Eptinezumab Effective in Difficult-to-Treat Migraine

TOPLINEIntravenous (IV) eptinezumab 100 mg reduced monthly migraine days (MMDs) in patients with difficult-to-treat migraine who had failed at least 3 prior prophylactic treatments and were naive to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs). At 12 months, around 45% of patients achieved at least a 50% reduction in MMDs, with significant improvements in headache-related impact, quality of life, and emotional burden.METHODOLOGYA prospective, observational, single-center study conducted in France from June 2023 to September 2025 evaluated eptinezumab effectiveness and safety in migraine prevention.A total of 302 adult patients with migraine (mean age, 48.0 years; 83.8% women) were included, all of whom had at least 8 MMDs, had failed at least 3 previous prophylactic treatments across amitriptyline, botulinum toxin, beta-blockers, candesartan, or topiramate, and were CGRP mAb naive.Among participants, 60.9% had chronic migraine and 39.1% had episodic migraine; 75.8% of patients presented with medication overuse.Patients received eptinezumab 100 mg intravenously every 12 weeks, with effectiveness and safety assessed at months 3, 6, and 12 using prospective headache diaries and patient-reported outcome measures.The primary endpoint was the 50% responder rate, defined as proportion of patients achieving at least a 50% reduction in MMDs at months 3, 6, and 12 from baseline; secondary endpoints included 30% and 75% responder rates, changes in monthly headache days (MHDs), Headache Impact Test-6 (HIT-6), Hospital Anxiety and Depression Scale comprising two subscales (HADS-A and HADS-D), Migraine Interictal Burden Scale-4 (MIBS-4), and EuroQol 5-Dimension (EQ-5D) scores.TAKEAWAYThe 50% responder rate was 35.4% at month 3, 39.1% at month 6, and 45.7% at month 12; the 30% responder rate was 48.7%, 56.1%, and 63.0% at months 3, 6, and 12, respectively; the 75% responder rate was 10.9%, 15.4%, and 23.2% at the respective timepoints.Mean MMDs decreased significantly from 17.0 at baseline to 12.5 at month 3, 11.4 at month 6, and 9.2 at month 12 (all P < .001); mean MHDs decreased from 18.6 at baseline to 10.8 at month 12 (P < .001).Mean HIT-6 scores decreased from 67.0 at baseline to 58.4 at month 12 (P < .001); mean HADS-A scores decreased from 10.0 to 8.1 (P < .001); mean HADS-D scores decreased from 7.3 to 5.5 (P < .001); mean MIBS-4 scores decreased from 6.3 to 4.3 (P < .001).The percentage of patients with medication overuse decreased from 75.8% at baseline to 31.6% at month 12 (P < .001); among patients with chronic migraine at baseline, 68.8% were classified as episodic migraine by month 12. Adverse events were uncommon and mostly mild, transient, and self-limited.IN PRACTICE"This French real-word study confirms the effectiveness and safety of eptinezumab in difficult-to-treat patients with migraine who had previously failed non-migraine specific treatments and are naive to CGRP mAbs. For the international migraine community, these findings, which are consistent with those obtained with other CGRP mAbs, further support the clinical value of this innovative class of migraine therapies," the authors of the study wrote.SOURCEThe study was led by S. Ferrao-Malheiro, Pain Department, UR2CA-PIN, FHU InovPain, CHU Nice and Côte d'Azur University in Nice, France. It was published online on July 29 in The Journal of Headache and Pain.LIMITATIONSThe single-center design may limit generalizability to the broader French population. A paper headache diary was used rather than an electronic diary. MMDs and MHDs were only assessed during the last 4 weeks of the 3-month period between infusions. The study evaluated only the 100 mg dose of eptinezumab and dose escalation to 300 mg was not performed due to financial constraints.DISCLOSURESThe study was supported by FHU InovPain. One author reported receiving personal fees for consultancy activities from multiple pharmaceutical companies including AbbVie/Allergan, Amgen, Eli Lilly, and others.This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.