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Laboratory Safety of Dupilumab in Patients Aged 6–11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial by Amy S. Paller; Andreas Wollenberg; Elaine Siegfried; Diamant Thaçi; Michael J. Cork; Peter D. Arkwright; Melinda Gooderham; Xian Sun; John T. O’Malley; Faisal A. Khokhar; Jignesh Vakil; Ashish Bansal; Karli Rosner; Brad Shumel; Noah A. Levit is a Medicine article available to read on EtoBox.

What is Laboratory Safety of Dupilumab in Patients Aged 6–11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial about?

## Background Previous studies of dupilumab in adolescents and adults with moderate-to-severe atopic dermatitis (AD) showed no clinically meaningful adverse changes in laboratory parameters. ## Objective The aim of this study was to assess laboratory outcomes in children aged 6–11 years with severe AD in a randomized, placebo-controlled, phase III trial of dupilumab. ## Methods Children aged 6–11 years with severe AD were randomized 1:1:1 to 16 weeks of dupilumab 300 mg every 4 weeks, 100 or 200 mg every 2 weeks, or matching placebo, all with concomitant topical corticosteroids (TCS). Blood samples were collected at baseline and Weeks 4, 8, and 16; urine samples were collected at baseline and Weeks 4 and 16. ## Results Of 367 patients enrolled in the study, 362 were included in the safety analysis, 351 completed study treatment, and 4 withdrew due to treatment-emergent adverse events not related to laboratory abnormalities. Both dupilumab + TCS groups showed overall trends toward increases in mean blood levels of eosinophils and alkaline phosphatase, and decreases in mean blood levels of platelets, neutrophils, and lactate dehydrogenase levels, without corresponding mean changes in

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Author

Amy S. Paller; Andreas Wollenberg; Elaine Siegfried; Diamant Thaçi; Michael J. Cork; Peter D. Arkwright; Melinda Gooderham; Xian Sun; John T. O’Malley; Faisal A. Khokhar; Jignesh Vakil; Ashish Bansal; Karli Rosner; Brad Shumel; Noah A. Levit

Publisher

Springer Science and Business Media LLC

Published

2021

Language

EN

Field

Medicine (Health Sciences)