Prockl Victoria, Nickel Florian T, Utz Kathrin S, Fröhlich Kilian, Engelhorn Tobias, Hilz Max-Josef, Lee De-Hyung, Linker Ralf A, Huhn Konstantin
Department of Neurology, University of Erlangen, Germany.
Department of Neuroradiology, University of Erlangen, Germany.
J Neurol Sci. 2020 Aug 15;415:116973. doi: 10.1016/j.jns.2020.116973. Epub 2020 Jun 11.
Pivotal trials showed good clinical efficiency of the monoclonal antibody ocrelizumab while being well tolerated and manageable in multiple sclerosis (MS). However, data on adverse events in everyday practice are scarce. Hence, our study aims at investigating short-term tolerability of ocrelizumab in a "real-world" setting.
In this retrospective cohort study, data of 128 (86 relapsing-remitting, 42 progressive) MS patients at initiation of ocrelizumab were analyzed at the MS center of the University of Erlangen, Germany. Additionally, follow-up data of 68 patients at 6-months retreatment were analyzed. Structured phone interviews were applied after ocrelizumab initiation to report undocumented side effects.
Patients predominantly switched from monoclonal antibodies (46%), orals (20%), injectables (10%), steroids or immunosuppressants (each 8%), with a mean interval of 9.0 months after the last application of the previous immunotherapy. Applying a combined premedication with steroids, antihistamines and antipyretics for >90% of patients, ocrelizumab treatment was well tolerated and mainly comprised mild (n = 59/128 at initiation, n = 5/68 at 6 months retreatment) and rarely moderate (n = 7/128 at initiation, n = 2/68 at 6 months) side effects. Predominantly mild infusion related reactions (IRR) were reported with a declining percentage over the follow-up applications. Infections occurred rarely. No severe side effects were observed. Secondary, treatment appeared efficient when looking at clinical surrogates of stable disease.
Our study delineates good short-term tolerability of ocrelizumab in a miscellaneous "real-world" MS cohort. Additional studies are warranted to confirm these beneficial findings and to reveal safety concerns in the longer-term follow-up.
关键试验表明，单克隆抗体奥瑞珠单抗在治疗多发性硬化症（MS）时临床疗效良好，且耐受性良好、易于管理。然而，日常实践中关于不良事件的数据却很少。因此，我们的研究旨在调查奥瑞珠单抗在“真实世界”环境中的短期耐受性。
在这项回顾性队列研究中，德国埃尔朗根大学MS中心分析了128例（86例复发缓解型、42例进展型）开始使用奥瑞珠单抗治疗的MS患者的数据。此外，还分析了68例患者在6个月再次治疗时的随访数据。在开始使用奥瑞珠单抗后，通过结构化电话访谈报告未记录的副作用。
患者主要从单克隆抗体（46%）、口服药物（20%）、注射剂（10%）、类固醇或免疫抑制剂（各8%）转换而来，上次使用前一种免疫疗法后的平均间隔时间为9.0个月。超过90%的患者联合使用类固醇、抗组胺药和解热药进行预处理，奥瑞珠单抗治疗耐受性良好，主要包括轻度副作用（开始治疗时n = 59/128，6个月再次治疗时n = 5/68），中度副作用很少见（开始治疗时n = 7/128，6个月时n = 2/68）。主要报告的是轻度输液相关反应（IRR），随着后续用药，其发生率呈下降趋势。感染很少发生。未观察到严重副作用。其次，从疾病稳定的临床替代指标来看，治疗似乎是有效的。
我们的研究表明，奥瑞珠单抗在一个混杂的“真实世界”MS队列中具有良好的短期耐受性。有必要进行更多研究以证实这些有益发现，并揭示长期随访中的安全问题。
