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

Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma - Outcomes From a Multinational Register Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma; Allergy; Allergic Rhinitis
• Intervention / Treatment: Drug: SQ SLIT-tablet

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 Type: Observational
• Enrollment (Estimated): 49844

Contacts and Locations

• Study Contact: Name: Julie F Rask Larsen, MD PhD; Phone Number: +4525286000; Email: JREDK@alk.net
• Study Contact Backup: Name: Sarah Buchs, MSc; Phone Number: +4540976173; Email: SBCDK@alk.net

Study Locations

• Denmark
  • Copenhagen
    • Hørsholm, Copenhagen, Denmark, DK-2970
      • ALK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Allergic rhinitis patients with and without asthma treated with SQ SLIT-tablet	Drug: SQ SLIT-tablet; SQ grass SLIT-tablet and/or SQ house dust mite SLIT-tablet
Allergic rhinitis patients with and without asthma not treated with SQ SLIT-tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication use for asthma	Overall number of prescriptions and by individual drug classes	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
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

Other Outcome Measures

Outcome Measure	Time Frame
Health care resource utilisation assessed by ambulatory care visits	From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Health care resource utilisation assessed by hospitalisations	From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Health care resource utilisation assessed by cost	From pre-index to follow-up year(s), assessed from 2005 and up to 2021

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Collaborators: Quantify Research
• Investigators: Study Director: Julie F Rask Larsen, MD PhD, ALK

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: House dust mite; Allergy immunotherapy; Grass; Sublingual immunotherapy (SLIT)-tablets; Retrospective cohort study
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Asthma; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: NI-X-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No