Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.

Study Overview
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Brief Summary
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This was a retrospective registry-based study utilizing data collected in association with clinical care of patients. All data was stored in electronic health records at Terveystalo data base, and no patients were contacted for the study.

Detailed Description
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Patients initiating erenumab treatment between 20.9.2018 - 15.10. 2019, and data on sick leave days, diagnoses and health care visits as well as medications based on prescriptions were assessed. Following time frames for analyses of sick leaves and health care utilization in patients on erenumab treatment and in controls were reported: Follow-up analyses: For cases (erenumab) with occupational healthcare, a minimum of 12 months on erenumab treatment was required for the analysis of sick leaves and visits Pre erenumab: Follow-up data before index (defined as the first reimbursement decision/prescription for erenumab, or initiation of erenumab injections (before reimbursement approval)) from the Terveystalo database of those with consent Post erenumab: Follow-up data after index, from the Terveystalo database of those with consent Time frames for comparison (sick leaves and visits): One year before index vs. >12 months erenumab after index, One year before index vs. 6-12 months of erenumab after index (patient years), sensitivity analysis Time frames for comparison (medications): 12 months before index vs. 12 months post follow-up Controls (triptan treated migraine patients): Corresponding time frames as in cases.

Official Title
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Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities Based on Occupational Health Care Registry in Finland: an Observational Retrospective Mirror-image Study (REFI)

Conditions
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Migraine

Intervention / Treatment
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* Other: Erenumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients on erenumab treatment ATC: N02CX07 Diagnosis of migraine (ICD G43) Consented Occupational healthcare Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Erenumab responder patients<br>Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses | Other: Erenumab<br>* Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses<br>|
| Migraine controls<br>Age and gender matched migraine patients on triptan medication, excluding those on botulinum toxin, erenumab and fremanezumab to benchmark the level of HCRU, sick leaves, and medication patterns | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sick leave days (headache) | Sick leaves included migraine or head-ache related registered sick leave days at Terveystalo in the occupational healthcare cohort and controls. | throughout the study, approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of sick leave days (all cause) | Sick leaves included all registered sick leave days at Terveystalo in the occupational healthcare cohort and controls. | throughout the study, approximately 2 years | 
| Change in number of healthcare visits (head-ache related) | Number of headache related healthcare visits were reported. | throughout the study, approximately 2 years | 
| Change in number of healthcare visits (all cause) | Number of healthcare visits were reported. | throughout the study, approximately 2 years | 
| Medication patterns: Number of patients receiving medications of interest | The number of patients receiving medications of interest in erenumab treated patients in migraine patient controls were reported. | throughout the study, approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erenumab,, CGRP,, real world evidence,, sick leaves,, working impairment,, health care visits,, prescriptions,, migraine