Marcus Maurer1, Ana Giménez-Arnau2, Jonathan A Bernstein3, Chia-Yu Chu4, Inna Danilycheva5, Michihiro Hide6, Michael Makris7, Martin Metz1, Sinisa Savic8, Karl Sitz9, Weily Soong10, Petra Staubach11, Gordon Sussman12, Avantika Barve13, Alis Burciu14, Eva Hua15, Reinhold Janocha14, Thomas Severin14. 1. Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany. 2. Dermatology Department, Hospital del Mar, IMIM Universitat Autònoma Barcelona, Barcelona, Spain. 3. University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio, USA. 4. Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan. 5. National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russia. 6. Department of Dermatology, Hiroshima University, Hiroshima, Japan. 7. Allergy Unit, 2nd Department of Dermatology and Venereology, National and Kapodistrian University, "Attikon" University Hospital, Athens, Greece. 8. 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. 9. Little Rock Allergy and Asthma Clinic, Little Rock, Arkansas, USA. 10. Alabama Allergy & Asthma Center - AllerVie Health, Clinical Research Center of Alabama, Birmingham, Alabama, USA. 11. Department of Dermatology, University Medical Center, Mainz, Germany. 12. Division of Allergy and Clinical Immunology, University of Toronto, Canada. 13. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. 14. Novartis Pharma AG, Basel, Switzerland. 15. China Novartis Institutes for Biomedical Research Co. Ltd, Shanghai, China.
Abstract
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.
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.
Authors: Ana Giménez-Arnau; Marcus Maurer; Jonathan Bernstein; Petra Staubach; Nathalie Barbier; Eva Hua; Thomas Severin; Yolandi Joubert; Reinhold Janocha; Maria-Magdalena Balp Journal: Clin Transl Allergy Date: 2022-02 Impact factor: 5.871
Authors: Robert A Wood; R Sharon Chinthrajah; Alexander Eggel; Ivan Bottoli; Aurelie Gautier; Maximilian Woisetschlaeger; Paolo Tassinari; Pablo Altman Journal: World Allergy Organ J Date: 2022-09-13 Impact factor: 5.516