Unlocking Real-World Insights into Migraine Treatment: Illuminating Long-Term Safety and Utilization of Galcanezumab

Galcanezumab (Emgality®) is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway for migraine prophylaxis. While clinical trials demonstrated efficacy and short-term safety, questions remain around long-term safety, rare adverse events, and use in patient populations excluded from trials (e.g., older adults, those with cardiovascular risk).

Research challenge

To address these gaps, a retrospective cohort study (EU PAS Register EUPAS27594) was initiated to evaluate drug utilization and long-term safety of galcanezumab across routine clinical practice in Europe, including serious cardiovascular events, hypersensitivity reactions, and malignancies.

Post-authorization safety and utilization studies face several challenges:

• Detecting rare and long-latency events (e.g., malignancy, serious hypersensitivity) that are too infrequent for clinical trials to capture
• Studying populations excluded from randomized controlled trials (RCTs), such as patients ≥65 years or those with preexisting cardiovascular conditions, who may be at differential risk
• Ensuring complete capture of healthcare encounters across care settings and validating diagnostic or outcome measures
• Harmonizing data across different European databases with varying coding systems and completeness