在早期复发性复发性多发性硬化症中使用ocrelizumab:第三期b组合4年,单臂,开放标签试验
Hans-Peter Hartung1, Ralph H B Benedict1, Thomas Berger1
1From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany; Brain and Mind Centre (H.-P.H.), University of Sydney, Australia; Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic; Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY; Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria; Mellen Center for MS (R.A.B.), Cleveland Clinic, OH; Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France; Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands; Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada; Department of Neurology (T.H.), Akershus University Hospital, Lørenskog; Institute of Clinical Medicine (T.H.), University of Oslo, Norway; Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey; Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain; Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy; Loyola University Chicago (A.P.R.), IL; Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium; Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora; Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel; F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland; and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands.
在四年内,ocrelizumab在未经治疗的患者中有效治疗了早期复发性缓解性多发性硬化症 (RRMS),显著降低了疾病活性,并保持了有利的安全性. 这表明ocrelizumab是一种可行的一线治疗新诊断的RRMS.
科学领域:
- 神经免疫学 神经免疫学
- 临床神经学 临床神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- 多发性硬化症 (MS) 的早期治疗对于减少疾病活动和长期进展至关重要.
- 在复发性MS (RMS) 中确立了ocrelizumab的有效性,但在早期RMS中作为一线治疗的数据是有限的.
- 该ENSEMBLE研究旨在评估ocrelizumab在早期复发性复发性MS (RRMS) 的未经治疗的患者中长期的有效性和安全性.
研究的目的:
- 评估ocrelizumab作为早期RRMS患者的一线治疗的4年有效性.
- 评估ocrelizumab在这个特定患者群体中的安全性.
- 确定没有疾病活性证据的患者比例 (NEDA-3) 和其他关键的临床和MRI结果.
主要方法:
- 一项前性的,为期4年的,单臂的,开放的,IIIb期研究 (ENSEMBLE) 涉及早期RRMS的未经治疗的患者.
- 患者接受了每24周内静脉注射600毫克的ocrelizumab.
- 用NEDA-3 (没有复发,24周确认残疾进展[CDP]和MRI活动),年复发率 (ARR),CDP,残疾改善和扩展残疾状态量表 (EDSS) 评分的变化来衡量有效性.
主要成果:
- 在192周,很大一部分患者 (66.4%) 达到NEDA-3,其中90.9%没有复发,81.8%没有24周的CDP.
- 调整后的ARR低 (0.020),血清神经丝光链 (NfL) 水平降低至健康捐赠者的范围内.
- 没有观察到新的或意想不到的安全信号,与已知的ocrelizumab安全概况一致.
结论:
- 经过4年时间的ocrelizumab治疗导致大多数未经治疗的早期RRMS患者的持续低疾病活性.
- 观察到的安全性概况与ocrelizumab.b.的已知数据一致.
- 积极的益处风险概况表明,ocrelizumab可以考虑在新诊断的早期RMS患者中作为一线治疗.
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