&2 [pooled] - NCT02277743/NCT02277769; CAFÉ - NCT02755649; CHRONOS - NCT02260986).
Patients received subcutaneous DPL 300mg every 2 weeks (q2w) or placebo for 16 weeks (SOLO); DPL q2w + concomitant topical corticosteroids (TCS) or placebo + TCS for 16 weeks (CAFÉ); or 52 weeks (CHRONOS). Least squares mean percent change from baseline (BL) at Weeks 16 (SOLO, CAFÉ) and 52 (CHRONOS) in total GISS and categorical change in severity of AD signs over time are reported.
BL characteristics in all treatment groups were generally similar in each trial. Early improvement with DPL treatment in total GISS scores was observed by Week 1 in SOLO, and by Week 2 in CAFÉ and CHRONOS. Percent change in total GISS with DPL 300 mg q2w vs control was –49.2% vs –22.1% in SOLO,
–55.2% vs –29.0% in CAFÉ at Week 16, and –62.7% vs –41.3% in CHRONOS at Week 52 (P<0.0001 for all). Individual signs severity also improved over time vs control with majority of patients achieving lower scores by the end of treatment. DPL was generally well tolerated.
DPL 300 mg q2w monotherapy or with concomitant TCS resulted in rapid improvement in total GISS compared with control consistently across all 4 trials, and results were maintained until end of treatment. Improvements were seen with DPL treatment vs control over time in all individual AD signs: erythema, infiltration/papulation, excoriation, and lichenification.

Effect of Dupilumab on Global Individual Signs Score Outcomes in Adults With Moderate-to-Severe Atopic Dermatitis: Combined Results From Four Phase 3 Trials