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Multicenter Study
. 2025 Jun 25;50(7):1373-1384.
doi: 10.1093/ced/llaf062.

Efficacy and drug survival of tralokinumab in patients with severe atopic dermatitis: an 18-month multicentre study

Francesca Barei  1 , Paolo Calzari, Elena Pezzolo, Maddalena Napolitano, Mariateresa Rossi, Mario Bruno Guanti, Francesca Caroppo, Anna Belloni Fortina, Cataldo Patruno, Anna Campanati, Tommaso Bianchelli, Giovanni Marco D'Agostino, Eustachio Nettis, Francesco Pugliese, Vincenzo Picone, Ilaria Trave, Emanuele Cozzani, Luca Stingeni, Katharina Hansel, Matilde Dall'Olio, Benedetta Galli, Rosa Coppola, Vincenzo Panasiti, Martina Maurelli, Giampiero Girolomoni, Michela Ortoncelli, Simone Ribero, Angelo Valerio Marzano  1 , Silvia Mariel Ferrucci  1
Affiliations
Multicenter Study

Efficacy and drug survival of tralokinumab in patients with severe atopic dermatitis: an 18-month multicentre study

Francesca Barei et al. Clin Exp Dermatol. .

Abstract

Background: Tralokinumab has demonstrated efficacy in the treatment of atopic dermatitis (AD) in clinical trials and real-world settings. However, there are limited data regarding the long-term use of tralokinumab in real-world settings. Here, we report the findings of a multicentre Italian study conducted to address this knowledge gap.

Objectives: To evaluate the drug survival and efficacy of tralokinumab for up to 18 months in 471 patients with severe AD.

Methods: Eczema Area and Severity Index (EASI), Pruritus Numerical Rating Scale, Sleep Disturbance NRS, Dermatology Life Quality Index and Atopic Dermatitis Control Tool (ADCT) scores were recorded for up to 18 months in patients with AD treated with tralokinumab. Drug survival was analysed using the Kaplan-Meier method.

Results: The overall drug survival rate was 81.5% at 12 months. A statistically significantly higher rate of drug survival was found in women (P = 0.006, log-rank = 7.49), in patients with no family history of AD (P = 0.02, log-rank = 5.96) and in patients aged ≥ 60 years (P = 0.02; log-rank = 5.6), when considering drug survival due to inefficacy. We found a significant reduction in the clinical scores evaluated, with patients naïve to biologics or Janus kinase inhibitors (JAKi) showing more rapid improvement. In univariate regression analysis, the following characteristics were associated with an increased likelihood of achieving EASI-75 (≥ 75% improvement in EASI vs. baseline): being a woman [odds ratio (OR) 1.61, 95% confidence interval (CI) 1.03-2.53; P = 0.04], having no atopic comorbidities (OR 1.69, 95% CI 1.03-2.78; P = 0.04), having no family history of AD (OR 1.67, 95% CI 1.05-2.65; P = 0.01) and having received no concomitant systemic treatment in the previous 12 months (OR 22.07, 95% CI 2.80-173.69; P = 0.003). In multivariate analysis, only a lack of concomitant systemic treatment in the previous 12 months remained statistically significant (OR 23.04, 95% CI 2.79-190.05; P = 0.004).

Conclusions: Significant improvements in clinical scores were found in patients with AD treated with tralokinumab, with patients naïve to biologics or JAKi experiencing more rapid progress.

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Conflict of interest statement

Conflicts of interest: S.F. is principal investigator in clinical trials for Amgen, Sanofi, Novartis, Lilly, LEO Pharma and AbbVie; and she is an advisory board member or speaker for Novartis, Menarini, Sanofi, AbbVie and LEO Pharma. F.B. has received honoraria from LEO Pharma. M.B.G. has received honoraria from LEO Pharma, AbbVie, Sanofi, Menarini, Novartis, Cantabria, Lilly and Pfizer. I.T. has received honoraria from AbbVie, LEO Pharma, Galderma and Novartis. E.C. has received honoraria from Eli Lilly. M.R. has served as a speaker and consultant for AbbVie, Sanofi, LEO Pharma, Pfizer, L’Oréal and Almirall. E.N. has received grants from Sanofi, AbbVie, LEO Pharma, GSK and AstraZeneca. E.P. has been a consultant and speaker for Sanofi, LEO Pharma, AbbVie, Pfizer, Novartis, Galderma, Janssen, Almirall and Boehringer Ingelheim. F.C. has received honoraria from Sanofi, LEO Pharma, Amgen, Novartis and AbbVie. A.B.F. has received honoraria from Sanofi, LEO Pharma, Amgen, Novartis, AbbVie, Eli Lilly, Unifarco and Almirall. G.G. has received personal fees from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, LEO Pharma, Merck Serono, Novartis, Pfizer, Pierre Fabre, Samsung Bioepis and Sanofi. S.R. has received honoraria from Sanofi, AbbVie, Almirall, UCB, Novartis, LEO Pharma and Eli Lilly. A.V.M. reports consultancy/advisory board disease-relevant honoraria from AbbVie, Boehringer Ingelheim, Novartis, Pfizer, Sanofi and UCB. C.P. has conflicts of interest with AbbVie, Almirall, Amgen, Galderma, La Roche-Posay, Leo Pharma, Lilly, Novartis, Pfizer, Pierre Fabre and Sanofi. M.N. reports consulting fees from AbbVie, Lilly, LEO Pharma, Almirall, Sanofi, Regeneron and Pfizer; payment/honoraria from AbbVie, Lilly, LEO Pharma, Almirall, Sanofi and Pfizer, and participation on the Data Safety Monitoring Boards/Advisory Boards from Lilly, Sanofi, LEO Pharma, AbbVie and Almirall, and support for attending meetings/travel from Lilly, Sanofi and Abbvie. K.H. has been speaker or has participated to advisory boards for AbbVie, Almirall, Amgen, Bristol-Meyer Squibb, Eli Lilly, LeoPharma, Novartis, Sanofi and UCB. L.S. acted as a speaker or investigator for AbbVie, Almirall, Amgen, Bristol-Meyer Squibb, Eli Lilly, Janssen, Leo Pharma, Novartis and Sanofi. The other authors declare no conflicts of interest.

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