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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

Jaffuel D1,2, Serrano E3, Leroyer C4, Chartier A5, Demoly P1,6

1Department of Respiratory Diseases, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, France.
2Inserm U1046 – CNRS 9214 – University of Montpellier, Montpellier, France.
3Department of ENT and Head and Neck Surgery, Hôpital Larrey, University Hospital of Toulouse, Toulouse, France.
4Clinical Investigation Center, CIC Inserm 1412, Hôpital Cavale Blanche, University Hospital of Brest, Brest, France.
5Medical Department, ALK, Courbevoie, France.
6IDESP, UMR UA11 Univ Montpellier - INSERM, Montpellier, France. 

J Investig Allergol Clin Immunol 2024; Vol. 34(5)
doi: 10.18176/jiaci.0934

Background: There are still gaps in the knowledge regarding the effectiveness of house dust mite (HDM) sublingual immunotherapy (SLIT) on allergic rhinitis (AR) and asthma (AA)-associated sleep disorders. A non-interventional study was conducted to assess the effect of the Standardized quality (SQ) HDM SLIT-tablet on safety and symptoms in adults with HDM respiratory allergies. The aim was to describe the status of insomnia and daytime sleepiness in AR and/or AA patients 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 moderate-to-severe HDM AR, persistent despite the use of symptom-relieving medication; or HDM AA not well controlled by inhaled corticosteroids and associated with mild-to-severe HDM AR. Sleep symptoms were measured using the Insomnia Severity Index (ISI) questionnaire and the Epworth Sleepiness Scale (ESS).
Results: A total of 1,526 adult patients were enrolled and 1,483 were included in the analysis. At baseline, 41.5% of patients reported sleep disorders: 77.0% of them had insomnia and 28.9% suffered from excessive daytime sleepiness. Insomnia was significantly more frequent among patients with uncontrolled AR (83.1%) than those with controlled AR (52.6%) (p<0.0001). Over time, 48.3% and 59.7% of patients reported an improvement greater than the minimal clinically important difference on the ISI and ESS scales respectively.
Conclusion: In patients with HDM AR and/or asthma associated sleep disorders, an improvement in subjective insomnia and sleepiness was observed after one year of treatment with the SQ HDM SLIT-tablet in a real-life setting.

Key words: Allergen immunotherapy, Allergic rhinitis, Allergic asthm, Control, House dust mite, Sleep