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

Completed

• Conditions: Migraine
• Interventions: Other: Erenumab

• Registration Number: NCT05375097
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study Start: 2020-07-03
• Primary Completion: 2021-05-14
• Study Completion: 2021-05-14
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Erenumab responder patients	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in number of healthcare visits (all cause)	throughout the study, approximately 2 years	Number of healthcare visits were reported.
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 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.
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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 East Hanover, New Jersey, United States