Bassem Yamout, Raed Alroughani, Samar Frouk Ahmed Mohamed, Akram M Al-Mahdawi, Samia Joseph Khoury, Nabil El Ayoubi, Jihad Inshasi, Jabir Alkhaboori, Abdullah Al-Asmi, Riadh Gouider, Salman Aljarallah, Nuha Alkhawajah, Yaser Al Malik, Ahmad Abulaban, Seraj Makkawi, Osama Khojah, Taghrid El-Hajj, Joelle Massouh, Husam AlSalamat, Hani Dimassi, Amal Al-Hajje, Pascale Salameh, Farid Boumediene, Maya Zeineddine
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This study aimed to compare the effectiveness and safety of natalizumab versus ocrelizumab/rituximab in a real-world cohort of relapsing-remitting multiple sclerosis (RRMS) patients using data from the Middle East and North Africa Committee for the Treatment and Research in Multiple Sclerosis (MENACTRIMS) registry.</p><p><strong>Methods: </strong>This registry-based, retrospective, multicentre study was carried out in seven Middle Eastern countries by analysing data from the MENACTRIMS registry. All adults RRMS patients treated with natalizumab, rituximab or ocrelizumab and maintained on treatment for at least 12 months were included. Patients were matched using propensity scores. Primary outcomes were annualised relapse rate (ARR), confirmed disability progression and improvement and MRI activity.</p><p><strong>Results: </strong>A total of 1954 patients met the inclusion criteria, with 1277 receiving anti-CD20 therapy (768 on rituximab and 509 on ocrelizumab) and 677 natalizumab. Natalizumab significantly reduced ARR compared with anti-CD20 therapies (0.062 vs 0.092, p=0.001). Confirmed disability progression rates, MRI outcomes and no evidence of disease activity (NEDA-3) were similar between the two groups. However, natalizumab demonstrated higher rates of disability improvement compared with anti-CD20 therapies (9.3% vs 5.5%, p=0.03). Adverse events were more frequent in the anti-CD20 group (36.4% vs 27.5% for natalizumab, p=0.001).</p><p><strong>Conclusion: </strong>In this large, real-world cohort, natalizumab was associated with lower ARR, greater likelihood of disability improvement, lesser adverse events, but lower persistence compared with anti-CD20 therapies. 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引用次数: 0
摘要
背景：比较natalizumab和抗cd20单克隆抗体安全性和有效性的头对头随机试验或现实世界研究是有限的。本研究旨在比较natalizumab与ocrelizumab/rituximab在真实世界复发-缓解型多发性硬化症（RRMS）患者队列中的有效性和安全性，使用来自中东和北非多发性硬化症治疗和研究委员会（MENACTRIMS）注册的数据。方法：通过分析MENACTRIMS登记处的数据，在七个中东国家进行了这项基于登记的回顾性多中心研究。所有接受natalizumab、rituximab或ocrelizumab治疗并持续治疗至少12个月的成人RRMS患者均被纳入研究。使用倾向评分对患者进行匹配。主要结果是年复发率（ARR）、确认的残疾进展和改善以及MRI活动。结果：共有1954例患者符合纳入标准，其中1277例接受抗cd20治疗（768例接受利妥昔单抗治疗，509例接受奥克雷单抗治疗），677例接受那他单抗治疗。与抗cd20治疗相比，Natalizumab显著降低了ARR （0.062 vs 0.092, p=0.001）。确诊的残疾进展率、MRI结果和无疾病活动证据（NEDA-3）在两组之间相似。然而，与抗cd20治疗相比，natalizumab显示出更高的残疾改善率（9.3% vs 5.5%, p=0.03）。抗cd20组的不良事件发生率更高（36.4% vs 27.5%, p=0.001）。结论：在这个庞大的现实世界队列中，与抗cd20治疗相比，natalizumab与更低的ARR、更大的残疾改善可能性、更少的不良事件相关，但持久性较低。这些发现为这些RRMS疗法的相对疗效和安全性提供了有价值的见解，有助于临床医生做出个性化的治疗决策。
Comparative effectiveness of natalizumab and anti-CD20 monoclonal antibodies in relapsing-remitting multiple sclerosis: a real-world propensity-score matched study.
Background: Head-to-head randomised trials or real-world studies comparing the safety and efficacy of natalizumab and anti-CD20 monoclonal antibodies are limited. This study aimed to compare the effectiveness and safety of natalizumab versus ocrelizumab/rituximab in a real-world cohort of relapsing-remitting multiple sclerosis (RRMS) patients using data from the Middle East and North Africa Committee for the Treatment and Research in Multiple Sclerosis (MENACTRIMS) registry.
Methods: This registry-based, retrospective, multicentre study was carried out in seven Middle Eastern countries by analysing data from the MENACTRIMS registry. All adults RRMS patients treated with natalizumab, rituximab or ocrelizumab and maintained on treatment for at least 12 months were included. Patients were matched using propensity scores. Primary outcomes were annualised relapse rate (ARR), confirmed disability progression and improvement and MRI activity.
Results: A total of 1954 patients met the inclusion criteria, with 1277 receiving anti-CD20 therapy (768 on rituximab and 509 on ocrelizumab) and 677 natalizumab. Natalizumab significantly reduced ARR compared with anti-CD20 therapies (0.062 vs 0.092, p=0.001). Confirmed disability progression rates, MRI outcomes and no evidence of disease activity (NEDA-3) were similar between the two groups. However, natalizumab demonstrated higher rates of disability improvement compared with anti-CD20 therapies (9.3% vs 5.5%, p=0.03). Adverse events were more frequent in the anti-CD20 group (36.4% vs 27.5% for natalizumab, p=0.001).
Conclusion: In this large, real-world cohort, natalizumab was associated with lower ARR, greater likelihood of disability improvement, lesser adverse events, but lower persistence compared with anti-CD20 therapies. These findings provide valuable insights into the comparative efficacy and safety of these RRMS therapies, aiding clinicians in personalised treatment decisions.
期刊介绍：
The Journal of Neurology, Neurosurgery & Psychiatry (JNNP) aspires to publish groundbreaking and cutting-edge research worldwide. Covering the entire spectrum of neurological sciences, the journal focuses on common disorders like stroke, multiple sclerosis, Parkinson’s disease, epilepsy, peripheral neuropathy, subarachnoid haemorrhage, and neuropsychiatry, while also addressing complex challenges such as ALS. With early online publication, regular podcasts, and an extensive archive collection boasting the longest half-life in clinical neuroscience journals, JNNP aims to be a trailblazer in the field.
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