Major allergen content consistency of SQ house dust mite sublingual immunotherapy tablets and relevance across geographic regions.
Ann Allergy Asthma Immunol
; 117(3): 298-303, 2016 09.
Article
em En
| MEDLINE
| ID: mdl-27613464
ABSTRACT
BACKGROUND:
Consistency in composition and potency, particularly regarding major allergens, is crucial for the quality of extracts for allergen immunotherapy.OBJECTIVE:
To characterize the major allergen composition of house dust mite (HDM) extracts commercially available in the United States and the SQ HDM sublingual immunotherapy (SLIT) tablet, and to relate the composition to patient sensitization patterns.METHODS:
Der 1/Der 2 ratios were determined in 10,000- and 30,000-AU/mL HDM extracts from 5 US companies and the SQ HDM SLIT-tablet. Allergen content was analyzed by enzyme-linked immunosorbent assay and compared with an in-house reference. Sensitivity toward Der p 1, Der p 2, and Der p 10 was determined in serum from randomly selected subgroups of 220 individuals from North American and European SQ HDM SLIT-tablet trials.RESULTS:
Mean Der 1/Der 2 ratios in US HDM extracts ranged from 0.4 to 20.5. For the SQ HDM SLIT-tablet (20 batches), variability did not exceed 12% regarding content of Der f 1 (SD, 11.9%; 95% confidence interval [CI], 0.94-1.06), Der p 1 (SD, 6.1%; 95% CI, 0.97-1.03), and combined Der 2 allergen (SD, 6.4%; 95% CI, 0.97-1.03), indicating a consistent Der 1/Der 2 ratio. High allergen sensitivity frequencies toward Der p 1 and Der p 2 were observed regardless of geographic region. Efficacy of the SQ HDM SLIT-tablet has been demonstrated in 5 clinical trials.CONCLUSION:
The SQ HDM SLIT-tablet has efficacy potential for a broad range of patients because it includes a consistent 11 ratio of the 2 major HDM allergens to which individuals were most frequently sensitized across geographic regions. Efficacy has been demonstrated.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Comprimidos
/
Alérgenos
/
Antígenos de Dermatophagoides
/
Imunoterapia Sublingual
Tipo de estudo:
Clinical_trials
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Ann Allergy Asthma Immunol
Assunto da revista:
ALERGIA E IMUNOLOGIA
Ano de publicação:
2016
Tipo de documento:
Article