Table 1.
Study | EASI | Pruritus (VAS) IGA | IGA | BSA | SCORAD | GISS | POEM | HADS | DLQI |
---|---|---|---|---|---|---|---|---|---|
Phase I–II | |||||||||
4 weeks monotherapy (day 29)43 | EASI 50 in 59% dupilumab group versus 19% placebo EASI 75 in 29% dupilumab group versus 6% placebo Overall, −58% EASI dupilumab group versus −25% placebo |
−41% dupilumab group −19% placebo |
0 (clear) or 1 (almost clear) in 12% dupilumab group versus 6% placebo | −37% dupilumab group −15% placebo |
N/A | N/A | N/A | N/A | N/A |
12 weeks monotherapy (day 85)43 | EASI 50 in 85% dupilumab group versus 35% placebo EASI 75 in 62% dupilumab group versus 15% placebo Overall, improvement in EASI of 74% in the dupilumab group versus 23% placebo |
−56% dupilumab group −15% placebo |
0 (clear) or 1 (almost clear) in 40% dupilumab group versus 7% placebo | −60% dupilumab group −18% placebo |
N/A | N/A | N/A | N/A | N/A |
4 weeks combination therapy (day 29)43 | EASI 50 in 100% dupilumab group versus 50% placebo EASI 75 in 62% dupilumab group versus 40% placebo Overall, improvement in EASI of 76% in the dupilumab group versus 53% placebo |
−71% dupilumab group −25% placebo |
0 (clear) or 1 (almost clear) in 52% dupilumab group versus 30% placebo | −64% dupilumab group −37% placebo |
N/A | N/A | N/A | N/A | N/A |
Phase III | |||||||||
16 weeks monotherapy (day 112) – SOLO1 study (receiving dupilumab every week or every other week)48 | EASI 75 in 52% weekly dupilumab group versus 51 every other week dupilumab group versus 15% placebo Overall, improvement in EASI of 72% in weekly dupilumab group versus 72% in every other week dupilumab group versus 38% placebo |
≥4 points on numerical rating scale: in 40% of weekly dupilumab group versus 41% of every other week dupilumab group versus 12% placebo | 0 or 1 (or reduction of ≥2 points from baseline) in 37% weekly dupilumab group versus 38% in every other week dupilumab group versus 10% placebo | −34% weekly dupilumab group versus −33% every other week dupilumab group versus 15% placebo | −57% weekly dupilumab group versus −58% every other week dupilumab group versus 29% placebo | −52% weekly dupilumab group versus −53% every other week dupilumab group versus 26% placebo | −11% weekly dupilumab group versus −12% every other week dupilumab group versus 5% placebo | −5% weekly dupilumab group versus −5% every other week dupilumab group versus 3% placebo | −9% weekly dupilumab group versus −9% every other week dupilumab group versus 5% placebo |
16 weeks monotherapy (day 112) – SOLO2 study (receiving dupilumab every week or every other week)48 | EASI 75 in 48% weekly dupilumab group versus 44 every other week dupilumab group versus 12% placebo Overall, improvement in EASI of 69% in weekly dupilumab group versus 67% in every other week dupilumab group versus 31% placebo |
≥4 points on numerical rating scale: in 39% of weekly dupilumab group versus 36% of every other week dupilumab group versus 13% placebo | 0 or 1 (or reduction of ≥2 points from baseline) in 36% weekly dupilumab group versus 36% in every other week dupilumab group versus 8% placebo | −32% weekly dupilumab group versus −31% every other week dupilumab group versus 13% placebo | −54% weekly dupilumab group versus −51% every other week dupilumab group versus 20% placebo | −47% weekly dupilumab group versus −46% every other week dupilumab group versus 18% placebo | −11% weekly dupilumab group versus −10% every other week dupilumab group versus 3% placebo | −6% weekly dupilumab group versus −5% every other week dupilumab group versus 1% placebo | −10% weekly dupilumab group versus −9% every other week dupilumab group versus 4% placebo |
Abbreviations: EASI, Eczema Area and Severity Index; VAS, visual analog scale; IGA, Investigator’s Global Assessment; BSA, body surface area; SCORAD, SCORing Atopic Dermatitis; GISS, Global Individual Sign Score; POEM, Patient-Oriented Eczema Measure; HADS, Hospital Anxiety and Depression Scale; DLQI, Dermatology Life Quality Index; N/A, not applicable.