Evidence map›Paper›PMID 39540587›Full record

Trial reportAllergy2025

One-strength dose escalation of house dust mite depot product for subcutaneous immunotherapy is safe and tolerable.

M Jutel, C Vogelberg, K Duwensee, D Troyke, L Klimek

Abstract readRandomized Controlled TrialClinical Trial, Phase II
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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Update on HDM Allergy: Principal Changes over the Years.International journal of molecular sciences · 2025
    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

5 authors.

M JutelAll-MED Medical Research Institute, Wrocław, Poland.ORCID https://orcid.org/0000-0003-1555-9379
C VogelbergDepartment of Pediatrics, Faculty of Medicine and University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.ORCID https://orcid.org/0000-0002-4881-8368
K DuwenseeAllergopharma GmbH & Co. KG, Reinbek, Germany.
D TroykeAllergopharma GmbH & Co. KG, Reinbek, Germany.
L KlimekCenter for Rhinology and Allergology, Wiesbaden, Germany.ORCID https://orcid.org/0000-0002-2455-0192

Funding

Allergopharma GmbH & Co. KG
6 · The paper itself

Abstract

backgroundAllergen immunotherapy (AIT) aims at modulating the immune response by administration of allergen preparations at regular intervals over several years (1). For subcutaneous AIT (SCIT), the treatment is initiated with a dose escalation phase followed by a maintenance dose administration. Over the last decade, there has been a trend towards shortening dose escalation regimens to increase patient adherence. This open-label, phase II trial aimed to investigate the safety and tolerability of a house dust mites (HDMs) SCIT product when used in a newly designed one-strength dose escalation scheme.

methodPatients, aged 12-65, suffering from HDM-allergic rhinitis/rhinoconjunctivitis ± asthma were included. Patients were randomized to the one-strength (6 injections from the highest strength 3) or the Standard dose escalation regimen (14 injections from strengths 1 to 3) using the HDMs-SCIT product. All adverse events were reported. Tolerability was assessed on the Likert scale.

resultsOne hundred and forty-three patients were randomized, 79 adults and 64 adolescents. In total, the one-strength regimen caused more adverse drug reactions (ADRs) than the Standard regimen (p = .0457). With both regimens most ADRs were local reactions which occurred more often in the one-strength group (p = .0393). But there was no significant difference in the number of patients affected by systemic or serious ADRs between both regimens. No relevant differences occurred between the two age groups and no other risks were observed for adolescents compared to adults.

conclusionThe safety and tolerability of both regimens can be considered comparable, as most ADRs were local reactions, primarily rated as mild in intensity. Nevertheless, the one-strength regimen caused more ADRs. Reducing the number of injections from 14 to 6 while using only one strength offers the potential to improve patient adherence which further might increase clinical efficacy. Future trials could confirm this hypothesis.

Indexed as

AllergensAntigens, DermatophagoidesDesensitization, ImmunologicPyroglyphidaeAdolescentAdultAgedAnimalsAsthmaChildFemaleHumansInjections, SubcutaneousMaleMiddle AgedRhinitis, AllergicAllergensAntigens, Dermatophagoideshouse dust mitesone‐strength dose escalation schemesafetysubcutaneous allergen immunotherapytolerability

Identifiers

PMID39540587
PMCPMC11891436

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Registered trials

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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.