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Inicio Allergologia et Immunopathologia Effectiveness and safety of Omalizumab in the treatment of chronic spontaneous u...
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Vol. 47. Issue 6.
Pages 515-522 (November - December 2019)
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Vol. 47. Issue 6.
Pages 515-522 (November - December 2019)
Original Article
DOI: 10.1016/j.aller.2019.05.003
Effectiveness and safety of Omalizumab in the treatment of chronic spontaneous urticaria: Systematic review and meta-analysis
N.P.M. Rubinia, L.F.C. Ensinab, E.M.K. Silvac, F. Sanod, D. Solée,
Corresponding author

Corresponding author at: Rua dos Otonis 725, Vila Clementino, São Paulo 04025-002, SP, Brazil.
a School of Medicine and Surgery, Federal University of the State of Rio de Janeiro (UNIRIO), Rio de Janeiro, Brazil
b Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Escola Paulista de Medicina, Federal University of São Paulo (EPM-UNIFESP), São Paulo, Brazil
c Division of Emergency and Evidence Based Medicine, EPM-UNIFESP and Researcher of Cochrane Center of Brazil, São Paulo, Brazil
d Nipo-Brazilian Hospital, São Paulo, Brazil
e Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, EPM-UNIFESP, São Paulo, Brazil
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Tables (2)
Table 1. Characteristics of the studies included in the meta-analysis.
Table 2. Summary of the meta-analyses of Omalizumab 300mg in the treatment of Chronic Spontaneous Urticaria.
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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.


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


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.


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.


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

anti-IgE monoclonal antibody
Chronic urticaria


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