Tolerability and Safety of Sublingual Immunotherapy in Patients with Tree Pollen Allergy in Daily Practice—An Open, Prospective, Non-Interventional Study

To investigate the tolerability and safety of two sublingual tree pollen extracts approved in 2018, a non-interventional study (NIS) was performed. This NIS was an 8-month observational study conducted at 84 sites throughout Germany. Study participants received either a sublingual liquid allergen ex...

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Bibliographic Details
Published in:Journal of clinical medicine 2023-08, Vol.12 (17), p.5517
Main Authors: Owenier, Christoph, Barnowski, Cornelia, Leineweber, Margret, Yu, Donghui, Verhagen, Marjan, Distler, Andreas
Format: Article
Language:English
Subjects:
Allergens
Allergic reaction
Allergies
Allergy
Asthma
Clinical medicine
Drug therapy
Hay fever
Health aspects
Immunotherapy
Marketing
Patient outcomes
Patients
Pollen
Rhinitis
Seasons
Sublingual drugs
Testing
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Summary:To investigate the tolerability and safety of two sublingual tree pollen extracts approved in 2018, a non-interventional study (NIS) was performed. This NIS was an 8-month observational study conducted at 84 sites throughout Germany. Study participants received either a sublingual liquid allergen extract of birch pollen (SBPE) or a liquid allergen extract consisting of a mixture of birch, hazel, and alder tree pollen (STPE). Data from 432 patients were analyzed for the occurrence of adverse events and patient compliance. At least one local reaction occurred in 69 (22.2%) patients, whereas systemic reactions were only observed in 27 (6.3%) patients. STPE-treated patients developed systemic reactions more frequently than SBPE-treated patients (SBPE: 9 (4.3%) vs. STPE: 18 (8.0%)). Only one patient developed a systemic grade III reaction. Severe systemic grade IV reactions were not observed. A total of 348 (98.6%) of the patients who completed all visits were satisfied or very satisfied with the sublingual immunotherapy (SLIT), and 322 (71%) patients completed all visits. Both investigated products were well tolerated by the patients and demonstrated a good safety profile. AEs were observed less frequently than in the preceding clinical phase III trial, and no new safety concerns were identified.
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm12175517