Department of Neurology, Leiden University Medical Center, 2300 RC Leiden, Netherlands
Department of Neurology, Charite Universitatsmedizin Berlin, Berlin, Germany.
J Neurol Neurosurg Psychiatry. 2022 Mar;93(3):254-262. doi: 10.1136/jnnp-2021-327480. Epub 2021 Nov 29.
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.
评估在 2-4 种偏头痛预防药物治疗失败的发作性偏头痛（EM）患者中，依瑞奈尤单抗的个体和群体长期疗效和安全性。
完成 LIBERTY 研究 12 周双盲治疗阶段（DBTP）的参与者可继续进入开放标签扩展阶段（OLEP），每月接受依瑞奈尤单抗 140mg 治疗，最长可达 3 年。第 112 周评估的主要结局为：每月偏头痛天数（MMD）减少≥50%、≥75%和 100%的患者比例（组应答率和个体应答率）、与基线相比的 MMD 变化、安全性和耐受性。
共有 246 例患者（118 例继续使用依瑞奈尤单抗，122 例转为安慰剂）进入 OLEP。共有 181 例（240 例的 75.4%）完成 112 周，24.6%的患者停药，主要原因是疗效不佳（44.0%）、患者决定（37.0%）和不良事件（AE；12.0%）。第 112 周时，≥50%应答率为 57.2%（173/240）。在 DBTP 结束时，≥50%应答者中，36/52（69.2%）在≥50%的访视中仍为应答者，22/52（42.3%）在>80%的访视中为应答者。DBTP 结束时无应答者中，60/185（32.4%）至少在一半的访视中转为≥50%应答者，24/185（13.0%）转为>80%访视中的≥50%应答者。第 112 周时，平均（标准差）MMD 从基线减少了 4.2（5.0）天。常见 AE（≥10%）为鼻咽炎、流感和背痛。
在 2-4 种偏头痛预防药物治疗失败的难治性 EM 患者中，依瑞奈尤单抗的疗效可维持 112 周。依瑞奈尤单抗治疗安全且耐受良好，与既往研究一致。
NCT03096834。
