A 24-week prospective, multicenter, real-world study on eptinezumab's effectiveness and safety in migraine prevention (EMBRACE II).

INTRODUCTION

We evaluated the effectiveness, tolerability, and safety of eptinezumab in preventing high-frequency episodic migraine (HFEM) and chronic migraine (CM) over 24 weeks in real-world. We also assessed its impact during the first treatment week, in patients failing monoclonal antibodies targeting the calcitonin gene-related peptide (anti-CGRP mAbs), and the effects of dose escalation to 300 mg in patients requiring enhanced control.

METHODS

EMBRACE II is a multicenter (n = 22), prospective, 24-week, real-world study involving consecutive patients with HFEM or CM who had failed > 3 preventive treatments. Eptinezumab (100 mg, with the option for escalation to 300 mg at week 12) was administered quarterly.

PRIMARY ENDPOINT

change in monthly migraine days (MMD), for HFEM or monthly headache days (MHD), for CM, between weeks 21-24 and baseline. Secondary endpoints: changes in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), Migraine Disability Assessment Scale (MIDAS), Migraine Interictal Burden Scale (MIBS-4), and responder rates.

RESULTS

Of the 215 participants who had received ≥ 1 eptinezumab dose, 74 were treated for ≥ 24 weeks and considered for effectiveness analysis. Eptinezumab significantly (p < 0.001) reduced MMD/MHD (- 10.5), MAI (- 15.6), NRS (- 2.2), HIT-6 (- 9.9), MIDAS (- 48.7), and MIBS-4 (- 4.3). ≥ 50% responders were 69%, ≥ 75% responders 39.2%, and 100% responders 4.1%. Comparing the first week with the last baseline week, a significant reduction in migraine days was observed (- 3.7; p < 0.001). Significant improvements were seen in patients failing anti-CGRP mAbs (32.4%) and in those escalating to 300 mg (33.8%). Half of the subjects reported being "very much improved" or "much improved". The adverse events were infrequent (2.8%).

CONCLUSIONS

This real-world study documents that 24-week eptinezumab treatment is rapidly effective and well tolerated in migraine patients with multiple therapeutic failures (including anti-CGRP mAbs). One-third of patients escalated to 300 mg at week 12, achieving further significant migraine-related disability reduction.