Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma

Active, not recruiting

• Conditions: Asthma; Allergic Rhinitis; Allergy
• Interventions: Drug: SQ SLIT-tablet

• Registration Number: NCT05476484
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

To assess the impact of SQ SLIT-tablets (SQ Grass SLIT-tablet and SQ HDM SLIT-tablet) in Danish and Swedish allergic rhinitis (AR) patients, with or without asthma, between 2007-2020.

Detailed Description

Allergic rhinitis (AR) is an inflammatory disorder, characterised by pruritus, sneezing, rhinorrhoea, and nasal congestion. It is one of the most common disorders worldwide, with an estimated global prevalence of 10-30%. AR is a chronic and progressive disease, as the underlying respiratory allergy can progress into allergic asthma. The prevalence of asthma in patients with AR is high and estimated between 10-40%. The presence of AR commonly exacerbates asthma, increasing the risk of asthma exacerbations, emergency visits and hospitalisations for asthma.

Recently, the high-quality retrospective cohort REACT study (ClinicalTrial.gov: NCT04125888) found that allergy immunotherapy (AIT) was associated with long-term reduction in AR medication use as well as significant reductions in both controller and reliever asthma medication and concurrent lower risk of asthma exacerbation and pneumonia in subjects with pre-existing asthma. The SQ sublingual immunotherapy (SLIT)-tablets have robust evidence from randomised controlled trials (RCTs), but real-world evidence (RWE) is needed to complement the findings from RCTs by looking at e.g. longer time horizons and broader patient populations. As the REACT study was not designed to specifically look at evidence-based AIT treatments like the SQ SLIT-tablets, the real-world effectiveness of SQ SLIT tablets remain to be further elucidated.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 49844

Inclusion Criteria

AR-patients identified by dispensations of prescribed AR medications and/or ICD10-codes of AR in specialty care

For the SQ SLIT-tablet cohort:

• at least 2 dispensings within 365 days of SQ SLIT-tablets (ATC: V01AA02 and V01AA03)

For the control cohort:

• unexposed subjects will be identified from the study population of AR-patients that may be eligible to receive SQ SLIT-tablets, but have not dispensed a prescription of SQ SLIT-tablets during the index year of the case or prior to that year

Exclusion Criteria

• allergy immunotherapy treatment with grass or HDM allergens prior to the index event

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allergic rhinitis patients with and without asthma treated with SQ SLIT-tablet	SQ SLIT-tablet	-

Primary Outcome Measures

Name	Time	Method
Symptom-relieving medication use for allergic rhinitis	From pre-index to follow-up year(s), assessed from 2005 and up to 2021	Overall number of prescriptions and by individual drug classes

Secondary Outcome Measures

Name	Time	Method
Medication use for asthma	From pre-index to follow-up year(s), assessed from 2005 and up to 2021	Overall number of prescriptions and by individual drug classes
Lower airway infections assessed by prescriptions of antibiotics and diagnosis codes for pneumonia	From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Asthma disease severity assessed by reliever and controller medication prescriptions and hospitalisations due to asthma	From pre-index to follow-up year(s), assessed from 2005 and up to 2021

Trial Locations

Locations (1)

ALK; 🇩🇰 Hørsholm, Copenhagen, Denmark