Messoud Ashina (Copenhagen/ DK), Caroline Roos (Paris/ FR), David Ayer (Indianapolis, IN/ US), Dustin Ruff (Indianapolis, IN/ US), John Krege (Indianapolis, IN/ US), Lily Qian Li (Indianapolis, IN/ US), Mika Komori (Hyogo/ JP), Saygin Gonderten (Dubai/ AE)
Abstract text (incl. figure legends and references)
Background: This OLE collected data for ≤1 year about dose optimization, patterns of use, migraine-related disability, and quality of life during lasmiditan treatment.
Methods: Patients (pts) who completed the CENTURION study (EUDRACT: 2018-001661-17 / NCT: NCT03670810) started lasmiditan 100 mg; dose may adjust to 50/200 mg. Migraine Disability Assessment (MIDAS) and Migraine Specific Quality of Life Questionnaire (MSQ) were used.
Results: In all, 445 (intention-to-treat) treated ≥1 attack with lasmiditan. 8654 of 11327(76.4%) attacks were treated with lasmiditan (84.9% were moderate/severe pain). Reasons for not treating with lasmiditan were planning to drive or operate machinery (8% of attacks) or thought another medication would work better (6% of attacks). Most pts (47.0%) remained on 100 mg. Mean improvements in MIDAS Total Score was -13.0(24.9) at month 12. Mean improvement in the MSQ total score was 11.3(19.4) at month 12. Treatment-emergent adverse events (TEAEs) reported in ≥5% of pts included dizziness, paresthesia, fatigue, nausea, vertigo, somnolence, and asthenia. Most TEAEs were mild/moderate in severity. Four (0.9%) pts reported a serious TEAE; 1(0.2%) self-reported case of serotonin syndrome lasting 1 hr:40 min not requiring intervention was considered related to lasmiditan.
Conclusions: In the relatively real-world conditions, lasmiditan therapy was associated with a high completion rate (72.1%). Most attacks were treated with lasmiditan and remained on 100 mg throughout. Pts showed improvements in migraine-related disability and quality of life. There were no new safety findings.