Clinical and experimental dermatology · 2025
Efficacy and drug survival of tralokinumab in patients with severe atopic dermatitis: an 18-month multicentre study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Barei Francesca, Calzari Paolo, Pezzolo Elena, Napolitano Maddalena, Rossi Mariateresa, Guanti Mario Bruno, Caroppo Francesca, Belloni Fortina Anna, Patruno Cataldo, Campanati Anna, Bianchelli Tommaso, D'Agostino Giovanni Marco, Nettis Eustachio, Pugliese Francesco, Picone Vincenzo, Trave Ilaria, Cozzani Emanuele, Stingeni Luca, Hansel Katharina, Dall'Olio Matilde, Galli Benedetta, Coppola Rosa, Panasiti Vincenzo, Maurelli Martina, Girolomoni Giampiero, Ortoncelli Michela, Ribero Simone, Marzano Angelo Valerio, Ferrucci Silvia Mariel
Аннотация
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.
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.