Real-World Effectiveness and Safety of Lebrikizumab in Moderate-to- Severe Atopic Dermatitis: A Multicenter Study From Spain

Abstract

Estudio de uso clínico real de lebrikizumab en dermatitis atópica severa que incluyó 80 pacientes. Se observó una reducción rápida y profunda de los indicadores de severidad clínica, con alta tolerabilidad y seguridad.

Lebrikizumab, a high-affinity monoclonal antibody targeting interleukin-13 (IL-13), has recently been approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents by both the European Medicines Agency and the U.S. Food and Drug Administration [1]. Phase III clinical trials have demonstrated its robust efficacy and favorable safety profile [2], but real-world data on its performance in routine clinical practice remain scarce. We conducted a prospective, multicenter, observational study in Spain to evaluate the effectiveness and safety of lebrikizumab in daily clinical practice. The protocol was approved by the Ethics Committee of Hospital Universitario San Cecilio (DERM_HUSC_2024_015), and all procedures followed the Declaration of Helsinki and Good Clinical Practice guidelines, with written informed consent obtained from all participants. Eighty adults and adolescents with moderate-to-severe AD who initiated lebrikizumab between September 2024 and July 2025 were included. The mean age was 31.9±15.4 years, 55% were male, and the mean disease duration was 21.4 years. Most patients had received prior systemic therapy (86% cyclosporine, 48% dupilumab, 41% upadacitinib, 24% tralokinumab). Baseline disease severity reflected a high burden, with a mean Eczema Area and Severity Index (EASI) of 22.5, a Scoring Atopic Dermatitis (SCORAD) score of 56.7, pruritus numeric rating scale (NRS) of 7.9, and Dermatology Life Quality Index (DLQI) of 15.3. Demographic and clinical characteristics are shown in Table 1. Rapid improvement was observed by Week 4, with mean EASI decreasing to 12.4 (p<0.0001), SCORAD to 27.7, DLQI to 11.1, and pruritus NRS to 5.1. At Week 12, EASI and SCORAD continued to improve (EASI 5.0, SCORAD 16.4; p<0.0001), with 66.7% and 43.6% of patients achieving EASI75 and EASI90, respectively. By Week 24, mean EASI reached 1.0, DLQI 1.0, and pruritus NRS 1.0. All patients achieved at least EASI75, 75% EASI90, and 50% EASI100, with 83% reaching IGA 0/1 (Figure 1). No serious adverse events occurred, and lebrikizumab was well tolerated, with rare conjunctivitis and no relevant laboratory abnormalities.