Igarashi Hisaka, Shibata Mamoru, Ozeki Akichika, Day Kathleen Ann, Matsumura Taka
Department of Internal Medicine, Fujitsu Clinic, Kawasaki, Japan.
Department of Neurology, Tokyo Dental College Ichikawa General Hospital, Ichikawa, Japan.
J Pain Res. 2021 Nov 16;14:3555-3564. doi: 10.2147/JPR.S326905. eCollection 2021.
This study aimed to extensively evaluate the onset and maintenance effect of galcanezumab compared with placebo for the prevention of episodic migraine in Japanese patients.
This was a post-hoc analysis of a Phase 2, multicenter, randomized, double-blind, placebo-controlled study conducted between December 2016 and January 2019 (ClinicalTrials.gov: NCT02959177). Patients aged between 18 and 65 years with episodic migraine were randomized to receive a monthly injection of galcanezumab (120 mg: N = 115, 240 mg: N = 114) or placebo (N = 230) for 6 months. Outcome measures included onset of effect at weekly and daily intervals-assessed by change from baseline in the number of migraine headache days and the proportion of patients with migraine headache-with galcanezumab versus placebo. To further confirm the onset and maintenance effect, the 50% response rate was also evaluated.
The mean change from baseline in weekly migraine headache days was significantly reduced with galcanezumab (-0.97 days) compared with placebo (-0.10 days) at week 1 ( ≤ 0.0001), which was maintained at all subsequent weeks up to week 4 (all ≤ 0.0001 vs placebo). A significantly smaller proportion of galcanezumab-treated patients had migraine headache compared with placebo-treated patients at day 1 after the first injection (13.6% vs 31.4%, respectively; ≤ 0.0001), which was also maintained at all subsequent days during the first week after the first injection. Furthermore, the 50% response rate was significantly higher with galcanezumab compared with placebo from week 1 through month 6.
The onset of the migraine preventive effect of galcanezumab was rapid compared with placebo, starting from day 1 after the first injection in Japanese patients with episodic migraine. The effect was maintained during the first week and first month, and throughout 6 months of monthly injections of galcanezumab. Galcanezumab is a promising preventive treatment in Japanese patients with episodic migraine.
本研究旨在广泛评估加卡尼单抗与安慰剂相比，对日本发作性偏头痛患者预防发作性偏头痛的起效和维持效果。
这是一项对2016年12月至2019年1月期间开展的一项2期、多中心、随机、双盲、安慰剂对照研究的事后分析（ClinicalTrials.gov：NCT02959177）。年龄在18至65岁之间的发作性偏头痛患者被随机分组，接受每月一次的加卡尼单抗注射（120mg：N = 115，240mg：N = 114）或安慰剂（N = 230），为期6个月。疗效指标包括每周和每日的起效情况，通过偏头痛头痛天数相对于基线的变化以及偏头痛头痛患者的比例来评估加卡尼单抗与安慰剂的疗效。为进一步确认起效和维持效果，还评估了50%应答率。
在第1周时，与安慰剂组（-0.10天）相比，加卡尼单抗组（-0.97天）每周偏头痛头痛天数相对于基线的平均变化显著降低（≤0.0001），且在随后直至第4周的所有周均保持这一差异（与安慰剂相比均≤0.0001）。在首次注射后第1天，接受加卡尼单抗治疗的患者出现偏头痛头痛的比例显著低于接受安慰剂治疗的患者（分别为13.6%和31.4%；≤0.0001），且在首次注射后的第一周内所有后续日期均保持这一差异。此外，从第1周到第6个月，加卡尼单抗组的50%应答率显著高于安慰剂组。
与安慰剂相比，加卡尼单抗对日本发作性偏头痛患者偏头痛预防作用起效迅速，从首次注射后的第1天开始。在第一周和第一个月以及整个每月注射加卡尼单抗的6个月期间，该效果均得以维持。加卡尼单抗是日本发作性偏头痛患者一种有前景的预防性治疗药物。
