Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies

FitzGerald, J. Mark; Bleecker, Eugene R.; Menzies‐Gow, Andrew; Zangrilli, James; Hirsch, Ian; Metcalfe, Paul; Newbold, Paul; Goldman, Mitchell

doi:10.1016/s2213-2600(17)30344-2

Cited by 244 publications

(181 citation statements)

References 27 publications

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“…In SIROCCO and CALIMA, eligibility criteria included a baseline blood eosinophil count of ≥300 cells/μL. In a post-hoc analysis of benralizumab-responsive patients in SIROCCO/CALIMA,16,17 benralizumab improved lung function and total asthma symptom score and decreased annual asthma exacerbation rate compared with placebo for patients with blood eosinophil counts ≥150 cells/μL. If a blood eosinophil count of ≥150 cells/μL at study inclusion had been used in this analysis of COBRA patients, the benralizumab-eligible population would have increased to 29%.…”

Section: Discussionmentioning

confidence: 99%

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort

Aubier

Thabut

Fabry-Vendrand

2018

JAA

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Background and objectiveBenralizumab (Fasenra™) has recently been approved as add-on maintenance treatment for adult patients with severe eosinophilic asthma inadequately controlled despite high-dosage inhaled corticosteroids plus long-acting β2-agonists. We aimed to identify and describe the clinical characteristics and disease burden of patients with severe, uncontrolled, eosinophilic asthma in France who may be eligible for treatment with benralizumab.Patients and methodsThis was a retrospective analysis of a prospective, noninterventional, observational study of patients in France enrolled in the Asthma and Bronchial Obstruction Cohort (COBRA). First, we selected adult patients with severe asthma, a documented blood eosinophil count, 12 months of baseline data, and 12 months of follow-up data. Of these study-eligible patients, we next determined the prevalence and described the clinical characteristics and disease burden of patients who would be eligible to receive benralizumab, namely those with ≥2 asthma exacerbations in the previous 12 months and a blood eosinophil count ≥300/μL who were receiving high-dosage inhaled corticosteroids/long-acting β2-agonists.ResultsOf the 441 patients eligible for this study, 85 (19%) met the criteria for benralizumab therapy. At study inclusion, benralizumab-eligible patients had a smaller prebronchodilator forced expiratory volume in 1 second and less effective asthma control compared with benralizumab-ineligible patients. During the 12-month follow-up period, benralizumab-eligible patients had greater frequencies of asthma exacerbations and hospitalizations compared with benralizumab-ineligible patients.ConclusionOf patients with severe asthma, approximately 20% were qualified for benralizumab treatment. Benralizumab-eligible patients had increased bronchial obstruction, worse asthma control, and a greater frequency of asthma exacerbations and hospitalizations during follow-up care compared with benralizumab-ineligible patients, demonstrating inadequate disease control for these patients.

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Section: Discussionmentioning

confidence: 99%

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort

Aubier

Thabut

Fabry-Vendrand

2018

JAA

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“…Greater improvements in asthma exacerbation rates were seen with benralizumab compared with placebo for patients with a combination of high blood eosinophil thresholds and a history of more frequent exacerbations. 62 The effectiveness of benralizumab as an OCS-sparing therapy in patients on daily OCS has also been demonstrated in a recent randomized controlled trial (ZONDA). The two benralizumab dosing regimens (30 mg administered subcutaneously either every 4 or 8 weeks) significantly reduced the median final OCS doses from baseline by 75%, as compared with a reduction of 25% in the placebo group (P < 0.001 for both comparisons).…”

Section: The Anti-il-5 Receptor Antibody Benralizumabmentioning

confidence: 98%

“…A pooled analysis of the results from the randomized DBPC SIROCCO and CALIMA phase 3 studies was performed to assess the efficacy of benralizumab according to different baseline blood eosinophil thresholds and exacerbation histories in adult patients with severe, uncontrolled asthma, randomly assigned to receive subcutaneous benralizumab 30 mg, either every 4 or 8 weeks (with the first three doses given every 4 weeks), or placebo every 4 weeks. Greater improvements in asthma exacerbation rates were seen with benralizumab compared with placebo for patients with a combination of high blood eosinophil thresholds and a history of more frequent exacerbations …”

Section: Other Biologics Which Could Be Of Interest In Children With mentioning

confidence: 99%

New perspectives of childhood asthma treatment with biologics

Just

Deschildre

Lejeune

et al. 2018

Pediatric Allergy Immunology

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Asthma is no longer considered as a single disease but rather as a syndrome corresponding to different entities and pathophysiologic pathways. A targeted strategy is part of personalized medicine which aims to better define each patient's phenotype and endotype so as to prescribe the most suitable treatment at an individual level. Omalizumab and, more recently, mepolizumab are the first biologics approved for children (6‐18 years). Omalizumab is now widely used to treat severe allergic asthma in children and is highly effective for asthma exacerbations and asthma control with a good safety profile. Moreover, several other drugs—lebrikizumab, dupilumab, tezepelumab, mepolizumab, reslizumab, benralizumab—are used or are being studied in both teenagers and adults and could benefit younger children in the near future. We hypothesize that defining the asthma phenotype/endotype regarding the type and intensity of inflammation, association with allergic or non‐allergic comorbidities, and airway remodeling should contribute to the choice of a specific biologic. Pediatric specificities have to be addressed and validated by studies in children. Long‐term effectiveness and particularly the impact on the natural history of asthma should also be investigated. Severe asthma in children is a complex disease, and patients have to be referred to a specialized pediatric asthma center to confirm diagnosis and initiate the best treatment strategy which could include biologics while taking into account their high cost.

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“…Nasopharyngitis was noted to be the most common adverse effect associated with treatment. Subanalyses have been completed using an eosinophil cut‐off of 150 cells/μL with statistically significant reductions in exacerbation rates also seen at this level, although higher blood eosinophils and more frequent exacerbations did predict greater improvements . Oral glucocorticoid‐sparing effect was evaluated by Nair and colleagues in 220 patients with oral glucocorticoid dependence and blood eosinophils >150 cells/μL.…”

Section: Emerging Treatments—beyond Phasementioning

confidence: 99%

New and emerging drug treatments for severe asthma

Brightling

Russell

Brightling

2018

Clin Experimental Allergy

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Asthma is a common chronic inflammatory condition of the airways affecting over 300 million people world-wide. In 5%-10% of cases, it is severe, with disproportionate healthcare resource utilization including costs associated with frequent exacerbations and the long-term health effects of systemic steroids. Characterization of inflammatory pathways in severe asthma has led to the development of targeted biological and small molecule therapies which aim to achieve disease control while minimizing corticosteroid-associated morbidity. Herein, we review currently licensed agents and those in development, and speculate how drug therapy for severe asthma might evolve and impact on clinical outcomes in the near future.

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Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies

Cited by 244 publications

References 27 publications

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort

New perspectives of childhood asthma treatment with biologics

New and emerging drug treatments for severe asthma

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