Evidence map›Paper›PMID 40120806›Full record

Trial reportThe journal of allergy and clinical immunology. In practice2025

Long-Term Efficacy and Safety of Benralizumab Treatment for PDGFRA-Negative Hypereosinophilic Syndrome.

Fei Li Kuang, Michelle A Makiya, JeanAnne M Ware, Lauren Wetzler, Celeste Nelson, Thomas Brown, Paneez Khoury, Amy D Klion

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of allergy and clinical immunology. In practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02130882 (A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Benralizumab), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT02130882 phase2 / phase3unknown statusnot on this map

A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Benralizumab (MEDI-563) in Reducing Eosinophilia in Subjects With Hypereosinophilic Syndrome (HES)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2023Enrolled20ConditionsRespiratory System Agents, Anti-Asthmatic Agents, Hematologic Diseases, Leukocyte DisordersArmsbenralizumab, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Consistent adherence to biologic therapies is critical for improving outcomes in asthma.The journal of allergy and clinical immunology. Global · 2026
    Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Fei Li KuangDivision of Allergy and Immunology, Northwestern University Feinberg School of Medicine, Chicago, Ill; Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Md.
Michelle A MakiyaLaboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Md.
JeanAnne M WareLaboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Md.
Lauren WetzlerLaboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Md.
Celeste NelsonLaboratory of Allergic Diseases, NIAID, NIH, Bethesda, Md.
Thomas BrownLaboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Md.
Paneez KhouryLaboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Md; Laboratory of Allergic Diseases, NIAID, NIH, Bethesda, Md.
Amy D KlionLaboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Md. Electronic address: amy.klion@nih.gov.

Funding

Eosinophils and Eosinophil Activation in the Pathogenesis of Human DiseaseZIAAI001130 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KLION, AMY · 2010 to 2025
$22.5M
Deciphering the roles of eosinophils and T lymphocytes in EGIDK23AI171085 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Fei Li Kuang · 2023 to 2026
$764k
Intramural NIH HHS ZIA AI001130NIAID NIH HHS K23 AI171085
6 · The paper itself

Abstract

backgroundTherapies for hypereosinophilic syndromes (HES) have variable efficacy and significant toxicity. Benralizumab (BENRA), an afucosylated monoclonal antibody that binds interleukin 5 receptor α expressed on eosinophils, reduced blood and tissue eosinophils in a 48-week, phase 2 study in PDGFRA-negative HES.

objectiveTo assess safety and efficacy of long-term BENRA treatment in PDGFRA-negative HES.

methodsTwenty PDGFRA-negative HES patients with severe and diverse clinical manifestations were treated in a double-blind, placebo-controlled clinical trial of BENRA (NCT02130882). Fourteen were followed on an open-label extension. Efficacy and safety were reviewed at each visit.

resultsAmong 14 long-term participants, 3 withdrew owing to loss of efficacy, and 1 owing to death unrelated to drug after 2 to 6 years. The remaining 10 participants received BENRA for at least 8 years (maximum exposure 10.1 y). Peripheral eosinophil counts remained suppressed in all participants. Eight participants attempted to taper from monthly to every-2-month dosing, of which 5 resumed monthly dosing owing to increased symptoms and/or eosinophil count. There were 11 serious adverse events: 10 hospitalizations (3 for infections, 5 for surgeries, and 2 for drug desensitization or observation) and 1 death from antibiotic-associated toxic epidermal necrolysis. None were attributed to BENRA. Eight participants reported injection-site reactions (23 total), all mild in severity and self-limited. Three malignancies and no parasitic infections were reported. Despite sustained eosinophil depletion, immunoglobulin levels and peripheral T-, B-, and natural killer-cell counts were stable for the duration of the study.

conclusionsLong-term BENRA therapy is effective and well-tolerated in HES patients without significant adverse effects.

Indexed as

Antibodies, Monoclonal, HumanizedHypereosinophilic SyndromeAdultAgedDouble-Blind MethodEosinophilsFemaleHumansMaleMiddle AgedReceptor, Platelet-Derived Growth Factor alphaTreatment OutcomeAntibodies, Monoclonal, HumanizedbenralizumabReceptor, Platelet-Derived Growth Factor alphaBenralizumabBiologic therapyEosinophilEosinophiliaHypereosinophilic syndromeInterleukin-5 receptor

Identifiers

PMID40120806
PMCPMC12146058

What Socratic holds

Textmetadata
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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 Socratic graph.