Evidence map›Paper›PMID 42432760›Full record

ArticleAllergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology2026

Efficacy and safety of the tree sublingual immunotherapy tablet in the subpopulation of Canadian children with allergic rhinitis and/or conjunctivitis: phase III trial results.

Rémi Gagnon, Terrie Dalgaard, Gry Schermann Ortving, Monika Gappa, Hendrik Nolte

Registry-linked trialAbstract read
In one paragraph

Article in Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04878354 (Efficacy and Safety of the SQ Tree Sublingual Immunotherapy Tablet in Children and Adolescents With Moderate to Severe Allergic Rhinitis and/or Conjunctivitis Induced by Pollen From Birch and Trees Belonging to the Birch Homologous Group), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

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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.

NCT04878354 phase3completednot on this map

Efficacy and Safety of the SQ Tree Sublingual Immunotherapy Tablet in Children and Adolescents With Moderate to Severe Allergic Rhinitis and/or Conjunctivitis Induced by Pollen From Birch and Trees Belonging to the Birch Homologous Group

TypeinterventionalSponsorALK-Abelló A/SRan2021 to 2023Enrolled952ConditionsAllergyArmsTree SLIT-tablet, Placebo SLIT-tablet
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0 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Rémi GagnonClinique Spécialisée en Allergie de la Capitale, 2600 Boul. Laurier suite 880, Québec, QC, G1V4W2, Canada. rgagnon@csacqc.ca.
Terrie DalgaardALK, Hørsholm, Denmark.
Gry Schermann OrtvingALK, Hørsholm, Denmark.
Monika GappaEvangelical Hospital Düsseldorf, Düsseldorf, Germany.
Hendrik NolteALK, Bedminster, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPollen from birch and other trees in the birch homologous group (e.g., oak) is a common trigger of allergic rhinitis and/or conjunctivitis (AR/C) in Canada. The efficacy and safety of the tree sublingual immunotherapy (SLIT)-tablet in children with AR/C was evaluated post hoc in the Canadian subpopulation of a phase III, double-blind trial (EudraCT2020-004372-17).

methodsChildren and adolescents aged 5-17 years with moderate-to-severe tree AR/C were randomized to either daily tree SLIT-tablet or placebo for up to 52 weeks. Participants had free access to symptom-relieving medication. The primary endpoint was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during birch pollen season (BPS). Average TCS during tree pollen season (TPS, consisting of birch, alder, hazel, and oak pollen seasons), oak pollen season (OPS), and pure OPS (excluding days from birch, alder, or hazel pollen seasons) were also analyzed.

resultsIn the Canadian subpopulation (n = 87), treatment with the tree SLIT-tablet reduced the average TCS by 26.8% versus placebo during BPS (absolute difference [95% CI] = 1.89 [-0.71, 4.49], p = 0.138), 32.0% during TPS (absolute difference = 2.14 [-0.03, 4.32], p = 0.042), 46.6% during OPS (absolute difference = 3.70 [0.98, 6.42], p = 0.004), and 50.6% during pure OPS (absolute difference = 4.20 [1.12, 7.27], p = 0.005). Reductions in DSS and DMS with tree SLIT-tablet versus placebo were also observed. In the total trial population (N = 952), tree SLIT-tablet treatment reduced the average TCS by 19.2% versus placebo during BPS (absolute difference = 1.13 [0.42, 1.84], p = 0.002), 16.8% during TPS (absolute difference = 0.76 [0.26, 1.26], p = 0.003), 23.4% during OPS (absolute difference = 1.32 [0.60, 2.05], p < 0.001), and 19.9% during pure OPS (absolute difference = 1.03 [0.27, 1.80], p = 0.009). The tree SLIT-tablet was well tolerated in the total trial and Canadian subgroup populations.

conclusionsThe tree SLIT-tablet demonstrated favorable efficacy and was well tolerated in Canadian children and adolescents with AR/C. CLINICAL

trial registrationEudraCT 2020-004372-17 and NCT04878354.

Indexed as

Allergic rhinitisBirchOakPollenSublingual immunotherapyTabletTree

Identifiers

PMID42432760
PMCPMC13640251

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