33583 Patients treated with ligelizumab achieve freedom from signs and symptoms of chronic spontaneous urticaria regardless of the angioedema status at baseline

Introduction: Presence of angioedema is an indicator of more severe disease in patients with chronic spontaneous urticaria. From the Phase-2b study data, we assess the effect of ligelizumab (a next-generation anti-IgE antibody) and omalizumab in subsets of patients, with or without angioedema at baseline. Methods: In this post hoc analysis, data across timepoints (ligelizumab 72 mg, 240 mg, and omalizumab 300 mg) from the multicenter, randomized, double-blind, active, and placebo-controlled Phase-2b study were analyzed. The proportion of patients without hives or itch (weekly Urticaria Activity Score [UAS7 = 0]) was assessed in the ligelizumab and omalizumab arms within patient subgroups stratified by angioedema status at baseline (with or without angioedema). Results: Baseline UAS7 (mean ± standard deviation) was similar for patients with or without angioedema across treatment groups: 33.1 ± 6.7 [N = 43] vs 30.2 ± 7.8 [N = 41], 29.8 ± 7.5 [N = 46] vs 30.9 ± 7.1 [N = 39] and 30.2 ± 8.5 [N = 48] vs 28.1 ± 7.0 [N = 37] for ligelizumab 72 mg, 240 mg, and omalizumab, respectively. At Week 12 (the primary efficacy endpoint), the proportion of patients on ligelizumab with UAS7 = 0 was numerically greater vs omalizumab in both subgroups (with angioedema: ligelizumab 72 mg and 240 mg vs omalizumab 48.8% and 41.3%, vs 27.1%, respectively; without angioedema: 39.0% and 38.5% vs 24.3%, respectively). The odds ratios (95% confidence interval) for UAS7 = 0 response for ligelizumab 72 mg and 240 mg vs omalizumab were 2.35 (0.98–5.65) and 1.85 (0.77–4.41) for patients with angioedema vs 2.03 (0.76–5.40) and 1.91 (0.71–5.13) for patients without angioedema, respectively. Conclusion: In this Phase-2b study, patients receiving ligelizumab showed a trend indicating a higher likelihood of achieving complete response vs omalizumab, independent of their baseline angioedema status.