Background: Tralokinumab has demonstrated efficacy in the treatment atopic dermatitis (AD) in both clinical trials and real-world settings. However, limited data exists on the long-term use of tralokinumab in real-world settings. Objective: A multicentric Italian study, evaluating tralokinumab's drug survival (DS) and efficacy up to 18 months of treatment among 471 patients with severe AD was conducted. Methods: EASI (Eczema Area and Severity Index), P-NRS (Pruritus Numerical Rating Scale), SD-NRS (Sleep Disturbance NRS), DLQI (Dermatology Life Quality Index) and ADCT (Atopic Dermatitis Control Tool) were recorded up to 18 months of treatment. DS was analyzed using Kaplan-Meier methodic. Results: Overall DS rate was 81.5% at 12 months. A significant higher DS was found for females (p<0.001, log-rank=11.90), patients with negative family history (FH) of AD (p=0.015, log-rank=5.96) and patients ≥60-year-old (p=0.018; log-rank=5.6) when considering DS due to inefficacy. The study demonstrates a significant reduction in the clinical scores evaluated, with patients naïve to biologics or Janus kinase inhibitors (JAKi) showing a faster improvement. In the univariate regression analysis, females (p=0.038, OR=1.613; C.I. 1.026-2.534), having no atopic comorbidity (p=0.039; OR=1.692; C.I. 1.027-2.783), negative FH of AD (p=0.031; OR=1.665; C.I. 1.047-2.649) and not using concomitant systemic treatment in the previous months (p=0.003; OR=22.065; C.I. 2.803-173.691) were associated with an increased likelihood of reaching EASI-75. In the multivariate analysis, only the latter variable remained significant (p=0.004, OR=23.037, C.I. 2.793-190.052). Conclusion: A significant improvement in clinical scores was observed, with patients naïve to biologics or JAKi experiencing faster progress. Female sex, absence of atopic comorbidities, and a negative FH of AD were linked to a higher likelihood of achieving EASI-75 in the univariate analysis but lost significance in the multivariate analysis. For discontinuation due to inefficacy, patients aged 60 and older, females, and those with a negative FH of AD had significantly better survival rates.
Efficacy and Drug Survival of Tralokinumab in Severe Atopic Dermatitis: An 18-Month Multicenter Experience
Stingeni, LucaConceptualization
;Hansel, KatharinaConceptualization
;Coppola, Rosa;
2025
Abstract
Background: Tralokinumab has demonstrated efficacy in the treatment atopic dermatitis (AD) in both clinical trials and real-world settings. However, limited data exists on the long-term use of tralokinumab in real-world settings. Objective: A multicentric Italian study, evaluating tralokinumab's drug survival (DS) and efficacy up to 18 months of treatment among 471 patients with severe AD was conducted. Methods: EASI (Eczema Area and Severity Index), P-NRS (Pruritus Numerical Rating Scale), SD-NRS (Sleep Disturbance NRS), DLQI (Dermatology Life Quality Index) and ADCT (Atopic Dermatitis Control Tool) were recorded up to 18 months of treatment. DS was analyzed using Kaplan-Meier methodic. Results: Overall DS rate was 81.5% at 12 months. A significant higher DS was found for females (p<0.001, log-rank=11.90), patients with negative family history (FH) of AD (p=0.015, log-rank=5.96) and patients ≥60-year-old (p=0.018; log-rank=5.6) when considering DS due to inefficacy. The study demonstrates a significant reduction in the clinical scores evaluated, with patients naïve to biologics or Janus kinase inhibitors (JAKi) showing a faster improvement. In the univariate regression analysis, females (p=0.038, OR=1.613; C.I. 1.026-2.534), having no atopic comorbidity (p=0.039; OR=1.692; C.I. 1.027-2.783), negative FH of AD (p=0.031; OR=1.665; C.I. 1.047-2.649) and not using concomitant systemic treatment in the previous months (p=0.003; OR=22.065; C.I. 2.803-173.691) were associated with an increased likelihood of reaching EASI-75. In the multivariate analysis, only the latter variable remained significant (p=0.004, OR=23.037, C.I. 2.793-190.052). Conclusion: A significant improvement in clinical scores was observed, with patients naïve to biologics or JAKi experiencing faster progress. Female sex, absence of atopic comorbidities, and a negative FH of AD were linked to a higher likelihood of achieving EASI-75 in the univariate analysis but lost significance in the multivariate analysis. For discontinuation due to inefficacy, patients aged 60 and older, females, and those with a negative FH of AD had significantly better survival rates.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
