Real-world experience of ocrelizumab in multiple sclerosis in a Spanish population.
Real-world experience of ocrelizumab in multiple sclerosis in a Spanish population.
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DOI：
10.1002/acn3.51282
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发表时间：
2021-03
影响因子：
5.3
通讯作者：
Sempere AP
中科院分区：
文献类型：
--
作者：
Fernandez-Diaz E;Perez-Vicente JA;Villaverde-Gonzalez R;Berenguer-Ruiz L;Candeliere Merlicco A;Martinez-Navarro ML;Gracia Gil J;Romero-Sanchez CM;Alfaro-Saez A;Diaz I;Gimenez-Martinez J;Mendez-Miralles MA;Millan-Pascual J;Jimenez-Pancho J;Mola S;Sempere AP
临床试验表明，接受ocrelizumab治疗的多发性硬化症（MS）患者有更好的结局。然而，ocrelizumab在临床实践中的数据有限。本研究的目的是在真实的临床环境中评价ocrelizumab治疗多发性硬化症（MS）的初步安全性特征和有效性。我们进行了一项回顾性研究，包括来自西班牙东南部9家公立医院的连续患者，他们在获得批准后接受了ocrelizumab。共纳入228例MS患者（144例复发缓解型MS [RRMS]，25例继发性进展型MS [SPMS]和59例原发性进展型MS [PPMS]）。中位随访期为12个月（范围：1 - 32）。91.2%的复发性MS（RMS）人群在第1年未达到疾病活动性（NEDA）状态证据，而37.5%的PPMS患者检测到残疾进展（中位随访期为19个月）。报告的最常见不良事件为输注相关反应和感染，最常见的感染为尿路感染，其次为上呼吸道感染和COVID-19。在我们的真实的环境中的初步结果表明，ocrelizumab在抑制疾病活动方面表现出优异的结果，具有有利和一致的安全性特征。
Pivotal trial have shown that patients with multiple sclerosis (MS) receiving ocrelizumab had better outcomes. However, data on ocrelizumab in clinical practice are limited. The aim of this study was to evaluate the preliminary safety profile and effectiveness of ocrelizumab treatment for multiple sclerosis (MS) in a real‐world clinical setting. We conducted a retrospective study including consecutive patients from nine public hospitals in south‐eastern Spain who received ocrelizumab after it was approved. A total of 228 MS patients were included (144 with relapsing–remitting MS [RRMS], 25 secondary progressive MS [SPMS], and 59 primary progressive MS [PPMS]). Median follow‐up period was 12 months (range, 1‐32). No evidence of disease activity (NEDA) status at year 1 was achieved in 91.2% of the relapsing MS (RMS) population, while disability progression was detected in 37.5% of the PPMS patients (median follow‐up period, 19 months). The most common adverse events reported were infusion‐related reactions and infections, with the most common infections being urinary tract infections followed by upper respiratory infections and COVID‐19. The preliminary results in our real‐world setting show that ocrelizumab presented excellent results in suppressing disease activity with a favorable and consistent safety profile.
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影响因子：
6
作者：
Hauer L;Perneczky J;Sellner J
通讯作者：
Sellner J
影响因子：
2.5
作者：
Daniels, K.;van der Nat, P. B.;van de Garde, E. M. W.
通讯作者：
van de Garde, E. M. W.
影响因子：
5.8
作者：
Martinez-Yelamos, S.;Martinez-Yelamon, A.;Arbizu, Tx
通讯作者：
Arbizu, Tx
影响因子：
9.9
作者：
Lublin FD;Reingold SC;Cohen JA;Cutter GR;Sørensen PS;Thompson AJ;Wolinsky JS;Balcer LJ;Banwell B;Barkhof F;Bebo B Jr;Calabresi PA;Clanet M;Comi G;Fox RJ;Freedman MS;Goodman AD;Inglese M;Kappos L;Kieseier BC;Lincoln JA;Lubetzki C;Miller AE;Montalban X;O'Connor PW;Petkau J;Pozzilli C;Rudick RA;Sormani MP;Stüve O;Waubant E;Polman CH
通讯作者：
Polman CH
影响因子：
48
作者：
Thompson, Alan J.;Banwell, Brenda L.;Cohen, Jeffrey A.
通讯作者：
Cohen, Jeffrey A.