TY - JOUR
TI - Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study
AU - Maurer, M.
AU - Giménez-Arnau, A.
AU - Bernstein, J.A.
AU - Chu, C.-Y.
AU - Danilycheva, I.
AU - Hide, M.
AU - Makris, M.
AU - Metz, M.
AU - Savic, S.
AU - Sitz, K.
AU - Soong, W.
AU - Staubach, P.
AU - Sussman, G.
AU - Barve, A.
AU - Burciu, A.
AU - Hua, E.
AU - Janocha, R.
AU - Severin, T.
JO - Allergy: European Journal of Allergy and Clinical Immunology
PY - 2021
VL - null
TODO - null
SP - null
PB - John Wiley and Sons Inc
SN - null
TODO - 10.1111/all.15175
TODO - null
TODO - Background: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02477332 and NCT02649218. © 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
ER -