加巴喷丁治疗发作性偏头痛患者的疗效：III 期 PERSIST 研究开放标签期的结果。
Galcanezumab in patients with episodic migraine: results from the open-label period of the phase 3 PERSIST study.
机构信息
Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Department of Neurology, First Affiliated Hospital of Kunming Medical University, Kunming, China.
出版信息
J Headache Pain. 2023 Aug 4;24(1):103. doi: 10.1186/s10194-023-01613-1.
BACKGROUND
The phase 3 randomized PERSIST study demonstrated the efficacy and tolerability of galcanezumab, a humanized anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for prevention of episodic migraines. We present findings from the open-label extension (OLE) of PERSIST, which evaluated the long-term efficacy and safety of galcanezumab in patients from China, India, and Russia.
METHODS
Patients completing the 3-month double-blind period of PERSIST were eligible for the 3-month OLE. Patients previously randomized to galcanezumab (GMB/GMB group) continued to receive galcanezumab 120 mg at all three visits during the OLE whereas patients randomized to placebo received a 240 mg loading dose of galcanezumab and then two 120 mg doses (PBO/GMB group). The primary outcome was the mean change (from double-blind baseline) in the number of monthly migraine headache days (MHDs) to month 6. Other endpoints included percent reduction in monthly MHDs from double-blind baseline to month 6, functional outcomes, safety and tolerability.
RESULTS
Overall, 99% of patients completing the double-blind period entered the OLE, and 96% completed through month 6. Patients in the GMB/GMB group achieved continued improvements in efficacy, with the reduction from baseline in the mean number of monthly MHDs, and slightly increasing from 4.01 days at the end of the double-blind period to 4.62 at the end of the OLE. Of patients who were ≥ 50% responders to galcanezumab at month 3, 66% maintained this response through to month 6. Patients in the PBO/GMB group experienced a rapid reduction in the number of monthly MHDs after initiation of galcanezumab, with a mean reduction from baseline of 4.56 days by month 6. The long-term benefits of galcanezumab were also supported by improvements in other efficacy and functional endpoints. All safety findings were consistent with the known long-term safety profile of galcanezumab; no patients experienced a treatment-related serious adverse event.
CONCLUSIONS
Galcanezumab was efficacious and well-tolerated in patients with episodic migraine from China, India and Russia, for up to 6 months.
TRIAL REGISTRATION
ClinicalTrisABSTRACT_pals.gov NCT03963232, registered May 24, 2019.
背景
在 3 期随机 PERSIST 研究中，证明了 galcanezumab 的疗效和耐受性，galcanezumab 是一种人源化抗降钙素基因相关肽（CGRP）单克隆抗体，用于预防阵发性偏头痛。我们展示了 PERSIST 的开放标签扩展（OLE）的研究结果，该研究评估了 galcanezumab 在来自中国、印度和俄罗斯的患者中的长期疗效和安全性。
方法
完成 PERSIST 3 个月双盲期的患者有资格参加 3 个月的 OLE。先前随机分配至 galcanezumab（GMB/GMB 组）的患者在 OLE 的所有 3 次就诊中继续接受 120mg galcanezumab，而随机分配至安慰剂的患者接受 240mg galcanezumab 的负荷剂量，然后接受两次 120mg 剂量（PBO/GMB 组）。主要终点是从双盲基线到第 6 个月每月偏头痛头痛天数（MHDs）的平均变化。其他终点包括从双盲基线到第 6 个月每月 MHDs 的百分比减少、功能结果、安全性和耐受性。
结果
总体而言，完成双盲期的患者中有 99%进入了 OLE，其中 96%完成了第 6 个月的治疗。GMB/GMB 组患者的疗效持续改善，从基线到第 6 个月的平均每月 MHDs 减少，从双盲期末的 4.01 天略有增加到 OLE 期末的 4.62 天。在第 3 个月对 galcanezumab 应答率≥50%的患者中，有 66%在第 6 个月时仍保持该应答率。PBO/GMB 组患者在开始使用 galcanezumab 后，每月 MHDs 迅速减少，到第 6 个月时平均减少了 4.56 天。galcanezumab 的长期益处也得到了其他疗效和功能终点的支持。所有安全性发现均与 galcanezumab 的已知长期安全性概况一致；没有患者出现与治疗相关的严重不良事件。
结论
galcanezumab 在来自中国、印度和俄罗斯的阵发性偏头痛患者中，最长 6 个月的疗效和耐受性良好。
试验注册
ClinicalTrials.gov NCT03963232，于 2019 年 5 月 24 日注册。
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