Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one‐year extension study

  • Marcus Maurer
    Dermatological Allergology Allergie‐Centrum‐Charité Department of Dermatology and Allergy Charité – Universitätsmedizin Berlin Berlin Germany
  • Ana Giménez‐Arnau
    Dermatology Department, Hospital del Mar IMIM Universitat Autònoma Barcelona Barcelona Spain
  • Jonathan A. Bernstein
    University of Cincinnati College of Medicine and Bernstein Clinical Research Center Cincinnati Ohio USA
  • Chia‐Yu Chu
    Department of Dermatology National Taiwan University Hospital and National Taiwan University College of Medicine Taipei Taiwan
  • Inna Danilycheva
    National Research Center – Institute of Immunology Federal Medical‐Biological Agency of Russia Moscow Russia
  • Michihiro Hide
    Department of Dermatology Hiroshima University Hiroshima Japan
  • Michael Makris
    Allergy Unit 2nd Department of Dermatology and Venereology National and Kapodistrian University "Attikon” University Hospital Athens Greece
  • Martin Metz
    Dermatological Allergology Allergie‐Centrum‐Charité Department of Dermatology and Allergy Charité – Universitätsmedizin Berlin Berlin Germany
  • Sinisa Savic
    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
  • Karl Sitz
    Little Rock Allergy and Asthma Clinic Little Rock Arkansas USA
  • Weily Soong
    Alabama Allergy & Asthma Center – AllerVie Health Clinical Research Center of Alabama Birmingham Alabama USA
  • Petra Staubach
    Department of Dermatology University Medical Center Mainz Germany
  • Gordon Sussman
    Division of Allergy and Clinical Immunology University of Toronto Canada
  • Avantika Barve
    Novartis Pharmaceuticals Corporation East Hanover New Jersey USA
  • Alis Burciu
    Novartis Pharma AG Basel Switzerland
  • Eva Hua
    China Novartis Institutes for Biomedical Research Co. Ltd Shanghai China
  • Reinhold Janocha
    Novartis Pharma AG Basel Switzerland
  • Thomas Severin
    Novartis Pharma AG Basel Switzerland

抄録

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate the long‐term safety and re‐treatment efficacy of ligelizumab 240 mg in patients who completed the core study and extension study.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p><jats:p>Trial Registration: ClinicalTrials.gov Identifier: NCT02477332 and NCT02649218.</jats:p></jats:sec>

収録刊行物

  • Allergy

    Allergy 77 (7), 2175-2184, 2021-11-22

    Wiley

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