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Clinical Trial
. 2025 Mar;80(3):807-816.
doi: 10.1111/all.16370. Epub 2024 Nov 14.

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

M Jutel  1   2 , C Vogelberg  3 , K Duwensee  4 , D Troyke  4 , L Klimek  5
Affiliations
Clinical Trial

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

M Jutel et al. Allergy. 2025 Mar.

Abstract

Background: Allergen 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.

Method: Patients, 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.

Results: One 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.

Conclusion: The 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.

Keywords: house dust mites; one‐strength dose escalation scheme; safety; subcutaneous allergen immunotherapy; tolerability.

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Conflict of interest statement

M.J. reports personal fees from ALK‐Abello, Allergopharma, Stallergenes, Anergis, Allergy Therapeutics, Leti, HAL, GSK, Novartis, Teva, Takeda, Chiesi, Pfizer, Regeneron, Astra Zeneka, Lallemand, Shire, CELLTRION Inc. Genetech, Roche, Verona, Lek Pharmaceuticals, Arcutis Biotherapeutics, FAES FARMA outside of submitted work and is the Allergy Journal Deputy Editor and EAACI Board of Officers Member—Past President. C.V. has received personal fees for lectures or consultancy from Aimmune Therapeutics, Allergopharma, ALK‐Abello, AstraZeneca, Bencard Allergie, DBV Technology, LETI Pharma, Novartis Pharma, Orion Pharma, Sanofi Aventis, and Stallergenes outside of submitted work. He is the President of the Society of Paediatric Allergology and Environmental Medicine and member of AeDA, DGAKI, EAACI, ERS. K.D. and D.T. are employees of Allergopharma GmbH & Co. KG, Reinbek, Germany. L.K. reports grants and personal fees from Allergopharma, grants and personal fees from Viatris, personal fees from HAL Allergie, personal fees from ALK Abelló, grants and personal fees from LETI Pharma, grants and personal fees from Stallergenes, grants from Quintiles, grants and personal fees from Sanofi, grants from ASIT bio‐tech, grants from Lofarma, personal fees from Allergy Therapeutics, grants from AstraZeneca, grants and personal fees from GSK, grants from Inmunotek, personal fees from Cassella med, personal fees from Novartis, personal fees from Regeneron Pharmaceuticals, personal fees from ROXALL Medizin GmbH, outside the submitted work; and Membership: AeDA; DGHNO; Deutsche Akademie fürAllergologie und klinische Immunologie; HNO‐BV; GPA; EAACI.

Figures

FIGURE 1
FIGURE 1
(A) Proportion of patients in the total population (adults and adolescents) experiencing and (B) number of total, local, systemic, and serious adverse drug reactions (ADRs) in the one‐strength and standard group. p‐values, Fisher's Exact test.
FIGURE 2
FIGURE 2
Number of adverse drug reactions (ADRs) in relation to individual injection number in the total population, including adults, and adolescents.
FIGURE 3
FIGURE 3
Overall tolerability of the one‐strength and standard dose escalation schemes assessed by investigators at the final visit for the total population (adolescents and adults) (p‐value from Mann–Whitney U‐test).
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