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Summary   Background  In the U.S.A., an Investigator's Global Assessment ( IGA ) score of ≤ 1 (clear or almost clear skin) has been the standard measure in regulatory outcomes for registration clinical trials in atopic dermatitis ( AD ), including those supporting the recent approval of dupilumab.    Objectives  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 ). The trials were registered at ClinicalTrials.gov:  NCT 02277743 and  NCT 02277769.    Results  At week 16, 278 of 449 dupilumab q2w‐treated patients (median age 36·0 years) and 396 of 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), affected  BSA  (−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 compared with placebo. The  IGA  ≤ 1 end point significantly underestimates clinically relevant dupilumab treatment effects.

british journal of dermatology

Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator's Global Assessment: a pooled analysis of data from two phase  III  trials