偏头痛患者对抗 CGRP 单克隆抗体和肉毒毒素 A 的持续使用：一项回顾性队列研究。

Persistence to anti-CGRP monoclonal antibodies and onabotulinumtoxinA among patients with migraine: a retrospective cohort study.

机构信息

Michigan State University College of Human Medicine, MI, East Lansing, USA.

Lundbeck LLC, IL, Deerfield, USA.

出版信息

J Headache Pain. 2023 Aug 2;24(1):101. doi: 10.1186/s10194-023-01636-8.

DOI:10.1186/s10194-023-01636-8

PMID:37532991

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10394944/

Abstract

BACKGROUND

To date, real-world evidence on persistence to anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAbs) or onabotulinumtoxinA have excluded eptinezumab. This retrospective cohort study was performed to compare treatment persistency among patients with migraine on anti-CGRP mAbs (erenumab, fremanezumab, galcanezumab, or eptinezumab) or onabotulinumtoxinA.

METHODS

This retrospective study used IQVIA PharmMetrics data. Adult patients with migraine treated with an anti-CGRP mAb or onabotulinumtoxinA who had 12 months of continuous insurance enrollment before starting treatment were included. A "most recent treatment episode" analysis was used in which the most recent episode was defined as the latest treatment period with the same drug (anti-CGRP mAb or onabotulinumtoxinA) without a ≥ 15-day gap in medication supply on/after June 25, 2020, to December 31, 2021. Patients were indexed at the start of their most recent episode. Patients were considered non-persistent and discontinued the therapy associated with their most recent episode if there was ≥ 15-day gap in medication supply. A Cox proportional-hazards model estimated the discontinuation hazard between treatments. The gap periods and cohort definition were varied in sensitivity analyses.

RESULTS

The study included 66,576 patients (median age 46 years, 88.6% female). More eptinezumab-treated patients had chronic migraine (727/1074), ≥ 3 previous acute (323/1074) or preventive (333/1074) therapies, and more prior treatment episodes (3) than other treatment groups. Based on a 15-day treatment gap, patients on subcutaneous anti-CGRP mAbs had a 32% (95% CI: 1.19, 1.49; erenumab), 42% (95% CI: 1.27, 1.61; galcanezumab), and 58% (95% CI: 1.42, 1.80; fremanezumab) higher discontinuation hazard than those receiving eptinezumab, with this relationship attenuated, but still statistically significant based on 30-day and 60-day treatment gaps. There was no significant difference in the discontinuation hazard between eptinezumab and onabotulinumtoxinA. Based on a 15-day treatment gap among patients who newly initiated therapy, the discontinuation hazard of subcutaneous anti-CGRP mAbs remained significantly higher compared to eptinezumab and onabotulinumtoxinA.

CONCLUSION

Patients treated with eptinezumab demonstrated persistency that was higher than subcutaneous anti-CGRP mAbs and similar to onabotulinumtoxinA.

摘要

背景

迄今为止，关于抗降钙素基因相关肽（anti-CGRP）单克隆抗体（mAb）的持久性或肉毒毒素 A 的真实世界证据均排除了依替利珠单抗。本回顾性队列研究旨在比较偏头痛患者使用 anti-CGRP mAb（依那西普单抗、fremanezumab、galcanezumab 或依替利珠单抗）或肉毒毒素 A 的治疗持久性。

方法

本回顾性研究使用了 IQVIA PharmMetrics 数据。纳入了使用 anti-CGRP mAb 或肉毒毒素 A 治疗的偏头痛成年患者，在开始治疗前连续 12 个月有医疗保险。采用“最近治疗期”分析，最近治疗期定义为使用相同药物（anti-CGRP mAb 或肉毒毒素 A）的最新治疗期，在 2020 年 6 月 25 日至 2021 年 12 月 31 日期间药物供应无≥15 天的中断。患者从最近治疗期开始入组。如果药物供应有≥15 天的中断，则认为患者非持续性并停止与最近治疗期相关的治疗。Cox 比例风险模型估计了两种治疗方法之间的停药风险。在敏感性分析中，调整了间隙期和队列定义。

结果

研究纳入了 66576 名患者（中位年龄 46 岁，88.6%为女性）。与其他治疗组相比，更多依替利珠单抗治疗的患者患有慢性偏头痛（727/1074）、≥3 次既往急性（323/1074）或预防性（333/1074）治疗、以及更多既往治疗发作（3 次）。基于 15 天的治疗间隙期，皮下注射 anti-CGRP mAb 的患者停药风险分别高出 32%（95%CI：1.19，1.49；依那西普单抗）、42%（95%CI：1.27，1.61；加奈珠单抗）和 58%（95%CI：1.42，1.80；fremanezumab），与依替利珠单抗相比，这种关系减弱，但基于 30 天和 60 天的治疗间隙期仍具有统计学意义。依替利珠单抗与肉毒毒素 A 之间的停药风险无显著差异。在新开始治疗的患者中，基于 15 天的治疗间隙期，皮下注射 anti-CGRP mAb 的停药风险仍明显高于依替利珠单抗和肉毒毒素 A。