SQ HDM Sublingual Immunotherapy Tablet for the Treatment of HDM Allergic Rhinitis and Asthma Improves Subjective Sleepiness and Insomnia: An Exploratory Analysis of the Real-life CARIOCA Study.

Background: Knowledge of the effectiveness of house dust mite (HDM) sublingual immunotherapy (SLIT) in allergic rhinitis (AR) and asthma associated sleep disorders remains incomplete. A noninterventional study was conducted to assess the effect of the standardized quality (SQ) HDM SLIT tablet on safety and symptoms in adults with respiratory allergies caused by HDM. The study also assessed the status of insomnia and daytime sleepiness in patients with AR and/or asthma-associated sleep disorders treated with the SQ HDM SLIT tablet.

Methods: This was a 12-month multicenter, longitudinal, and prospective study. Participants started the SQ HDM SLIT tablet for moderateto-severe HDM-induced AR that was persistent despite the use of symptom relieving medication or HDM-induced asthma-associated sleep disorders that were not well controlled with inhaled corticosteroids and were associated with mild-to-severe HDM-induced AR. Sleep symptoms were measured using the Insomnia Severity Index (ISI) questionnaire and the Epworth Sleepiness Scale (ESS).

Results: A total of 1526 adult patients were enrolled, and 1483 were eventually included in the analysis. At baseline, 41.5% of patients reported sleep disorders; of these, 77.0% had insomnia and 28.9% experienced excessive daytime sleepiness. Insomnia was significantly more frequent among patients with uncontrolled AR (83.1%) than among those with controlled AR (52.6%) (P<.0001). Over time, 48.3% and 59.7% of patients, respectively, reported an improvement greater than the minimal clinically important difference in the ISI and ESS scales.

Conclusion: In patients with HDM-induced AR and/or asthma-associated sleep disorders, an improvement in subjective insomnia and sleepiness was observed after 1 year of treatment with the SQ HDM SLIT tablet in a real-life setting.