[{"id":"solo1-iga01","name":"IGA 0/1 at Week 16","type":"PRIMARY","unit":"%","results":[{"notes":"38% vs 10% placebo","value":38,"arm_id":"dupixent-300-q2w-solo1","p_value":"<0.001","arm_name":"Dupilumab 300mg Q2W"},{"value":10,"arm_id":"placebo-solo1","arm_name":"Placebo"}],"timepoint":"Week 16","description":"Proportion of patients achieving Investigator Global Assessment score of 0 (clear) or 1 (almost clear) with ≥2-point reduction from baseline. IGA is the gold standard for measuring overall AD severity."}]

SOLO 1 met primary endpoint: 38% IGA 0/1 with dupilumab 300mg Q2W vs 10% placebo (p<0.001). EASI-75: 51% vs 15% (p<0.001). Rapid and clinically meaningful improvement in AD.

SOLO 1 (n=671): Well-tolerated. Most common AEs: nasopharyngitis 11% vs 13%, injection site reactions 10% vs 5%, conjunctivitis 10% vs 2%, headache 6% vs 7%. Conjunctivitis is a known class effect of IL-4Rα blockade. No significant SAE signal vs placebo.

SOLO 1 established Dupixent as the first biologic for AD. The 38% vs 10% IGA 0/1 result was practice-changing. Conjunctivitis signal (10% vs 2%) is a known IL-4Rα class effect but manageable. This study, along with SOLO 2, supported the original FDA approval.

First-in-class IL-4Rα blocker for moderate-to-severe AD. Blocks both IL-4 and IL-13 signaling driving type 2 inflammation in skin.