Clinical trial NCT05476484: Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma
Official title: Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma - Outcomes From a Multinational Register Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Allergy
Allergic Rhinitis
Asthma
Keywords: Allergy immunotherapy
Sublingual immunotherapy (SLIT)-tablets
Grass
House dust mite
Retrospective cohort study
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Quantify Research
First posted: 2022-07-27
Enrollment: 49844
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AR-patients identified by dispensations of prescribed AR medications and/or ICD10-codes of AR in specialty care

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom-relieving medication use for allergic rhinitis
timeFrame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Secondary outcomes:
measure: Medication use for asthma
timeFrame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
measure: Asthma disease severity assessed by reliever and controller medication prescriptions and hospitalisations due to asthma
timeFrame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
measure: Lower airway infections assessed by prescriptions of antibiotics and diagnosis codes for pneumonia
timeFrame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Other outcomes:
measure: Health care resource utilisation assessed by ambulatory care visits
timeFrame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
measure: Health care resource utilisation assessed by hospitalisations
timeFrame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
measure: Health care resource utilisation assessed by cost
timeFrame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Locations:
city: Hørsholm
country: Denmark
facility: ALK
state: Copenhagen
Study officials:
affiliation: ALK
name: Julie F Rask Larsen, MD PhD
role: STUDY_DIRECTOR
References: