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Erenumab and galcanezumab in chronic migraine prevention: effects after treatment termination
The Journal of Headache and Pain ( IF 7.3 ) Pub Date : 2019-06-03 , DOI: 10.1186/s10194-019-1018-8
Bianca Raffaelli , Valeria Mussetto , Heike Israel , Lars Neeb , Uwe Reuter

BackgroundMonoclonal antibodies (mAbs) targeting the CGRP pathway are safe and efficacious therapies for the prevention of migraine. In this study we assessed the effects of discontinuation of preventive erenumab and galcanezumab treatment in patients with chronic migraine.MethodsThis retrospective pooled analysis included completers of the open-label extension study phase for the preventive treatment of chronic migraine with galcanezumab (NCT02614261; 9 months) and erenumab (NCT02174861; 12 months) in a single headache center. We compare migraine data until week 12 after open-label treatment completion, when patients did not have any pharmacological preventive medication, to study baseline values of the double-blind trial period, and to the last 4 weeks of the open-label extension. The assessment included changes in monthly migraine days, headache hours, days with severe headache and acute headache medication use.ResultsData from 16 patients after galcanezumab (n = 9) and erenumab (n = 7) open-label treatment completion were analyzed. The mean number of monthly migraine days was 18.38 ± 3.74 at baseline, and 12.19 ± 4.53 in the last 4 weeks of the open-label extension (p < 0.001). Monthly migraine days remained significantly reduced compared to baseline during the entire 12-week observation period after open-label termination (p = 0.002), with a reduction of 5.38 ± 4.92 in weeks 1–4 (p = 0.001), 4.75 ± 4.15 in weeks 5–8 (p = 0.001), and 3.93 ± 5.45 in weeks 9–12 (p = 0.014). There was no significant difference in monthly migraine days between the 12 weeks after open-label termination and the last 4 weeks of the open-label phase (p = 0.228). All other analyses revealed numerical improvement through week 12 in comparison to baseline.ConclusionsIn this small, self-selected cohort, the results indicate a therapeutic effect of monoclonal antibodies targeting the CRGP pathway in chronic migraine prevention after treatment termination up to 12 weeks.

中文翻译:

Erenumab 和 galcanezumab 用于慢性偏头痛预防:治疗终止后的影响

背景靶向 CGRP 通路的单克隆抗体 (mAb) 是预防偏头痛的安全有效疗法。在这项研究中,我们评估了停止使用 erenumab 和 galcanezumab 治疗对慢性偏头痛患者的影响。 方法这项回顾性汇总分析包括使用 galcanezumab 预防性治疗慢性偏头痛的开放标签扩展研究阶段的完成者(NCT02614261;9 个月)和 erenumab(NCT02174861;12 个月)在一个单一的头痛中心。我们比较了开放标签治疗完成后第 12 周的偏头痛数据,此时患者没有任何药物预防药物,以研究双盲试验期的基线值,以及开放标签扩展的最后 4 周。评估包括每月偏头痛天数的变化,头痛小时数、严重头痛天数和急性头痛药物使用。结果分析了 16 名患者在 galcanezumab(n = 9)和 erenumab(n = 7)开放标签治疗完成后的数据。每月平均偏头痛天数在基线时为 18.38 ± 3.74,在开放标签扩展的最后 4 周为 12.19 ± 4.53 (p < 0.001)。在开放标签终止后的整个 12 周观察期内,与基线相比,每月偏头痛天数仍显着减少(p = 0.002),第 1-4 周减少 5.38 ± 4.92(p = 0.001),减少 4.75 ± 4.15第 5–8 周 (p = 0.001),第 9–12 周为 3.93 ± 5.45 (p = 0.014)。在开放标签终止后的 12 周和开放标签阶段的最后 4 周之间,每月偏头痛天数没有显着差异(p = 0.228)。
更新日期:2019-06-03
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