Efficacy and Safety of HDM SLIT Tablet in Japanese Adults with Allergic Asthma.

BACKGROUND: The standardized quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT) tablet has demonstrated efficacy and safety for allergic asthma (AA) in European trials. OBJECTIVE: To evaluate the efficacy and safety of SQ HDM SLIT tablet treatment for up to 19 months in Japanese adults with AA. METHODS: In this randomized, double-blind, placebo-controlled trial, patients aged 18 to 64 years with AA were randomly assigned (1:1:1) to SQ HDM SLIT doses of 10,000 or 20,000 Japanese Allergy Unit or placebo. Subjects had Asthma Control Questionnaire score of 1.0 to 1.5 and daily inhaled corticosteroid use of 200 to 400 mu g of fluticasone propionate at randomization. The primary end point was the time from randomization to the first asthma exacerbation as the inhaled corticosteroid dose was being reduced. RESULTS: Of the 826 randomized subjects, 693 (84%) completed the trial. No statistically significant differences between the active groups and the placebo group were observed for the primary or any other efficacy end points. However, post hoc analysis indicated a significant difference between the 20,000 Japanese Allergy Unit and placebo groups among subjects who used a short-acting beta(2)-agonist during the baseline period (hazard ratio, 0.70; 95% CI, 0.48-1.00; P = .04997). No deaths or anaphylactic reactions were reported. Most adverse events were mild to moderate in severity. CONCLUSIONS: The trial demonstrated a favorable safety profile of the SQ HDM SLIT tablet in Japanese adult patients with AA. The treatment appeared to be efficacious in patients requiring rescue medication (ie, short-acting beta(2)-agonist) at baseline in the efficacy assessment using asthma exacerbation during inhaled corticosteroid reduction (JapicCTI number 121847). (C) 2019 American Academy of Allergy, Asthma & Immunology