Effectiveness and safety of Omalizumab in the treatment of chronic spontaneous urticaria: Systematic review and meta-analysis

Allergol Immunopathol (Madr). 2019 Nov-Dec;47(6):515-522. doi: 10.1016/j.aller.2019.05.003. Epub 2019 Oct 11.


Introduction: Chronic spontaneous urticaria (CSU) affects approximately 1% of the population, affecting both children and adults. Omalizumab (Oma) is a therapeutic option for patients with refractory forms of CSU.

Objectives: To determine the effectiveness and safety of Oma in the treatment of CSU.

Methods: Systematic review (Cochrane Collaboration methodology) of randomized clinical trials comparing Oma to placebo in refractory CSU treatment. The search is based on MEDLINE; EMBASE, Central Cochrane Library, and LILACS. The outcomes evaluated were: control of the illness, adverse events, and quality of life.

Results: Of the 848 identified studies 13 were selected for further review and six were included in the meta-analysis. For all outcomes, high-quality evidence has confirmed that Oma is effective in the treatment of CSU. The dosage of 300mg/month achieved better results; namely a significant reduction in pruritus, papules, and urticaria activity, as well as an increase in the number of patients with a controlled condition, improvement in the quality of life and no differences in adverse events compared to the placebo.

Conclusions: High-quality evidence demonstrates that Oma is effective and safe in the treatment of CSU refractory to therapy with H1 antihistamines.

Keywords: Chronic urticaria; Omalizumab; anti-IgE; anti-IgE monoclonal antibody.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Anti-Allergic Agents / therapeutic use*
  • Chronic Urticaria / drug therapy*
  • Drug Therapy, Combination
  • Histamine H1 Antagonists / therapeutic use
  • Humans
  • Immunoglobulin E / metabolism
  • Immunotherapy / methods*
  • Omalizumab / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Treatment Outcome


  • Anti-Allergic Agents
  • Histamine H1 Antagonists
  • Omalizumab
  • Immunoglobulin E