未经批准:背景:DRAGON是第3阶段,随机,双盲,安慰剂对照研究,该研究评估了erenumab在亚洲慢性偏头痛(CM)患者中的疗效和安全性,该患者在全球关键CM研究中未得到充分代表。
方法:DRAGON研究在包括中国大陆在内的9个亚洲国家或地区进行,印度,大韩民国,马来西亚,菲律宾,新加坡,台湾,泰国,和越南。CM(年龄18-65岁)的患者(N=557)被随机分配(1:1),每月一次皮下给erenumab70mg或匹配的安慰剂,为期12周。主要终点是12周双盲治疗阶段(DBTP)从基线到最后4周的每月偏头痛天数(MMD)的变化。次要终点包括MMD降低≥50%,每月急性头痛药物治疗天数的变化,改良偏头痛残疾评估(MIDAS),和安全。研究提供了MMD从基线变化的主要终点。
结果:在基线时,平均(SD)年龄为41.7(±10.9)岁,81.5%(n=454)的患者为女性。平均偏头痛持续时间为18.0(±11.6)年,平均MMD为19.2(±5.4)。97.8%(n=545)的随机患者完成了DBTP。总的来说,erenumab组和安慰剂组的人口统计学和基线特征平衡,但安慰剂组中女性比例略高.在第12周时,erenumab的MMD自基线的调整平均变化为-8.2天,安慰剂为-6.6天。erenumab与安慰剂的差异具有统计学意义(与安慰剂的校正平均差:-1.57[95CI:-2.83,-0.30];P=0.015).与安慰剂相比,使用erenumab治疗的患者MMD降低≥50%的比例更高(47.0%vs36.7%,P=0.014)。在第12周,与安慰剂相比,在接受erenumab治疗的患者中观察到每月急性头痛药物治疗天数(-5.34vs-4.66)和mMIDAS评分(-14.67vs-12.93)的更大减少。erenumab的安全性和耐受性与安慰剂相当,除了便秘的发生率(erenumab为8.6%,安慰剂为3.2%)。
结论:DRAGON研究证明了erenumab70mg在亚洲CM患者中的有效性和安全性。与之前的试验相比,在DBTP期间没有观察到新的安全性信号。
背景:NCT03867201。
UNASSIGNED: BACKGROUND: DRAGON was a phase 3, randomised, double-blind, placebo-controlled
study which evaluated the efficacy and safety of erenumab in patients with chronic migraine (CM) from Asia not adequately represented in the global pivotal CM
study.
METHODS: DRAGON
study was conducted across 9 Asian countries or regions including mainland China, India, the Republic of Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam. Patients (N = 557) with CM (aged 18-65 years) were randomised (1:1) to receive once-monthly subcutaneous erenumab 70 mg or matching placebo for 12 weeks. The primary endpoint was the change in monthly migraine days (MMD) from baseline to the last 4 weeks of the 12-week double-blind treatment phase (DBTP). Secondary endpoints included achievement of ≥ 50% reduction in MMD, change in monthly acute headache medication days, modified migraine disability assessment (mMIDAS), and safety.
Study was powered for the primary endpoint of change from baseline in MMD.
RESULTS: At baseline, the mean (SD) age was 41.7 (± 10.9) years, and 81.5% (n = 454) patients were women. The mean migraine duration was 18.0 (± 11.6) years, and the mean MMD was 19.2 (± 5.4). 97.8% (n = 545) randomised patients completed the DBTP. Overall, demographics and baseline characteristics were balanced between the erenumab and placebo groups except for a slightly higher proportion of women in the placebo group. At Week 12, the adjusted mean change from baseline in MMD was - 8.2 days for erenumab and - 6.6 days for placebo, with a statistically significant difference for erenumab versus placebo (adjusted mean difference vs placebo: - 1.57 [95%CI: - 2.83, - 0.30]; P = 0.015). A greater proportion of patients treated with erenumab achieved ≥ 50% reduction in MMD versus placebo (47.0% vs 36.7%, P = 0.014). At Week 12, greater reductions in monthly acute headache medication days (- 5.34 vs - 4.66) and mMIDAS scores (- 14.67 vs - 12.93) were observed in patients treated with erenumab versus placebo. Safety and tolerability profile of erenumab was comparable to placebo, except the incidence of constipation (8.6% for erenumab vs 3.2% for placebo).
CONCLUSIONS: DRAGON
study demonstrated the efficacy and safety of erenumab 70 mg in patients with CM from Asia. No new safety signals were observed during the DBTP compared with the previous trials.
BACKGROUND: NCT03867201.