BACKGROUND: Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody with proven efficacy in patients with moderate-to-severe and severe persistent allergic (IgE-mediated) asthma. OBJECTIVE: To review clinical study data to assess the safety profile of omalizumab. METHODS: We analysed the safety of omalizumab using data from completed clinical studies (up to 1 year) involving more than 7500 patients with asthma, rhinitis or related conditions and up to 4 years in one study of patients with severe allergic asthma, as well as post-marketing safety data. Analysis focuses on the risk of immune-system effects, hypersensitivity reactions, malignant neoplasia, parasitic infections and thrombocytopenia. RESULTS: Omalizumab exhibited a good safety and tolerability profile that was maintained up to 4 years in one study. The incidence of anaphylaxis was 0.14% in omalizumab-treated patients and 0.07% in control patients. No omalizumab-treated patient developed measurable anti-omalizumab antibodies. Post-marketing, based on estimated exposure of 57,300 patients (June 2003-December 2006), the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients. Current clinical trial data do not support an increased risk of malignant neoplasia or thrombocytopenia with omalizumab. CONCLUSION: Data indicate that the proven efficacy of add-on omalizumab in patients with moderate-to-severe or severe allergic asthma is accompanied by a favourable safety and tolerability profile.
BACKGROUND:Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody with proven efficacy in patients with moderate-to-severe and severe persistent allergic (IgE-mediated) asthma. OBJECTIVE: To review clinical study data to assess the safety profile of omalizumab. METHODS: We analysed the safety of omalizumab using data from completed clinical studies (up to 1 year) involving more than 7500 patients with asthma, rhinitis or related conditions and up to 4 years in one study of patients with severe allergic asthma, as well as post-marketing safety data. Analysis focuses on the risk of immune-system effects, hypersensitivity reactions, malignant neoplasia, parasitic infections and thrombocytopenia. RESULTS:Omalizumab exhibited a good safety and tolerability profile that was maintained up to 4 years in one study. The incidence of anaphylaxis was 0.14% in omalizumab-treatedpatients and 0.07% in control patients. No omalizumab-treatedpatient developed measurable anti-omalizumab antibodies. Post-marketing, based on estimated exposure of 57,300 patients (June 2003-December 2006), the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients. Current clinical trial data do not support an increased risk of malignant neoplasia or thrombocytopenia with omalizumab. CONCLUSION: Data indicate that the proven efficacy of add-on omalizumab in patients with moderate-to-severe or severe allergic asthma is accompanied by a favourable safety and tolerability profile.
Authors: William W Busse; Wayne J Morgan; Peter J Gergen; Herman E Mitchell; James E Gern; Andrew H Liu; Rebecca S Gruchalla; Meyer Kattan; Stephen J Teach; Jacqueline A Pongracic; James F Chmiel; Suzanne F Steinbach; Agustin Calatroni; Alkis Togias; Katherine M Thompson; Stanley J Szefler; Christine A Sorkness Journal: N Engl J Med Date: 2011-03-17 Impact factor: 91.245
Authors: Marek L Kowalski; Ignacio Ansotegui; Werner Aberer; Mona Al-Ahmad; Mubeccel Akdis; Barbara K Ballmer-Weber; Kirsten Beyer; Miguel Blanca; Simon Brown; Chaweewan Bunnag; Arnaldo Capriles Hulett; Mariana Castells; Hiok Hee Chng; Frederic De Blay; Motohiro Ebisawa; Stanley Fineman; David B K Golden; Tari Haahtela; Michael Kaliner; Connie Katelaris; Bee Wah Lee; Joanna Makowska; Ulrich Muller; Joaquim Mullol; John Oppenheimer; Hae-Sim Park; James Parkerson; Giovanni Passalacqua; Ruby Pawankar; Harald Renz; Franziska Rueff; Mario Sanchez-Borges; Joaquin Sastre; Glenis Scadding; Scott Sicherer; Pongsakorn Tantilipikorn; James Tracy; Vera van Kempen; Barbara Bohle; G Walter Canonica; Luis Caraballo; Maximiliano Gomez; Komei Ito; Erika Jensen-Jarolim; Mark Larche; Giovanni Melioli; Lars K Poulsen; Rudolf Valenta; Torsten Zuberbier Journal: World Allergy Organ J Date: 2016-10-12 Impact factor: 4.084
Authors: Michael W Handlogten; Ana P Serezani; Anthony L Sinn; Karen E Pollok; Mark H Kaplan; Basar Bilgicer Journal: J Immunol Date: 2014-01-31 Impact factor: 5.422