Real-World Effectiveness and Safety of Dupilumab, Tralokinumab, and Upadacitinib in Patients with Atopic Dermatitis: A 52-Week International, Multicenter Retrospective Cohort Study
- PMID: 40459711
- PMCID: PMC12256366
- DOI: 10.1007/s13555-025-01453-8
Real-World Effectiveness and Safety of Dupilumab, Tralokinumab, and Upadacitinib in Patients with Atopic Dermatitis: A 52-Week International, Multicenter Retrospective Cohort Study
Abstract
Introduction: Evaluating the real-world effectiveness, safety, and tolerability of targeted biologic and non-biologic therapies in patients with atopic dermatitis (AD) treated in routine clinical practice remains crucial. In this international, multicenter, retrospective, comparative study we aimed to evaluate the 52-week effectiveness, safety, and tolerability of dupilumab, tralokinumab, and upadacitinib in patients with AD aged ≥ 12 years.
Methods: Effectiveness was assessed at weeks 16, 24, and 52 using Eczema Area and Severity Index (EASI) and itch Numerical Rating Scale (NRS) scores. Safety was measured via adverse events (AEs).
Results: A total of 1286 treatment courses were included: 62.5% received dupilumab, 24.3% received upadacitinib, and 13.1% received tralokinumab. Upadacitinib demonstrated higher effectiveness than dupilumab and tralokinumab across all time points and most evaluated outcomes both on the overall population and the biologic-/JAKi-naïve population, including stringent treatment targets such as EASI 90 response and combined EASI 90 + itch NRS 0/1 response. While upadacitinib demonstrated superior effectiveness, it was associated with a higher incidence of AEs, both leading to and not leading to treatment discontinuation, including thromboembolic events, lipid abnormalities, and hematologic abnormalities. In contrast, conjunctivitis was the most frequently observed AE among patients receiving biologics.
Conclusion: This study provides a comprehensive real-world comparison of dupilumab, tralokinumab, and upadacitinib in AD, highlighting upadacitinib's superior effectiveness in achieving stringent treatment targets, both in the short and long term, but also a higher incidence of AEs. However, the considerable heterogeneity of the study population, an inherent limitation of real-world studies, must be acknowledged when interpreting these findings.
Keywords: Atopic dermatitis; Dupilumab; Effectiveness; Safety; Tralokinumab; Upadacitinib.
© 2025. The Author(s).
Conflict of interest statement
Declarations. Conflicts of Interest: Tiago Torres has received consultancy and/or speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Amgen, Almirall, Amgen, Apogee Therapeutics, Arena Pharmaceuticals, Biocad, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Fresenius-Kabi, Johnson & Johnson Innovative Medicine, LEO Pharma, Eli Lilly, MSD, Mylan, Novartis, Pfizer, Samsung-Bioepis, Sanofi-Genzyme, Sandoz, STADA and UCB. Jensen Yeung has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Anacor, Apogee, Arcutis, Astellas, Bausche, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Coherus, Dermira, Forward, Fresenius Kabi, Galderma, Incyte, Janssen, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, UCB, and Xenon. Vimal H. Prajapati has been an advisor, consultant, and/or speaker for: AbbVie, Actelion, Amgen, Apogee Therapeutics, Aralez, Arcutis, Aspen, Bausch Health, BioScript Solutions, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cipher, CorEvitas, Eczema Society of Canada, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Incyte, JAMP Pharma, J&J Innovative Medicine, Janssen, Johnson & Johnson, LEO Pharma, Medexus, Novartis, Organon, Pediapharm, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, Tribute, UCB, and Valeant; investigator for: AbbVie, AnaptysBio, Apogee Therapeutics, Arcutis, Arena, Asana, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, CorEvitas, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, J&J Innovative Medicine, Janssen, LEO Pharma, Meiji Pharma, Nektar Therapeutics, Nimbus Lakshmi, Novartis, Pfizer, RAPT Therapeutics, Regeneron, Reistone, Roche, Sanofi Genzyme, Sun Pharma, Takeda, and UCB; received grants from: AbbVie, Bausch Health, Janssen, LEO Pharma, Novartis, and Sanofi Genzyme. Anna Balato has received fees from