Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study.
Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study.
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DOI：
10.1136/jnnp-2021-327480
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发表时间：
2022-03
期刊：
影响因子：
--
通讯作者：
Stites T
中科院分区：
文献类型：
--
作者：
Ferrari MD;Reuter U;Goadsby PJ;Paiva da Silva Lima G;Mondal S;Wen S;Tenenbaum N;Pandhi S;Lanteri-Minet M;Stites T
目的：评价埃伦单抗在2-4次预防失败的发作性偏头痛(EM)患者中的个人和群体的长期疗效和安全性。完成利伯蒂研究的为期12周的双盲治疗阶段的参与者可以继续进入开放标签扩展阶段，每月接受埃伦单抗140 mg，最长可持续3年。在第112周评估的主要结果是：作为集体应答率和个人应答率的每月偏头痛天数(≥)减少50%，≥减少75%和100%，MMD较基线改变，安全性和耐受性。总体而言，240/246人(97.6%)进入了OLEP(118人继续服用ERENOAB，122人从安慰剂转向)。总计181/240(75.4%)达到112周，24.6%停止，主要原因是缺乏疗效(44.0%)、参与者决定(37.0%)和不良事件(不良反应；12.0%)。112周时≥50%应答率为57.2%。在DBTP结束时≥50%的应答者中，36/52(69.2%)仍然是≥50%的 应答者，22/52(42.3%)在80%的就诊中仍是应答者。在DBTP结束时无应答者中，60/185(32.4%)在至少一半的就诊中转为≥应答者，24/185(13.0%)在80%的就诊中转为≥应答者。平均(SD)MMD较基线变化为−4.2d(5.0d)。常见不良反应(≥)为鼻咽炎、流行性感冒、腰背痛，占10%。在患有难治性EM的患者中，疗效持续了112周，之前的2-4种偏头痛预防措施都失败了。Erenumab治疗是安全的，耐受性良好，与之前的研究一致。NCT03096834
To evaluate individual and group long-term efficacy and safety of erenumab in individuals with episodic migraine (EM) for whom 2–4 prior preventatives had failed. Participants completing the 12-week double-blind treatment phase (DBTP) of the LIBERTY study could continue into an open-label extension phase (OLEP) receiving erenumab 140 mg monthly for up to 3 years. Main outcomes assessed at week 112 were: ≥50%, ≥75% and 100% reduction in monthly migraine days (MMD) as group responder rate and individual responder rates, MMD change from baseline, safety and tolerability. Overall 240/246 (97.6%) entered the OLEP (118 continuing erenumab, 122 switching from placebo). In total 181/240 (75.4%) reached 112 weeks, 24.6% discontinued, mainly due to lack of efficacy (44.0%), participant decision (37.0%) and adverse events (AEs; 12.0%). The ≥50% responder rate was 57.2% (99/173) at 112 weeks. Of ≥50% responders at the end of the DBTP, 36/52 (69.2%) remained responders at ≥50% and 22/52 (42.3%) at >80% of visits. Of the non-responders at the end of the DBTP, 60/185 (32.4%) converted to ≥50% responders in at least half the visits and 24/185 (13.0%) converted to ≥50% responders in >80% of visits. Change from baseline at 112 weeks in mean (SD) MMD was −4.2 (5.0) days. Common AEs (≥10%) were nasopharyngitis, influenza and back pain. Efficacy was sustained over 112 weeks in individuals with difficult-to-treat EM for whom 2–4 prior migraine preventives had failed. Erenumab treatment was safe and well tolerated, in-line with previous studies. NCT03096834
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