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Background <p>Randomized clinical trials have demonstrated the efficacy and safety of eptinezumab. The aim of this study was to evaluate the effectiveness and safety of eptinezumab in a real-world setting among patients with difficult-to-treat migraine in France.</p> Methods <p>This is a one year-prospective real-word study including all consecutive adult patients from the <i>Federation Hospitalo-Universitaire</i> InovPain registry who received intravenous eptinezumab 100&#xa0;mg.</p> Results <p>Three hundred and two patients (83.8% female / mean age of 48.0 ± 13.9 years) were included. Patients had at least 8 monthly migraine days, had failed at least 3 previous prophylactic treatments across amitryptiline, betablockers, botulinum toxin, candesartan, and topiramate and were Calcitonin Gene Related Peptide monoclonal antibodies naïve. Among them, 184 patients (60.9%) had chronic migraine and 118 (39.1%) had episodic migraine, whereas 229 patients (75.8%) presented a medication overuse. Regarding the primary endpoint, 50% responder rate at month 3, month 6, and month 12 was 35.4% (107/302), 39.0% (96/246), and 45.7% (63/138), respectively. ≥30% responder rate at month 3, month 6, and month 12 was 48.7% (147/302), 56.1% (138/246), and 63.0% (87/138), respectively. ≥75% responder rates at M3, M6, and M12 was 10.9% (33/302), 15.4% (38/246), and 23.2% (32/138), respectively. The effectiveness of eptinezumab was confirmed by significant changes in the values of all patient reported outcome measures at all assessment time points compared with baseline, demonstrating improvement in functional impact (Headache Impact Test-6), emotional impact (Hospital Anxiety Depression Scale), interictal burden (Migraine Interictal Burden Scale-4), and quality of life (Euro Qol-5 Dimensions descriptive system and visual analogue scale). According to Patient Global Impression of Change, the proportions of patients reporting being “much improved” or “very much improved” were 41.9% at month 3, 54.8% at month 6 and 74.4% at month 12. Overall, effectiveness appeared similar in episodic migraine and chronic migraine except at month12, where rates of 50% and 75% response were significantly higher in the chronic migraine (50% response: 53.8% vs. 34.5%, <i>p</i> = 0.025; 75% response: 30% vs. 13.8%, <i>p</i> = 0.026). Adverse events were uncommon and mostly mild, transient, and self-limited with few expected hypersensitivity reactions.</p> Conclusions <p>This French real-word study confirms the effectiveness and safety of eptinezumab in difficult-to-treat patients with migraine who and have failed non-specific preventive migraine treatments and are naïve to Calcitonin Gene Related Peptide monoclonal antibodies.</p> Clinical trial number <p>Not applicable.</p>

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Twelve-months prospective real-world assessment of effectiveness and safety of eptinezumab in migraine patients difficult-to-treat and naïve to CGRP monoclonal antibodies: results of the French FHU INOVPAIN registry

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  • 发表日期：

    2026年7月29日

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  • S. Ferrao-Malheiro,
  • R. Fabre,
  • T. Jiacomini,
  • M. Lanteri-Minet

摘要

Background

Randomized clinical trials have demonstrated the efficacy and safety of eptinezumab. The aim of this study was to evaluate the effectiveness and safety of eptinezumab in a real-world setting among patients with difficult-to-treat migraine in France.

Methods

This is a one year-prospective real-word study including all consecutive adult patients from the Federation Hospitalo-Universitaire InovPain registry who received intravenous eptinezumab 100 mg.

Results

Three hundred and two patients (83.8% female / mean age of 48.0 ± 13.9 years) were included. Patients had at least 8 monthly migraine days, had failed at least 3 previous prophylactic treatments across amitryptiline, betablockers, botulinum toxin, candesartan, and topiramate and were Calcitonin Gene Related Peptide monoclonal antibodies naïve. Among them, 184 patients (60.9%) had chronic migraine and 118 (39.1%) had episodic migraine, whereas 229 patients (75.8%) presented a medication overuse. Regarding the primary endpoint, 50% responder rate at month 3, month 6, and month 12 was 35.4% (107/302), 39.0% (96/246), and 45.7% (63/138), respectively. ≥30% responder rate at month 3, month 6, and month 12 was 48.7% (147/302), 56.1% (138/246), and 63.0% (87/138), respectively. ≥75% responder rates at M3, M6, and M12 was 10.9% (33/302), 15.4% (38/246), and 23.2% (32/138), respectively. The effectiveness of eptinezumab was confirmed by significant changes in the values of all patient reported outcome measures at all assessment time points compared with baseline, demonstrating improvement in functional impact (Headache Impact Test-6), emotional impact (Hospital Anxiety Depression Scale), interictal burden (Migraine Interictal Burden Scale-4), and quality of life (Euro Qol-5 Dimensions descriptive system and visual analogue scale). According to Patient Global Impression of Change, the proportions of patients reporting being “much improved” or “very much improved” were 41.9% at month 3, 54.8% at month 6 and 74.4% at month 12. Overall, effectiveness appeared similar in episodic migraine and chronic migraine except at month12, where rates of 50% and 75% response were significantly higher in the chronic migraine (50% response: 53.8% vs. 34.5%, p = 0.025; 75% response: 30% vs. 13.8%, p = 0.026). Adverse events were uncommon and mostly mild, transient, and self-limited with few expected hypersensitivity reactions.

Conclusions

This French real-word study confirms the effectiveness and safety of eptinezumab in difficult-to-treat patients with migraine who and have failed non-specific preventive migraine treatments and are naïve to Calcitonin Gene Related Peptide monoclonal antibodies.

Clinical trial number

Not applicable.