Impact of AIT on Allergic Rhinitis and Asthma

ALK-Abelló A/S92,048 enrolled

Overview

The study will assess the effectiveness of AIT treatment in real clinical practice in Germany.

Allergic rhinitis (AR) affects 23-30% of the European population and is associated with a major burden on public health. AR and asthma frequently coexist, and may both be caused by allergen exposure. While the efficacy of AIT, i.e. reduce symptoms and medication use in patients with AR and asthma, has been demonstrated in several randomized clinical trials, little is known about the use and effectiveness of AIT in real world clinical practice. This study is a retrospective database study that uses real-world data from Germany. The study population consists of AR patients with and without asthma treated with AIT and matched controls not treated with AIT. Information about the patients and treatments will be obtained from the 'BKK German Sickness Fund Database' from 2007 until 2017.

Study Type

OBSERVATIONAL

Enrollment

92,048

Conditions

Allergy Respiratory Disease

Interventions

Allergy immunotherapy (AIT)DRUG

Immunotherapy for different types of allergies

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria for the AIT cohort: * At least two index-AIT prescriptions during the first FU-year * At least one confirmed AR diagnosis during the study period * Continuous enrollment (no gaps in insurance time-defined by days) for 12 months before the index event (in the pre-index period) * Continuous enrollment (no gaps in insurance time-defined by days) for at least 12 months after the index event (in the post-index period) Inclusion Criteria for the Control Cohort: \- For the control groups, the same inclusion criteria will apply, with the exception of inclusion criterion 1, i.e. controls have not received AIT before baseline. Exclusion Criteria: \- AIT prescription 12 months before the index event (in the pre-index period) for the AIT treatment group

Locations (1)

ALK Abelló

Hørsholm, Denmark

Outcomes

Primary Outcomes

Allergic rhinitis medication use

Number of patients with an AR prescription and number of prescriptions by drug class

Time frame: From pre-index year to follow-up year(s), assessed from 2007 and up to 2017

Secondary Outcomes

Asthma medication use

Number of patients with an asthma prescription and number of prescriptions by drug class

Time frame: From pre-index to follow-up year(s), assessed from 2007 and up to 2017

Change in asthma disease severity

Change in asthma disease severity assessed by asthma diagnoses, asthma medication use and severe asthma exacerbation

Time frame: From pre-index to follow-up year(s), assessed from 2007 and up to 2017

Data from ClinicalTrials.gov

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