降钙素基因相关肽单克隆抗体预防偏头痛的有效性：观察性队列研究的系统评价和荟萃分析。

Effectiveness of Calcitonin Gene-Related Peptide Monoclonal Antibodies in the Prevention of Migraine: A Systematic Review and Meta-Analysis of Observational Cohort Studies.

机构信息

Department of Pharmacy, Pharmaceutical Sciences Postgraduate Programme, Universidade Federal do Paraná, Av. Pref. Lothario Meissner, 632, Curitiba, Parana, Brazil.

出版信息

Clin Drug Investig. 2023 Sep;43(9):669-680. doi: 10.1007/s40261-023-01301-7. Epub 2023 Sep 4.

DOI:10.1007/s40261-023-01301-7

PMID:37665501

Abstract

BACKGROUND AND OBJECTIVE

Migraine is a neurological disorder characterized by episodes of moderate-to-severe headache. The emergence of drugs derived from monoclonal antibodies specific for the calcitonin gene has brought forth a therapeutic option for patients in whom the traditional treatments have failed. This study aimed to evaluate the clinical effectiveness of calcitonin gene-related peptide antibodies in the prevention of migraine through a systematic review and meta-analysis of observational cohort studies.

METHODS

A literature search for evidence was performed in electronic databases for observational studies that evaluated adult patients with migraine receiving calcitonin gene-related peptide receptor antagonists (e.g. erenumab, fremanezumab, galcanezumab and eptinezumab) and reported effectiveness outcomes (mean reduction in monthly migraine/headache days, and proportion of patients with 50% or greater reduction in migraine/headache days).

RESULTS

During the screening process, 47 records were included for data extraction and qualitative and quantitative analyses. The overall rate of patients with a reduction of at least 50% of mean monthly migraine days was 54% (95% CI 49-59%), and overall mean monthly migraine reduction was about 7.7 days (95% CI 8.4-7.0 days). Regarding the outcome ≥ 50% reduction in mean monthly headache reduction, the overall rate of patients with a reduction of at least 50% was 57% (95% CI 48-64%), and the overall mean monthly headache reduction was approximately 8.8 days (95% CI 10.1-7.5 days). Subgroup analyses considering the drug treatment used and type of migraine were consistent with previous results.

CONCLUSIONS

The use of calcitonin gene-related peptide antibodies in real-world studies to prevent migraine demonstrates promising effectiveness outcomes, in agreement with those reported in previously published randomized clinical trial reports.

摘要

背景和目的

偏头痛是一种以中重度头痛发作为特征的神经科疾病。降钙素基因相关肽单克隆抗体类药物的出现为传统治疗失败的患者提供了一种治疗选择。本研究旨在通过对观察性队列研究的系统评价和荟萃分析，评估降钙素基因相关肽抗体在偏头痛预防中的临床疗效。

方法

在电子数据库中对评估接受降钙素基因相关肽受体拮抗剂（如依那西普单抗、雷美替胺、加兰他敏和依替唑仑）的偏头痛成年患者的观察性研究进行文献检索，并报告有效性结局（每月偏头痛/头痛天数的平均减少，以及偏头痛/头痛天数减少 50%或更多的患者比例）。

结果

在筛选过程中，有 47 条记录被纳入数据提取和定性及定量分析。至少有 50%的患者每月偏头痛天数减少的总体比例为 54%（95%CI：49-59%），每月偏头痛平均减少约 7.7 天（95%CI：8.4-7.0 天）。关于每月头痛减少至少 50%的结局，至少有 50%的患者每月头痛减少至少 50%的总体比例为 57%（95%CI：48-64%），每月头痛平均减少约 8.8 天（95%CI：10.1-7.5 天）。考虑药物治疗和偏头痛类型的亚组分析结果与先前的结果一致。