Trial reportBMJ open2016
Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma.
Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01603277 (A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.
- Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis.Respiratory research · 2019Pooled it
- Pharmacokinetics, Safety and Tolerability of Intravenous Lenzilumab, an Anti-GM-CSF Monoclonal Antibody Drug, in Healthy Korean Subjects.Drug design, development and therapy · 2025Trial
- Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial.The Lancet. Respiratory medicine · 2022Trial
- Mechanisms and therapeutic strategies of asthma: from bench to bedside.Signal transduction and targeted therapy · 2026Review
- Group 2 innate lymphoid cells program pulmonary adaptive immunity via granulocyte-macrophage colony-stimulating factor.The Journal of allergy and clinical immunology · 2026Article
- Tissue macrophages: origin, heterogenity, biological functions, diseases and therapeutic targets.Signal transduction and targeted therapy · 2025Review
- Anti-GM-CSF autoantibodies in myeloid leukemias.Best practice & research. Clinical haematology · 2025Review
- Asthma Biologics Across the T2 Spectrum of Inflammation in Severe Asthma: Biomarkers and Mechanism of Action.Journal of asthma and allergy · 2025Review
- Effects of Eosinophilopoietins and C-C Chemokines on Chemotaxis, Adhesion, and ROS Production of Blood Eosinophil Subtypes in Asthma Patients.Journal of inflammation research · 2025Article
- Treatment with onion bulb extract both prevents and reverses allergic inflammation in a murine model of asthma.Pharmaceutical biology · 2024Article
- Promising treatment biomarkers in asthma.Frontiers in drug safety and regulation · 2023Review
- Article
- An exploratory study investigating biomarkers associated with autoimmune pulmonary alveolar proteinosis (aPAP).Scientific reports · 2022Observational
- Human autoantibodies underlying infectious diseases.The Journal of experimental medicine · 2022Article
- Eosinophils in the Field of Nasal Polyposis: Towards a Better Understanding of Biologic Therapies.Clinical reviews in allergy & immunology · 2022Review
- Phase 1 study of lenzilumab, a recombinant anti-human GM-CSF antibody, for chronic myelomonocytic leukemia.Blood · 2020Article
- Contributions of Eosinophils to Human Health and Disease.Annual review of pathology · 2020Review
- GM-CSF in inflammation.The Journal of experimental medicine · 2020Review
- GM-CSF: A Promising Target in Inflammation and Autoimmunity.ImmunoTargets and therapy · 2020Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe wished to evaluate the effects of an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody (KB003) on forced expiratory volume in 1 s (FEV1), asthma control and asthma exacerbations in adult asthmatics inadequately controlled by long-acting bronchodilators and inhaled/oral corticosteroids. SETTINGS: 47 ambulatory asthma care centres globally. PRIMARY OUTCOME MEASURES: Change in FEV1 at week 24.
participants311 were screened, 160 were randomised and 129 completed the study.
interventions7 intravenous infusions of either 400 mg KB003 or placebo at baseline and weeks 2, 4, 8, 12, 16 and 20. PRIMARY AND SECONDARY OUTCOME MEASURES: FEV1 at week 24, asthma control, exacerbation rates and safety in all participants as well as prespecified subgroups. MAIN
resultsIn the KB003 treated group, FEV1 at week 24 improved to 118 mL compared with 54 mL in the placebo group (p=0.224). However, FEV1 improved to 253 vs 26 mL at week 24 (p=0.02) in eosinophilic asthmatics (defined as >300 peripheral blood eosinophils/mL at baseline) and comparable improvements were seen at weeks 20 (p=0.034) and 24 (p=0.077) in patients with FEV1 reversibility ≥ 20% at baseline and at weeks 4 (p=0.029), 16 (p=0.018) and 20 (p=0.006) in patients with prebronchodilator FEV1 ≤ 50% predicted at baseline. There were no effects on asthma control or exacerbation rates. The most frequent adverse events in the KB003 group were rhinosinusitis and headache. There was no significant difference in antidrug antibody response between placebo and treated groups. There were no excess infections or changes in biomarkers known to be associated with the development of pulmonary alveolar proteinosis.
conclusionsHigher doses and/or further asthma phenotyping may be required in future studies with KB003. TRIAL REGISTRATION NUMBER: NCT01603277; Results.
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Registered trials
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.