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加奈珠单抗治疗偏头痛且既往预防药物治疗失败 3-4 种药物类别的患者的疗效：CONQUER 研究的亚组分析。

Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study.

机构信息

Eli Lilly and Company, Medical Affairs CRS, Indianapolis, IN, 46285, USA.

University College London (UCL) Queen Square Institute of Neurology and National Hospital for Neurology and Neurosurgery, London, UK.

出版信息

J Headache Pain. 2021 Sep 30;22(1):113. doi: 10.1186/s10194-021-01322-7.

DOI:10.1186/s10194-021-01322-7

PMID:34592919

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8482748/

Abstract

BACKGROUND

Chronic migraine (CM) and episodic migraine (EM) are associated with substantial headache-related disability, poor quality of life and global societal burden. In this subgroup analysis from the CONQUER study, we report efficacy outcomes from a pre-specified analysis of galcanezumab versus placebo in patients with CM or EM and 3-4 prior preventive medication category failures due to inadequate efficacy (after at least 2 months at maximum tolerated dose), or safety or tolerability reasons. The patient population is of particular interest due to evidence of decreased quality of life and increased economic burden among patients with migraine that is inadequately managed and is of interest to decision-makers globally.

METHODS

Key outcomes included overall mean change from baseline in monthly migraine headache days and proportions of patients achieving ≥30% (CM), ≥50%, and ≥ 75% reduction (response rates) in monthly migraine headache days across Months 1-3. Patient functioning and disability were evaluated at Month 3.

RESULTS

Of the 462 randomized patients, 186 (40.3%) had a history of 3-4 preventive category failures. Galcanezumab versus placebo resulted in significantly (P ≤ .001) larger overall mean reduction in monthly migraine headache days (total: - 5.49 versus - 1.03; CM: - 6.70 versus - 1.56; EM: - 3.64 versus - 0.65). Similarly, the ≥50% response rate was significantly (P ≤ .001) higher with galcanezumab versus placebo (total: 41.0 versus 12.7; CM: 41.5 versus 8.4; EM: 41.1 versus 16.5). In the CM group, the ≥30% response rate was significantly higher in the galcanezumab group than the placebo group (CM, 57.5 versus 19.8, P ≤ .0001) as was the ≥75% response rate (13.3 versus 2.6, P ≤ .05). Galcanezumab also resulted in significant (P < .0001) improvements in patient functioning and reductions in disability.

CONCLUSIONS

Galcanezumab was effective in a difficult-to-treat population of patients with CM or EM who had failed 3-4 prior preventive medication categories.

TRIAL REGISTRATION

CONQUER. Clinicaltrials.gov identifier: NCT03559257 .

摘要

背景

慢性偏头痛（CM）和阵发性偏头痛（EM）与严重的头痛相关残疾、生活质量差和全球社会负担有关。在 CONQUER 研究的这项预先指定的分析中，我们报告了加奈珠单抗与安慰剂相比在因疗效不足（在最大耐受剂量至少 2 个月后）、安全性或耐受性原因而有 3-4 次预防性药物类别失败的 CM 或 EM 患者中的疗效结果。由于治疗不足的偏头痛患者生活质量下降和经济负担增加，因此该患者人群尤其受到关注，这也是全球决策者关注的问题。

方法

主要终点包括基线至第 1-3 个月期间每月偏头痛头痛天数的总体平均变化，以及每月偏头痛头痛天数减少≥30%（CM）、≥50%和≥75%（反应率）的患者比例。在第 3 个月评估患者的功能和残疾情况。

结果

在 462 名随机患者中，有 186 名（40.3%）有 3-4 次预防性类别失败的病史。加奈珠单抗与安慰剂相比，每月偏头痛头痛天数的总体平均降幅显著更大（总：-5.49 对-1.03；CM：-6.70 对-1.56；EM：-3.64 对-0.65）。同样，加奈珠单抗与安慰剂相比，≥50%的反应率也显著更高（总：41.0%对 12.7%；CM：41.5%对 8.4%；EM：41.1%对 16.5%）。在 CM 组中，加奈珠单抗组的≥30%反应率显著高于安慰剂组（CM，57.5%对 19.8%，P≤0.0001），≥75%反应率也显著高于安慰剂组（CM，13.3%对 2.6%，P≤0.05）。加奈珠单抗还显著改善了患者的功能并降低了残疾程度。