Francesca Barei, 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, Silvia Mariel Ferrucci
{"title":"曲洛单抗治疗严重特应性皮炎的疗效和药物生存期:一项18个月的多中心研究","authors":"Francesca Barei, 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, Silvia Mariel Ferrucci","doi":"10.1093/ced/llaf062","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>To evaluate the drug survival and efficacy of tralokinumab for up to 18 months in 471 patients with severe AD.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":10324,"journal":{"name":"Clinical and Experimental Dermatology","volume":" ","pages":"1373-1384"},"PeriodicalIF":2.8000,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and drug survival of tralokinumab in patients with severe atopic dermatitis: an 18-month multicentre study.\",\"authors\":\"Francesca Barei, 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, Silvia Mariel Ferrucci\",\"doi\":\"10.1093/ced/llaf062\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>To evaluate the drug survival and efficacy of tralokinumab for up to 18 months in 471 patients with severe AD.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":10324,\"journal\":{\"name\":\"Clinical and Experimental Dermatology\",\"volume\":\" \",\"pages\":\"1373-1384\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-06-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Experimental Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ced/llaf062\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Experimental Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ced/llaf062","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Efficacy and drug survival of tralokinumab in patients with severe atopic dermatitis: an 18-month multicentre study.
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.
期刊介绍:
Clinical and Experimental Dermatology (CED) is a unique provider of relevant and educational material for practising clinicians and dermatological researchers. We support continuing professional development (CPD) of dermatology specialists to advance the understanding, management and treatment of skin disease in order to improve patient outcomes.