Soni-Brahmbhatt, Seema

Aim Incorporating patient-reported outcomes (PROs) into clinical practice and real-world research is essential to enable a more holistic assessment of treatment effectiveness, beyond migraine frequency alone. Given the number of calcitonin gene-related peptide (CGRP)-targeted treatments available, switching between CGRP-targeted preventive therapies is a common practice. Real-world evidence on switching to intravenous eptinezumab in adults with migraine for whom prior subcutaneous or oral CGRP-targeted preventive therapies failed is limited. The ongoing INFUSE study was designed to evaluate the real-world effectiveness of switching to eptinezumab in US clinical practice among adults with migraine for whom ≥1 prior CGRP-targeted preventive therapy had failed. Methods INFUSE, a real-world, non-interventional study evaluating the effectiveness of eptinezumab in US clinical practice, included adults with migraine for whom ≥1 prior CGRP-targeted preventive therapy had failed and who were newly initiating eptinezumab treatment. PROs were collected electronically. To provide an overall assessment of the change in migraine disease, Patient Global Impression of Change (PGIC) was utilized. Other outcomes allowed for the evaluation of novel end points, such as brain fog and participant-defined good days. Results The baseline population included 190 participants (female, 88.9%; 35–54 years of age, 53.7%). At month 6, 44.1% (95% confidence interval (CI): 35.3–53.4%) of participants reported “much/very much improved” on PGIC, and 75.7% (95% CI: 66.9–82.7%) reported any improvement. Mean good days increased by 6.3 per month at month 6 ( P < 0.001). Among participants reporting brain fog at baseline (93.7%), 55.8% (95% CI: 46.2–64.9%) reported improvement at month 6. Conclusion This research provides insights into capturing the broader migraine burden and the holistic impact of preventive treatment and highlights the potential for achieving ambitious goals. In this population for whom ≥1 prior CGRP-targeted preventive therapy had failed, switching to eptinezumab was associated with participant-reported, clinically meaningful improvements in PROs, including frequency, disability, disease status, and brain fog.

ABSTRACT Background This post hoc analysis examined the reduction in monthly headache days ( MHDs ) by frequency category shifts and associated improvements following eptinezumab treatment. Methods The DELIVER trial evaluated eptinezumab in adults with migraine for whom 2–4 previous preventive treatments failed. During a 24‐week, double‐blind, placebo‐controlled period followed by a 48‐week extension period, participants received IV eptinezumab 100 mg, 300 mg, or placebo every 12 weeks, with all receiving eptinezumab beginning Week 25 (dose‐blinded). Participants were categorized by MHD frequency: > 14, 8–14, 4 to < 8, 1 to < 4, 0. MHD category shifts were evaluated in the total population and several subgroups (including participants with > 14 baseline MHDs and early ≥ 50% responders). In participants reporting < 8 MHDs after all doses, the associated changes in headache intensity and disease status were evaluated. Results Of randomized participants, 88% (782/890) completed the trial. The percentage of participants randomized initially to eptinezumab who reported < 4 MHDs was 23% (138/592) over Weeks 1–12 and 47% (236/498) over Weeks 61–72; 9% reported 0 MHDs after the final dose. Of participants randomized initially to eptinezumab who shifted from ≥ 8 MHDs at baseline to < 8 over Weeks 1–12, 71% (170/241) reported < 8 MHDs for the rest of the trial; of those who shifted from > 14 to < 8 MHDs, 66% (49/74) reported < 8 MHDs for the rest of the trial. Reduction to < 8 MHDs was associated with robust improvements in headache intensity and disease burden. Conclusions Eptinezumab was associated with sustained reduction in MHD category, with some achieving headache/migraine freedom in patients with a history of preventive treatments that failed. Trial Registration ClinicalTrials.gov (identifier: NCT04418765; https://www.clinicaltrials.gov/ct2/show/NCT04418765 ) and EudraCT (identifier: 2019‐004497‐25; https://www.clinicaltrialsregister.eu/ctr‐search/search?query=2019‐004497‐25 )