Laboratory safety of dupilumab in patients aged 6–11 years with severe atopic dermatitis : results from a phase III clinical trial

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

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 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 6–11 years treated with dupilumab + TCS for severe AD.

Trial Registration

ClinicalTrials.gov Identifier: NCT03345914.

Metadata

Item Type:	Article
Authors/Creators:	Paller, A.S. Wollenberg, A. Siegfried, E. Thaçi, D. Cork, M.J. https://orcid.org/0000-0003-4428-2428 Arkwright, P.D. Gooderham, M. Sun, X. O’Malley, J.T. Khokhar, F.A. Vakil, J. Bansal, A. Rosner, K. Shumel, B. Levit, N.A.
Copyright, Publisher and Additional Information:	© 2021 The Author(s). This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/4.0/.
Dates:	Published: September 2021 Published (online): 31 August 2021 Accepted: 23 June 2021
Institution:	The University of Sheffield
Academic Units:	The University of Sheffield > Sheffield Teaching Hospitals
Depositing User:	Symplectic Sheffield
Date Deposited:	08 Oct 2021 13:06
Last Modified:	08 Oct 2021 13:06
Status:	Published
Publisher:	Springer Nature
Refereed:	Yes
Identification Number:	10.1007/s40272-021-00459-x
Related URLs:	Author
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:178845

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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

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