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Cited by 666

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.

Randomized, Double-Blind, Placebo-controlled Study of Brodalumab, a Human Anti–IL-17 Receptor Monoclonal Antibody, in Moderate to Severe Asthma

Busse, William W., Holgate, Stephen, Kerwin, Edward, Chon, Yun, Feng, JingYuan, Lin, Joseph, Lin, Shao-Lee·2013·American Journal of Respiratory and Critical Care Medicine
DOI 10.1164/rccm.201212-2318oc
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Abstract

RATIONALE: IL-17 signaling has been implicated in development and persistence of asthma. Cytokine-targeted strategies blocking IL-17 receptor signaling may be beneficial in asthma treatment. OBJECTIVES: To determine efficacy and safety of brodalumab, a human anti-IL-17 receptor A monoclonal antibody, in subjects with inadequately controlled moderate to severe asthma taking regular inhaled corticosteroids. METHODS: Three hundred two subjects were randomized to brodalumab (140, 210, or 280 mg) or placebo. Primary endpoint was change in Asthma Control Questionnaire (ACQ) score from baseline to Week 12. Secondary endpoints included FEV1, symptom scores, and symptom-free days. Prespecified subgroup analyses were conducted to identify potential responsive subpopulations. Analyses included randomized subjects receiving one or more doses of investigational product using last-observation-carried-forward imputation. MEASUREMENTS AND MAIN RESULTS: Demographics and baseline characteristics were generally balanced among groups (n = 302; n = 226 brodalumab). For the overall study population, no treatment differences were observed. Nine prespecified subgroups were examined without corrections for multiple testing. In only the high-reversibility subgroup (post-bronchodilator FEV1 improvement ≥ 20%; n = 112) was an ACQ change with nominal significance noted; ACQ responses were nominally significant in the 210-mg group (estimated treatment difference, 0.53) but not significant in the higher 280-mg group (estimated treatment difference, 0.38). Adverse events, generally balanced among groups, were most commonly asthma, upper respiratory tract infection, and injection site reaction. CONCLUSIONS: Inhibition of IL-17 receptor A did not produce a treatment effect in subjects with asthma. The results of the high-reversibility subgroup analysis are of uncertain significance, requiring further study of brodalumab in this asthma subpopulation. Clinical trial registered with www.clinicaltrials.gov (NCT01199289).

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Metadata

Authors
Busse, W. W., Holgate, S., Kerwin, E., Chon, Y., Feng, J., Lin, J., & Lin, S.-L.
Venue
American Journal of Respiratory and Critical Care Medicine
Publisher
Oxford University Press (OUP)
Published
2013-12-01
Volume
188
Issue
11
Pages
1294-1302
ISSN
  • 1073-449X (ISSN-L)
  • 1535-4970
DOI
10.1164/rccm.201212-2318oc
OpenAlex
W2019394772
Cited by
666
References
24
FWCI
29.38
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Randomized, Double-Blind, Placebo-controlled Study of Brodalumab, a Human Anti–IL-17 Receptor Monoclonal Antibody, in Moderate to Severe Asthma. https://app.cochat.ai/papers/10.1164/rccm.201212-2318oc
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Busse, W. W., Holgate, S., Kerwin, E., Chon, Y., Feng, J., Lin, J., & Lin, S.-L. (2013). Randomized, Double-Blind, Placebo-controlled Study of Brodalumab, a Human Anti–IL-17 Receptor Monoclonal Antibody, in Moderate to Severe Asthma. American Journal of Respiratory and Critical Care Medicine. https://doi.org/10.1164/rccm.201212-2318oc

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.