Monthly Headaches and Severity in Patients on Galcanezumab or Traditional Preventive Migraine Medication: A 24-Month Claims and Electronic Health Records Study.

INTRODUCTION

Migraine, affecting millions globally, imposes a significant burden on patients and healthcare systems. Calcitonin gene-related peptide monoclonal antibodies are recommended as first-line preventive treatments by international guidelines, yet real-world prospective studies comparing their year-long effectiveness to standard of care (SOC) treatments are time-consuming, resource-intense and therefore limited. This study aimed to test the utility of claims data and electronic health records (EHR) by evaluating changes in monthly headache days (MHDs) and disease severity among US patients with migraine receiving galcanezumab versus traditional standard-of-care preventive migraine medications.

METHODS

A real-world study was conducted using Optum data from US administrative claims and EHR of patients diagnosed with migraine and receiving galcanezumab or SOC. Changes in MHDs over a 24-month follow-up were converted from changes in acute medication using the Pharmacy Quality Alliance (PQA) measure for Migraine Preventive Therapy, and migraine severity was assessed using EHR free text. Data were analyzed using two-sample t-test, chi-square and Fisher exact tests.

RESULTS

Of 63,939 patients with eligible claims, 28,264 (44.2%) had notes in EHR; of those, 227 and 65 patients had information for migraine severity and headache days, respectively. Patients receiving galcanezumab showed significant improvement in MHDs compared to the SOC cohort when assessed using PQA measures (mean [SD] change from baseline to follow-up, - 0.18 [4.76] vs 0.15 [3.85]; p < 0.001). A significantly greater proportion of patients treated with galcanezumab exhibited a 50% reduction (25.9% vs 16.7%; p < 0.001) and 75% reduction (15.7% vs 11.6%; p < 0.001) in MHDs than the standard-of-care cohort. Mean change in migraine severity and MHDs was not determined by EHR because of low sample sizes.

CONCLUSION

In this exploration of multiple data sources and methodologies, changes in MHDs over 24 months were small in patients treated with galcanezumab or SOC. While real-world data from administrative claims and EHR provided insights, limitations such as small sample sizes for migraine severity data and challenges in extracting clinical outcomes underscore the need for further research.