Background Migraine is recognized as the second leading cause of disability globally. Lasmiditan is a novel, selective serotonin 5-HT 1F receptor agonist developed for acute treatment of migraine. Here we analyzed effects of lasmiditan on migraine disability assessed with the Migraine Disability Assessment (MIDAS) scale for interim data from a long-term safety study. Methods Completers of two single-attack parent studies were offered participation in the 1 year GLADIATOR study, that randomized participants to treatment with lasmiditan 100 mg or 200 mg taken as needed for migraine attacks of at least moderate severity. Changes in MIDAS were modeled using a mixed model repeated measures analysis. Results The sample included 1978 patients who received ≥1 lasmiditan dose and were followed for a median of 288 days. Baseline mean MIDAS scores for the lasmiditan 100-mg and 200-mg groups were 29.4 and 28.9, respectively, indicating severe migraine-related disability. Relative to baseline, MIDAS total scores were significantly lower at 3, 6, 9, and 12 months for both dose groups. At 12 months, changes in MIDAS scores were − 12.5 and − 12.2 for lasmiditan 100 mg and 200 mg, respectively, with 49% and 53% of patients, respectively, achieving at least a 50% decrease in MIDAS total score. Statistically significant improvements were also seen for work and/or school absenteeism and presenteeism, monthly headache days, and mean headache pain intensity at all time points up to 1 year. Findings for patients who completed all visits versus those dropping out early were similar. Responses were generally similar for the lasmiditan 100 mg or 200 mg doses, between subgroups defined based on the number of baseline monthly migraine attacks (≤5 vs. >5), and also between subgroups defined by pain-free response (yes/no) during initial attacks. Conclusions Long-term treatment with lasmiditan was associated with significant reductions in migraine-related disability, including both work or school absenteeism and presenteeism. The similarity of responses in completers and those who dropped out suggests that selective attrition does not account for the improvements. Benefits were significant at 3 months and maintained through 12 months. Trial registration clinicaltrials.gov NCT02565186 ; first posted October 1, 2015.

中文翻译：

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长期使用 lasmiditan 治疗后偏头痛相关残疾的轨迹：GLADIATOR 研究的结果

背景 偏头痛被认为是全球第二大残疾原因。Lasmiditan 是一种新型选择性血清素 5-HT 1F 受体激动剂，专为偏头痛的急性治疗而开发。在这里，我们分析了 lasmiditan 对偏头痛残疾的影响，并使用偏头痛残疾评估 (MIDAS) 量表来评估长期安全性研究的中期数据。方法 两项单次发作家长研究的完成者被邀请参加为期 1 年的 GLADIATOR 研究，该研究随机将参与者随机接受 lasmiditan 100 mg 或 200 mg 治疗，根据需要服用至少中等严重程度的偏头痛发作。使用混合模型重复测量分析对 MIDAS 的变化进行建模。结果 样本包括 1978 名接受≥1 lasmiditan 剂量的患者，随访中位时间为 288 天。lasmiditan 100 mg 和 200 mg 组的基线平均 MIDAS 评分分别为 29.4 和 28.9，表明存在严重的偏头痛相关残疾。相对于基线，两个剂量组在 3、6、9 和 12 个月时的 MIDAS 总分均显着降低。12 个月时，lasmiditan 100 mg 和 200 mg 的 MIDAS 评分变化分别为 - 12.5 和 - 12.2，分别有 49% 和 53% 的患者实现 MIDAS 总评分至少下降 50%。工作和/或学校缺勤和出勤率、每月头痛天数以及长达 1 年的所有时间点的平均头痛疼痛强度也有统计学上的显着改善。完成所有就诊的患者与提前退出的患者的结果相似。对于 lasmiditan 100 mg 或 200 mg 剂量，根据基线每月偏头痛发作次数定义的亚组之间（≤5 次与 >5 次）以及根据无痛反应定义的亚组之间（是/否），反应总体相似在最初的攻击期间。结论 lasmiditan 的长期治疗可显着减少偏头痛相关的残疾，包括工作或学校缺勤和缺勤。完成者和退出者的反应相似，表明选择性减员并不能解释进步。3 个月时效果显着，并持续 12 个月。试验注册 ClinicalTrials.gov NCT02565186 ；首次发布于 2015 年 10 月 1 日。