Atopic dermatitis (AD) is an inflammatory skin disorder mainly caused by Th2 cytokines, especially interleukin (IL) 13. Tralokinumab, an IgG4 monoclonal antibody that neutralizes IL-13, has demonstrated safety and efficacy in clinical trials for treatment of adults with moderate to severe AD.1,2 Concerns arose during the COVID-19 pandemic that immunomodulatory drugs may increase disease susceptibility or severity or interfere with SARS-CoV-2 vaccination. The aim of the study was to assess outcomes of COVID-19 and SARS-CoV-2 vaccination among adult patients with AD treated with tralokinumab in the ECZTEND trial (NCT03587805).
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: June 25, 2022.
Published Online: October 12, 2022. doi:10.1001/jamadermatol.2022.3488
Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2022 Blauvelt A et al. JAMA Dermatology.
Corresponding Author: Andrew Blauvelt, MD, MBA, Oregon Medical Research Center, 9495 SW Locust St, Ste G, Portland, OR 97223 (email@example.com).
Author Contributions: Dr Blauvelt had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Blauvelt, Langley, Gjerum, Guttman-Yassky.
Acquisition, analysis, or interpretation of data: All authors.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Langley.
Administrative, technical, or material support: Langley, Gjerum.
Supervision: Blauvelt, Pink, Elewski, Guttman-Yassky.
Conflict of Interest Disclosures: Dr Blauvelt reported receiving personal fees and other support from LEO Pharma for serving as a speaker, scientific consultant, and clinical study investigator during the conduct of the study; honoraria from AbbVie and UCB for serving as a speaker; honoraria from AbbVie, Abcentra, Aligos Therapeutics, Almirall, Amgen, Arcutis Biotherapeutics, Arena Pharmaceuticals, ASLAN Pharmaceuticals, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant Sciences, EcoR1 Capital, Eli Lilly and Company, Evommune, Forte Biosciences, Galderma, Incyte, Janssen, Landos Biopharma, Novartis, Pfizer, RAPT Therapeutics, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, Vibliome Therapeutics, and Xencor for serving as a scientific adviser; and clinical study funds for his institution from AbbVie, Amgen, Arcutis Biotherapeutics, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant Sciences, Eli Lilly and Company, Galderma, Incyte, Janssen, Novartis, Pfizer, Regeneron, Sun Pharma, and UCB for acting as a clinical study investigator. Dr Pink reported receiving grants from Amgen outside the submitted work; personal fees from Sanofi, Galderma, Almirall, UCB, and Janssen for serving as an adviser and speaker; personal fees from AbbVie, Lilly, Boehringer Ingelheim, and Novartis for serving as an adviser, speaker, and investigator; personal fees from LEO Pharma for serving as an adviser, speaker, and investigator and providing educational support; personal fees from Bristol Myers Squibb for serving as an adviser and investigator; personal fees from Amgen for serving as an adviser; and nonfinancial support from UCB, LEO Pharma, and Novartis for providing educational support. Dr Worm reported receiving honoraria from ALLERGOPHARMA, Mylan Germany, AbbVie Deutschland, Lilly Deutschland, Swixx BioPharma, Pharm Research Associates (UK) Ltd, Actelion Pharmaceuticals Deutschland, AstraZeneca, Worg Pharmaceuticals (Hangzhou) Co Ltd, Aimmune Therapeutics, ALK-Abelló Arzneimittel, Phadia Laboratory Systems, HAL Allergy, Amgen, Regeneron Pharmaceuticals, Stallergenes Greer, DBV Technologies, Bencard Allergie, Novartis, Biotest AG, and Boehringer Ingelheim for serving on advisory boards or participating in lecture activities outside the submitted work. Dr Langley reported receiving grants from LEO Pharma and Pfizer for serving as a principal investigator and on advisory boards; grants from AbbVie, Janssen, UCB, Lilly, Novartis, and Amgen for serving as a principal investigator and speaker and on advisory boards; and grants from Sun Pharma for serving as a speaker and on the advisory board outside the submitted work. Dr Elewski reported receiving grants and personal fees from LEO Pharma, Novartis, UCB, Bristol Myers Squibb, and Boehringer Ingelheim and grants from Pfizer, Amgen, Lilly, and AbbVie. Dr Gjerum reported receiving personal fees from LEO Pharma during the conduct of the study. Dr Guttman-Yassky reported receiving grants from Icahn School of Medicine at Mount Sinai during the conduct of the study; receiving research funds as an employee of Mount Sinai from AbbVie, Almirall, Amgen, AnaptysBio, Asana BioSciences, AstraZeneca, Boerhinger Ingelhiem, Cara Therapeutics, Celgene Corp, Eli Lilly and Company, Galderma, Glenmark/Ichnos Sciences, Innovaderm Research, Janssen, Kao Corp, Kiniksa Pharmaceuticals, Kyowa Kirin, LEO Pharma, Novan, Novartis, Pfizer, Ralexar Therapeutics, Regeneron Pharmaceuticals, and UCB; and serving as a consultant for AbbVie, Almirall, Amgen, Arena Pharmaceuticals, Asana BioSciences, ASLAN Pharmaceuticals, AstraZeneca, Boerhinger Ingelhiem, Bristol Meyers Squibb, Cara Therapeutics, Celgene Corp, Connect Pharma, Eli Lilly and Company, EMD Serono, Evidera, Galderma, Ichnos Sciences, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Pandion Therapeutics, Pfizer, RAPT Therapeutics, Regeneron Pharmaceuticals, Sanofi, SATO Pharmaceutical, Siolta Therapeutics, Target PharmaSolutions, UCB, and Ventyx Biosciences.
Additional Contributions: The authors wish to thank the following individuals for their kind input on the draft manuscript: Antonio Costanzo, MD, Humanitas University, Milano, Italy; Leon Kircik, MD, Icahn School of Medicine at Mount Sinai, New York, New York; and Thomas Mark, PhD, Emilie Jorgensen, MSc, Joshua Corriveau, PharmD, MBA, and Adriana Guana, MD, LEO Pharma. Medical writing support, including assisting authors with the development of the manuscript drafts and incorporation of comments, was provided by Clair Geary, PhD, Paul Shea, BA, and Meredith Whitaker, PhD, Alphabet Health, New York, New York, supported by LEO Pharma.
Additional Information: The authors received no honoraria related to the development of this publication.
Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.
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