Efficacy and safety of HDM SLIT-tablet in Japanese adults with allergic asthma.

Abstract

BACKGROUND\nThe SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet has demonstrated efficacy and safety for allergic asthma (AA) in European trials.\n\n\nOBJECTIVE\nTo evaluate the efficacy and safety of SQ HDM SLIT-tablet treatment for up to 19 months in Japanese adults with AA.\n\n\nMETHODS\nIn this randomized, double-blind, placebo-controlled trial, patients aged 18-64 with AA were randomly assigned (1:1:1) to SQ HDM SLIT doses of 10,000 or 20,000 Japanese Allergy Unit (JAU) or placebo. Subjects had Asthma Control Questionnaire score of 1.0-1.5 and daily inhaled corticosteroid (ICS) use of 200-400 μg of fluticasone propionate at randomization. The primary endpoint was the time from randomization to the first asthma exacerbation as the ICS dose was being reduced.\n\n\nRESULTS\nOf the 826 randomized subjects, 693 (84%) completed the trial. No statistically significant differences between the active groups and placebo group were observed for the primary or any other efficacy endpoints. However, post-hoc analysis indicated a significant difference between the 20,000 JAU and placebo groups among subjects who used a short-acting β2-agonist (SABA) during the baseline period (hazard ratio 0.70, 95% confidence interval 0.48-1.00, P=0.04997). No deaths or anaphylactic reactions were reported. Most adverse events were mild to moderate in severity.\n\n\nCONCLUSION\nThe 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 (i.e., SABA) at baseline in the efficacy assessment using asthma exacerbation during ICS reduction (JapicCTI number 121847).