依瑞奈单抗治疗既往预防治疗失败或合并预防治疗的日本偏头痛患者的疗效和安全性：一项 3 期随机试验的亚组分析。
Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial.
机构信息
Department of Neurology Headache Center, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Shimotsuga District, Tochigi, 321-0293, Japan.
Saitama International Headache Center, Saitama, Japan.
出版信息
J Headache Pain. 2021 Sep 18;22(1):110. doi: 10.1186/s10194-021-01313-8.
BACKGROUND
These subgroup analyses of a Phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of erenumab 70 mg in Japanese migraine patients with/without prior preventive treatment failure(s) ("failed-yes" and "failed-no" subgroups) and with/without concomitant preventive treatment ("concomitant preventive-yes" and "concomitant preventive-no" subgroups).
METHODS
Overall, 261 patients were randomized; 130 and 131 patients to erenumab 70 mg and placebo, respectively. Subgroup analyses evaluated the change from baseline to Months 4-6 in mean monthly migraine days (MMD) (primary endpoint), achievement of a ≥50% reduction in mean MMD, and change from baseline in mean monthly acute migraine-specific medication (MSM) treatment days. Treatment-emergent adverse events were also evaluated.
RESULTS
Of the 261 patients randomized, 117 (44.8%) and 92 (35.3%) patients were in the failed-yes and concomitant preventive-yes subgroups, respectively. Erenumab 70 mg demonstrated consistent efficacy across all subgroups, with greater reductions from baseline in mean MMD versus placebo at Months 4-6 (treatment difference versus placebo [95% CI], failed-yes: - 1.9 [- 3.3, - 0.4]; failed-no: - 1.4 [- 2.6, - 0.3]; concomitant preventive-yes: - 1.7 [- 3.3, 0.0]; concomitant preventive-no: - 1.6 [- 2.6, - 0.5]). Similar results were seen for achievement of ≥50% reduction in mean MMD and change from baseline in mean monthly acute MSM treatment days. The safety profile of erenumab 70 mg was similar across subgroups, and similar to placebo in each subgroup.
CONCLUSION
Erenumab was associated with clinically relevant improvements in all efficacy endpoints and was well tolerated across all subgroups of Japanese migraine patients with/without prior preventive treatment failure(s) and with/without concomitant preventive treatment.
TRIAL REGISTRATION
Clinicaltrials.gov . NCT03812224. Registered January 23, 2019.
背景
这项 3 期、随机、双盲、安慰剂对照研究的亚组分析评估了依瑞奈单抗 70mg 对有/无前期预防性治疗失败（“失败阳性”和“失败阴性”亚组）以及有/无同期预防性治疗（“同期预防性治疗阳性”和“同期预防性治疗阴性”亚组）的日本偏头痛患者的疗效和安全性。
方法
共有 261 名患者随机分组，分别接受依瑞奈单抗 70mg 和安慰剂治疗，各 130 名和 131 名患者。亚组分析评估了从基线到第 4-6 个月时平均每月偏头痛天数（MMD）（主要终点）的变化、达到 MMD 减少≥50%的比例以及从基线时每月急性偏头痛专用药物（MSM）治疗天数的变化。还评估了治疗中出现的不良事件。
结果
在随机的 261 名患者中，117 名（44.8%）和 92 名（35.3%）患者分别处于失败阳性和同期预防性治疗阳性亚组。与安慰剂相比，依瑞奈单抗 70mg 在所有亚组中均显示出一致的疗效，在第 4-6 个月时 MMD 的平均减少量更大（与安慰剂的治疗差异[95%CI]，失败阳性：-1.9[-3.3，-0.4]；失败阴性：-1.4[-2.6，-0.3]；同期预防性治疗阳性：-1.7[-3.3，0.0]；同期预防性治疗阴性：-1.6[-2.6，-0.5]）。在达到 MMD 减少≥50%的比例和从基线时每月急性 MSM 治疗天数的变化方面也观察到了相似的结果。依瑞奈单抗 70mg 的安全性特征在各亚组中相似，且在每个亚组中与安慰剂相似。
结论
依瑞奈单抗可使所有疗效终点均有临床意义的改善，且在有/无前期预防性治疗失败以及有/无同期预防性治疗的日本偏头痛患者各亚组中均具有良好的耐受性。
试验注册
Clinicaltrials.gov. NCT03812224. 2019 年 1 月 23 日注册。
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