在多次预防性治疗失败的偏头痛患者中，氟雷马尼单抗在 24 周内的早期和持续疗效：多中心、前瞻性、真实世界的 FRIEND2 研究。
Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study.
机构信息
Headache and Pain Unit, IRCCS San Raffaele Roma, Via Della Pisana 235, 00163, Rome, Italy.
San Raffaele University, Rome, Italy.
出版信息
J Headache Pain. 2023 Mar 23;24(1):30. doi: 10.1186/s10194-023-01561-w.
BACKGROUND
To verify the long-term (24-week) efficacy, safety, and tolerability of fremanezumab in real-life patients with high-frequency episodic migraine (HFEM: ≥ 8 days/month) or chronic migraine (CM: ≥ 15 days/month), and multiple preventive treatment failures.
METHODS
This is a prospective, cohort, real-life study at 28 headache centers on consecutive patients affected by HFEM or CM with multiple preventive treatment failures who were prescribed subcutaneous fremanezumab (225 mg monthly/675 mg quarterly) for ≥ 24 weeks. Primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM at weeks 21-24 compared to baseline. Secondary endpoints encompassed changes in monthly analgesic medications, ≥ 50%, ≥ 75%, and 100% responder rates, and variation in NRS, HIT-6 and MIDAS scores at the same time interval. Changes in MMDs/MHDs, monthly analgesic medications, ≥ 50%, ≥ 75%, and 100% responder rates, and variation in NRS and HIT-6 scores at week 4 were also monitored.
RESULTS
Four hundred ten patients who had received ≥ 1 dose of fremanezumab were considered for safety analysis while 148 patients treated for ≥ 24 weeks were included in the efficacy analysis. At weeks 21-24, fremanezumab significantly (p < 0.001) reduced MMDs, MHDs, monthly analgesic medications and NRS, HIT-6, and MIDAS scores in both HFEM and CM compared to baseline. The proportions of ≥ 50%, ≥ 75% and 100% responders at weeks 21-24were 75.0%, 30.8%, 9.6% (HFEM), and 72.9, 44.8 and 1% (CM). A significant (p < 0.001) decrease in MMDs, MHDs, monthly analgesic medications and NRS, HIT-6, and MIDAS scores in both HFEM and CM was already present at week 4. The proportions of ≥ 50%, ≥ 75%, and 100% responders at week 4 were 67.6%, 32.4%, 11.8% (HFEM) and 67.3%, 40%, 1.8% (CM). CM remitted to episodic migraine and medication overuse to no-medication overuse in 83.3 and 75% of patients at week 24, and in 80 and 72.4% at week 4. Adverse events were rare (2.4%), mild and transient. No patient discontinued treatment for any reason.
CONCLUSIONS
Fremanezumab is characterized by an early and sustained efficacy in HFEM and CM patients with multiple preventive treatment failures in real-life, revealing an optimal safety and tolerability profile.
背景
为了验证在现实生活中患有高频发作性偏头痛（HFEM：≥8 天/月）或慢性偏头痛（CM：≥15 天/月）且多次预防性治疗失败的患者中，使用佛来美尼单抗的长期（24 周）疗效、安全性和耐受性，进行了此项前瞻性、队列、真实世界研究。在 28 个头痛中心，对连续就诊的多次预防性治疗失败的 HFEM 或 CM 患者进行了研究，这些患者接受了皮下注射佛来美尼单抗（每月 225mg/每季度 675mg）治疗，治疗时间≥24 周。主要终点是与基线相比，HFEM 患者的每月偏头痛发作天数（MMD）和 CM 患者的每月头痛天数（MHD）在第 21-24 周的变化。次要终点包括每月镇痛药使用量、≥50%、≥75%和 100%应答率的变化，以及同一时间间隔 NRS、HIT-6 和 MIDAS 评分的变化。还监测了第 4 周 MMD/MHD、每月镇痛药使用量、≥50%、≥75%和 100%应答率以及 NRS 和 HIT-6 评分的变化。
结果
共 410 名接受了至少一剂佛来美尼单抗治疗的患者被纳入安全性分析，而 148 名接受了至少 24 周治疗的患者被纳入疗效分析。在第 21-24 周时，与基线相比，佛来美尼单抗显著（p＜0.001）降低了 HFEM 和 CM 患者的 MMD、MHD、每月镇痛药使用量和 NRS、HIT-6 和 MIDAS 评分。在第 21-24 周时，≥50%、≥75%和 100%应答率的患者比例分别为 75.0%、30.8%、9.6%（HFEM）和 72.9%、44.8%、1%（CM）。在第 4 周时，HFEM 和 CM 患者的 MMD、MHD、每月镇痛药使用量和 NRS、HIT-6 和 MIDAS 评分已经显著（p＜0.001）降低。在第 4 周时，≥50%、≥75%和 100%应答率的患者比例分别为 67.6%、32.4%、11.8%（HFEM）和 67.3%、40%、1.8%（CM）。在第 24 周时，83.3%和 75%的 CM 患者转为发作性偏头痛，75%和 72.4%的患者药物滥用转为非药物滥用；在第 4 周时，80%和 72.4%的 CM 患者转为发作性偏头痛，72.4%和 67.2%的患者药物滥用转为非药物滥用。不良反应罕见（2.4%），为轻度且短暂。没有患者因任何原因停止治疗。
结论
在现实生活中，多次预防性治疗失败的 HFEM 和 CM 患者中，佛来美尼单抗具有早期和持续的疗效，表现出理想的安全性和耐受性特征。
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