Responder Rates With Eptinezumab Over 24 Weeks in Patients With Prior Migraine Preventive Treatment Failures
Messoud Ashina1, Richard B Lipton2, Jessica Ailani3, Jan Versijpt4, Simona Sacco5, Dimos D Mitsikostas6, Cecilie Christoffersen7, Bjorn Sperling7, Anders Ettrup7
1Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, 2Department of Neurology, Albert Einstein College of Medicine, 3Department of Neurology, Georgetown University Hospital, 4Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Department of Neurology, 5Department of Biotechnological and Clinical Sciences, University of L’Aquila, 61st Department of Neurology, Aeginition Hospital, Medical School, National and Kapodistrian University of Athens, 7H. Lundbeck A/S
Objective:
To report the consistency of response to eptinezumab and potential for response in initial non-responders in patients with prior preventive treatment failures.
Background:
Eptinezumab is an intravenous anti-calcitonin gene-related peptide monoclonal antibody approved for preventive treatment of migraine. In the DELIVER study, eptinezumab treatment resulted in greater reductions than placebo in monthly migraine days (MMDs).
Design/Methods:
DELIVER (NCT04418765) randomized adults with episodic or chronic migraine and 2-4 prior preventive treatment failures to infusion with eptinezumab 100mg, 300mg, or placebo every 12 weeks. Migraine responder rates (MRRs) of ≥30%, ≥50%, and ≥75% over Weeks 1-12 and 13-24, MRRs over 4-week intervals, and the percentage of initial non-responders (Weeks 1-12) achieving response to their second infusion (Weeks 13-24) were calculated. MRRs are calculated as an average percentage change from baseline in MMDs over the specified interval.
Results:
The full analysis set included 890 patients (100mg, n=299; 300mg, n=293; placebo, n=298). Between Weeks 1-12 and 13-24, respectively, ≥30% MRRs increased from 65.9% to 70.4% (100mg), from 71.0% to 74.5% (300mg), versus 36.9% to 43.1% (placebo; P<0. 0001 for both doses/timepoints vs placebo). The ≥30%, ≥50%, and ≥75% MRRs were generally maintained or further increased over the 24-week period, with further numerical increases in responder rates observed after the second eptinezumab infusion. Across treatment groups, response over Weeks 1-12 was generally maintained over Weeks 13-24; however, of patients with <30% response over Weeks 1-12, 34.7% (100mg), 30.4% (300mg), vs 21.1% (placebo) achieved ≥30% response over Weeks 13-24, and 16.8% (100mg), 15.2% (300mg), vs 6.5% (placebo) achieved ≥50% response.
Conclusions:
Across MRR thresholds, most patients who responded to eptinezumab during Weeks 1-12 maintained response during Weeks 13-24, with responder rates further increasing from the first to the second infusion. Approximately one-third of initial non-responders became responders after their second infusion.