Evidence map›Paper›PMID 29779247›Full record

Trial reportAllergy2018

Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy.

M Worm, T Higenbottam, O Pfaar, R Mösges, W Aberer, K Gunawardena, D Wessiepe, D Lee, M F Kramer, M Skinner and 2 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Allergy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Focused allergic rhinitis practice parameter for Canada.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2024
    Article
  8. Review
  9. Review
  10. Review
  11. Guideline on allergen immunotherapy in IgE-mediated allergic diseases: S2K Guideline of the German Society of Allergology and Clinical Immunology (DGAKI), Society of Pediatric Allergology and Environmental Medicine (GPA), Medical Association of German Allergologists (AeDA), Austrian Society of Allergology and Immunology (ÖGAI), Swiss Society for Allergology and Immunology (SSAI), German Dermatological Society (DDG), German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), German Society of Pediatrics and Adolescent Medicine (DGKJ), Society of Pediatric Pulmonology (GPP), German Respiratory Society (DGP), German Professional Association of Otolaryngologists (BVHNO), German Association of Paediatric and Adolescent Care Specialists (BVKJ), Federal Association of Pneumologists, Sleep and Respiratory Physicians (BdP), Professional Association of German Dermatologists (BVDD).Allergologie select · 2022
    Article
  12. Review
  13. Review
  14. EAACI Allergen Immunotherapy User's Guide.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2020
    Review
  15. Review
  16. Article
  17. Article
  18. 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

12 authors.

M WormDepartment Campus Charité Mitte, Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-3449-1245
T HigenbottamAllergy Therapeutics, Worthing, UK.ORCID 0000-0002-0166-3899
O PfaarDepartment of Otorhinolaryngology Head and Neck Surgery, University of Medicine, Mannheim, Germany, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.ORCID 0000-0003-4374-9639
R MösgesHospital of the University of Cologne, Cologne, Germany.ORCID 0000-0002-1928-810X
W AbererUniversity Hospital Clinic, Graz, Austria.
K GunawardenaKGPharmaConsulting Ltd., Worthing, UK.
D WessiepeMetronomia Clinical Research GmbH, Muenchen, Germany.
D LeeBencard Allergie, München, Germany.
M F KramerAllergy Therapeutics, Worthing, UK.
M SkinnerAllergy Therapeutics, Worthing, UK.
B LeesAllergy Therapeutics, Worthing, UK.
S ZielenClinic for Child and Adolescent Medicine, Allergology, Pneumonology and Cystic Fibrosis, Goethe University Frankfurt am Main, Frankfurt, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX

methodsThe studies were conducted in Germany, Austria and Poland (EudraCT numbers: 2012-004336-28 PQBirch203 and 2015-000984-15 PQBirch204) using a wide range of cumulative doses. In both studies, subjects were administered 6 therapy injections weekly outside the pollen season. Conjunctival Provocation Tests were performed at screening, baseline and 3-4 weeks after completing treatment, to quantify the reduction in Total Symptom Scores (as the primary endpoint) with each cumulative dose. Multiple Comparison Procedure and Modeling analysis was used to test for the dose response, shape of the curve and estimation of the median effective dose (ED

resultsStatistically significant dose responses (P < .01 & .001) were seen, respectively. The highest cumulative dose in PQBirch204 (27 300 standardized units [SU]) approached a plateau. Potency of the PQBirch was demonstrated by an ED

conclusionIncreasing the cumulative dose of PQBirch 5.5-fold from 5100 to 27 300 SU achieved an absolute point difference from placebo of 1.91, a relative difference 32.3% and an increase in efficacy of 50%, without compromising safety. The cumulative dose response was confirmed to be curvilinear in shape.

Indexed as

Desensitization, ImmunologicAdolescentAdultAllergensAllergoidsAustriaBetulaDose-Response Relationship, ImmunologicDrug Administration ScheduleFemaleGermanyHumansMaleMiddle AgedPlant ExtractsPolandAllergensAllergoidsPlant ExtractsPollinex QuattroVaccinesallergen immunotherapybirch pollen allergoidcumulative dosedose response curve

Identifiers

PMID29779247
PMCPMC6175210

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.