Trial reportThe Journal of allergy and clinical immunology2013
Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia.
Trial report in The Journal of allergy and clinical immunology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 211 papers, 10 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
211 citing papers in PubMed, 10 syntheses or guidelines pooled it, 501 citations in OpenAlex.
- Benralizumab in severe eosinophilic asthma: a comprehensive systematic review and meta-analysis of randomized controlled trials evaluating lung function, asthma control, and safety outcomes.Systematic reviews · 2026Pooled it
- Pooled it
- Adverse events of anti-IL-5 drugs in patients with eosinophilic asthma: a meta-analysis of randomized controlled trials and real-world evidence-based assessments.BMC pulmonary medicine · 2024Pooled it
- The clinical efficacy of type 2 monoclonal antibodies in eosinophil-associated chronic airway diseases: a meta-analysis.Frontiers in immunology · 2023Pooled it
- Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022Pooled it
- Adverse events of benralizumab in moderate to severe eosinophilic asthma: A meta-analysis.Medicine · 2019Pooled it
- Efficacy and safety of benralizumab in patients with eosinophilic asthma: a meta-analysis of randomized placebo-controlled trials.Frontiers of medicine · 2018Pooled it
- Anti-interleukin 5 Therapy for Eosinophilic Asthma: a Meta-analysis of Randomized Clinical Trials.Clinical reviews in allergy & immunology · 2018Pooled it
- Anti-IL5 therapies for asthma.The Cochrane database of systematic reviews · 2017Pooled it
- Efficacy and Safety of Anti-Interleukin-5 Therapy in Patients with Asthma: A Systematic Review and Meta-Analysis.PloS one · 2016Pooled it
- Benralizumab versus placebo for hypereosinophilic syndrome: a randomized, placebo-controlled phase 3 trial.Nature medicine · 2026Trial
- Benralizumab for allergic asthma: a randomised, double-blind, placebo-controlled trial.The European respiratory journal · 2024Trial
- Activated sputum eosinophils associated with exacerbations in children on mepolizumab.The Journal of allergy and clinical immunology · 2024Trial
- Benralizumab for eosinophilic gastritis: a single-site, randomised, double-blind, placebo-controlled, phase 2 trial.The lancet. Gastroenterology & hepatology · 2023Trial
- Relationship Between Benralizumab Exposure and Efficacy for Patients With Severe Eosinophilic Asthma.Clinical pharmacology and therapeutics · 2019Trial
- Benralizumab forThe New England journal of medicine · 2019Trial
- Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma.The European respiratory journal · 2018Trial
- Distinct endotypes of steroid-resistant asthma characterized by IL-17A(high) and IFN-γ(high) immunophenotypes: Potential benefits of calcitriol.The Journal of allergy and clinical immunology · 2015Trial
- Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study.The Lancet. Respiratory medicine · 2014Trial
- Development of a suspension array assay in multiplex for the simultaneous measurement of serum levels of four eosinophil granule proteins.Journal of immunological methods · 2014Trial
151 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
12 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundMany asthmatic patients exhibit sputum eosinophilia associated with exacerbations. Benralizumab targets eosinophils by binding IL-5 receptor α, inducing apoptosis through antibody-dependent cell-mediated cytotoxicity.
objectivesWe sought to evaluate the safety of benralizumab in adults with eosinophilic asthma and its effects on eosinophil counts in airway mucosal/submucosal biopsy specimens, sputum, bone marrow, and peripheral blood.
methodsIn this multicenter, double-blind, placebo-controlled phase I study, 13 subjects were randomized to single-dose intravenous placebo or 1 mg/kg benralizumab (day 0; cohort 1), and 14 subjects were randomized to 3 monthly subcutaneous doses of placebo or 100 or 200 mg of benralizumab (days 0, 28, and 56; cohort 2). Cohorts 1 and 2 were consecutive.
resultsThe incidence of adverse events was similar between groups. No serious adverse events related to benralizumab occurred. In cohort 1 intravenous benralizumab produced a median decrease from baseline of 61.9% in airway mucosal eosinophil counts (day 28; placebo: +19.6%; P = .28), as well as an 18.7% decrease (day 21) in sputum and a 100% decrease (day 28) in blood counts. Eosinophils were not detectable in bone marrow of benralizumab-treated subjects (day 28, n = 4). In cohort 2 subcutaneous benralizumab demonstrated a combined (100 + 200 mg) median reduction of 95.8% in airway eosinophil counts (day 84; placebo, 46.7%; P = .06), as well as an 89.9% decrease (day 28) in sputum and a 100% decrease (day 84) in blood counts.
conclusionSingle-dose intravenous and multiple-dose subcutaneous benralizumab reduced eosinophil counts in airway mucosa/submucosa and sputum and suppressed eosinophil counts in bone marrow and peripheral blood. The safety profile supports further development. Additional studies are needed to assess the clinical benefit in asthmatic patients.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.