Pediatric Allergy and Immunology
ORIGINAL ARTICLE
Asthma
Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents Gustavo J. Rodrigo1 & Hugo Neffen2 1
Departamento de Emergencia, Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay; 2Unidad de Medicina Respiratoria, Hospital de ~os ‘O. Allassia’, Santa Fe, Argentina Nin
To cite this article: Rodrigo GJ, Neffen H. Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents. Pediatr Allergy Immunol 2015: 26: 551–556.
Keywords asthma; children; efficacy; omalizumab; safety Correspondence Gustavo J. Rodrigo, Departamento de Emergencia, Hospital Central de las Fuerzas Armadas. Av. 8 de Octubre 3020, Montevideo 11600, Uruguay Tel.: (5982) 708-2354 Fax: (5982) 900-6313 E-mail: [email protected] Accepted for publication 7 May 2015 DOI:10.1111/pai.12405
Abstract Background: There are less data on omalizumab treatment in pediatric asthma than in adult population. Thus, to establish the efficacy and safety of subcutaneous omalizumab as an add-on therapy, a systematic review of placebo-controlled studies was performed. Methods: Primary outcome was the frequency of asthma exacerbations. Secondary outcomes included spirometric measures, rescue medication use, asthma symptoms, health-related quality of life, and adverse events. Results: Three randomized controlled trials (1381 participants) fulfilled the selection criteria. During the stable phase, omalizumab decreased the number of patients with at least one significant asthma exacerbation (26.7% vs. 40.6%, NNTB = 7, 95% CI, 5, 11). The predefined post hoc subgroup analysis showed that duration of treatment did not influence this result. During the steroid reduction phase, omalizumab reduced the number of patients with at least one exacerbation (RR = 0.48, 95% CI, 0.38, 0.61; NNTB = 6, 95% CI, 4, 8) and also the mean number of asthma exacerbations per patient (MD = 0.44, 95% CI, 0.72, 0.17) when compared to placebo. The frequency of serious adverse events was similar between omalizumab (5.2%) and placebo (5.6%), and there were no evidence of increased risk of hypersensitivity reactions, nor malignant neoplasms. Conclusions: Data indicate that the efficacy of an add-on omalizumab in patients with moderate-to-severe allergic asthma uncontrolled with recommended inhaled steroid treatment is accompanied by an acceptable safety profile.
Omalizumab is the first anti-immunoglobulin E (anti-IgE) recombinant humanized monoclonal antibody that binds to the Fc portion of the free IgE inhibiting the binding of IgE to highaffinity IgE receptors, thus interfering with cell activation and mediator release. This molecule also downregulates the expression of high-affinity IgE receptors (FCeRI) on mast cells and basophils (1, 2). Different regulatory agencies have approved omalizumab as an add-on therapy for uncontrolled persistent allergic asthma with recommended inhaled steroid treatment, with specific indications. Thus, the Food and Drug Administration (FDA) has licensed its use in adults and adolescents (≥12 years of age) with moderate-to-severe persistent asthma who have either a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids (3). On the other hand, the European
Medicines Agency authorized omalizumab plus a long-acting inhaled beta2-agonist (LABA), in children at least 6 years of age and above, with allergic asthma (positive skin test) and frequent severe exacerbations, in spite of treatment with high doses of inhaled corticosteroids (ICS) (4). This group should also have reduced lung function tests (
ORIGINAL ARTICLE
Asthma
Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents Gustavo J. Rodrigo1 & Hugo Neffen2 1
Departamento de Emergencia, Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay; 2Unidad de Medicina Respiratoria, Hospital de ~os ‘O. Allassia’, Santa Fe, Argentina Nin
To cite this article: Rodrigo GJ, Neffen H. Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents. Pediatr Allergy Immunol 2015: 26: 551–556.
Keywords asthma; children; efficacy; omalizumab; safety Correspondence Gustavo J. Rodrigo, Departamento de Emergencia, Hospital Central de las Fuerzas Armadas. Av. 8 de Octubre 3020, Montevideo 11600, Uruguay Tel.: (5982) 708-2354 Fax: (5982) 900-6313 E-mail: [email protected] Accepted for publication 7 May 2015 DOI:10.1111/pai.12405
Abstract Background: There are less data on omalizumab treatment in pediatric asthma than in adult population. Thus, to establish the efficacy and safety of subcutaneous omalizumab as an add-on therapy, a systematic review of placebo-controlled studies was performed. Methods: Primary outcome was the frequency of asthma exacerbations. Secondary outcomes included spirometric measures, rescue medication use, asthma symptoms, health-related quality of life, and adverse events. Results: Three randomized controlled trials (1381 participants) fulfilled the selection criteria. During the stable phase, omalizumab decreased the number of patients with at least one significant asthma exacerbation (26.7% vs. 40.6%, NNTB = 7, 95% CI, 5, 11). The predefined post hoc subgroup analysis showed that duration of treatment did not influence this result. During the steroid reduction phase, omalizumab reduced the number of patients with at least one exacerbation (RR = 0.48, 95% CI, 0.38, 0.61; NNTB = 6, 95% CI, 4, 8) and also the mean number of asthma exacerbations per patient (MD = 0.44, 95% CI, 0.72, 0.17) when compared to placebo. The frequency of serious adverse events was similar between omalizumab (5.2%) and placebo (5.6%), and there were no evidence of increased risk of hypersensitivity reactions, nor malignant neoplasms. Conclusions: Data indicate that the efficacy of an add-on omalizumab in patients with moderate-to-severe allergic asthma uncontrolled with recommended inhaled steroid treatment is accompanied by an acceptable safety profile.
Omalizumab is the first anti-immunoglobulin E (anti-IgE) recombinant humanized monoclonal antibody that binds to the Fc portion of the free IgE inhibiting the binding of IgE to highaffinity IgE receptors, thus interfering with cell activation and mediator release. This molecule also downregulates the expression of high-affinity IgE receptors (FCeRI) on mast cells and basophils (1, 2). Different regulatory agencies have approved omalizumab as an add-on therapy for uncontrolled persistent allergic asthma with recommended inhaled steroid treatment, with specific indications. Thus, the Food and Drug Administration (FDA) has licensed its use in adults and adolescents (≥12 years of age) with moderate-to-severe persistent asthma who have either a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids (3). On the other hand, the European
Medicines Agency authorized omalizumab plus a long-acting inhaled beta2-agonist (LABA), in children at least 6 years of age and above, with allergic asthma (positive skin test) and frequent severe exacerbations, in spite of treatment with high doses of inhaled corticosteroids (ICS) (4). This group should also have reduced lung function tests (
