Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial

Lisa A. Beck*, Thomas Bieber, Stephan Weidinger, Marie Tauber, Hidehisa Saeki, Alan D. Irvine, Lawrence F. Eichenfield, Thomas Werfel, Petra Arlert, Li Jiang, Mads Røpke, Amy S. Paller

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

Background: Atopic dermatitis (AD) is characterized by microbial dysbiosis, immune dysregulation, and an impaired skin barrier. Microbial dysbiosis in AD involves a reduction in diversity primarily driven by an increased abundance of Staphylococcus aureus. Tralokinumab, an approved treatment for adults with moderate-to-severe AD, improves the skin barrier and immune abnormalities by specifically targeting the interleukin 13 cytokine, but its impact on the skin microbiome is unknown. Objective: To investigate how tralokinumab affects the skin microbiome by examining the lesional skin of adults with moderate-to-severe AD from the phase 3 ECZTRA 1 trial (NCT03131648). Methods: Microbiome profiling, S aureus abundance, and biomarker data were assessed in a subset of ECZTRA 1 participants (S aureus abundance at baseline and week 16; microbiome profiling at baseline, and week 8/16; and serum sampling before dose and week 4/8/16/28/52). Results: Tralokinumab treatment led to increased microbial diversity, reduced S aureus abundance, and increased abundance of the commensal coagulase-negative Staphylococci. Limitations: Limitations include a lack of S aureus abundance data at week 8, sampling site variation between participants, and possible influence from concomitant systemic antiinfectives. Conclusion: Our findings indicate specific targeting of the interleukin 13 cytokine with tralokinumab can directly and/or indirectly improve microbial dysbiosis seen in AD skin.

Original languageEnglish (US)
Pages (from-to)816-823
Number of pages8
JournalJournal of the American Academy of Dermatology
Volume88
Issue number4
DOIs
StatePublished - Apr 2023

Funding

Funding sources: ECZTRA 1 and this study were funded by LEO Pharma A/S. Medical writing support was funded by LEO Pharma A/S, according to Good Publication Practice guidelines (https://www.ismpp.org/gpp3). The authors received no honoraria related to the development of this publication.The authors wish to thank the study participants, site PIs, and coordinators. Medical writing support, including assisting authors with the development of the manuscript drafts and incorporation of comments, was provided by Meredith Whitaker, PhD, and Krista Mills of Alphabet Health (New York, NY), supported by LEO Pharma A/S, according to Good Publication Practice guidelines (https://www.ismpp.org/gpp3).

Keywords

  • ECZTRA 1
  • Shannon diversity
  • Staphylococcus aureus
  • atopic dermatitis
  • coagulase-negative Staphylococci (CoNS)
  • interleukin (IL)-13
  • microbiome
  • skin
  • tralokinumab

ASJC Scopus subject areas

  • Dermatology

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