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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIT Cohort | Allergic rhinitis patients with and without asthma treated with AIT |
| |
| Control Cohort | Allergic rhinitis patients with and without asthma not treated with AIT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergy immunotherapy (AIT) | Drug | Immunotherapy for different types of allergies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Allergic rhinitis medication use | Number of patients with an AR prescription and number of prescriptions by drug class | From pre-index year to follow-up year(s), assessed from 2007 and up to 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma medication use | Number of patients with an asthma prescription and number of prescriptions by drug class | From pre-index to follow-up year(s), assessed from 2007 and up to 2017 |
| Change in asthma disease severity |
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Inclusion Criteria for the AIT cohort:
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
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Allergic rhinitis patients with and without asthma
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| Name | Affiliation | Role |
|---|---|---|
| Mercedes Romano, PharmD, MBA, MSc | ALK Abelló | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALK Abelló | Hørsholm | DK-2970 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34901915 | Derived | Fritzsching B, Contoli M, Porsbjerg C, Buchs S, Larsen JR, Elliott L, Rodriguez MR, Freemantle N. Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study. Lancet Reg Health Eur. 2021 Nov 30;13:100275. doi: 10.1016/j.lanepe.2021.100275. eCollection 2022 Feb. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D012140 | Respiratory Tract Diseases |
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Change in asthma disease severity assessed by asthma diagnoses, asthma medication use and severe asthma exacerbation
| From pre-index to follow-up year(s), assessed from 2007 and up to 2017 |