Efficacy and Safety of Tralokinumab in Real Life: Possible Predictive Rapid Response Factors

Abstract:Background: Tralokinumab has been recently approved for the management of moderate-to-severe atopic dermatitis (AD). Despite its effectiveness and safety have been widely reported, there are no studies investigating factors that may affect clinical outcomes. Objective: To evaluate the effectiveness and safety of tralokinumab, also to investigate possible predictive response factors that may affect the time of onset of treatment response. Methods: A monocentric retrospective real-life study was performed enrolling AD patients undergoing treatment with tralokinumab for at least 24 weeks. AD severity was assessed at baseline and at week (W)16, and W24. Similarly, treatment-related adverse events (AEs) were evaluated at each follow-up visit. Results: A total of 57 patients were enrolled. AD severity started to improve at W4, continued to improve at W16 and W24. In our cohort, we found out that gender, age, atopic comorbidities, and previous treatments did not affect treatment outcomes. However, we observed that patients with higher Pruritus-Numerical Rating Scale (≥8), relapsing form of AD, Eczema Area and Severity Index (EASI) ≤24, and Investigator Global Assessment (IGA) ≤3 achieved more frequently EASI75 response at W16. No significant AEs were collected. Conclusions: Our study confirmed the effectiveness and safety of tralokinumab. In particular, a higher pruritus, a relapsing course of the disease, a reduced EASI, a reduced IGA, and a brief duration of the disease seem to be associated with the fastest onset of treatment effectiveness.