Unit of Neurology, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, FG, Italy.
Unit of Biostatistics, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, FG, Italy.
Neurol Sci. 2017 Oct;38(10):1779-1789. doi: 10.1007/s10072-017-3054-y. Epub 2017 Jul 19.
OnabotulinumtoxinA was approved for treatment of chronic migraine (CM) after publication of Phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials. However, the PREEMPT trials lasted only up to 1 year. The main aim of our retrospective study was to evaluate whether a prolonged treatment of onabotulinumtoxinA (18 months, six quarterly cycles) will sustain or further improve the efficacy results and the quality of life achieved at 6 and 12 months. Patients were adults with CM with or without overuse of drugs, with at least six regularly repeat onabotulinumtoxinA treatments, administered according to the PREEMPT protocol. The outcomes were investigated after 6, 12, and 18 months of treatment with respect to baseline and with respect to each previous study time point. Headache days and hours, and dosage of headache medication taken with latency period, were collected from the patients daily. Quality of life was evaluated by means of the Migraine Disability Assessment (MIDAS) questionnaire. At each study time point, the proportion of responder patients with respect to baseline was evaluated. For all measures, the baseline data were referred to the previous month before starting. Forty-seven patients were evaluated. Our data show a decrease in the monthly headache days and hours, at each study evaluation, with respect to the previous one. They showed that beyond the first year, a statistically significant difference in the monthly days of headache compared at 18 vs. 12 months is observed. A significantly higher proportion of patients (with a response greater than 75% decrease from baseline in the frequency of headache days and hours) was observed at month 18 compared to month 12. The proportion of patients in MIDAS grade I increased over time, and a statistically significant improvement in MIDAS I score was obtained from month 12 to month 18. A positive modification in the consumption of analgesics over time was observed (p for trend <0.001). The mean acute drug latency strongly decreased over time. Our study confirmed that onabotulinumtoxinA is an effective treatment to reduce headache-related disability and improve patients' quality of life, highlighting that upon repeated administration, the therapy efficacy increases significantly and a progressive trend of "first-time response" is observed for the entire period under consideration.
肉毒杆菌毒素 A 获批用于治疗慢性偏头痛（CM），此前已公布了 3 期研究评估偏头痛预防治疗（PREEMPT）试验结果。然而，PREEMPT 试验仅持续了 1 年。本回顾性研究的主要目的是评估肉毒杆菌毒素 A 的长期治疗（18 个月，6 个季度周期）是否会维持或进一步改善 6 个月和 12 个月时达到的疗效结果和生活质量。患者为患有 CM 的成年人，无论是否滥用药物，均至少接受了 6 次定期重复肉毒杆菌毒素 A 治疗，且治疗方法均符合 PREEMPT 方案。根据基线以及前一个研究时间点评估治疗 6、12 和 18 个月后的结果。从患者日常记录中收集头痛天数和时间以及头痛药物的潜伏期和剂量。采用偏头痛残疾评估（MIDAS）问卷评估生活质量。在每个研究时间点，根据基线评估应答患者的比例。对于所有措施，基线数据均参考开始前的前一个月。共评估了 47 名患者。我们的数据显示，在每个研究评估中，每月头痛天数和时间均较前一个月减少。结果表明，在第一年之后，与 12 个月相比，18 个月时每月头痛天数的差异具有统计学意义。与 12 个月相比，在 18 个月时观察到具有更高比例的患者（头痛天数和时间的频率比基线下降超过 75%的反应者）。随着时间的推移，MIDAS 等级 I 的患者比例增加，从 12 个月到 18 个月，MIDAS I 评分有显著改善。随着时间的推移，镇痛药的消耗呈正性变化（趋势检验 p<0.001）。平均急性药物潜伏期随时间明显缩短。我们的研究证实肉毒杆菌毒素 A 是一种有效治疗方法，可降低与头痛相关的残疾程度并改善患者的生活质量，突出表明在重复给药时，治疗效果显著增加，并且在整个考虑期间观察到“首次反应”的显著递增趋势。
