HOUSE DUST MITE SUBLINGUAL IMMUNOTHERAPY TABLET IMPACT ON RHINITIS DAYS IN CHILDREN WITH ALLERGIC RHINITIS/RHINOCONJUNCTIVITIS

Symptoms of allergic rhinitis/rhinoconjunctivitis (AR/C) may interfere with children’s daily activities and school performance. Rhinitis days by severity were assessed in a clinical trial of the house dust mite (HDM) sublingual immunotherapy tablet (SLIT-tablet) in children with HDM AR/C. Children ages 5-11 years (N=1,460 randomized) received daily HDM SLIT-tablet or placebo for ≈52 weeks in this phase 3, randomized, double-blind trial (NCT04145219). Children had free access to symptom-relieving medication. Rhinitis days were based on the rhinitis daily symptom score [DSS] and rhinitis daily medication score [DMS]. Secondary endpoints were the proportion and odds ratio of a rhinitis mild day [DSS=0 or 1 and DMS=0] or exacerbation day [DSS≥6, or DSS=5 and one individual symptom scored as 3]. An exploratory endpoint was symptom-free days [DSS=0 and DMS=0]. During the last 2 weeks of the baseline period, both the HDM SLIT-tablet and placebo groups experienced a mean of 13 rhinitis exacerbation days. During the last 8 weeks of treatment, the odds of having a rhinitis symptom-free or mild day were higher with HDM SLIT-tablet treatment than with placebo, and the odds of an exacerbation day were lower (all p<0.001; Figure ). During the last 8 weeks, children treated with HDM SLIT-tablet had an average of 24 rhinitis mild days (median=22) compared with 20 days for placebo (median=12). Treatment with the HDM SLIT-tablet significantly increases the likelihood of days with mild or no rhinitis symptoms and decreases the likelihood of days with severe rhinitis symptoms for children with HDM AR/C.