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. 2025 May;15(5):1251-1257.
doi: 10.1007/s13555-025-01405-2. Epub 2025 Apr 15.

Long-Term Efficacy and Potential Predictors of Tralokinumab Dose Optimization in Elderly Patients: A Multicentre Study

Francisco Javier Melgosa Ramos  1   2 , Sergio Santos Alarcón  3 , Jose María Sánchez Motilla  4 , Pedro Mercader  5
Affiliations

Long-Term Efficacy and Potential Predictors of Tralokinumab Dose Optimization in Elderly Patients: A Multicentre Study

Francisco Javier Melgosa Ramos et al. Dermatol Ther (Heidelb). 2025 May.

Abstract

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease that significantly affects elderly patients, particularly those with multiple comorbidities. Tralokinumab, an IL- 13-neutralizing monoclonal antibody, is approved at 300 mg every 2 weeks (Q2 W), with the option to optimize to a once-monthly (Q4 W) regimen in patients achieving optimal disease control. This study evaluates its long-term efficacy and safety in elderly patients (> 65 years) and explores predictors of treatment response and optimization.

Methods: A retrospective multicenter study was conducted across four Spanish hospitals, including patients > 65 years old with moderate-to-severe AD treated with tralokinumab. The primary endpoints were treatment efficacy and safety at weeks 16, 24, and 52, while secondary endpoints included identifying predictors of treatment response and successful dose optimization.

Results: A total of 24 patients (mean age 75.3 ± 8.4 years, 45.8% male) were included. A significant reduction in EASI (Eczema Area and Severity Index), Pruritus NRS (Numerical Rating Scale), DLQI (Dermatology Life Quality Index), and BSA (Body Surface Area) scores was observed at weeks 16, 24, and 52 (p < 0.05). Dose optimization to 300 mg Q4 W was achieved in 25% of patients. Male sex (p = 0.042) and higher baseline EASI (p = 0.004) were associated with poorer early response, whereas a shorter time to systemic treatment initiation (p = 0.023) increased the likelihood of dose optimization. No serious adverse events or neoplasm progression were reported.

Conclusion: Tralokinumab demonstrated sustained efficacy and safety in elderly patients with moderate-to-severe AD, even with multiple comorbidities. Dose optimization to Q4 W was feasible in a subset of patients. Early systemic treatment initiation was linked to better outcomes, emphasizing the need for proactive disease management.

Keywords: Atopic dermatitis; Elderly patients; Optimization; Tralokinumab.

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Conflict of interest statement

Declarations. Conflict of Interest: Francisco Javier Melgosa Ramos has received honoraria and/or travel grants and/or has acted as an advisory board member for Novartis, Abbvie, Janssen Cilag, UCB, Lilly, LEO Pharma, L’Oreal, Sanofi, Almirall, and Amgen. Sergio Santos Alarcón has received honoraria and/or travel grants and/or has acted as an advisory board member for Almirall, Abbvie, Adium Pharma, Amgen, Pfizer, Novartis, Janssen-Cilag, Lilly, Leo Pharma, UCB Pharma, Pierre Fabre, Isdin, Sanofi, and Viñas. Jose María Sánchez Motilla has received honoraria and/or travel grants and/or has acted as an advisory board member for Sanofi, Leo Pharma, Abbie, Pfizer, Lilly, Almirall, and Novartis. Pedro Mercader has received honoraria and/or travel grants and/or has acted as an advisory board member for Sanofi, Leo Pharma, Lilly, Almirall, and Abbvie. Ethical Approval: The study was conducted in compliance with national regulations and ethical principles governing biomedical research in Spain. According to the national legislation (Law 14/2007 on Biomedical Research and the EU General Data Protection Regulation [GDPR] 2016/679), research involving anonymized data may be exempt from requiring Institutional Review Board (IRB) approval. In this case, due to the full anonymization of the data, an exemption was granted in accordance with the applicable regulations. The patient in this manuscript has given informed consent to the publication of their case details.

Figures

Fig. 1
Fig. 1
Comorbidity profile of the patients
Fig. 2
Fig. 2
Tralokinumab effectiveness during the follow-up period
See this image and copyright information in PMC

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