Efficacy and safety of <scp>SQ</scp> house dust mite sublingual immunotherapy‐tablet in Japanese children

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>The <jats:styled-content style="fixed-case">SQ</jats:styled-content> house dust mite (<jats:styled-content style="fixed-case">HDM</jats:styled-content>) sublingual immunotherapy (<jats:styled-content style="fixed-case">SLIT</jats:styled-content>)‐tablet (<jats:styled-content style="fixed-case">TO</jats:styled-content>‐203, Torii, Japan/<jats:styled-content style="fixed-case">ALK</jats:styled-content>, 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 <jats:styled-content style="fixed-case">HDM</jats:styled-content> allergic rhinitis (<jats:styled-content style="fixed-case">AR</jats:styled-content>).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In this randomized, double‐blind, placebo‐controlled trial, 458 Japanese children were randomly assigned to a daily <jats:styled-content style="fixed-case">SQ HDM SLIT</jats:styled-content>‐tablet [10 000 Japanese Allergy Unit (<jats:styled-content style="fixed-case">JAU</jats:styled-content>), equivalent to 6 <jats:styled-content style="fixed-case">SQ</jats:styled-content>‐<jats:styled-content style="fixed-case">HDM</jats:styled-content> in Europe and the <jats:styled-content style="fixed-case">US</jats:styled-content>] or placebo (1:1) treatment for 1 year. Inclusion required an <jats:styled-content style="fixed-case">AR</jats:styled-content> symptom score of ≥7 on at least 7 days during a 14‐day run‐in period while symptomatic treatment was withdrawn.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 (<jats:styled-content style="fixed-case">TCRS</jats:styled-content>) comprising <jats:styled-content style="fixed-case">AR</jats:styled-content> symptom and medication scores during the last 8 weeks of the treatment period.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The analysis of primary endpoint demonstrated statistically significant absolute reduction in <jats:styled-content style="fixed-case">TCRS</jats:styled-content> of 1.22 with a relative difference of 23% (95% confidence interval, 14% to 31%) in the 10 000 <jats:styled-content style="fixed-case">JAU</jats:styled-content> compared with placebo. Predefined stratified analyses revealed the same degree of efficacy of 1.11 (<jats:italic>P </jats:italic>=<jats:italic> </jats:italic>0.002), 21% (8% to 32%) and 1.36 (<jats:italic>P </jats:italic>=<jats:italic> </jats:italic>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>This trial, for the first time, demonstrated the efficacy and safety of the <jats:styled-content style="fixed-case">HDM SLIT</jats:styled-content>‐tablet in pediatric patients with moderate‐to‐severe <jats:styled-content style="fixed-case">HDM AR</jats:styled-content> (Japic<jats:styled-content style="fixed-case">CTI</jats:styled-content>‐152953).</jats:p></jats:sec>