Department of Neurology, Charite Universitatsmedizin Berlin, Berlin, Germany.
Universitatsmedizin Greifswald, Greifswald, Germany.
Eur J Neurol. 2024 Dec;31(12):e16437. doi: 10.1111/ene.16437. Epub 2024 Aug 12.
HER-MES was the first head-to-head study of erenumab against topiramate (standard of care). This post hoc analysis of the HER-MES study evaluated the effect of erenumab versus topiramate on patient-reported outcomes at week 24.
Adult patients with episodic or chronic migraine (n = 777) were randomized (1:1) to monthly subcutaneous erenumab (n = 389) or daily oral topiramate (n = 388). Migraine-related disability, as measured by the Headache Impact Test 6 (HIT-6) and Short Form 36 Health Survey version 2 (SF-36v2), was analysed in the entire study cohort and true completers.
In the erenumab group (vs. topiramate), significant improvements were reported in Headache Impact Test 6 total scores (composite populations, -10.88 vs. -7.72; true completers, -11.92 vs. -10.61) and a higher proportion of patients achieved a ≥5-point reduction from baseline with erenumab (composite populations, 72.2% vs. 53.9%; true completers, 79.64% vs. 71.43%). The adjusted mean change from baseline in the SF-36v2 score was greater with erenumab for both physical component summary (composite population, 5.48 vs. 3.63; true completers, 5.95 vs. 5.23) and mental component summary (composite populations, 1.00 vs. -1.18; true completers, 1.74 vs. -0.33). A higher proportion of patients on erenumab versus topiramate had a ≥5-point improvement in SF-36v2 for the physical component summary (composite populations, 47.7% vs. 37.4%; true completers, 52.1% vs. 48.9%) and mental component summary (composite populations, 25.3% vs. 16.8%; true completers, 27.3% vs. 17.7%).
This post hoc analysis demonstrated that patients treated with erenumab had significant improvements in headache impact and quality of life as measured by patient-reported outcomes versus patients treated with topiramate.
HER-MES 是依瑞奈尤单抗对比托吡酯（对照疗法）的首次头对头研究。本项 HER-MES 研究的事后分析评估了依瑞奈尤单抗对比托吡酯在第 24 周时对患者报告结局的影响。
入组 777 例发作性或慢性偏头痛的成年患者，按 1:1 比例随机分为每月皮下注射依瑞奈尤单抗（n=389）或每日口服托吡酯（n=388）。采用头痛影响测试 6 项（HIT-6）和健康调查简表 36 版本 2（SF-36v2）评估偏头痛相关残疾，在整个研究队列和真实完成者中进行分析。
与托吡酯组相比，依瑞奈尤单抗组报告的头痛影响测试 6 总分（复合人群：-10.88 比-7.72；真实完成者：-11.92 比-10.61）显著改善，并且更多的依瑞奈尤单抗治疗患者实现了基线至少 5 分的改善（复合人群：72.2%比 53.9%；真实完成者：79.64%比 71.43%）。对于 SF-36v2 评分，依瑞奈尤单抗治疗的患者在生理成分综合评分（复合人群：5.48 比 3.63；真实完成者：5.95 比 5.23）和心理成分综合评分（复合人群：1.00 比-1.18；真实完成者：1.74 比-0.33）的平均变化值均大于托吡酯。依瑞奈尤单抗组相较于托吡酯组，在 SF-36v2 生理成分综合评分（复合人群：47.7%比 37.4%；真实完成者：52.1%比 48.9%）和心理成分综合评分（复合人群：25.3%比 16.8%；真实完成者：27.3%比 17.7%）方面，有更高比例的患者得到了至少 5 分的改善。
本项事后分析表明，与托吡酯治疗的患者相比，接受依瑞奈尤单抗治疗的患者的头痛影响和生活质量在患者报告结局方面有显著改善。
