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.
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。