| アブストラクト | 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. |
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| 投稿者 | Maurer, Marcus; Gimenez-Arnau, Ana; Bernstein, Jonathan A; Chu, Chia-Yu; Danilycheva, Inna; Hide, Michihiro; Makris, Michael; Metz, Martin; Savic, Sinisa; Sitz, Karl; Soong, Weily; Staubach, Petra; Sussman, Gordon; Barve, Avantika; Burciu, Alis; Hua, Eva; Janocha, Reinhold; Severin, Thomas |
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| 組織名 | Dermatological Allergology, Allergie-Centrum-Charite, Department of Dermatology;and Allergy, Charite - Universitatsmedizin Berlin, Berlin, Germany.;Dermatology Department, Hospital del Mar, IMIM Universitat Autonoma Barcelona,;Barcelona, Spain.;University of Cincinnati College of Medicine and Bernstein Clinical Research;Center, Cincinnati, Ohio, USA.;Department of Dermatology, National Taiwan University Hospital and National;Taiwan University College of Medicine, Taipei, Taiwan.;National Research Center - Institute of Immunology Federal Medical-Biological;Agency of Russia, Moscow, Russia.;Department of Dermatology, Hiroshima University, Hiroshima, Japan.;Allergy Unit, 2nd Department of Dermatology and Venereology, National and;Kapodistrian University, "Attikon" University Hospital, Athens, Greece.;Leeds Biomedical Research Centre, Department of Clinical Immunology and Allergy,;Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), St James's;University Hospital, Leeds, UK.;Little Rock Allergy and Asthma Clinic, Little Rock, Arkansas, USA.;Alabama Allergy & Asthma Center - AllerVie Health, Clinical Research Center of;Alabama, Birmingham, Alabama, USA.;Department of Dermatology, University Medical Center, Mainz, Germany.;Division of Allergy and Clinical Immunology, University of Toronto, Canada.;Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.;Novartis Pharma AG, Basel, Switzerland.;China Novartis Institutes for Biomedical Research Co. Ltd, Shanghai, China. |
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