Summary
Background
In the US, an Investigator's Global Assessment (IGA) score of ≤ 1 (clear/almost clear skin) has been the regulatory outcome standard measure for registration clinical trials in atopic dermatitis (AD), including those supporting the recent approval of dupilumab.
Objective
To evaluate the treatment effect of dupilumab in patients with IGA>1 at the end of treatment, using other validated outcome measures for AD signs, symptoms and quality of life.
Methods
LIBERTY AD SOLO 1 and 2 were two 16‐week, randomized, double‐blind trials enrolling adult patients with moderate‐to‐severe AD (IGA≥3) inadequately controlled with topical treatment. We performed a post‐hoc analysis in patients receiving dupilumab 300 mg every 2 weeks (q2w) or placebo. Outcome measures in patients with IGA>1 included Eczema Area and Severity Index (EASI), pruritus Numerical Rating Scale (NRS), affected Body Surface Area (BSA), Patient‐Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI).
Results
At Week 16, 278/449 dupilumab q2w‐treated patients (median age 36·0 years) and 396/443 placebo‐treated patients had IGA>1. Among patients with IGA>1 at Week 16, dupilumab significantly improved several outcome measures compared with placebo: EASI (–48·9% vs. –11·3%, P<0·001), pruritus NRS (–35·2% vs. –9·1%, P < 0·001), BSA affected (–23·1% vs. –4·5%, P<0·001), POEM score ≥ 4‐point improvement (57·4% vs. 21·0%, P<0·001), and DLQI score ≥ 4‐point improvement (59·3% vs. 24·4%, P<0·001).
Conclusions
In patients with IGA>1 at Week 16, dupilumab induced statistically significant benefits in multiple validated outcome measures versus placebo. The IGA≤1 endpoint significantly underestimates clinically relevant dupilumab treatment effects.
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