Background and importance Migraine is a very disabling and prevalent disease that needs new therapies to reduce episodes and improve patient’s quality of life. Erenumab and galcanezumab are subcutaneous monoclonal antibodies recently approved for migraine prophylaxis in patients with previous treatment failures.
Aim and objectives To assess the effectiveness and security in real-world conditions
Material and methods Observational retrospective study that included patients with the funded indication to start erenumab and galcanezumab in Spain (8 or more migraine days/month and three or more previous treatment failures) that were in treatment with any of them between October 2020 and September 2021.To evaluate the effectiveness, we recorded the average number of migraine days per month (NMDM) and the score of Headache Impact Test (HIT-6) for each patient at the beginning and at the end of the study period. Effectiveness is established in episodic migraine (EM) when there is a minimal reduction in the average NMDM of 50% and in chronic migraine (CM) when NMDM are reduced at least 30% with a decrease of minimum 5 points on HIT-6 score from the baseline value.
Results A total of 339 patients (80.27% women; mean age 46.7±11.4 years) were included. Before starting the prophylaxis, the average number of MDM of the previous 3 months were 21±7.4 days and the HIT-6 score was 66.20±5.82 points. After a mean follow-up period of 6.7±4.6 months per patient, patients that reached a response for each group according to the mentioned criteria were collected in the following table:
Only 12 (3.54%) patients discontinued treatment because of adverse effects (AE): 10 (83.33%) were in treatment with erenumab, and 2 (16.67%) with galcanezumab.
Conclusion and relevance We found in our study a higher proportion of responsive patients for each drug and type of migraine than did most clinical assays. In general these drugs are well tolerated, but it seems that erenumab has more limiting AE than galcanezumab in our population study. More real-world studies are needed to confirm these findings.
Conflict of interest No conflict of interest