针对降钙素基因相关肽及其受体的单克隆抗体的观察性研究。

An observational study on monoclonal antibodies against calcitonin-gene-related peptide and its receptor.

机构信息

Neurology Unit, Department of Clinical and Experimental Sciences, Università degli Studi di Brescia, Brescia, Italy.

出版信息

Eur J Neurol. 2023 Jun;30(6):1764-1773. doi: 10.1111/ene.15761. Epub 2023 Mar 15.

Abstract

BACKGROUND AND PURPOSE

Based on their pharmacological target, two classes of calcitonin-gene-related peptide (CGRP) monoclonal antibodies (mAbs) have been identified: antibodies against the CGRP ligand-galcanezumab, fremanezumab, eptinezumab-and antibodies against the CGRP receptor (CGRP-R), erenumab. The aim of the present study was to compare anti-CGRP versus anti-CGRP-R mAbs in patients with high frequency episodic and chronic migraine.

METHODS

All patients on monthly treatment with anti-CGRP mAbs with an available 6 months' follow-up at January 2022 were included. Data on efficacy outcome were collected following one (T1), three (T3) and six (T6) months of treatment, and included monthly headache/migraine days, the Migraine Disability Assessment Scale (MIDAS) and Headache Impact Test 6 (HIT-6) scores, pain intensity, analgesics consumption and response rates (>50% headache days reduction compared to baseline).

RESULTS

In all, 152 patients were enrolled, of whom 68 were in treatment with anti-CGRP mAbs (49 galcanezumab, 19 fremanezumab) and 84 with the anti-CGRP-R (erenumab). MIDAS scores were significantly lower in the anti-CGRP group at T1 and T3 (respectively p < 0.02 and p < 0.03) as well as the number of mean migraine days at T3 (p < 0.01). At T3 and T6 outcome measures were comparable, although a significantly higher percentage of super-responders was found in the anti-CGRP group (respectively p < 0.04 and p < 0.05), with a similar overall percentage of responders.

CONCLUSIONS

The present study on a real-world sample confirms the beneficial effect of both anti-CGRP and anti-CGRP-R mAbs, with a more favorable outcome for anti-CGRP antibodies.

摘要

背景与目的

基于其药理学靶点,已确定两种降钙素基因相关肽(CGRP)单克隆抗体(mAb)类别:针对 CGRP 配体甘丙肽的抗体-加兰肽单抗、佛来美肽单抗、依替利珠单抗和针对 CGRP 受体(CGRP-R)的抗体-埃普尼珠单抗。本研究旨在比较高频率发作性和慢性偏头痛患者使用抗 CGRP 与抗 CGRP-R mAb 的效果。

方法

纳入所有在 2022 年 1 月接受抗 CGRP mAb 每月治疗且随访时间超过 6 个月的患者。在治疗第 1 个月(T1)、第 3 个月(T3)和第 6 个月(T6)收集疗效结果数据,包括每月头痛/偏头痛天数、偏头痛残疾评估量表(MIDAS)和头痛影响测试 6 项(HIT-6)评分、疼痛强度、镇痛药使用和应答率(与基线相比,头痛天数减少>50%)。

结果

共纳入 152 例患者,其中 68 例接受抗 CGRP mAb(49 例加兰肽单抗,19 例佛来美肽单抗)治疗,84 例接受抗 CGRP-R(埃普尼珠单抗)治疗。T1 和 T3 时,抗 CGRP 组的 MIDAS 评分明显更低(分别为 p<0.02 和 p<0.03),T3 时的平均偏头痛天数也更少(p<0.01)。T3 和 T6 时的结果测量指标相当,但抗 CGRP 组的超级应答者比例更高(分别为 p<0.04 和 p<0.05),且总应答者比例相似。

结论

本真实世界样本研究证实了两种抗 CGRP 和抗 CGRP-R mAb 的有益效果,抗 CGRP 抗体的效果更优。

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