Evidence map›Paper›PMID 39495086›Full record

Trial reportAllergy2025

The SQ tree sublingual immunotherapy tablet is effective and well tolerated in children-A pivotal phase III trial.

Monika Gappa, Rémi Gagnon, Fritz Horak, Ewa Cichocka-Jarosz, Terrie Dalgaard, Kate Hargreaves, Jan Mikler, Andrzej Emeryk, Kirsten Skamstrup Hansen, Oliver Pfaar

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Recent advances in allergen immunotherapy.Chinese medical journal · 2026
    Review
  6. 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.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026
    Article
  7. Review
  8. Treatment of allergic rhinitis with allergen immunotherapy in children and adolescents-Adherence, rhinitis severity, and asthma onset.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Article
  9. Efficacy and safety of Sublingual immunotherapy for allergic rhinitis: an overview of systematic reviews and meta analyses.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Review
  10. Review
  11. Article
  12. Review
  13. 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

10 authors.

Monika GappaCenter for Paediatric and Adolescent Medicine, Evangelic Hospital Düsseldorf, Düsseldorf, Germany.ORCID https://orcid.org/0009-0006-8001-1165
Rémi GagnonClinique spécialisée en allergie de la capitale, Québec City, Québec, Canada.
Fritz HorakAllergiezentrum Wien West, Vienna, Austria.ORCID https://orcid.org/0009-0001-6620-9224
Ewa Cichocka-JaroszDepartment of Pediatrics, Jagiellonian University Medical College, Kraków, Poland.ORCID https://orcid.org/0000-0002-8428-5976
Terrie DalgaardALK-Abelló, Hørsholm, Denmark.
Kate HargreavesALK-Abelló, Hørsholm, Denmark.
Jan MiklerPediatric clinic, University hospital in Martin and Jessenius medical faculty in Martin, Commenius University, Bratislava, Slovakia.
Andrzej EmerykDepartment of Pulmonary Disease and Children Rheumatology, Medical University of Lublin, Lublin, Poland.
Kirsten Skamstrup HansenAllergy Clinic & Department of Paediatrics, Herlev-Gentofte Hospital, Hellerup, Denmark.
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

Funding

The study and manuscript writing were funded by ALK-Abelló, Hørsholm, Denmark
6 · The paper itself

Abstract

backgroundAllergic rhinitis and/or conjunctivitis (AR/C) induced by tree pollen is common and negatively impacts quality of life in children and adolescents. This phase III trial investigated the efficacy and safety of the SQ tree SLIT-tablet in a paediatric population (5-17 years) with moderate-to-severe AR/C induced by pollen from birch and trees in the birch homologous group.

methodsNine hundred and fifty-two subjects were randomized (1:1) to daily treatment with SQ tree SLIT-tablet or placebo for up to 52 weeks and had free access to AR/C symptom-relieving medications. The primary endpoint was the average total combined score (TCS); sum of average daily symptom score (DSS) and average daily medication score (DMS) during the birch pollen season (BPS). Key secondary endpoints included average DSS and DMS during BPS and average TCS, DSS and DMS during tree pollen season (TPS).

resultsSQ tree SLIT-tablet demonstrated a statistically significant and clinically relevant treatment effect compared with placebo for the TCS during BPS with an absolute treatment difference of 1.29 (95% CI: 0.58, 2.00; p = .0004) and a relative reduction of 21.9% (95% CI: 10.6, 31.9). Results were substantiated by reductions in both DSS and DMS versus placebo during the BPS and in DSS, DMS and TCS during the TPS. Treatment was generally well tolerated. Most treatment-related adverse events were mild or moderate local administration site reactions.

conclusionThis is the first paediatric trial to provide robust evidence of efficacy and safety of the SQ tree SLIT-tablet in tree pollen-induced AR/C in a paediatric population (5-17 years).

Indexed as

AllergensRhinitis, Allergic, SeasonalSublingual ImmunotherapyTreesAdolescentBetulaChildChild, PreschoolFemaleHumansMalePollenTabletsTreatment OutcomeAllergensTabletsallergic rhinoconjunctivitisallergy immunotherapychildrensublingual immunotherapy tablettree pollen

Identifiers

PMID39495086
PMCPMC11891417

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.