Atopic dermatitis (AD) is a chronic inflammatory skin disease that causes excessively itchy skin and can negatively affect patients’ quality of life. Individuals with AD often have atopic comorbidities (ie, allergy-related conditions), such as asthma, hay fever, food allergies, and/or eye allergies. Tralokinumab, a medication approved for treating moderate-to-severe AD in patients aged 12 years and older,1,2 targets an immune messenger protein called interleukin-13,3–5 which contributes to the signs and symptoms of AD and is also involved in other allergy-related conditions.
The article titled “Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities” published in the Annals of Allergy, Asthma & Immunology looked at whether tralokinumab benefits patients with moderate-to-severe AD who have additional allergy-related conditions.6 In this exploratory analysis, data were combined from four phase 3 clinical trials,7–9 funded by LEO Pharma, in adults and adolescents with moderate-to-severe AD who received either tralokinumab or an inactive drug (ie, placebo) for 16 weeks. Patient data were grouped by their self-reported current and/or history of asthma, hay fever, food allergies, and/or eye allergies. Patients could report multiple allergy-related conditions, but their severity was not assessed.
Prior to tralokinumab treatment, patients with history of at least one allergy-related condition had more severe AD compared with patients with no allergy-related history. After 16 weeks, a greater percentage of patients who received tralokinumab versus placebo showed substantial improvements in AD severity, regardless of allergy-related history. Improvements included achievement of clinician-rated “clear or almost clear” skin and at least a 75% reduction in disease severity. The frequencies of reported side effects were higher in patients with history of at least one allergy-related condition compared with patients with no allergy-related history but were similar between patients who received tralokinumab versus placebo. Most side effects were mild or moderate, with a low occurrence of serious side effects or those leading to patients stopping tralokinumab treatment. Limitations of this analysis include the lack of longer-term outcomes beyond Week 16 and its exploratory nature, as the ECZTRA trials were not designed to directly compare treatment responses among patients with different allergy histories.
Overall, tralokinumab reduced AD severity in adults and adolescents with moderate-to-severe AD, regardless of allergy history, supporting its use as a treatment option for patients with AD who have co-occurring allergy-related conditions.
Conflicts of Interest
Amy S. Paller has been an Investigator for AbbVie, Biomendics, Dermavant, Eli Lilly, Incyte, Johnson & Johnson Innovative Medicine, Regeneron, UCB; Consultant for Abeona, Arcutis, BioCryst, Boerhinger-Ingelheim, Castle Creek, Chiesi, Dermavant, Johnson & Johnson Innovative Medicine, Krystal, LEO Pharma, Lilly, L’Oréal, MoonLake Immunotherapeutics, Peltheos, Quoin, Regeneron, and Sanofi; Data safety monitoring board for AbbVie, Abeona, Biocryst, Daiichi Sankyo, and Galderma. Weily Soong has received research funding from AbbVie, Amgen, AstraZeneca, Galderma, Genentech, GlaxoSmithKline, Glenmark, Incyte, Innovaderm, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, and Vanda; speaker fees from Abbvie, Amgen, AstraZeneca, GlaxoSmithKline, Pfizer, Regeneron, and Sanofi; and consulting fees from AbbVie, Genentech, Incyte, Regeneron Pharmaceuticals, Sanofi, and UCB. Mark Boguniewicz has been an investigator for Incyte, Regeneron, and Sanofi; and served as a scientific adviser or consultant for AbbVie, Amgen, Arcutis, Astria, Dermavant, Eli Lilly, Incyte, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme. Bob Geng has been a consultant for Abbvie, Eli Lilly, Incyte, LEO Pharma, Pfizer, Regeneron, and Sanofi; a speaker for Abbvie, Pfizer, Regeneron, and Sanofi; and received research funding from Incyte, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi. Jacob P. Thyssen is an employee of LEO Pharma A/S and holds stock option, and served previously as an advisor for AbbVie, Almirall, Arena Pharmaceuticals, Aslan Pharmaceuticals, Coloplast, Eli Lilly, OM Pharma, Pfizer, Regeneron, Sanofi-Genzyme, and Union Therapeutics; a speaker for AbbVie, Almirall, Eli Lilly, Pfizer, Regeneron, and Sanofi Genzyme; and received research grants from Pfizer, Regeneron, and Sanofi Genzyme. Niels Bennike is an employee of LEO Pharma A/S. Shannon K. R. Schneider is an employee of LEO Pharma Inc. Andreas Wollenberg has served as an advisor or paid speaker for, or participated in clinical trials (with honoraria paid to the institution) sponsored by: AbbVie, Aileens, Almirall, Amgen, Beiersdorf, Bioderma, Bioproject, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, DKSH, Eli Lilly, Galapagos, Galderma, Glenmark, GSK, Hans Karrer, Hexal, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oréal, Maruho, MedImmune, MSD, Mylan, MSD, Novartis, Pfizer, Pierre Fabre, Regeneron, Sandoz, Santen, Sanofi-Aventis, and UCB.
The ECZTRA 1 (NCT03131648), ECZTRA 2 (NCT03160885), ECZTRA 3 (NCT03363854), and ECZTRA 6 (NCT03526861) clinical trials were sponsored by LEO Pharma A/S (Ballerup, DK). Medical writing support, including assisting authors with the development of the manuscript drafts and incorporation of comments, was provided by Matthew Hartmann, PhD of Alphabet Health (New York, NY, US), and supported by LEO Pharma Inc. (Madison, NJ, US) according to Good Publication Practice guidelines (). The authors received no honoraria related to the development of this publication.