Real-world effectiveness and safety of tralokinumab in moderate-to-severe atopic dermatitis with malignancy, chronic infections, and multimorbidity

Introduction Patients with moderate-to-severe atopic dermatitis (AD) and significant comorbidities are frequently excluded from randomized clinical trials, limiting the applicability of evidence to these clinically complex patients. We evaluated the effectiveness and safety of tralokinumab in this setting. Methods Multicenter retrospective study including adults with moderate-to-severe AD treated with tralokinumab (300 mg every 2 weeks) in Spanish tertiary hospitals (June 2022-December 2025). Special populations included patients with malignancies, advanced cardiovascular or renal disease, chronic infections, or neurologic disorders. Outcomes included Eczema Area and Severity Index (EASI), pruritus NRS, safety events, and treatment optimization. Analyses were descriptive. Results Twenty-one patients (aged 27-90 years) with high multimorbidity burden were included. Comorbidities comprised malignancies (n = 9), advanced heart disease (n = 7), neurologic disorders (n = 4), chronic kidney disease (n = 2), latent tuberculosis (n = 2), and HIV (n = 2). Mean EASI decreased from 19.3 to 3.45 (~ 82% reduction) and pruritus Numeric Rating Scale (NRS) from 7 to 2 (~ 71% reduction) after a mean follow-up of 24.6 months. Approximately 70% achieved EASI ≤ 3 and 50% EASI 0-1. Median follow-up was 24.6 months. Dose interval extension was feasible in 33.3% of patients. No tumor progression, infection reactivation, major cardiovascular events, or severe adverse events were observed. Conclusions Tralokinumab showed sustained effectiveness and a favorable safety profile in clinically complex patients with AD. These real-world findings support IL-13 blockade as a valuable therapeutic option for multimorbid populations that are underrepresented in clinical trials.