Headache Outpatient Clinic, Neurology Department, Agios Andreas State General Hospital of Patras, 26352 Patras, Greece.
Euromedica General Clinic, 54645 Thessaloniki, Greece.
Toxins (Basel). 2022 Dec 2;14(12):847. doi: 10.3390/toxins14120847.
We sought to assess the effectiveness of combining dual therapy with onabotulinumtoxinA (BTX) add-on to anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (anti-CGRP MAbs) in treatment-refractory patients with chronic migraine (CM). We retrospectively reviewed the medical files of 19 treatment-refractory patients with CM who had failed to two oral migraine preventatives, at least three consecutive BTX cycles (less than 30% response rate), at least three consecutive sessions with either fremanezumab or erenumab (less than 30% response rate), and were eventually switched to dual therapy with BTX add-on to any of the already-given anti-CGRP MAbs. We then assessed from baseline to each monotherapy or dual intervention predefined efficacy follow-up the changes in the following efficacy outcomes: (i) monthly headache days (MHD), (ii) monthly days with moderate/severe peak headache intensity, and (iii) monthly days with intake of any acute headache medication. Response (50% reduction in MHD) rates, safety, and tolerability were also determined. In the majority of cases ( = 14), dual targeting proved effective and was associated with clinically meaningful improvement in all efficacy variables; 50% response rates (also disability and QOL outcomes) coupled with favorable safety/tolerability. Our results advocate in favor of the view that dual therapy is effective and should be considered in difficult-to-treat CM patients who have failed all available monotherapies.
我们旨在评估在对曲安奈德(BTX)添加物联合治疗无反应的慢性偏头痛(CM)患者中,将双重疗法与抗降钙素基因相关肽(CGRP)单克隆抗体(抗 CGRP MAbs)联合使用的效果。我们回顾性分析了 19 名治疗抵抗的 CM 患者的医疗档案,这些患者在使用两种口服偏头痛预防药物、至少三个连续 BTX 周期(反应率低于 30%)、至少三个连续使用弗雷美昔单抗或依那西普疗程(反应率低于 30%)后均治疗失败,最终转换为 BTX 添加物联合已给予的任何一种抗 CGRP MAbs 的双重疗法。然后,我们评估了从基线到每种单药或双重干预的预定义疗效随访中,以下疗效结果的变化:(i)每月头痛天数(MHD),(ii)每月中度/重度头痛强度峰值天数,以及(iii)每月服用任何急性头痛药物的天数。还确定了反应率(MHD 减少 50%)、安全性和耐受性。在大多数情况下(n=14),双重靶向治疗有效,并与所有疗效变量的临床意义上的改善相关;50%的反应率(也包括残疾和 QOL 结果),加上良好的安全性/耐受性。我们的结果支持这样一种观点,即双重治疗是有效的,并且应该考虑用于所有可用的单药治疗均失败的难治性 CM 患者。