Efficacy and safety of omalizumab in children and adolescents with moderate-to-severe asthma: A systematic literature review

Corren, Jonathan; Kavati, Abhishek; Ortiz, Benjamin; Colby, Jennifer; Ruiz, Kimberly; Maiese, B.A.; Cadarette, Sarah M; Panettieri, Reynold A.

doi:10.2500/aap.2017.38.4067

Cited by 53 publications

(44 citation statements)

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“…Similar to results reported by this SR, all previous systematic reviews evaluating benralizumab, dupilumab and omalizumab efficacy and safety in adolescent/adults with allergic severe asthma reported a reduction of approximately half of annualized exacerbations in the population . The reduction in the exacerbation rates reported by the previous systematic reviews that evaluated omalizumab in children 6‐11 years old was also very similar . Aligned with the current results the systematic review that evaluated asthma control and quality of life in adolescent/adults population for omalizumab reported an improvement on these outcomes.…”

Section: Discussionsupporting

confidence: 84%

Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: A systematic review for the EAACI Guidelines ‐ recommendations on the use of biologicals in severe asthma

Agache

Rocha

Beltrán

et al. 2020

Allergy

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102

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Allergic asthma is a frequent asthma phenotype. Both IgE and type 2 cytokines are increased, with some degree of overlap with other phenotypes. Systematic reviews assessed the efficacy and safety of benralizumab, dupilumab and omalizumab (alphabetical order) vs standard of care for patients with uncontrolled severe allergic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthmarelated outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE. All three biologicals reduced with high certainty the annualized asthma exacerbation rate: benralizumab incidence rate ratios (IRR) 0.63 (95% CI 0.50 − 0.81); dupilumab IRR 0.58 (95%CI 0.47 − 0.73); and omalizumab IRR 0.56 (95%CI 0.42 − 0.73). Benralizumab and dupilumab improved asthma control with high certainty and omalizumab with moderate certainty; however, none reached the minimal important difference (MID). Both benralizumab and omalizumab improved QoL with high certainty, but only omalizumab reached the MID. Omalizumab enabled ICS dose reduction with high certainty. Benralizumab and omalizumab showed an increase in drug-related adverse events (AEs) with low to moderate certainty. All three biologicals had moderate certainty for an ICER/QALY value above the willingness to pay threshold. There was high certainty that in children 6-12 years old omalizumab decreased the annualized exacerbation rate [IRR 0.57 (95%CI 0.45-0.72)], improved QoL [relative risk 1.43 (95%CI 1.12 −1.83)], reduced ICS [mean difference (MD) −0.45 (95% CI −0.58 to −0.32)] and rescue medication use [ MD −0.41 (95%CI −0.66 to −0.15)]. K E Y W O R D S benralizumab, dupilumab, exacerbations, omalizumabsevere allergic asthma | 1045 AGACHE Et Al.

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Section: Discussionsupporting

confidence: 84%

Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: A systematic review for the EAACI Guidelines ‐ recommendations on the use of biologicals in severe asthma

Agache

Rocha

Beltrán

et al. 2020

Allergy

Self Cite

102

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“…Also, there is reason to suppose that antieosinophil strategies may be deleterious in children, given the role of the eosinophil in immune homeostasis [74]. There are extensive paediatric data on efficacy and safety of the anti-IgE monoclonal omalizumab [75][76][77], so there should be no reason not to replicate these studies for other anti-IL-5 strategies, in the absence of a reliable biomarker of efficacy. In summary, it is essential to perform paediatric trials of these new agents that evaluate the impact of these treatments on development and long-term outcomes, and also to pursue research into biomarkers of efficacy [78].…”

