Erenumab in Chronic Migraine Patients Who Previously Failed Five First-Line Oral Prophylactics and OnabotulinumtoxinA: A Dual-Center Retrospective Observational Study
Erenumab in Chronic Migraine Patients Who Previously Failed Five First-Line Oral Prophylactics and OnabotulinumtoxinA: A Dual-Center Retrospective Observational Study
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DOI：
10.3389/fneur.2020.00417
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发表时间：
2020-05-28
影响因子：
3.4
通讯作者：
Reuter, Uwe
中科院分区：
文献类型：
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作者：
Raffaelli, Bianca;Kalantzis, Rea;Reuter, Uwe
背景：德国当局仅在既往使用至少5种口服抗抑郁药治疗失败或有此类禁忌症的患者中报销erenumab预防偏头痛的费用。在这项现实分析中，我们评估了慢性偏头痛（CM）患者对erenumab的治疗反应，这些患者接受了五种口服抗抑郁药和onabotulinumtoxinA（BoNTA）。方法：我们分析了来自两个德国头痛中心的139例至少注射过一次erenumab的CM患者的回顾性数据。患者既往对β受体阻滞剂、氟桂利嗪、托吡酯、阿米替林、丙戊酸盐和BoNTA反应不充分或有禁忌症。该分析的主要终点是12周erenumab治疗过程中每月头痛天数较4周基线期的平均变化。次要终点是治疗期间每月偏头痛天数、严重头痛天数、急性头痛药物天数和曲坦摄入量的变化。结果：Erenumab（起始剂量70 mg）导致首次治疗后每月头痛天数减少-3.7（95% CI 2.4-5.1），三个治疗周期后减少-4.7（95% CI 2.9-6.5）（两者均为p< 0.001）。所有次要终点参数均随时间降低。在第9-12周，一半患者（51.11%）每月头痛天数减少>30%。只有4.3%的患者因副作用而终止erenumab治疗。结论：在这个难治性CM人群中，erenumab在现实世界中显示出与临床试验数据相似的疗效。耐受性良好，未出现安全性问题。Erenumabis是除BoNTA外所有一线预防药物均失败的CM患者的治疗选择。
Background:German authorities reimburse migraine prevention with erenumab only in patients who previously did not have therapeutic success with at least five oral prophylactics or have contraindications to such. In this real-world analysis, we assessed treatment response to erenumab in patients with chronic migraine (CM) who failed five oral prophylactics and, in addition, onabotulinumtoxinA (BoNTA). Methods:We analyzed retrospective data of 139 CM patients with at least one injection of erenumab from two German headache centers. Patients previously did not respond sufficiently or had contraindications to beta-blockers, flunarizine, topiramate, amitriptyline, valproate, and BoNTA. Primary endpoint of this analysis was the mean change in monthly headache days from the 4-weeks baseline period over the course of a 12-weeks erenumab therapy. Secondary endpoints were changes in monthly migraine days, days with severe headache, days with acute headache medication, and triptan intake in the treatment period. Results:Erenumab (starting dose 70 mg) led to a reduction of -3.7 (95% CI 2.4-5.1) monthly headache days after the first treatment and -4.7 (95% CI 2.9-6.5) after three treatment cycles (p< 0.001 for both). All secondary endpoint parameters were reduced over time. Half of patients (51.11%) had a >30% reduction of monthly headache days in weeks 9-12. Only 4.3% of the patients terminated erenumab treatment due to side effects. Conclusion:In this treatment-refractory CM population, erenumab showed efficacy in a real-world setting similar to data from clinical trials. Tolerability was good, and no safety issues emerged. Erenumabis is a treatment option for CM patients who failed all first-line preventives in addition to BoNTA.