Safety and effectiveness of a 300 IR house dust mite sublingual tablet: descriptive 4-year final analysis of a post-marketing surveillance in Japan.
Immunotherapy
; 15(16): 1401-1414, 2023 11.
Article
em En
| MEDLINE
| ID: mdl-37727966
ABSTRACT
Background:
Data are limited for clinical outcomes with house dust mite (HDM) allergen immunotherapy beyond 2 years' observation. Materials &methods:
A post-marketing drug-use survey assessed the safety and effectiveness of the 300 index of reactivity (IR) HDM tablet during use for up to 4 years in Japan.Results:
538 patients were evaluable for safety and 383 for effectiveness. Most adverse drug reactions (ADRs) occurred early and were local reactions; 5.6% of 249 total events were reported during years 2 to 4 as new ADRs after the interim analysis. The CAP-RAST score was identified as a potential risk factor for ADRs. The proportion of evaluable patients with severe allergic rhinitis symptoms decreased from 46.4% at baseline (n = 317) to 1.0% at 4 years (n = 104). Patients (n = 16) who discontinued 300 IR HDM tablet due to symptomatic improvement had sustained improvement relative to baseline 1 to 2 years later.Conclusion:
Long-term use of the 300 IR HDM tablet is safe and effective.
The 300 index of reactivity house dust mite (HDM) sublingual tablet (Actair®) is a treatment option for people with HDM allergy. A Japanese study investigated the safety and effectiveness of the HDM sublingual tablet during its use for up to 4 years. Less than a third of patients (29%) reported adverse effects, mainly itching or irritation in the mouth. The percentage of patients with no allergic rhinitis symptoms increased from 0.3% before treatment to 57.7% after 4 years of use. The percentage of patients who perceived that their allergic rhinitis had improved 'substantially' compared with before treatment increased from 22.3% at 6 months to 73.5% at 4 years. Patients who ended treatment with the HDM sublingual tablet because their symptoms had improved continued to perceive benefit 1 to 2 years later. Clinical Trial Registration University hospital Medical Information Network (UMIN) Clinical Trials Registry identifier UMIN000042840.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
/
Imunoterapia Sublingual
/
Rinite Alérgica
Tipo de estudo:
Prognostic_studies
/
Risk_factors_studies
/
Screening_studies
Limite:
Animals
/
Humans
País/Região como assunto:
Asia
Idioma:
En
Revista:
Immunotherapy
Assunto da revista:
ALERGIA E IMUNOLOGIA
/
TERAPEUTICA
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Japão