Maurer, MarcusGiménez Arnau, Anna MariaBernstein, Jonathan A.Chu, Chia-YuDanilycheva, InnaHide, MichihiroMakris, MichaelMetz, MartinSavic, SinisaSitz, KarlSoong, WeilyStaubach, PetraSussman, GordonBarve, AvantikaBurciu, AlisHua, EvaJanocha, ReinholdSeverin, Thomas2022-07-152022-07-152022Maurer M, Giménez-Arnau A, Bernstein JA, Chu CY, Danilycheva I, Hide M, et al. Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: a one-year extension study. Allergy. 2022 Jul; 77(7): 2175-84. DOI: 10.1111/all.151750105-4538http://hdl.handle.net/10230/53747Background: Ligelizumab, a next-generation, humanized anti-immunoglobulin E (IgE) monoclonal antibody is in development as a treatment for patients with chronic spontaneous urticaria, whose symptoms are inadequately controlled with standard-of-care therapy. Objective: To evaluate the long-term safety and re-treatment efficacy of ligelizumab 240 mg in patients who completed the core study and extension study. Methods: this open-label, single-arm, long-term Phase 2b extension study was designed to assess patients who were previously administered various doses of ligelizumab, omalizumab or placebo in the Phase 2b, dose-finding core study and who presented with active disease after Week 32. In the extension study, patients received ligelizumab 240 mg subcutaneously every 4 weeks, for 52 weeks and were monitored post-treatment for 48 weeks. Results: overall, ligelizumab was well-tolerated with no newly identified safety signals. A total of 95.4% (226/237) screened patients received ligelizumab 240 mg in the extension study; 84.1% (190/226) of patients experienced at least one treatment-emergent adverse event. Most reported events were mild (41.6%) or moderate (35.8%) and mostly unrelated to the study treatment. At Week 12, 46.5% of patients had a complete response increasing to 53.1% after 52 weeks. Following 52 weeks of extension study treatment, 75.8% (95% confidence interval, 69.9, 81.3) of patients had cumulative complete responses. The median time to relapse in complete responders was 38 weeks. Conclusion: the long-term safety profile of ligelizumab 240 mg in patients with chronic spontaneous urticaria was consistent with the core study and re-treatment efficacy was shown.application/pdfengThis is an open access article under the terms of the Creative Commo ns Attribution-NonCo mmercial License, http://creativecommons.org/licenses/by-nc/4.0/, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.© 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.info:eu-repo/semantics/articlehttp://dx.doi.org/10.1111/all.15175IgEChronic spontaneous urticariaLigelizumabOmalizumabUrticariainfo:eu-repo/semantics/openAccess