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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT05375097

Collaborator

(none)

162

Enrollment

Location

10.3

Actual Duration (Months)

15.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Other: Erenumab

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.

Study Design

Study Type:

Observational

Actual Enrollment :

162 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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)

Actual Study Start Date :

Jul 3, 2020

Actual Primary Completion Date :

May 14, 2021

Actual Study Completion Date :

May 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Erenumab responder patients 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 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
Migraine controls 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

Arm

Intervention/Treatment

Erenumab responder patients

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

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

Migraine controls

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in number of sick leave days (all cause) [throughout the study, approximately 2 years]
Sick 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 years]
Number of headache related healthcare visits were reported.
Change in number of healthcare visits (all cause) [throughout the study, approximately 2 years]
Number of healthcare visits were reported.
Medication patterns: Number of patients receiving medications of interest [throughout the study, approximately 2 years]
The number of patients receiving medications of interest in erenumab treated patients in migraine patient controls were reported.