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Abstract：
BACKGROUND: Many patients with chronic migraine do not achieve clinically meaningful improvement in their headache frequency with monotherapy. The burden associated with chronic migraine calls for a multifaceted treatment approach targeting multiple aspects of migraine pathophysiology.
OBJECTIVE: The aim of this study was to evaluate the effect of concurrent anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) and onabotulinumtoxinA (onabot) treatment on median monthly migraine days (MMD) in patients with chronic migraine, through a retrospective study.
METHODS: The electronic medical records of Cleveland Clinic patients either concurrently (dual therapy) or consecutively (monotherapy) treated with anti-CGRP mAbs and onabot between June 2018 and November 2021 were extracted. Only adult patients (≥ 18 years of age) were included in this study. MMDs for 194 concurrently treated (86.6% female and a median [interquartile range] age of 51 [41-61] years) and 229 consecutively treated (88.2% female and median age of 47 [IQR 39-57] years) patients were examined at baseline, after first therapy of either anti-CGRP mAb or onabot, and following dual therapy for 3 consecutive months. The reduction of MMDs for each treatment group were compared. The same approach was utilized to compare consecutive monotherapy at separate times (n = 229) and dual-therapy groups.
RESULTS: The initial treatment of the dual-therapy group reduced the median (IQR) MMDs from 30 (30-30) to 15 (12-30) [p < 0.0001]. After initiation of dual therapy, the median MMDs was further decreased from 15 (12-30) to 8 (3-22) [p < 0.0001]. A majority [132/194 (68.0%)] of the dual-therapy patients reported a ≥ 50% reduction in MMD and 90/194 (46.4%) reported a ≥ 75% reduction. For the consecutive monotherapy group, median MMDs changed from a baseline of 30 (25-30) to 15 (8-25) from onabot monotherapy and decreased from 25 (15-30) to 12 (4-25) after anti-CGRP mAb monotherapy. Almost half (113/229 [49.3%] from onabot, and 104/229 [45.4%] from anti-CGRP mAb) of these patients achieved a ≥ 50% reduction in MMDs and a minority (38/229 [16.6%] from onabot, and 45/229 [19.7%] from anti-CGRP mAb) achieved a reduction of ≥ 75%. Additionally, dual therapy showed significant improvement in MMDs compared with monotherapy of either treatment (p < 0.0001).
CONCLUSIONS: Dual therapy of anti-CGRP mAbs and onabot may be more efficacious than monotherapy, possibly due to their synergistic mechanisms of action.
OBJECTIVE: The aim of this study was to evaluate the effect of concurrent anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) and onabotulinumtoxinA (onabot) treatment on median monthly migraine days (MMD) in patients with chronic migraine, through a retrospective study.
METHODS: The electronic medical records of Cleveland Clinic patients either concurrently (dual therapy) or consecutively (monotherapy) treated with anti-CGRP mAbs and onabot between June 2018 and November 2021 were extracted. Only adult patients (≥ 18 years of age) were included in this study. MMDs for 194 concurrently treated (86.6% female and a median [interquartile range] age of 51 [41-61] years) and 229 consecutively treated (88.2% female and median age of 47 [IQR 39-57] years) patients were examined at baseline, after first therapy of either anti-CGRP mAb or onabot, and following dual therapy for 3 consecutive months. The reduction of MMDs for each treatment group were compared. The same approach was utilized to compare consecutive monotherapy at separate times (n = 229) and dual-therapy groups.
RESULTS: The initial treatment of the dual-therapy group reduced the median (IQR) MMDs from 30 (30-30) to 15 (12-30) [p < 0.0001]. After initiation of dual therapy, the median MMDs was further decreased from 15 (12-30) to 8 (3-22) [p < 0.0001]. A majority [132/194 (68.0%)] of the dual-therapy patients reported a ≥ 50% reduction in MMD and 90/194 (46.4%) reported a ≥ 75% reduction. For the consecutive monotherapy group, median MMDs changed from a baseline of 30 (25-30) to 15 (8-25) from onabot monotherapy and decreased from 25 (15-30) to 12 (4-25) after anti-CGRP mAb monotherapy. Almost half (113/229 [49.3%] from onabot, and 104/229 [45.4%] from anti-CGRP mAb) of these patients achieved a ≥ 50% reduction in MMDs and a minority (38/229 [16.6%] from onabot, and 45/229 [19.7%] from anti-CGRP mAb) achieved a reduction of ≥ 75%. Additionally, dual therapy showed significant improvement in MMDs compared with monotherapy of either treatment (p < 0.0001).
