Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio 1, L'Aquila, Italy.
PhD school in neurosciences; Department of biomedical, metabolic and neural sciences, University of Modena and Reggio Emilia, Modena, Italy.
J Headache Pain. 2022 Mar 19;23(1):38. doi: 10.1186/s10194-022-01408-w.
Monoclonal antibodies acting on the calcitonin gene-related peptide (CGRP) or its receptor have changed migraine preventive treatment. Those treatments have led to reconsidering the outcomes of migraine prevention. Available data mostly considered benefits in terms of relative efficacy (percent or absolute decrease in monthly migraine days [MMDs] or headache days compared with baseline). However, not enough attention has been paid to residual MMDs and/or migraine-related disability in treated patients. In the present study, we aimed at comparing the relative and absolute efficacy of erenumab.
ESTEEMen was a collaborative project among 16 European headache centers which already performed real-life data collections on patients treated with erenumab for at least 12 weeks. For the present study, we performed a subgroup analysis on patients with complete data on MMDs at baseline and at weeks 9-12 of treatment. Starting from efficacy thresholds proposed by previous literature, we classified patients into 0-29%, 30-49%, 50-74%, and ≥75% responders according to MMD decrease from baseline to weeks 9-12 of treatment. For each response category, we reported the median MMDs and Headache Impact test-6 (HIT-6) scores at baseline and at weeks 9-12. We categorized the number of residual MMDs at weeks 9-12 as follows: 0-3, 4-7, 8-14, ≥15. We classified HIT-6 score into four categories: ≤49, 50-55, 56-59, and ≥60. To keep in line with the original scope of the ESTEEMen study, calculations were performed in men and women.
Out of 1215 patients, at weeks 9-12, 381 (31.4%) had a 0-29% response, 186 (15.3%) a 30-49% response, 396 (32.6%) a 50-74% response, and 252 (20.7%) a ≥75% response; 246 patients (20.2%) had 0-3 residual MMDs, 443 (36.5%) had 4-7 MMDs, 299 (24.6%) had 8-14 MMDs, and 227 (18.7%) had ≥15 MMDs. Among patients with 50-74% response, 246 (62.1%) had 4-7 and 94 (23.7%) 8-14 residual MMDs, while among patients with ≥75% response 187 (74.2%) had 0-3 and 65 (25.8%) had 4-7 residual MMDs.
The present study shows that even patients with good relative response to erenumab may have a clinically non-negligible residual migraine burden. Relative measures of efficacy cannot be enough to thoroughly consider the efficacy of migraine prevention.
针对降钙素基因相关肽（CGRP）或其受体的单克隆抗体改变了偏头痛预防性治疗。这些治疗方法促使人们重新考虑偏头痛预防的结果。现有数据主要考虑了相对疗效（与基线相比，每月偏头痛天数[MMD]或头痛天数的百分比或绝对减少）。然而，对于接受治疗的患者，MMD 残留和/或偏头痛相关残疾的问题并没有得到足够的重视。在本研究中，我们旨在比较依瑞奈尤单抗的相对和绝对疗效。
ESTEEMen 是一项由 16 个欧洲头痛中心合作开展的项目，这些中心已经对接受依瑞奈尤单抗治疗至少 12 周的患者进行了真实世界数据收集。为了进行本研究，我们对基线和治疗第 9-12 周 MMD 数据完整的患者进行了亚组分析。根据先前文献提出的疗效阈值，我们将患者分为 0-29%、30-49%、50-74%和≥75%的应答者，根据治疗第 9-12 周 MMD 从基线的下降情况进行分类。对于每个应答类别，我们报告基线和治疗第 9-12 周时的 MMD 和头痛影响测试-6（HIT-6）评分中位数。我们将治疗第 9-12 周时的 MMD 残留量分为以下几类：0-3、4-7、8-14、≥15。我们将 HIT-6 评分分为四类：≤49、50-55、56-59、≥60。为了与 ESTEEMen 研究的原始范围保持一致，我们在男性和女性中进行了计算。
在 1215 名患者中，治疗第 9-12 周时，381 名（31.4%）患者的应答率为 0-29%，186 名（15.3%）为 30-49%，396 名（32.6%）为 50-74%，252 名（20.7%）为≥75%；246 名（20.2%）患者的 MMD 残留量为 0-3，443 名（36.5%）为 4-7，299 名（24.6%）为 8-14，227 名（18.7%）为≥15。在 50-74%应答者中，246 名（62.1%）患者的 MMD 残留量为 4-7，94 名（23.7%）为 8-14，而在≥75%应答者中，187 名（74.2%）患者的 MMD 残留量为 0-3，65 名（25.8%）为 4-7。
本研究表明，即使对依瑞奈尤单抗有良好的相对应答，患者仍可能存在临床不容忽视的偏头痛残留负担。相对疗效指标不能充分考虑偏头痛预防的疗效。
