Shortened up-dosing with sublingual immunotherapy drops containing tree allergens is well tolerated and elicits dose-dependent clinical effects during the first pollen season.
AE, adverse event
ARIA, Allergic Rhinitis and its Impact on Asthma
Adherence
Asthma
Conjunctivitis
IgE, immunoglobulin E
Immunotherapy
N, number
PHD, Patient's Hay Fever Diary
Pollen allergy
Pre-seasonal
RCAT, Rhinitis Control Assessment Test
Rhinitis
SD, standard deviation
SLI, symptom load index
SLIT
SLIT, sublingual immunotherapy
SmPC, Summary of Product Characteristics
Sublingual immunotherapy
TU, therapeutic units
V, visit
sIgE, specific immunoglobulin E
Journal
The World Allergy Organization journal
ISSN: 1939-4551
Titre abrégé: World Allergy Organ J
Pays: United States
ID NLM: 101481283
Informations de publication
Date de publication:
2019
2019
Historique:
received:
09
08
2018
revised:
06
11
2018
accepted:
07
01
2019
entrez:
3
4
2019
pubmed:
3
4
2019
medline:
3
4
2019
Statut:
epublish
Résumé
This study compared a rapid home-based up-dosing schedule for sublingual immunotherapy (SLIT) drops containing tree pollen allergens with two previously established schedules. Furthermore, the clinical effect of the SLIT was investigated with respect to patients' first pollen season under treatment. In this open-label, prospective, patient-preference, non-interventional study, local and systemic reactions were compared between three up-dosing groups using a SLIT formulation containing birch, alder, and hazel pollen extracts (ORALVAC In 33 study centres in Germany and Austria, 164 patients were included. The treatment was well tolerated, without difference between the groups during the up-dosing phase. At the end of the assessment, 96.1% rated the tolerability of the treatment as good or very good. Local reactions were mostly mild in severity and no serious adverse events occurred. Symptom scores decreased from the 2016 pollen season to the 2017 pollen season. As for the ARIA classification, 79.0% of patients had persistent, moderate-to-severe rhinitis before treatment, but only 18.6% had the same classification after treatment. In all, 62.4% of patients achieved symptom control, and 34.3% of patients required no symptomatic medication after treatment. The rhinoconjunctivitis score was 34.4% lower for pre-seasonal treatment initiation than for the control group. Crowd-sourced symptom load indices showed that the 2016 season caused slightly more symptoms; however, it is assumed that this difference of 0.3-0.5 (score range 0-10) was of less clinical relevance. The treatment administered using the rapid home-based up-dosing schedule was safe and well tolerated. Symptom relief and reduction in medication use were observed during the first pollen season with SLIT. NCT03097432 (clinicaltrials.gov).
Sections du résumé
BACKGROUND
BACKGROUND
This study compared a rapid home-based up-dosing schedule for sublingual immunotherapy (SLIT) drops containing tree pollen allergens with two previously established schedules. Furthermore, the clinical effect of the SLIT was investigated with respect to patients' first pollen season under treatment.
METHODS
METHODS
In this open-label, prospective, patient-preference, non-interventional study, local and systemic reactions were compared between three up-dosing groups using a SLIT formulation containing birch, alder, and hazel pollen extracts (ORALVAC
RESULTS
RESULTS
In 33 study centres in Germany and Austria, 164 patients were included. The treatment was well tolerated, without difference between the groups during the up-dosing phase. At the end of the assessment, 96.1% rated the tolerability of the treatment as good or very good. Local reactions were mostly mild in severity and no serious adverse events occurred. Symptom scores decreased from the 2016 pollen season to the 2017 pollen season. As for the ARIA classification, 79.0% of patients had persistent, moderate-to-severe rhinitis before treatment, but only 18.6% had the same classification after treatment. In all, 62.4% of patients achieved symptom control, and 34.3% of patients required no symptomatic medication after treatment. The rhinoconjunctivitis score was 34.4% lower for pre-seasonal treatment initiation than for the control group. Crowd-sourced symptom load indices showed that the 2016 season caused slightly more symptoms; however, it is assumed that this difference of 0.3-0.5 (score range 0-10) was of less clinical relevance.
CONCLUSION
CONCLUSIONS
The treatment administered using the rapid home-based up-dosing schedule was safe and well tolerated. Symptom relief and reduction in medication use were observed during the first pollen season with SLIT.
TRIAL REGISTRATION NUMBER
BACKGROUND
NCT03097432 (clinicaltrials.gov).
Identifiants
pubmed: 30937138
doi: 10.1016/j.waojou.2019.100012
pii: S1939-4551(19)30099-7
pii: 100012
pmc: PMC6439405
doi:
Banques de données
ClinicalTrials.gov
['NCT03097432']
Types de publication
Journal Article
Langues
eng
Pagination
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