CONCLUSIONS: Dual therapy of anti-CGRP mAbs and onabot may be more efficacious than monotherapy, possibly due to their synergistic mechanisms of action.
摘要：
背景：许多慢性偏头痛患者的头痛频率在单一治疗中没有达到有临床意义的改善。与慢性偏头痛相关的负担需要针对偏头痛病理生理学的多个方面的多方面治疗方法。
目的：这项研究的目的是评估同时使用抗降钙素基因相关肽（CGRP）单克隆抗体（mAb）和单株霉素A（onabot）治疗的效果慢性偏头痛患者的平均每月偏头痛天数（MMD），通过回顾性研究。
方法：提取了2018年6月至2021年11月期间使用抗CGRPmAb和onabot同时（双重治疗）或连续（单一治疗）治疗的克利夫兰诊所患者的电子病历。本研究仅包括成年患者（≥18岁）。同时治疗的194例患者（86.6%为女性，中位[四分位距]年龄为51[41-61]岁）和连续治疗的229例患者（88.2%为女性，中位年龄为47[IQR39-57]岁）在基线时进行了检查，在首次治疗抗CGRPmAb或onabot后，并连续3个月进行双重治疗。比较各治疗组的MMD降低情况。使用相同的方法来比较不同时间的连续单一疗法(n=229)和双重疗法组。
结果：双重治疗组的初始治疗将中位数（IQR）MMD从30（30-30）降低到15（12-30）[p<0.0001]。在开始双重治疗后，MMD中位数从15(12-30)进一步下降至8(3-22)[p<0.0001].大多数[132/194（68.0％）]的双重治疗患者报告MMD降低≥50％，90/194（46.4％）报告降低≥75％。对于连续的单药治疗组，单药治疗后,中位MMD从基线的30(25-30)变为15(8-25),抗CGRPmAb单药治疗后从25(15-30)降至12(4-25).几乎一半（113/229[49.3%]来自onabot，来自抗CGRPmAb的104/229[45.4%])这些患者的MMD降低≥50%，少数患者(来自onabot的38/229[16.6%]，和45/229[19.7%]来自抗CGRPmAb)的降低≥75%。此外,与任一治疗的单药治疗相比,双重治疗显示MMD显著改善(p<0.0001).
结论：抗CGRPmAb和onabot的双重治疗可能比单一治疗更有效，可能是由于它们的协同作用机制。
目的：这项研究的目的是评估同时使用抗降钙素基因相关肽（CGRP）单克隆抗体（mAb）和单株霉素A（onabot）治疗的效果慢性偏头痛患者的平均每月偏头痛天数（MMD），通过回顾性研究。
方法：提取了2018年6月至2021年11月期间使用抗CGRPmAb和onabot同时（双重治疗）或连续（单一治疗）治疗的克利夫兰诊所患者的电子病历。本研究仅包括成年患者（≥18岁）。同时治疗的194例患者（86.6%为女性，中位[四分位距]年龄为51[41-61]岁）和连续治疗的229例患者（88.2%为女性，中位年龄为47[IQR39-57]岁）在基线时进行了检查，在首次治疗抗CGRPmAb或onabot后，并连续3个月进行双重治疗。比较各治疗组的MMD降低情况。使用相同的方法来比较不同时间的连续单一疗法(n=229)和双重疗法组。
结果：双重治疗组的初始治疗将中位数（IQR）MMD从30（30-30）降低到15（12-30）[p<0.0001]。在开始双重治疗后，MMD中位数从15(12-30)进一步下降至8(3-22)[p<0.0001].大多数[132/194（68.0％）]的双重治疗患者报告MMD降低≥50％，90/194（46.4％）报告降低≥75％。对于连续的单药治疗组，单药治疗后,中位MMD从基线的30(25-30)变为15(8-25),抗CGRPmAb单药治疗后从25(15-30)降至12(4-25).几乎一半（113/229[49.3%]来自onabot，来自抗CGRPmAb的104/229[45.4%])这些患者的MMD降低≥50%，少数患者(来自onabot的38/229[16.6%]，和45/229[19.7%]来自抗CGRPmAb)的降低≥75%。此外,与任一治疗的单药治疗相比,双重治疗显示MMD显著改善(p<0.0001).
结论：抗CGRPmAb和onabot的双重治疗可能比单一治疗更有效，可能是由于它们的协同作用机制。
