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Abstract：
BACKGROUND: This analysis of two Japanese clinical trials evaluated efficacy and safety after galcanezumab (GMB) discontinuation in patients with episodic migraine (EM) and chronic migraine (CM).
METHODS: Data were from a 6-month, randomized, double-blind, placebo [PBO]-controlled primary trial (patients with EM) and a 12-month open-label extension trial (patients with EM/CM). Patients received 6 months\' (primary) or 12/18 months\' (extension) treatment with GMB 120 mg (GMB120) plus 240-mg loading dose or 240 mg (GMB240) with 4 months\' post-treatment follow-up. Efficacy was assessed as number of monthly migraine headache days during post-treatment. Safety was assessed via post-treatment-emergent adverse events (PTEAEs).
RESULTS: The analysis population included 186 patients from the primary trial (PBO N = 93; GMB120 N = 45; GMB240 N = 48), 220 patients with EM from the extension trial (PBO/GMB120 N = 57; PBO/GMB240 N = 55; GMB120/GMB120 N = 55; GMB240/GMB240 N = 53), and 55 patients with CM (GMB120 N = 28; GMB240 N = 27). In patients with EM receiving 6 months\' GMB120, mean standard deviation (SD) monthly migraine headache days increased from 5.69 (4.64) at treatment end to 6.24 (4.37) at end of follow-up but did not return to pre-treatment levels (8.80 [2.96]). In the extension trial, mean monthly migraine headache days in patients with EM receiving GMB120 were 4.13 (3.85) after 12 months and 4.45 (3.78) at end of follow-up, and 3.59 (3.48) after 18 months and 3.91 (3.57) at end of follow-up. Monthly migraine headache days in patients with CM (12 months\' GMB120) were 10.71 (4.61) at treatment end and 11.17 (5.64) at end of follow-up (pre-treatment 20.15 [4.65]). Similar results were seen for patients receiving GMB240. The most observed PTEAE after GMB discontinuation was nasopharyngitis.
CONCLUSIONS: Galcanezumab exhibited post-treatment efficacy for up to 4 months in Japanese patients with EM and with CM. No unexpected safety signals were observed.
BACKGROUND: ClinicalTrials.gov, NCT02959177 and NCT02959190.
METHODS: Data were from a 6-month, randomized, double-blind, placebo [PBO]-controlled primary trial (patients with EM) and a 12-month open-label extension trial (patients with EM/CM). Patients received 6 months\' (primary) or 12/18 months\' (extension) treatment with GMB 120 mg (GMB120) plus 240-mg loading dose or 240 mg (GMB240) with 4 months\' post-treatment follow-up. Efficacy was assessed as number of monthly migraine headache days during post-treatment. Safety was assessed via post-treatment-emergent adverse events (PTEAEs).
RESULTS: The analysis population included 186 patients from the primary trial (PBO N = 93; GMB120 N = 45; GMB240 N = 48), 220 patients with EM from the extension trial (PBO/GMB120 N = 57; PBO/GMB240 N = 55; GMB120/GMB120 N = 55; GMB240/GMB240 N = 53), and 55 patients with CM (GMB120 N = 28; GMB240 N = 27). In patients with EM receiving 6 months\' GMB120, mean standard deviation (SD) monthly migraine headache days increased from 5.69 (4.64) at treatment end to 6.24 (4.37) at end of follow-up but did not return to pre-treatment levels (8.80 [2.96]). In the extension trial, mean monthly migraine headache days in patients with EM receiving GMB120 were 4.13 (3.85) after 12 months and 4.45 (3.78) at end of follow-up, and 3.59 (3.48) after 18 months and 3.91 (3.57) at end of follow-up. Monthly migraine headache days in patients with CM (12 months\' GMB120) were 10.71 (4.61) at treatment end and 11.17 (5.64) at end of follow-up (pre-treatment 20.15 [4.65]). Similar results were seen for patients receiving GMB240. The most observed PTEAE after GMB discontinuation was nasopharyngitis.
