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Letter to the editor: European headache federation guidelines on the use of monoclonal antibodies acting on the calcitonin gene-related peptide or its receptor for migraine prevention
The Journal of Headache and Pain ( IF 7.3 ) Pub Date : 2019-06-04 , DOI: 10.1186/s10194-019-0994-z
Daniel D. Mikol , Josefin Snellman

To the Editor, We thank you for publishing the guidelines on the use of monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway for migraine prevention [1]. We believe that these guidelines will be of great importance for clinicians in guiding treatment decisions and ultimately benefiting patients with migraine, which is a significant contribution to the field. While reviewing the guidelines, we observed a few inconsistencies in the data presented for erenumab. On Page 20, Fig. 1 mentions “Treatment with Erenumab 140 mg results in a small unimportant increase of serious adverse events occurrence compared to placebo” [1]. However, as reflected in Fig. 1, the risk with placebo was 25 per 1000 and 11 per 1000 with erenumab. Hence, there is a “decrease” in serious adverse event occurrence observed with erenumab versus placebo, which we have highlighted in Fig. 1. We also observed an inconsistency within Fig. 2 (Page 30) that provides information on binding or neutralising antibodies for all pivotal trials included in this guideline [1]. In this table, the data from the ARISE study [2] have been erroneously shown for the STRIVE study [3]. Similarly, the data from the STRIVE study [3] have been shown for the ARISE study [2]. Also, the percentage of neutralising antibodies in the ARISE study is reported as 0.3%, whereas the correct value is 0.4% (n = 1/283). The proposed correction for this swapping of data between the ARISE and STRIVE studies and for correcting the value for the neutralising antibodies is presented in Fig. 2. In addition, Fig. 2 includes frequencies of neutralising antibodies for the 7 mg and 21 mg doses, which were used in a relatively small Phase 2 proof-of-concept study [4]. These doses were ineffective, not studied further, and are not commercially available. Hence, for proper guidance to clinicians, we suggest omitting the data for 7 mg and 21mg. We would like to acknowledge the efforts and contributions of the consensus panel for drafting these guidelines. The data inconsistencies highlighted in this letter could have affected the final results and recommendations made in the guidelines. Moreover, the erroneous data may be cited by authors in upcoming publications, which may potentially affect the recommendations for the mAbs targeting the CGRP pathway. Hence, we request that you consider the proposed amendments to address these inconsistencies for the benefit of the readers.

中文翻译:

致编辑的信:欧洲头痛联合会关于使用作用于降钙素基因相关肽或其受体的单克隆抗体预防偏头痛的指南

致编辑,我们感谢您发布了使用靶向降钙素基因相关肽 (CGRP) 通路的单克隆抗体 (mAb) 预防偏头痛的指南 [1]。我们相信,这些指南对于临床医生指导治疗决策并最终使偏头痛患者受益非常重要,这是对该领域的重大贡献。在审查指南时,我们发现 erenumab 的数据存在一些不一致之处。在第 20 页,图 1 提到“与安慰剂相比,使用 Erenumab 140 mg 治疗导致严重不良事件发生率的小幅不重要增加”[1]。然而,如图 1 所示,安慰剂组的风险为每 1000 人 25,而 erenumab 组的风险为每 1000 人 11。因此,与安慰剂相比,erenumab 的严重不良事件发生率“减少”,我们在图 1 中强调了这一点。我们还观察到图 2(第 30 页)中的不一致之处,该图提供了有关所有关键抗体的结合或中和抗体的信息本指南中包含的试验 [1]。在这个表中,来自 ARISE 研究 [2] 的数据被错误地显示为 STRIVE 研究 [3]。同样,来自 STRIVE 研究 [3] 的数据已用于 ARISE 研究 [2]。此外,ARISE 研究中中和抗体的百分比报告为 0.3%,而正确值为 0.4% (n = 1/283)。对 ARISE 和 STRIVE 研究之间的这种数据交换以及对中和抗体值进行修正的建议修正如图 2 所示。图 2 包括 7 毫克和 21 毫克剂量的中和抗体频率,它们用于相对较小的 2 期概念验证研究 [4]。这些剂量是无效的,没有进一步研究,也没有市售。因此,为了给临床医生提供适当的指导,我们建议省略 7 mg 和 21 mg 的数据。我们要感谢共识小组为起草这些指南所做的努力和贡献。这封信中强调的数据不一致可能会影响指南中提出的最终结果和建议。此外,作者可能会在即将发表的出版物中引用错误数据,这可能会影响针对 CGRP 途径的 mAb 的推荐。因此,
更新日期:2019-06-04
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