Section: Conditional Lowmentioning

confidence: 99%

Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline

et al. 2019

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This document provides clinical recommendations for the management of severe asthma. Comprehensive evidence syntheses, including meta-analyses, were performed to summarise all available evidence relevant to the European Respiratory Society/American Thoracic Society Task Force's questions. The evidence was appraised using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and the results were summarised in evidence profiles. The evidence syntheses were discussed and recommendations formulated by a multidisciplinary Task Force of asthma experts, who made specific recommendations on six specific questions. After considering the balance of desirable and undesirable consequences, quality of evidence, feasibility, and acceptability of various interventions, the Task Force made the following recommendations: 1) suggest using anti-interleukin (IL)-5 and anti-IL-5 receptor α for severe uncontrolled adult eosinophilic asthma phenotypes; 2) suggest using a blood eosinophil cut-point ≥150 μL−1 to guide anti-IL-5 initiation in adult patients with severe asthma; 3) suggest considering specific eosinophil (≥260 μL−1) and exhaled nitric oxide fraction (≥19.5 ppb) cut-offs to identify adolescents or adults with the greatest likelihood of response to anti-IgE therapy; 4) suggest using inhaled tiotropium for adolescents and adults with severe uncontrolled asthma despite Global Initiative for Asthma (GINA) step 4–5 or National Asthma Education and Prevention Program (NAEPP) step 5 therapies; 5) suggest a trial of chronic macrolide therapy to reduce asthma exacerbations in persistently symptomatic or uncontrolled patients on GINA step 5 or NAEPP step 5 therapies, irrespective of asthma phenotype; and 6) suggest using anti-IL-4/13 for adult patients with severe eosinophilic asthma and for those with severe corticosteroid-dependent asthma regardless of blood eosinophil levels. These recommendations should be reconsidered as new evidence becomes available.

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“…Furthermore, safety is an urgent, outstanding issue when treating children with asthma—there is a serious lack of safety information regarding biologics (with the exception of omalizumab) for patients below the age of 18 years. While over 10 years of omalizumab use has suggested a favorable long‐term safety profile in children and adolescents, all other biologic therapies need to demonstrate the same as soon as possible. Results of such studies may allow better informed treatment recommendations to be disseminated by guideline committees in the future.…”

Section: Potential For Biologics As Non‐steroid‐based Treatments In Pmentioning

confidence: 99%

Pediatric asthma: An unmet need for more effective, focused treatments

Papadopoulos

Čustović

Cabana

et al. 2018

Pediatric Allergy Immunology

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Background Despite remarkable advances in our understanding of asthma, there are still several unmet needs associated with the management of pediatric asthma. Methods A two‐day, face‐to‐face meeting was held in London, United Kingdom, on October 28 and 29, 2017, involving a group of international expert clinicians and scientists in asthma management to discuss the challenges and unmet needs that remain to be addressed in pediatric asthma. Results These unmet needs include a lack of clinical efficacy and safety evidence, and limited availability of non‐steroid‐based alternative therapies in patients <6 years of age. An increased focus on children is needed in the context of clinical practice guidelines for asthma; current pediatric practice relies mostly on extrapolations from adult recommendations. Furthermore, no uniform definition of pediatric asthma exists, which hampers timely and robust diagnosis of the condition in affected patients. Conclusions There is a need for a uniform definition of pediatric asthma, clearly distinguishable from adult asthma. Furthermore, guidelines which provide specific treatment recommendations for the management of pediatric asthma are also needed. Clinical trials and real‐world evidence studies assessing anti‐immunoglobulin E (IgE) therapies and other monoclonal antibodies in children <6 years of age with asthma may provide further information regarding the most appropriate treatment options in these vulnerable patients. Early intervention with anti‐IgE and non‐steroid‐based alternative therapies may delay disease progression, leading to improved clinical outcomes.

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Efficacy and safety of omalizumab in children and adolescents with moderate-to-severe asthma: A systematic literature review

Cited by 53 publications

References 0 publications

Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: A systematic review for the EAACI Guidelines ‐ recommendations on the use of biologicals in severe asthma

Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: A systematic review for the EAACI Guidelines ‐ recommendations on the use of biologicals in severe asthma

Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline

Pediatric asthma: An unmet need for more effective, focused treatments

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