Short- and long-term real-world effectiveness of omalizumab in severe allergic asthma: systematic review of 42 studies published 2008-2018

MacDonald, Karen; Kavati, Abhishek; Ortiz, Benjamin; Alhossan, Abdulaziz; Lee, Christopher S.; Abraham, Ivo

doi:10.1080/1744666x.2019.1574571

Cited by 66 publications

(56 citation statements)

References 86 publications

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“…Although short‐term safety data are reassuring, more accurate reporting is warranted, in combination with long‐term safety evaluation, including observational studies and registries . For omalizumab, there are good data available to support its efficacy and safety in the paediatric population; however, for benralizumab and dupilumab the data are limited highlighting the urgent unmet need for rigorous trials with biologicals in severe asthma in the paediatric population.…”

Section: Discussionmentioning

confidence: 99%

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

103

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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: Discussionmentioning

confidence: 99%

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

103

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“…The magnitude of improvement of severe eosinophilic asthmatics with mepolizumab in our cohort is similar to the one reported with omalizumab in severe allergic asthma in a recent review 27 . The reduction in exacerbations was however higher in our real‐life study with mepolizumab than that reported previously with omalizumab.…”

Section: Discussionmentioning

confidence: 99%

Real‐world experience with mepolizumab: Does it deliver what it has promised?

Schleich

Graff

Nekoee

et al. 2020

Clin Experimental Allergy

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Background: Randomized control trials performed in selected populations of severe eosinophilic asthmatics have shown that mepolizumab, an anti-IL5 therapy, was able to reduce exacerbations and OCS maintenance dose and in some studies, to improve asthma control and lung function.Objective: The aim of this study was to confirm the results of the RCTs in real-life in a population of 116 severe eosinophilic asthmatics treated with mepolizumab and who were followed up at the asthma clinic every month for at least 18 months. Severe asthmatics underwent FENO, lung function, asthma control and quality of life questionnaires, sputum induction and gave a blood sample at baseline, after 6 months and then every year. Results:We found a significant reduction in exacerbations by 85% after 6 months (P < .0001), which was maintained over time. We also found a significant and maintained reduction by 50% in the dose of oral corticosteroids (P < .001). Patients improved their ACT (+5.31pts, p<0.0001) ACQ (-1.13pts, P < .0001) and their AQLQ score (+1.24, P < .0001) at 6 months and this was maintained during follow-up. Only 37% reached asthma control (ACQ <1.5, ACT> 20). We observed a progressive increase in post-BD FEV1 that reached significance after 18 months (190ml or 11%, P < .01). Patients improving their FEV1had higher baseline sputum eosinophils than those not improving airway caliber. We found a significant reduction in sputum eosinophil counts by 60% after 6 months (P < .01) and a maintained reduction in blood eosinophil counts by 98% (P < .0001). Conclusion:In our real-life study, we confirm the results published in the RCTs showing a sharp reduction in exacerbation and oral corticosteroids dose and an improvement in asthma control and quality of life. Clinical relevance: Mepolizumab is efficient in severe eosinophilic asthma in real life. K E Y W O R D S eosinophils, exacerbations, lung function, mepolizumab, severe asthma, sputum

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“…One review of the literature, (80) evaluating 25 RCTs involving patients with moderate to severe allergic asthma, showed that omalizumab, when compared with a placebo, reduced the exacerbations by approximately 25%, decreased the number of hospitalizations, and allowed a slight reduction in the dose of ICS. A systematic review of 42 real-life studies, (81) two of which were conducted in Brazil, (82,83) showed that omalizumab improved asthma control, reduced the number of emergency room visits/hospitalizations, and allowed the use of lower doses of OCS and ICS.…”

Section: Omalizumabmentioning

confidence: 99%

2020 Brazilian Thoracic Association recommendations for the management of asthma

et al. 2020

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The pharmacological management of asthma has changed considerably in recent decades, as it has come to be understood that it is a complex, heterogeneous disease with different phenotypes and endotypes. It is now clear that the goal of asthma treatment should be to achieve and maintain control of the disease, as well as to minimize the risks (of exacerbations, disease instability, accelerated loss of lung function, and adverse treatment effects). That requires an approach that is personalized in terms of the pharmacological treatment, patient education, written action plan, training in correct inhaler use, and review of the inhaler technique at each office visit. A panel of 22 pulmonologists was invited to perform a critical review of recent evidence of pharmacological treatment of asthma and to prepare this set of recommendations, a treatment guide tailored to use in Brazil. The topics or questions related to the most significant changes in concepts, and consequently in the management of asthma in clinical practice, were chosen by a panel of experts. To formulate these recommendations, we asked each expert to perform a critical review of a topic or to respond to a question, on the basis of evidence in the literature. In a second phase, three experts discussed and structured all texts submitted by the others. That was followed by a third phase, in which all of the experts reviewed and discussed each recommendation. These recommendations, which are intended for physicians involved in the treatment of asthma, apply to asthma patients of all ages.

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Short- and long-term real-world effectiveness of omalizumab in severe allergic asthma: systematic review of 42 studies published 2008-2018

Cited by 66 publications

References 86 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

Real‐world experience with mepolizumab: Does it deliver what it has promised?

2020 Brazilian Thoracic Association recommendations for the management of asthma

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