原发性渐进性多发性硬化症未经药物治疗的患者的抗CD20疗法:一个多中心实践研究
Marion Hay1, Fabien Rollot1, Romain Casey1
1From the Neurology Department (M.H., A.K., G.E., E.L.P., L. Michel), Rennes University Hospital; Clinical Neuroscience Centre (M.H., A.K., G.E., E.L.P., L. Michel), CIC_P1414 INSERM, Rennes, University Hospital, Rennes University; Université Claude Bernard Lyon 1 (F.R., R.C., S.V.), Université de Lyon; Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-inflammation (F.R., R.C., S.V.), Hospices Civils de Lyon, Bron; Observatoire Français de la Sclérose en Plaques (F.R., R.C., S.V.), Centre de Recherche en Neurosciences de Lyon, INSERM 1028 et CNRS UMR 5292; EUGENE DEVIC EDMUS Foundation Against Multiple Sclerosis, state-approved foundation (F.R., R.C., S.V.), Bron; Department of Neurology (G.M.), Nancy University Hospital; Université de Lorraine (G.M.), Inserm, INSPIIRE, Nancy; MS Unit (P.L.), CHU de Montpellier; University of Montpellier (MUSE) (P.L.); Department of Neurology and Clinical Investigation Center (J.D.S.), CHU de Strasbourg, CIC 1434, INSERM 1434; Service de Neurologie (D.-A.L.), CHU Nantes, Nantes Université, INSERM, Center for Research in Transplantation and Translational Immunology, UMR 1064, CIC INSERM 1413; Department of Neurology (C.P.), Fondation Rotschild, Paris; Department of Neurology (T.M.), CHU de Dijon, EA4184; Department of Neurology (E.T.), Nimes University Hospital; IGF (E.T.), University of Montpellier, CNRS, INSERM; CHU de Caen (G.D.), MS Expert Centre, Department of Neurology, Normandy University, Caen; Neurology (C.L.-F.), UR2CA_URRIS, Centre Hospitalier Universitaire Pasteur2, Université Nice Côte d'Azur, Nice; Department of Neurology (J.C.), CHU de Toulouse, CRC-SEP; Université Toulouse III (J.C.), Infinity, INSERM UMR1291-CNRS UMR5051; Service de Neurologie (E.B.), CHU de Besançon; Sorbonne Universités (B.S.), Paris Brain Institute, ICM, Inserm UMR S 1127, CNRS UMR 7225, and Department of Neurology, AP-HP, Hôpital de la Pitié Salpêtrière; CHU Clermont-Ferrand (P.C.), CRC SEP Auvergne, Department of Neurology, and INSERM NeuroDol U1107; Département de Neurologie (E.M.), Hôpital Pitié-Salpêtrière, APHP; Centre de Ressources et de Compétences SEP Paris (E.M.); Departement of Neurology (O.H.), Centre de Ressource et Compétences SEP IDF Ouest, Hôpital de Poissy; CHU Lille (H.Z.), CRCSEP Lille, Univ Lille, U1172; Department of Neurology (A.R.), University Hospital of Bordeaux; Neurocentre Magendie (A.R.), Bordeaux University, INSERM U1215; Department of Neurology (O.C.), CHU Grenoble Alpes, Neurology MS Clinic Grenoble, Grenoble Alpes University Hospital, La Tronche; Department of Neurology (S.M.), CHU de Reims, CRC-SEP; Department of Neurology (A.A.-K.), CHU d'Amiens; Departement of Neurology (B.B.), CHU de Rouen; Service de Neurologie (J.P.), Pôle de Neurosciences Cliniques, APHM, Hôpital de la Timone, Aix Marseille Univ; Department of Neurology (L. Magy), Hôpital Dupuytren, CHU de Limoges; Department of Neurology (J.-P.N.), Hôpital Jean Bernard, CHU La Milétrie, Poitiers; Department of Neurology (J.-P.C.), Hôpital Nord, CHU de Saint-Étienne; CRC SEP and Department of Neurology (I.D.), Hôpital Bretonneau, CHU de Tours; Department of Neurology (A.W.), Hôpital Henri Mondor, APHP, Créteil; Department of Neurology (M.T.), Hôpital Foch, Suresnes; Department of Neurology (C.L.), CHU Bicêtre; and Department of Neurology (K.H.), Hôpital Pierre Delafontaine, Centre Hospitalier de Saint-Denis, France.
与未接受治疗的患者相比,抗CD20疗法在初级渐进性多发性硬化症 (PPMS) 患者中没有显著延迟残疾进展. 需要进一步评估,以确定PPMS中这些治疗方法的最佳风险/益处比.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
背景情况:
- 初级渐进性多发性硬化症 (PPMS) 是一种衰弱的神经系统疾病.
- 抗CD20疗法在MS中表现出不同的疗效,ocrelizumab成功,而rituximab在残疾进展方面失败.
- 在PPMS中评估抗CD20疗法对于治疗优化至关重要.
研究的目的:
- 为了比较用抗CD20疗法治疗的PPMS患者的确诊残疾进展 (CDP),与未经治疗的加权队列进行比较.
- 分析二次结果,包括复发率,MRI活动,CDP风险因素和严重感染发生率.
主要方法:
- 使用法国MS注册表 (2016-2021) 进行的回顾性研究.
- 包括PPMS患者 (扩展残疾状况尺度≤6.5),接受或未接受抗CD20疗法.
- 应用治疗权重的逆概率 (IPTW) 来比较结果,包括CDP的时间,复发,MRI活动和感染率.
主要成果:
- 在接受治疗和未接受治疗的PPMS患者之间,时间到第一个CDP没有显著差异 (HR 1.13,p=0.2113).
- 在治疗组中出现较少复发的非显著趋势 (HR 0.83,p=0.0809).
- 在接受治疗的群体中,严重感染的发病率更高 (6.67/100人年对比2.67).
结论:
- 抗CD20疗法在以前未经治疗的PPMS患者中,在延迟CDP方面没有表现出优于没有治疗的优势.
- 这项研究主要包括接受Rituximab治疗的患者,强调需要持续进行风险/益处评估.
- 第三类证据表明,目前的抗CD20疗法并不优于在PPMS中推迟CDP的无疗法.
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