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 na & iuml;ve 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 na & iuml;ve to biologics or JAKi experiencing more rapid progress.We conducted a multicentre study to evaluate the drug survival and efficacy of tralokinumab for up to 18 months in 471 patients with severe atopic dermatitis (AD). The patients' Eczema Area and Severity Index (EASI), Pruritus Numerical Rating Scale, Sleep Disturbance Numerical Rating Scale, Dermatology Life Quality Index and Atopic Dermatitis Control Tool scores were recorded. A significant improvement in the evaluated scores was seen after treatment with tralokinumab, with patients na & iuml;ve to biologics or Janus kinase inhibitors experiencing more rapid progress than those who were not. Our univariate analysis showed that being a woman, having an absence of atopic comorbidities and not having a family history of AD were linked to a higher likelihood of achieving EASI-75 (an improvement in EASI of >= 75% vs. baseline). When considering discontinuation due to inefficacy, patients aged >= 60 years, women and patients with no family history of AD demonstrated significantly better survival than patients who did not exhibit these characteristics.