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House dust mite sublingual tablet is effective and safe in patients with allergic rhinitis
Y Okamoto1, S Fujieda2, M Okano3
1Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
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.
Insights
House dust mite (HDM) tablets effectively treated allergic rhinitis (AR) in a large study. The 300 IR dose showed significant symptom improvement and good safety over one year.
Area of Science:
- Allergy and Immunology
- Clinical Trials
- Pharmaceutical Research
Background:
- House dust mite (HDM) is a primary indoor allergen triggering allergic rhinitis (AR) and asthma.
- Sublingual immunotherapy offers a potential cure for HDM-induced AR, but large-scale data is scarce.
- This study assessed the efficacy and safety of HDM tablets for HDM-induced AR in adolescents and adults.
Purpose of the Study:
- To evaluate the efficacy of HDM tablets in treating allergic rhinitis (AR).
- To assess the safety profile of HDM tablets in patients with AR.
- To determine the optimal therapeutic dosage for HDM-induced AR.
Main Methods:
- A 52-week, double-blind, randomized trial involving 968 subjects (aged 12-64 years).
- Participants were assigned to 300 index of reactivity (IR), 500 IR, or placebo HDM tablets.
- Primary endpoint: Average Adjusted Symptom Score (AASS); Secondary endpoints: symptom scores, rescue medication use, and quality of life (JRQLQ).
Main Results:
- Both 300 IR and 500 IR HDM tablets significantly improved AASS compared to placebo (P < 0.001).
- Nasal symptoms improved in both active groups; rescue medication use and JRQLQ scores improved with 300 IR.
- Adverse events were mostly mild, with no drug-related serious adverse events.
Conclusions:
- One-year treatment with 300 IR and 500 IR HDM tablets is effective and safe for allergic rhinitis.
- The recommended therapeutic dose for HDM-induced AR is 300 IR.
- HDM tablets represent a viable treatment option for allergic rhinitis management.
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