Thomas B Casale1, Jonathan A Bernstein2, Marcus Maurer3, Sarbjit S Saini4, Benjamin Trzaskoma5, Hubert Chen5, Clive E Grattan6, Ana Gimenéz-Arnau7, Allen P Kaplan8, Karin Rosén9. 1. Department of Medicine, Division of Allergy and Immunology, University of South Florida, Tampa, Fla. 2. Department of Internal Medicine and Division of Immunology/Allergy Section, University of Cincinnati, Cincinnati, Ohio. 3. Department of Dermatology and Allergy, Charité-Universitätsmedizin, Berlin, Germany. 4. Division of Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center, Baltimore, Md. 5. Genentech Inc., South San Francisco, Calif. 6. Department of Dermatology, Norfolk and Norwich University Hospital, Norwich, United Kingdom. 7. Department of Dermatology, Institut Mar d'Investigacions Mediques, Universitat Autonoma, Barcelona, Spain. 8. Department of Medicine, Division of Pulmonary and Critical Care and Allergy and Clinical Immunology, The Medical University of South Carolina, Charleston, SC. 9. Genentech Inc., South San Francisco, Calif. Electronic address: rosen.karin@gene.com.
Abstract
BACKGROUND: Data from the 3 omalizumab pivotal trials in patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) represent the largest database of patients reported to date with refractory disease (omalizumab, n = 733; placebo, n = 242). OBJECTIVE: The objective of this study was to compare results from ASTERIA I and II, which included only approved doses of H1-antihistamine as background therapy based on regulatory authority requirements, to those from GLACIAL, which permitted higher doses of H1-antihistamines as well as other types of background therapy, in a post hoc analysis. METHODS: Efficacy data from the placebo, omalizumab 150-mg, and omalizumab 300-mg treatment arms of ASTERIA I and II were pooled and analyzed (n = 162 and n = 160, respectively). The 300-mg treatment arm analyses were compared with the analysis of data from GLACIAL (n = 252) using analysis of covariance models. The key efficacy endpoint was change from baseline to week 12 in mean weekly itch severity score (ISS); other endpoints were also evaluated. Safety data were pooled from all 3 studies. RESULTS:Mean ISS was significantly reduced from baseline at week 12 in the pooled ASTERIA I and II omalizumab 150- and 300-mg treatment arms and in the GLACIAL omalizumab 300-mg arm. The weekly ISS reduction magnitude at week 12 was similar between the omalizumab 300-mg groups in the ASTERIA I and II pooled and GLACIAL studies. Similar treatment effect sizes were observed across multiple endpoints. Omalizumab was well tolerated and the adverse-event profile was similar regardless of background therapy for CIU/CSU. The overall safety profile was generally consistent with omalizumab therapy in allergic asthma. CONCLUSION:Omalizumab 300 mg was safe and effective in reducing CIU/CSU symptoms regardless of background therapy.
RCT Entities:
BACKGROUND: Data from the 3 omalizumab pivotal trials in patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) represent the largest database of patients reported to date with refractory disease (omalizumab, n = 733; placebo, n = 242). OBJECTIVE: The objective of this study was to compare results from ASTERIA I and II, which included only approved doses of H1-antihistamine as background therapy based on regulatory authority requirements, to those from GLACIAL, which permitted higher doses of H1-antihistamines as well as other types of background therapy, in a post hoc analysis. METHODS: Efficacy data from the placebo, omalizumab 150-mg, and omalizumab 300-mg treatment arms of ASTERIA I and II were pooled and analyzed (n = 162 and n = 160, respectively). The 300-mg treatment arm analyses were compared with the analysis of data from GLACIAL (n = 252) using analysis of covariance models. The key efficacy endpoint was change from baseline to week 12 in mean weekly itch severity score (ISS); other endpoints were also evaluated. Safety data were pooled from all 3 studies. RESULTS: Mean ISS was significantly reduced from baseline at week 12 in the pooled ASTERIA I and II omalizumab 150- and 300-mg treatment arms and in the GLACIAL omalizumab 300-mg arm. The weekly ISS reduction magnitude at week 12 was similar between the omalizumab 300-mg groups in the ASTERIA I and II pooled and GLACIAL studies. Similar treatment effect sizes were observed across multiple endpoints. Omalizumab was well tolerated and the adverse-event profile was similar regardless of background therapy for CIU/CSU. The overall safety profile was generally consistent with omalizumab therapy in allergic asthma. CONCLUSION:Omalizumab 300 mg was safe and effective in reducing CIU/CSU symptoms regardless of background therapy.