Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, L'Aquila, Italy.
Medical Toxicology Unit-Headache and Drug Abuse Research Center, Department of Biomedical, Metabolical and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
J Headache Pain. 2020 Apr 25;21(1):40. doi: 10.1186/s10194-020-01113-6.
Treatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM). Several studies assessed possible predictors of response to treatment with BT-A, but there is little knowledge on the frequency and predictors of sustained response. The aim of this study was to evaluate sustained response to BT-A in patients with CM.
In this prospective open-label study, 115 patients with CM and treated with BT-A were consecutively enrolled in two Italian headache centers and followed up for 15 months. Anytime responders were defined as those patients who achieved a ≥ 50% reduction in headache days during any three-month treatment cycle compared with the 3 months prior to initiation of BT-A treatment. Sustained responders were defined as those who achieved a ≥ 50% reduction in headache days within the third treatment cycle and maintained response until the end of follow-up. Non-responders were defined as those patients who never achieved a ≥ 50% reduction in headache days during the follow-up. Headache characteristics prior to BT-A treatment were assessed in order to evaluate their ability in predicting treatment response. The 115 enrolled patients (84.3% female; median age 50 years) had a median migraine duration of 30 years (interquartile range 22-38). At the end of follow-up, 66 patients (57.4%) were classified as anytime responders. Among the 51 patients who achieved a clinical response within the third month of treatment, 33 (64.7%) were sustained responders. Patients with sustained response had a lower CM duration (median 31 vs 65 months; P = 0.030) and a lower number of headache days (median 25 vs 30; P = 0.013) at baseline compared with non-responders.
About two thirds of patients who gain ≥50% response to BT-A within the third cycle of treatment maintain this positive response over time. More recent onset of CM and more headache-free days at baseline are associated with sustained response. We suggest not to delay preventive treatment of CM with BT-A, in order to increase the likelihood to achieve sustained clinical response.
肉毒杆菌毒素 A（BT-A）治疗对慢性偏头痛（CM）安全且有效。有几项研究评估了 BT-A 治疗反应的可能预测因素，但对于持续反应的频率和预测因素知之甚少。本研究旨在评估 CM 患者对 BT-A 的持续反应。
在这项前瞻性开放标签研究中，连续纳入了意大利两个头痛中心的 115 名 CM 患者并接受 BT-A 治疗，随访 15 个月。任何时候的应答者定义为与 BT-A 治疗前的 3 个月相比，在任何 3 个月的治疗周期中头痛天数减少≥50%的患者。持续应答者定义为在第三个治疗周期内头痛天数减少≥50%并保持应答直至随访结束的患者。无应答者定义为在随访期间从未达到头痛天数减少≥50%的患者。评估 BT-A 治疗前的头痛特征，以评估其预测治疗反应的能力。115 名入组患者（84.3%为女性；中位年龄 50 岁）偏头痛病史中位数为 30 年（四分位距 22-38）。随访结束时，66 名患者（57.4%）被归类为任何时候的应答者。在治疗的第三个月内达到临床应答的 51 名患者中，有 33 名（64.7%）为持续应答者。与无应答者相比，持续应答者的 CM 持续时间更短（中位数 31 个月 vs 65 个月；P=0.030），基线时头痛天数更少（中位数 25 天 vs 30 天；P=0.013）。
大约三分之二在第三个治疗周期内对 BT-A 治疗获得≥50%反应的患者随着时间的推移保持这种积极的反应。CM 发病时间较晚和基线时无头痛天数更多与持续反应相关。我们建议不要延迟使用 BT-A 进行 CM 的预防性治疗，以增加实现持续临床反应的可能性。
