Medical School Hannover, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.
Migraine and Headache Clinic, Königstein, Germany.
J Headache Pain. 2021 Jun 2;22(1):50. doi: 10.1186/s10194-021-01260-4.
Chronic migraine (CM) is associated with substantial economic burden. Real-world data suggests that onabotulinumtoxinA treatment for CM reduces healthcare resource utilisation (HRU) and related costs.
REPOSE was a 2-year prospective, multicentre, non-interventional, observational study to describe the real-world use of onabotulinumtoxinA in adult patients with CM. This analysis examined the impact of onabotulinumtoxinA on HRU. Patients received onabotulinumtoxinA treatment approximately every 12 weeks according to their physicians' discretion, guided by the summary of product characteristics (SPC) and PREEMPT injection paradigm. HRU outcome measures were collected at baseline and all administration visits and included headache-related hospitalizations and healthcare professional (HCP) visits. Health economic data, including family doctor and specialist visits, inpatient treatment for headache, acupuncture, technical diagnostics, use of nonpharmacologic remedies, and work productivity were also collected for patients enrolled at German study centres.
Overall, 641 patients were enrolled at 78 study centres across 7 countries (Germany, UK, Italy, Spain, Norway, Sweden, and Russia), 633 received ≥1 onabotulinumtoxinA dose, and 128 completed the 2-year study. Patients were, on average, aged 45 years, 85% were female, and 60% (n = 377) were from Germany. At the end of the 2-year observation period, significantly fewer patients reported headache-related hospitalizations (p < 0.02) and HCP visits (p < 0.001) within the past 3 months than in the 3 months before baseline. In the German population, reductions were observed across all health services at all follow-up visits compared with baseline. The percentage of patients who saw a family doctor decreased from 41.7% at baseline to 13.5% at administration visit 8 and visits to a medical specialist decreased from 61.7% to 5.2% of patients. Inpatient acute treatment and technical diagnostics declined from 6.4% and 19.7% of patients at baseline to 0.0% and 1.0% at administration 8, respectively. The use of nonpharmacologic remedies and medication for the acute treatment of migraine also decreased with continued onabotulinumtoxinA treatment. Work incapacity, disability, absenteeism, and impaired performance at school/work improved with onabotulinumtoxinA treatment for CM over the 2-year observation period.
Real-world evidence from REPOSE demonstrates that onabotulinumtoxinA treatment is associated with decreased HRU and supports the long-term benefits associated with the use of onabotulinumtoxinA for CM in clinical practice.
NCT01686581 . Name of registry: ClinicalTrials.gov. URL of registry: Date of retrospective registration: September 18, 2012. Date of enrolment of first patient: July 23, 2012.
慢性偏头痛(CM)与大量经济负担有关。真实世界的数据表明,肉毒毒素 A 治疗 CM 可减少医疗资源的利用(HRU)和相关成本。
REPOSE 是一项为期 2 年的前瞻性、多中心、非干预性、观察性研究,旨在描述肉毒毒素 A 在成年 CM 患者中的真实世界应用。该分析研究了肉毒毒素 A 对 HRU 的影响。根据其医生的判断,根据产品特性摘要(SPC)和 PREEMPT 注射模式,患者每 12 周左右接受一次肉毒毒素 A 治疗。HRU 结果测量在基线和所有管理访问时收集,包括与头痛相关的住院和医疗保健专业人员(HCP)访问。还为在德国研究中心登记的患者收集了健康经济学数据,包括家庭医生和专科医生的就诊、头痛的住院治疗、针灸、技术诊断、非药物治疗的使用以及工作生产力。
总体而言,来自 7 个国家(德国、英国、意大利、西班牙、挪威、瑞典和俄罗斯)的 78 个研究中心共登记了 641 名患者,633 名患者接受了≥1 次肉毒毒素 A 剂量,128 名患者完成了 2 年的研究。患者平均年龄为 45 岁,85%为女性,60%(n=377)来自德国。在 2 年观察期结束时,与基线相比,过去 3 个月报告与头痛相关的住院(p<0.02)和 HCP 就诊(p<0.001)的患者明显减少。在德国人群中,与基线相比,所有随访访视的所有医疗服务均有所减少。看家庭医生的患者比例从基线时的 41.7%降至第 8 次管理访视时的 13.5%,看医学专家的患者比例从基线时的 61.7%降至 5.2%。住院急性治疗和技术诊断分别从基线时的 6.4%和 19.7%的患者降至第 8 次管理访视时的 0.0%和 1.0%。随着肉毒毒素 A 的持续治疗,用于偏头痛急性治疗的非药物治疗和药物的使用也减少了。随着肉毒毒素 A 治疗 CM,2 年观察期间工作能力丧失、残疾、旷工和工作/学习表现受损情况得到改善。
REPOSE 的真实世界证据表明,肉毒毒素 A 治疗与 HRU 减少有关,并支持在临床实践中使用肉毒毒素 A 治疗 CM 的长期获益。
NCT01686581。注册名称:ClinicalTrials.gov。注册网址:注册日期:2012 年 9 月 18 日。首次患者入组日期:2012 年 7 月 23 日。