Real-World Evidence of Tralokinumab Effectiveness and Safety: A Systematic Review and Meta-analysis

Amalie Thorsti Møller Rønnstad¹, Christopher G Bunick^{2

3}, Raj Chovatiya^{4

5}, Masahiro Kamata⁶, Mia-Louise Nielsen¹, Daniel Isufi⁷, Simon F Thomsen^{1

8}, Christian Vestergaard⁹, Andreas Wollenberg^{10

11

12}, Alexander Egeberg^{1

13}, Jacob P Thyssen^{1

13}, Nikolai Loft¹⁴

Affiliations

¹ Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
² Program in Translational Biomedicine, Yale School of Medicine, Yale University, New Haven, CT, USA.
³ Department of Dermatology, Yale University, New Haven, CT, USA.
⁴ Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA.
⁵ Center for Medical Dermatology + Immunology Research, Chicago, IL, USA.
⁶ Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
⁷ Department of Dermatology and Allergy, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark.
⁸ Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
⁹ Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
¹⁰ Department of Dermatology and Allergy, University Hospital Augsburg, Augsburg, Germany.
¹¹ Comprehensive Center for Inflammation Medicine, University of Luebeck, Luebeck, Germany.
¹² Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.
¹³ Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
¹⁴ Department of Dermatology and Allergy, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark. nikolai.nguyen.loft@regionh.dk.

PMID: 40045152
DOI: 10.1007/s40257-025-00927-x

Meta-Analysis

Real-World Evidence of Tralokinumab Effectiveness and Safety: A Systematic Review and Meta-analysis

Amalie Thorsti Møller Rønnstad et al. Am J Clin Dermatol. 2025 May.

. 2025 May;26(3):411-424.

doi: 10.1007/s40257-025-00927-x. Epub 2025 Mar 5.

Authors

Affiliations

¹ Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
² Program in Translational Biomedicine, Yale School of Medicine, Yale University, New Haven, CT, USA.
³ Department of Dermatology, Yale University, New Haven, CT, USA.
⁴ Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA.
⁵ Center for Medical Dermatology + Immunology Research, Chicago, IL, USA.
⁶ Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
⁷ Department of Dermatology and Allergy, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark.
⁸ Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
⁹ Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
¹⁰ Department of Dermatology and Allergy, University Hospital Augsburg, Augsburg, Germany.
¹¹ Comprehensive Center for Inflammation Medicine, University of Luebeck, Luebeck, Germany.
¹² Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.
¹³ Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
¹⁴ Department of Dermatology and Allergy, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark. nikolai.nguyen.loft@regionh.dk.

PMID: 40045152
DOI: 10.1007/s40257-025-00927-x

Erratum in

Correction to: Real-World Evidence of Tralokinumab Effectiveness and Safety: A Systematic Review and Meta-analysis.
Rønnstad ATM, Bunick CG, Chovatiya R, Kamata M, Nielsen ML, Isufi D, Thomsen SF, Vestergaard C, Wollenberg A, Egeberg A, Thyssen JP, Loft N. Rønnstad ATM, et al. Am J Clin Dermatol. 2025 Jul;26(4):639. doi: 10.1007/s40257-025-00948-6. Am J Clin Dermatol. 2025. PMID: 40272773 No abstract available.

Abstract

Background: Tralokinumab, a first-in-class and second biologic approved for treating moderate-to-severe atopic dermatitis in adolescents and adults, has demonstrated consistent efficacy and safety across multiple clinical trials.

Objective: We aimed to assess the real-world effectiveness and safety of tralokinumab by performing a systematic review and meta-analysis on the real-world evidence of tralokinumab.

Methods: We systematically searched PubMed and EMBASE from inception until 28 July, 2024 for observational studies describing the effectiveness and safety of tralokinumab for the treatment of atopic dermatitis. The primary outcome was the proportion of patients achieving a ≥75% improvement in the Eczema Area and Severity Index (EASI-75) after 16 weeks and secondary outcomes included the proportion of patients achieving EASI-50 and EASI-90 and the proportion of patients experiencing adverse events.

Results: Nineteen unique studies encompassing 911 bio-naïve and bio-experienced patients with atopic dermatitis treated with tralokinumab were included. After 16 weeks of treatment, 82%, 59% and 26% of patients achieved EASI-50, EASI-75 and EASI-90, respectively, and the proportion of patients developing conjunctivitis was 3.2%.

Conclusions: Tralokinumab demonstrates strong effectiveness and good tolerability in real-world settings, with a high proportion of patients achieving a clinical response and adverse events being observed only infrequently.

