title: Omalizumab for the treatment of chronic spontaneous urticaria: A meta-analysis of randomized clinical trials.
abstract: Chronic spontaneous urticaria (CSU) is defined by itchy hives, angioedema, or both for at least 6 weeks. Omalizumab, an anti-IgE antibody that affects mast cell and basophil function, is a promising new treatment option. As of now, however, the efficacy and safety of different doses of omalizumab used in clinical trials for CSU have not been systematically analyzed and summarized.
  
  
  
  We sought to assess the efficacy and safety of different doses of omalizumab for the treatment of CSU in a meta-analysis of clinical trial results.
  
  
  
  Suitable trials were identified by searching PubMed, Medline, Embase, and Web of Science databases and with the help of omalizumab's manufacturers. Only double-blind, randomized, placebo-controlled studies with omalizumab-treated versus placebo-treated patients with CSU were included in this analysis.
  
  
  
  We identified 7 randomized, placebo-controlled studies with 1312 patients with CSU. Patients treated with omalizumab (75-600 mg every 4 weeks) had significantly reduced weekly itch and weekly wheal scores compared with the placebo group. Omalizumab's effects were dose dependent, with the strongest reduction in weekly itch and weekly wheal scores observed with 300 mg. Rates of complete response were significantly higher in the omalizumab group (relative risk, 4.55; P < .00001) and dose dependent, with the highest rates in the 300-mg group. Rates of patients with adverse events were similar in the omalizumab and placebo groups.
  
  
  
  This meta-analysis provides high-quality evidence for the efficacy and safety of omalizumab in patients with CSU and for treating these patients with 300 mg of omalizumab every 4 weeks.
authors.affiliation: Department of Dermatology and Venereology, First Hospital, Peking University, Beijing, China; Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Zuo-Tao
authors.initials: ZT
authors.lastname: Zhao
authors.affiliation: Research Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
authors.forename: Chun-Mei
authors.initials: CM
authors.lastname: Ji
authors.affiliation: Department of Cadre Health Care, Jiangsu Province Geriatric Institution, Jiangsu Province Official Hospital, Nanjing, China.
authors.forename: Wen-Jun
authors.initials: WJ
authors.lastname: Yu
authors.affiliation: Research Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Meng
authors.affiliation: Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Hawro
authors.affiliation: Research Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: weijifu@hotmail.com.
authors.forename: Ji-Fu
authors.initials: JF
authors.lastname: Wei
authors.affiliation: Department of Dermatology and Venereology, First Hospital, Peking University, Beijing, China; Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany. Electronic address: marcus.maurer@charite.de.
authors.forename: Marcus
authors.initials: M
authors.lastname: Maurer
mesh_terms: D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D006801:Humans; D016017:Odds Ratio; D000069444:Omalizumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017594:Publication Bias; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy*
chemical_list: D018926:Anti-Allergic Agents; D000069444:Omalizumab
keywords: CSU; Omalizumab; adverse event; meta-analysis; weekly itch score; weekly wheal score