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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05375097
Enrollment
162
Registered
2022-05-16
Start date
2020-07-03
Completion date
2021-05-14
Last updated
2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Erenumab,, CGRP,, real world evidence,, sick leaves,, working impairment,, health care visits,, prescriptions,, migraine

Brief summary

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

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.

Interventions

OTHERErenumab

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

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients on erenumab treatment ATC: N02CX07 * Diagnosis of migraine (ICD G43) * Consented * Occupational healthcare

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Number of sick leave days (headache)throughout the study, approximately 2 yearsSick leaves included migraine or head-ache related registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.

Secondary

MeasureTime frameDescription
Change in number of sick leave days (all cause)throughout the study, approximately 2 yearsSick leaves included all registered sick leave days at Terveystalo in the occupational healthcare cohort and controls.
Change in number of healthcare visits (head-ache related)throughout the study, approximately 2 yearsNumber of headache related healthcare visits were reported.
Change in number of healthcare visits (all cause)throughout the study, approximately 2 yearsNumber of healthcare visits were reported.
Medication patterns: Number of patients receiving medications of interestthroughout the study, approximately 2 yearsThe number of patients receiving medications of interest in erenumab treated patients in migraine patient controls were reported.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026