Evidence map›Paper›PMID 26993628›Full record

Trial reportRespiratory research2016

A randomized trial of the efficacy and safety of quilizumab in adults with inadequately controlled allergic asthma.

Jeffrey M Harris, Romeo Maciuca, Mary S Bradley, Christopher R Cabanski, Heleen Scheerens, Jeremy Lim, Fang Cai, Mona Kishnani, X Charlene Liao, Divya Samineni and 9 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 39 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 5 pooled it
9.0field-weighted citation impact, top 2% of its field
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.

NCT01582503 phase2completednot on this map

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)

TypeinterventionalSponsorGenentech, Inc.Ran2012 to 2014Enrolled578ConditionsAsthmaArmsMEMP1972A, placebo
NCT05042830 narecruitingnot on this mapstarted 2021, after this paper: background citation

Contribution of Local Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Production Upon Nasal Allergen Contact - an Explorative Pilot Study

TypeinterventionalSponsorMedical University of ViennaRan2021 to 2026Enrolled30ConditionsAllergyArmsBlood sampling, Nasal biopsies, Nasal specimen collection, Mucosal RNA sampling, Intranasal challenge
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 5 syntheses or guidelines pooled it, 98 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022
    Pooled it
  5. Anti-IL5 therapies for asthma.The Cochrane database of systematic reviews · 2017
    Pooled it
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Research Advances in Mast Cell Biology and Their Translation Into Novel Therapies for Anaphylaxis.The journal of allergy and clinical immunology. In practice · 2023
    Review
  16. Review
  17. Utilizing Biologics in Drug Desensitization.Current allergy and asthma reports · 2023
    Review
  18. Promising treatment biomarkers in asthma.Frontiers in drug safety and regulation · 2023
    Review
  19. Formononetin isolated fromFrontiers in allergy · 2022
    Article
  20. Article
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

19 authors at 5 institutions in 4 countries.

Jeffrey M HarrisGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA. harris.jeffrey@gene.com.
Romeo MaciucaGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Mary S BradleyGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Christopher R CabanskiGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Heleen ScheerensGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Jeremy LimGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Fang CaiGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Mona KishnaniGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
X Charlene LiaoGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Divya SamineniGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Rui ZhuGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Colette CochranGenentech, Inc, 1 DNA Way, South San Francisco, CA, 94080-4990, USA.
Weily SoongAlabama Allergy & Asthma Center, Birmingham, AL, USA.
Joseph D DiazAllergy and Asthma Research Center PA, San Antonio, TX, USA.
Patrick PerinAllergy Partners of New Jersey, Teaneck, NJ, USA.
Miguel TsukayamaClínica Ricardo Palma, Lima, Peru.
Dimo DimovTrakia University, Stara Zagora, Bulgaria.
Ioana AgacheTransylvania University, Faculty of Medicine, Brasov, Romania.
Steven G KelsenTemple University School of Medicine, Philadelphia, PA, USA.
Allergy, Asthma and Clinical Research Center · USTemple University · USTrakia University · BGTransylvania University of Brașov · ROUniversidad Ricardo Palma · PE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQuilizumab, a humanized IgG1 monoclonal antibody, targets the M1-prime segment of membrane-expressed IgE, leading to depletion of IgE-switched and memory B cells. In patients with mild asthma, quilizumab reduced serum IgE and attenuated the early and late asthmatic reaction following whole lung allergen challenge. This study evaluated the efficacy and safety of quilizumab in adults with allergic asthma, inadequately controlled despite high-dose inhaled corticosteroids (ICS) and a second controller.

methodsFive hundred seventy-eight patients were randomized to monthly or quarterly dosing regimens of subcutaneous quilizumab or placebo for 36 weeks, with a 48-week safety follow-up. Quilizumab was evaluated for effects on the rate of asthma exacerbations, lung function, patient symptoms, serum IgE, and pharmacokinetics. Exploratory analyses were conducted on biomarker subgroups (periostin, blood eosinophils, serum IgE, and exhaled nitric oxide).

resultsQuilizumab was well tolerated and reduced serum total and allergen-specific IgE by 30-40 %, but had no impact on asthma exacerbations, lung function, or patient-reported symptom measures. At Week 36, the 300 mg monthly quilizumab group showed a 19.6 % reduction (p = 0.38) in the asthma exacerbation rate relative to placebo, but this was neither statistically nor clinically significant. Biomarker subgroups did not reveal meaningful efficacy benefits following quilizumab treatment.

conclusionsQuilizumab had an acceptable safety profile and reduced serum IgE. However, targeting the IgE pathway via depletion of IgE-switched and memory B cells was not sufficient for a clinically meaningful benefit for adults with allergic asthma uncontrolled by standard therapy.

trial registrationClinicalTrials.gov NCT01582503.

Indexed as

Administration, InhalationAdolescentAdrenal Cortex HormonesAdultAgedAnti-Asthmatic AgentsAntibodies, Anti-IdiotypicAntibodies, MonoclonalAsthmaCombined Modality TherapyDose-Response Relationship, DrugFemaleHumansHypersensitivityMaleMiddle AgedAdrenal Cortex HormonesAnti-Asthmatic AgentsAntibodies, Anti-IdiotypicAntibodies, Monoclonalanti-IgE antibodiesAllergic asthmaBiomarkersCOSTAExacerbationsFEV1IgEM1 primeQuilizumab

Identifiers

PMID26993628
PMCPMC4797126
OpenAlexW2299467455

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.