CONCLUSIONS: Galcanezumab exhibited post-treatment efficacy for up to 4 months in Japanese patients with EM and with CM. No unexpected safety signals were observed.
BACKGROUND: ClinicalTrials.gov, NCT02959177 and NCT02959190.
摘要：
背景：这项对日本两项临床试验的分析评估了间歇性偏头痛（EM）和慢性偏头痛（CM）患者停用galcanezumab（GMB）后的疗效和安全性。
方法：数据来自6个月，随机化，双盲,安慰剂[PBO]对照的主要试验(EM患者)和12个月开放标签延伸试验(EM/CM患者).患者接受GMB120mg（GMB120）加240mg负荷剂量或240mg（GMB240）的6个月（主要）或12/18个月（延长）治疗，治疗后随访4个月。疗效评估为治疗后每月偏头痛的天数。通过治疗后紧急不良事件（PTEAE）评估安全性。
结果：分析人群包括186名来自初级试验的患者（PBON=93;GMB120N=45;GMB240N=48），来自扩展试验的220例EM患者（PBO/GMB120N=57;PBO/GMB240N=55;GMB120/GMB120N=55;GMB240/GMB240N=53），55例CM患者（GMB120N=28；GMB240N=27）。在接受6个月GMB120的EM患者中，平均标准偏差（SD）每月偏头痛天数从治疗结束时的5.69（4.64）增加到随访结束时的6.24（4.37），但没有恢复到治疗前的水平（8.80[2.96]）。在延期审判中，接受GMB120的EM患者在12个月后平均每月偏头痛天数为4.13（3.85），随访结束时平均为4.45（3.78），18个月后的3.59（3.48）和随访结束时的3.91（3.57）。CM患者（12个月GMB120）的每月偏头痛天数在治疗结束时为10.71（4.61），在随访结束时为11.17（5.64）（治疗前20.15[4.65]）。对于接受GMB240的患者也观察到类似的结果。GMB停药后观察最多的PTEAE是鼻咽炎。
结论：Galcanezumab在患有EM和CM的日本患者中显示了长达4个月的治疗后疗效。没有观察到意外的安全信号。
背景：ClinicalTrials.gov，NCT02959177和NCT02959190。
方法：数据来自6个月，随机化，双盲,安慰剂[PBO]对照的主要试验(EM患者)和12个月开放标签延伸试验(EM/CM患者).患者接受GMB120mg（GMB120）加240mg负荷剂量或240mg（GMB240）的6个月（主要）或12/18个月（延长）治疗，治疗后随访4个月。疗效评估为治疗后每月偏头痛的天数。通过治疗后紧急不良事件（PTEAE）评估安全性。
结果：分析人群包括186名来自初级试验的患者（PBON=93;GMB120N=45;GMB240N=48），来自扩展试验的220例EM患者（PBO/GMB120N=57;PBO/GMB240N=55;GMB120/GMB120N=55;GMB240/GMB240N=53），55例CM患者（GMB120N=28；GMB240N=27）。在接受6个月GMB120的EM患者中，平均标准偏差（SD）每月偏头痛天数从治疗结束时的5.69（4.64）增加到随访结束时的6.24（4.37），但没有恢复到治疗前的水平（8.80[2.96]）。在延期审判中，接受GMB120的EM患者在12个月后平均每月偏头痛天数为4.13（3.85），随访结束时平均为4.45（3.78），18个月后的3.59（3.48）和随访结束时的3.91（3.57）。CM患者（12个月GMB120）的每月偏头痛天数在治疗结束时为10.71（4.61），在随访结束时为11.17（5.64）（治疗前20.15[4.65]）。对于接受GMB240的患者也观察到类似的结果。GMB停药后观察最多的PTEAE是鼻咽炎。
结论：Galcanezumab在患有EM和CM的日本患者中显示了长达4个月的治疗后疗效。没有观察到意外的安全信号。
背景：ClinicalTrials.gov，NCT02959177和NCT02959190。
