Evidence map›Paper›PMID 42057631›Full record

Trial reportClinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology2026

Sustained Clinical Improvement in Birch Pollen Allergy After Two Pre-Seasonal Short Courses of Allergen-Specific Immunotherapy: A Long-Term Open-Label Extension Study.

Ralph Mösges, Friederike Hüffmeier, Ludger Klimek, Oliver Pfaar, Christian Neuhof, Anna Rybachuk, Cengizhan Acikel, Hacer Sahin, Silke Allekotte, Sandra Del Pozo and 6 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Trial
  2. 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

16 authors.

Ralph MösgesClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0000-0002-1928-810X
Friederike HüffmeierInstitute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.ORCID https://orcid.org/0009-0001-4110-0484
Ludger KlimekCenter for Rhinology & Allergology, Wiesbaden, Germany.ORCID https://orcid.org/0000-0002-2455-0192
Oliver PfaarDepartment of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.ORCID https://orcid.org/0000-0003-4374-9639
Christian NeuhofClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0009-0004-9323-6887
Anna RybachukClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0000-0001-5306-5412
Cengizhan AcikelClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0000-0001-5699-4305
Hacer SahinClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0000-0001-5516-2013
Silke AllekotteClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0000-0002-0222-5954
Sandra Del PozoInmunotek S.L., Madrid, Spain.ORCID https://orcid.org/0000-0001-5205-4105
José Luis SubizaInmunotek S.L., Madrid, Spain.ORCID https://orcid.org/0000-0002-0134-5321
Miguel CasanovasInmunotek S.L., Madrid, Spain.ORCID https://orcid.org/0000-0003-2330-3963
Mandy CuevasDepartment of Otorhinolaryngology, Technische Universität Dresden, Dresden, Germany.ORCID https://orcid.org/0009-0007-1117-2210
Laura DayClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0000-0001-5913-9208
Lea RadtkeClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0009-0000-9553-8345
Esther RaskopfClinCompetence Cologne GmbH, Cologne, Germany.ORCID https://orcid.org/0000-0002-6461-8593

Funding

Inmunotek S.L.
6 · The paper itself

Abstract

backgroundMannan-conjugated allergoids represent an effective option for treating allergic diseases. This study evaluated the clinical impact of the mannan-conjugated, polymerised birch pollen allergoid EP-088_T502 in patients with birch pollen-induced allergic rhinoconjunctivitis over 3 years.

methodsFollowing up to a double-blind, placebo-controlled dose-finding study, in this open, long-term extension study, 154 birch pollen-allergic patients were enrolled in Germany. Patients were treated with a cumulative dose of 48,000 mTU EP-088_T502 administered subcutaneously over five pre-seasonal visits in each of the two treatment years (2021, 2022) with a subsequent follow-up year in 2023. The primary efficacy endpoint was the combined symptom and medication score (CSMS) during the peak birch pollen season, which was compared with the CSMS of the placebo group during the peak pollen season of 2020. Safety, tolerability, and immunogenicity were also analysed.

resultsCompared to the placebo group of the preceding study, median CSMS during the peak birch pollen seasons showed reductions of 47.5% in 2021 (p < 0.001), 51.8% in 2022 (p < 0.001), and 36.5% in 2023 (p < 0.001). Median daily symptom scores were reduced by 40.7% in 2021 (p < 0.001), 40.7% in 2022 (p < 0.001), and 25.6% in 2023 (p < 0.010). Median daily medication scores reached 0.07 in 2021 and 0.04 in 2022 (p < 0.001) and were reduced by 65.9% in 2023 (p < 0.003). Immunological responses showed a 4.82-fold increase in Bet v1 sIgG4 (p = 0.001) and a marked decrease (-65.5%, p = 0.001) in the sIgE/sIgG4 ratio after the first treatment phase. EP-088_T502 demonstrated good safety and tolerability, with only six mild to moderate systemic allergic reactions (Grade I/II). No epinephrine was used.

conclusionIn this open-label study, two consecutive years of pre-seasonal short-course allergen immunotherapy (AIT) with EP-088_T502 markedly reduced symptoms and medication need in patients with birch pollen-induced rhinoconjunctivitis. Persistent therapeutic effects observed during the follow-up year, although limited by attrition of the study population, suggest sustained clinical improvement and indicate the potential disease-modifying impact of this treatment regimen.

Indexed as

AllergensBetulaDesensitization, ImmunologicPollenRhinitis, Allergic, SeasonalAdultAntigens, PlantConjunctivitis, AllergicDouble-Blind MethodFemaleHumansMaleMiddle AgedSeasonsTreatment OutcomeAllergensAntigens, Plantallergic rhinoconjunctivitisbirch pollencombined symptom and medication scoremannan conjugatepolymerised allergoid

Identifiers

PMID42057631
PMCPMC13429321

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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.