Evidence map›Paper›PMID 29150857›Full record

Trial reportAllergy2018

A randomized, double-blind, placebo-controlled, dose-finding trial with Lolium perenne peptide immunotherapy.

R Mösges, E M Kasche, E Raskopf, J Singh, L Sohlich, A Astvatsatourov, K Shah-Hosseini, S Pirotton, L Haazen, S R Durham and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized 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 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.5field-weighted citation impact, top 7% 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.

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

12 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Allergen immunotherapy: past, present and future.Nature reviews. Immunology · 2023
    Review
  6. Review
  7. EAACI Allergen Immunotherapy User's Guide.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2020
    Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. 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

13 authors at 3 institutions in 3 countries.

R MösgesInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Cologne, Germany.
E M KascheInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Cologne, Germany.
E RaskopfInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Cologne, Germany.ORCID 0000-0002-6461-8593
J SinghInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Cologne, Germany.
L SohlichInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Cologne, Germany.
A AstvatsatourovInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Cologne, Germany.
K Shah-HosseiniInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Cologne, Germany.
S PirottonASIT Biotech s.a., Brussels, Belgium.
L HaazenASIT Biotech s.a., Brussels, Belgium.
S R DurhamImmunomodulation and Tolerance Group, Allergy & Clinical Immunology, Inflammation, Repair and Development National Heart & Lung Institute, Imperial College London, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.
T LegonASIT Biotech s.a., Brussels, Belgium.
G ZadoyanInstitute of Medical Statistics, Informatics and Epidemiology (IMSIE), Faculty of Medicine, University of Cologne, Cologne, Germany.
M H ShamjiImmunomodulation and Tolerance Group, Allergy & Clinical Immunology, Inflammation, Repair and Development National Heart & Lung Institute, Imperial College London, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.ORCID 0000-0003-3425-3463
University of Cologne · DEASIT Biotech (Belgium) · BEAsthma UK · GB

Funding

Medical Research Council G1000758
6 · The paper itself

Abstract

backgroundA novel subcutaneous allergen immunotherapy formulation (gpASIT+™) containing Lolium perenne peptides (LPP) and having a short up-dosing phase has been developed to treat grass pollen-induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety.

methodsThis prospective, double-blind, placebo-controlled, phase IIb, parallel, four-arm, dose-finding study randomized 198 grass pollen-allergic adults to receive placebo or cumulative doses of 70, 170 or 370 μg LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen-specific immunoglobulins were analysed before and after treatment.

resultsConjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 μg; P = .023), 46.3% (370 μg), and 38.6% (70 μg) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per-protocol set). Also, 39% of patients in the 170-μg group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen-binding assays revealed a highly significant (P < .001) dose-dependent reduction in IgE allergen binding across all treatment groups (70 μg: 17.1%; 170 μg: 18.8%; 370 μg: 26.4%). Specific IgG

conclusionThree-week immunotherapy with 170 μg LPP reduced CPT reactivity significantly and increased protective specific antibodies.

Indexed as

AdultAllergensAntigens, PlantConjunctivitis, AllergicDesensitization, ImmunologicDouble-Blind MethodFemaleHumansInjections, SubcutaneousLoliumMalePeptidesRhinitis, Allergic, SeasonalAllergensAntigens, PlantPeptidesallergic rhinitisimmunotherapyLolium perennepeptidesryegrass pollen

Identifiers

PMID29150857
PMCPMC5947135
OpenAlexW2770000934

What OpenQuestion holds

Textmetadata
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.