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Perspective, Opinion, Commentary
06 Aug 2025
Effect of tralokinumab treatment in patients with moderate-to-severe atopic dermatitis and allergy-related conditions
Amy S. Paller, MD, Weily Soong, MD, Mark Boguniewicz, MD, Bob Geng, MD, Jacob P. Thyssen, MD, PhD, Niels Bennike, MD, PhD, Shannon K. R. Schneider, PhD, Andreas Wollenberg, MD
Perspective, Opinion, Commentary
25 May 2026
Effect of tralokinumab treatment in patients with moderate-to-severe atopic dermatitis and allergy-related conditions
Amy S. Paller, MD, Weily Soong, MD, Mark Boguniewicz, MD, Bob Geng, MD, Jacob P. Thyssen, MD, PhD, Niels Bennike, MD, PhD, Shannon K. R. Schneider, PhD, Andreas Wollenberg, MD
DOI:
10.64550/joid.3tdtzv65
Reviewed by:
Sonal Choudhary, MD, Kurt Ashack, MD
Abstract

Atopic dermatitis (AD) is a chronic inflammatory skin disease often associated with allergy-related comorbidities such as asthma, hay fever, food allergies, and eye allergies. This study evaluated the effects of tralokinumab treatment in patients with moderate-to-severe AD and coexisting allergy-related conditions. Data from four phase 3 clinical trials involving adults and adolescents with moderate-to-severe AD were analyzed over a 16-week period, comparing tralokinumab with placebo. Patients were grouped according to self-reported history of asthma, hay fever, food allergies, and eye allergies. Results showed that patients receiving tralokinumab demonstrated significant improvements in AD severity regardless of allergy history, including clearer skin and reduced disease severity. Reported side effects were generally mild to moderate and comparable to placebo. Overall, tralokinumab reduced AD severity in patients with moderate-to-severe AD, supporting its use as a treatment option for individuals with co-occurring allergy-related conditions.

Description:

Plain Language Summary

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.

Funding

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.

References
1. ADBRY® (tralokinumab-ldrm). Prescribing information. Accessed January 3, 2025. https://www.leo-pharma.us/adbrypi#page=1
2. Adtralza (tralokinumab). Summary of product characteristics. Accessed January 5, 2024. https://www.ema.europa.eu/en/documents/product-information/adtralza-epar-product-information_en.pdf
3. Popovic B., Breed J., Rees D.G... "Structural Characterisation Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Ralpha1 and IL-13Ralpha2." J Mol Biol, vol. 429, 1-20-2017, p. 208. DOI: 10.1016/j.jmb.2016.12.005.
Google Scholar
4. Tollenaere M. A. X., Molck C., Henderson I... "Tralokinumab Effectively Disrupts the IL-13/IL-13Ralpha1/IL-4Ralpha Signaling Complex but Not the IL-13/IL-13Ralpha2 Complex." JID Innov, vol. 3, 9-2023, p. 100214. DOI: 10.1016/j.xjidi.2023.100214.
Google Scholar
5. Simpson E. L., Guttman-Yassky E., Eichenfield L. F... "Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition." Allergy, vol. 78, 11-2023, p. 2875. DOI: 10.1111/all.15811.
Google Scholar
6. Paller A. S., Soong W., Boguniewicz M... "Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities." Ann Allergy Asthma Immunol, vol. 135, 10-2025, p. 425. DOI: 10.1016/j.anai.2025.06.022.
Google Scholar
7. Wollenberg A., Blauvelt A., Guttman-Yassky E... "Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2)." Br J Dermatol, vol. 184, 3-2021, p. 437. DOI: 10.1111/bjd.19574.
Google Scholar
8. Paller A. S., Flohr C., Cork M... "Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial." JAMA Dermatol, vol. 159, 6-1-2023, p. 596. DOI: 10.1001/jamadermatol.2023.0627.
Google Scholar
9. Silverberg J. I., Toth D., Bieber T... "Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial." Br J Dermatol, vol. 184, 3-2021, p. 450. DOI: 10.1111/bjd.19573.
Google Scholar
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DOI:
10.64550/joid.3tdtzv65
Reviewed by:
Sonal Choudhary, MD, Kurt Ashack, MD
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“Effect of tralokinumab treatment in patients with moderate-to-severe atopic dermatitis and allergy-related conditions”, JOID, vol. 1, no. 1, May 2026, doi: 10.64550/joid.3tdtzv65.
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