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

Novartis

Status: Completed

Conditions: Migraine

Treatments: Other: Erenumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05375097

CAMG334AFI03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None

Trial design

162 participants in 2 patient groups

Erenumab responder patients

Description:

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

Treatment:

Other: Erenumab

Migraine controls

Description:

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