House dust mite sublingual tablet is effective and safe in patients with allergic rhinitis

Autor: Y Yoshida, Yoshitaka Okamoto, Shigeharu Fujieda, Mitsuhiro Okano, Shinji Kakudo, Keisuke Masuyama
Rok vydání: 2016
Předmět:
Male
0301 basic medicine
medicine.disease_cause
Average Adjusted Symptom Score
0302 clinical medicine
Allergen
Japan
Clinical endpoint
Immunology and Allergy
Child
house dust mite
biology
Pyroglyphidae
Middle Aged
Treatment Outcome
Experimental Allergy and Immunology
sublingual immunotherapy tablet
Original Article
Female
Onset of action
Tablets
Adult
medicine.medical_specialty
Adolescent
Immunology
Placebo
Young Adult
03 medical and health sciences
Internal medicine
medicine
Animals
Humans
Adverse effect
Asthma
House dust mite
Sublingual Immunotherapy
allergic rhinitis
business.industry
clinical study
Allergens
Immunoglobulin E
biology.organism_classification
medicine.disease
Rhinitis
Allergic
Surgery
030104 developmental biology
030228 respiratory system
Immunoglobulin G
ORIGINAL ARTICLES
business
Zdroj: Allergy
ISSN: 0105-4538
DOI: 10.1111/all.12996
Popis: Background House dust mite (HDM) is the major indoor allergen for allergic diseases such as allergic rhinitis (AR) and asthma. Although sublingual immunotherapy is a curative treatment for HDM-induced AR, data from large-scale studies are limited. We evaluated the efficacy and safety of HDM tablets in adolescent and adult patients (aged 12–64 years) with HDM-induced AR with or without intermittent asthma. Methods In a double-blind trial in Japan, 968 subjects were randomized 1 : 1 : 1 to 300 index of reactivity (IR), 500 IR, or placebo groups. The primary endpoint was the Average Adjusted Symptom Score (AASS) in the last eight weeks of the 52-week treatment. Secondary endpoints included individual nasal and ocular symptom scores, rescue medication use, and the Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) scores. Results The AASS in the last eight weeks of treatment significantly improved in both the 300 IR and the 500 IR groups compared to that in the placebo group (P < 0.001). In the 300 IR group, the onset of action occurred at week 8–10. All four nasal symptoms significantly improved in both active treatment groups; rescue medication use and JRQLQ outcome improved in the 300 IR group. Most adverse events (AEs) were mild, and 16 serious AEs (SAEs) were reported; however, none of them were drug-related. Conclusions One-year treatment with 300 IR and 500 IR HDM tablets was effective without major safety concerns. The recommended therapeutic dose for AR is 300 IR.
Databáze: OpenAIRE
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