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Allergy. 2018 Dec;73(12):2352-2363. doi: 10.1111/all.13544. Epub 2018 Oct 10.

Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet in Japanese children.

Author information

1
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Yamanashi University, Yamanashi, Japan.
2
Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
3
Torii, Tokyo, Japan.
4
ALK, Hørsholm, Denmark.
5
Association of Pollen Information of Japan, Tokyo, Japan.
6
Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

Abstract

BACKGROUND:

The SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (TO-203, Torii, Japan/ALK, Denmark) treatment has been effective against respiratory allergic diseases in patients aged ≥12 years during European, Japanese, and North American trials. This trial was conducted to investigate the efficacy and safety of this treatment in Japanese children (5-17 years) with moderate-to-severe HDM allergic rhinitis (AR).

METHODS:

In this randomized, double-blind, placebo-controlled trial, 458 Japanese children were randomly assigned to a daily SQ HDM SLIT-tablet [10 000 Japanese Allergy Unit (JAU), equivalent to 6 SQ-HDM in Europe and the US] or placebo (1:1) treatment for 1 year. Inclusion required an AR symptom score of ≥7 on at least 7 days during a 14-day run-in period while symptomatic treatment was withdrawn. The primary endpoint was the total combined rhinitis score (TCRS) comprising AR symptom and medication scores during the last 8 weeks of the treatment period.

RESULTS:

The analysis of primary endpoint demonstrated statistically significant absolute reduction in TCRS of 1.22 with a relative difference of 23% (95% confidence interval, 14% to 31%) in the 10 000 JAU compared with placebo. Predefined stratified analyses revealed the same degree of efficacy of 1.11 (P = 0.002), 21% (8% to 32%) and 1.36 (P = 0.001), 26% (11% to 38%), respectively, in pediatric (5-11 years) and adolescent subjects (12-17 years). The treatment was well tolerated by both pediatric and adolescent subjects.

CONCLUSION:

This trial, for the first time, demonstrated the efficacy and safety of the HDM SLIT-tablet in pediatric patients with moderate-to-severe HDM AR (JapicCTI-152953).

KEYWORDS:

adolescent; allergy immunotherapy; house dust mite; pediatric; sublingual immunotherapy

PMID:
30043449
DOI:
10.1111/all.13544

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