Abbvie, Almirall, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, LeoPharma, Novartis, UCB. Stefano Caccavale has received fees from Abbvie, Aristo pharma Italy srl, Novartis, Eli Lilly, Boehringer Ingelheim. Maria João Cruz has been an advisor, consultant, speaker, and/or investigator for AbbVie, Almirall, Beiersdorf, Eli Lilly, Galderma, La Roche-Posay, LEO Pharma, Novartis, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals Inc., Sanofi. Francesca Prignano served as advisory board member and consultant and has received fees and speaker’s honoraria or has participated in clinical trials for AbbVie, Almirall, Leo Pharma, Eli Lilly, Janssen, Novartis, Biogen, Sanofi Genzyme, UCB, Boehringer Ingelheim. Niccolò Gori served as advisory board member and received honoraria for lectures for AbbVie, Sanofi, and LEO Pharma. Andrea Chiricozzi has served as advisory board member and consultant and has received fees and speaker’s honoraria or has participated in clinical trials for AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Galderma, Leo Pharma, Lilly, Janssen, Novartis, Pfizer, and Sanofi Genzyme. Ketty Peris has served on advisory board, received honoraria for lectures and/or research grants for Abbvie, Almirall, Lilly, Galderma, Leo Pharma, Pierre Fabre, Novartis, Sanofi, Sun Pharma, Janssen. Simone Ribero has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, and UCB. Michela Ortoncelli has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, and UCB. Elizabeth Lazaridou has received grants and speaker’s honoraria and/or has participated in advisory meetings and clinical trials for Abbvie, Novartis, Pfizer, Sanofi, Leo Pharma, Eli Lilly, Galderma, Janssen, UCB, Amgen, Pierre Fabre, Loreal, Boehringer Ingelheim, Incyte. Angelo Valerio Marzano reports consultancy/advisory boards disease-relevant honoraria from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, Leopharma, Novartis, Pfizer, Sanofi, and UCB. Silvia Mariel Ferrucci reports consultancy/advisory boards disease-relevant honoraria from Amgen, Sanofi, Novartis, Lilly, Leo Pharma, Abbvie, Novartis, Menarini. Spyridon Gkalpakiotis has served as a consultant, speaker, or investigator for AbbVie, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi and UCB. Pedro Herranz has received grants and speaker’s honoraria and/or has participated in advisory meetings and clinical for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Regeneron, Roche, Sandoz, Sanofi Genzyme, Takeda, UCB. Antonios G.A. Kolios has served as an investigator, speaker, and/or advisor for AbbVie, Abbott, AstraZeneca, Janssen, Eli Lilly, MSD, Pfizer, Celgene, Novartis, Actelion, Leo, Amgen, Alk-Abello, UCB, and does not hold any shares or other financial interest in any pharmaceutical company. Jose-Manuel Carrascosa has received grants and speaker’s honoraria and/or has participated in advisory meetings and clinical for AbbVie, Novartis, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme, UCB. Maria João Paiva Lopes has received grants and speaker’s honoraria and/or has participated in advisory meetings and clinical AbbVie, Almirall, Boehringer Ingelheim, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sanofi-Genzyme, Viatris. José Miguel Alvarenga has nothing to disclose. Pedro Farinha has nothing to disclose. Bruno Duarte has nothing to disclose. Monica Munera-Campos has nothing to disclose. Siddhartha Sood has nothing to disclose. Brian D. Rankin has nothing to disclose. Gilberto Pires Rosa has nothing to disclose. Athina Ioanna Daponte has nothing to disclose. Gianmarco Silvi has nothing to disclose. Stamatios Gregoriou has nothing to disclose. Natalia Rompoti has nothing to disclose. Tiago Torres, Jose-Manuel Carrascosa and Stamatios Gregoriou are Editorial Board members of Dermatology and Therapy. Tiago Torres, Jose-Manuel Carrascosa and Stamatios Gregoriou were not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Ethical Approval: The present study was conducted in accordance with the Declaration of Helsinki, initially published in 1964 on Ethical Principles for Medical Research Involving Human Subjects, and after approval by the local ethical committees. Patient consent was exempted due to the retrospective nature of the study and the use of de-identified, anonymized and aggregated data.
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