Laboratory Safety of Dupilumab in Patients Aged 6 to < 12 Years with Severe Atopic Dermatitis: Results from a Phase 3 Clinical Trial

Research output: Contribution to journalArticlepeer-review

  • External authors:
  • Amy S Paller
  • Andreas Wollenberg
  • Elaine C Siegfried
  • Diamant Thaci
  • Michael J. Cork
  • Melinda Gooderham
  • Xian Sun
  • John T O'Malley
  • Faisal Khokhar
  • Jignesh Vakil
  • Ashish Bansal
  • Karli Rosner
  • Brad Shumel
  • Noah A. Levit

Abstract

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: To assess laboratory outcomes in children aged 6 to < 12 years with severe AD in a randomized,  placebo-controlled, phase 3 trial of dupilumab. Methods: Children aged 6 to < 12 years with severe AD were randomized 1:1:1 to 16 weeks of dupilumab 300 mg  every 4 weeks, 100 or 200 mg every two 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. Bot 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 the placebo + TCS group. None of these changes were associated with symptoms or clinically meaningful adverse outcomes, and none led to treatment modification. No clinically significant changes or trends were observed for other measured laboratory parameters. Conclusion: There were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6 to < 12 years treated with dupilumab + TCS for severe AD.

Bibliographical metadata

Original languageEnglish
JournalPediatric Drugs
Publication statusAccepted/In press - 18 May 2021