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Conflict of interest statement

Declarations. Funding: No funding was received for the preparation of this article. Conflict of interest: Amalie Thorsti Møller Rønnstad has received research funding from the Department of Clinical Medicine, Copenhagen University and the Kgl Hofbundtmager Aage Bang Foundation. Masahiro Kamata received honoraria for lectures from LEO Pharma, AbbVie, Eli Lilly, Janssen, UCB, Boehringer Ingelheim, Bristol Myers Squibb, Kyowa Kirin, Torii, Taiho and Maruho. Mia-Louise Nielsen has received consultancy honoraria from LEO Pharma. Simon F. Thomsen has received research support from Janssen, LEO Pharma, Novartis, Sanofi and UCB, and has been a speaker/consultant for AbbVie, CSL, Eli Lilly, Janssen, Galderma, Incyte, LEO Pharma, Novartis, Pfizer, Sanofi, Symphogen, UCB and Union Therapeutics. Christian Vestergaard has been an investigator for AbbVie A/S, Pierre Fabre Dermo-Cosmetique, Novartis, LEO Pharma, Sanofi, Almirall, Galderma and Pfizer. He has served on advisory boards for Astellas Pharma, Almirall, Sanofi, Abb-Vie, Galderma, Leo Pharma and MEDA, and has been a speaker for Leo-Pharma, Astellas, MSD, AbbVie, Novartis Almirall, Sanofi and Pfizer. Raj Chovatiya served as an advisor, consultant, speaker and/or investigator for AbbVie, Amgen, AnaptysBio, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., RAPT, Regeneron, Sanofi, Sitryx, Takeda, TRexBio and UCB. Christopher G. Bunick has served as an investigator for AbbVie, Almirall, Apogee, Daiichi Sankyo, LEO Pharma, Ortho Dermatologics, Sun Pharma, Timber and Palvella, a consultant for AbbVie, Almirall, Apogee, Arcutis, Connect BioPharma, Eli Lilly, EPI Health/Novan, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, Takeda and UCB, and a speaker for and received honoraria from Allergan, Almirall, LEO Pharma, and UCB. 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’Oreal, Maruho, MedImmune, MSD, Mylan, MSD, Novartis, Pfizer, Pierre Fabre, Regeneron, Sandoz, Santen, Sanofi-Aventis and UCB. Alexander Egeberg has received research funding from Almirall, Pfizer, Eli Lilly, Novartis, Bristol-Myers Squibb, AbbVie, Janssen Pharmaceuticals, Boehringer Ingelheim, the Danish National Psoriasis Foundation, the Simon Spies Foundation and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as a consultant and/or speaker from Amgen, AbbVie, Almirall, Leo Pharma, Zuellig Pharma Ltd., Galápagos NV, Sun Pharmaceuticals, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly and Company, Novartis, Union Therapeutics, Galderma, Dermavant, UCB, Mylan, Bristol-Myers Squibb, McNeil Consumer Healthcare, Horizon Therapeutics, Boehringer Ingelheim and Janssen Pharmaceuticals. He is currently an employee at LEO Pharma. Jacob P. Thyssen has been an advisor for AbbVie, Almirall, Arena Pharmaceuticals, OM Pharma, Aslan Pharmaceuticals, Union Therapeutics, Eli Lilly & Co, LEO Pharma, Pfizer, Regeneron and Sanofi-Genzyme, a speaker for AbbVie, Almirall, Eli Lilly & Co, LEO Pharma, Pfizer, Regeneron and Sanofi-Genzyme, and received research grants from Pfizer, Regeneron and Sanofi-Genzyme. He is currently an employee at LEO Pharma. Nikolai Loft has been a paid speaker for Eli Lilly, Janssen Cilag and Sandoz, and received research funding from the LEO Foundation. Ethics approval: Not applicable. Consent to participate: Not applicable. Consent for publication: Not applicable. Availability of data and material: Data and material are available upon request. Code availability: The code is available upon request. Authors’ contributions: NL, DI, ATMR and M-LN had full access to all the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: NL, CGB, RC, JPT and AE. Acquisition, analysis and interpretation of data: all authors. Drafting of the manuscript: NL and ATMR. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: M-LN. Administrative, technical or material support: none. All authors read and approved the final manuscript.

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Real-World Evidence of Tralokinumab Effectiveness and Safety: A Systematic Review and Meta-analysis

Affiliations

Real-World Evidence of Tralokinumab Effectiveness and Safety: A Systematic Review and Meta-analysis

Authors

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Erratum in

Abstract

Conflict of interest statement

References

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