Braune Stefan, Dirks Petra, Colloud Seya, Wang Qing, Davies Evan, Heer Yanic, Zürcher Mel, Sun Diana, Bergmann Arnfin
NeuroTransData, Neuburg an der Donau, Germany.
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Neurol Ther. 2025 Jun 2. doi: 10.1007/s40120-025-00762-6.
Treatment persistence is critical to obtaining full therapeutic benefit and can indicate favorable outcomes. This study examined real-world persistence with ocrelizumab (OCR) versus other disease-modifying therapies (DMTs) and its association with outcomes in relapsing-remitting multiple sclerosis (RRMS) using German NeuroTransData (NTD) registry data.
This retrospective cohort analysis included outpatients with RRMS who initiated a DMT between January 2014 and April 2022. DMT initiation date was defined as the index date. DMTs were grouped into OCR, injectable, oral, oral for highly active disease (oral HA), and other intravenous (IV) therapies. Persistence, based on having continuous records of a DMT for 2 years from index date, was evaluated within each group. Association between persistence and the risk of relapse, 3-months confirmed disability progression (3mCDP), and sick leave were assessed.
Overall, 3907 patients with RRMS were included. OCR users had the highest persistence at 2 years (93%), then oral HA (78%), oral (67%), natalizumab (67%), and injectable therapies (55%). Compared with OCR users, patients initiating injectable (hazard ratio [HR] 8.51, 95% confidence interval [CI] 4.03-17.90), oral (HR 5.92, 95% CI 2.81-12.50), oral HA (HR 3.49, 95% CI 1.63-7.48) therapies, and natalizumab (HR 5.47, 95% CI 2.47-12.10) were more likely to discontinue. Adverse events (32.47%), lack of efficacy (21.17%), and patient-driven factors (19.73%) were the main reasons for discontinuation. Compared with persisters, non-persisters were associated with higher risks of relapse activity (rate ratio: 2.18, 95% CI 1.98-2.39), 3mCDP (rate ratio 1.52, 95% CI 1.28-1.77), and sick leave (rate ratio 1.71, 95% CI 1.49-1.98).
In a German real-world setting, patients initiating OCR achieved higher rates of persistence over 2 years compared with those on other DMTs. High persistence was associated with lower risk of clinical disease activity, disease progression, and sick leave.
治疗依从性对于获得充分的治疗益处至关重要,并且可以预示良好的治疗结果。本研究利用德国神经传输数据(NTD)登记处的数据,研究了奥瑞珠单抗(OCR)与其他疾病修饰疗法(DMT)在现实世界中的治疗依从性及其与复发缓解型多发性硬化症(RRMS)患者治疗结果的关联。
这项回顾性队列分析纳入了2014年1月至2022年4月期间开始使用DMT的RRMS门诊患者。DMT开始日期定义为索引日期。DMT分为OCR、注射剂、口服药、用于高度活动性疾病的口服药(口服HA)和其他静脉注射(IV)疗法。根据从索引日期起有连续2年的DMT记录来评估每组中的治疗依从性。评估了治疗依从性与复发风险、3个月确诊的残疾进展(3mCDP)和病假之间的关联。
总体而言,纳入了3907例RRMS患者。使用OCR的患者2年治疗依从性最高(93%),其次是口服HA(78%)、口服药(67%)、那他珠单抗(67%)和注射剂疗法(55%)。与使用OCR的患者相比,开始使用注射剂疗法(风险比[HR] 8.51,95%置信区间[CI] 4.03 - 17.90)、口服药(HR 5.92,95% CI 2.81 - 12.50)、口服HA(HR 3.49,95% CI 1.63 - 7.48)和那他珠单抗(HR 5.47,95% CI 2.47 - 12.10)的患者更有可能停药。不良事件(32.47%)、缺乏疗效(21.17%)和患者驱动因素(19.73%)是停药的主要原因。与坚持治疗的患者相比,未坚持治疗的患者复发活动风险更高(率比:2.18,95% CI 1.98 - 2.39)、3mCDP风险更高(率比1.52,95% CI 1.28 - 1.77)和病假风险更高(率比1.71,95% CI 1.49 - 1.98)。
在德国的现实世界环境中,与使用其他DMT的患者相比,开始使用OCR的患者在2年内实现了更高的治疗依从率。高治疗依从性与临床疾病活动、疾病进展和病假风险较低相关。