Del Canto Adolfo, Cárcamo Claudia, Garcia Lorena, Aylwin Ester, Jürgensen-Heinrich Lukas, Guzman-Carcamo Ignacio, de la Barra Juan, Gutierrez-Calquin Leticia, Barrera-Hormazabal Antonia, Cruz Juan Pablo, Bravo Sebastián, Pelayo Carolina, Soler Bernardita, Uribe-San-Martin Reinaldo, Ciampi Ethel
Departamento de Neurología, Pontificia Universidad Católica de Chile, Santiago, Chile.
Neurology, Hospital Sótero del Río, Santiago, Chile.
Mult Scler. 2025 Apr;31(4):444-454. doi: 10.1177/13524585241309835. Epub 2025 Jan 6.
Real-world studies are needed to expand our knowledge concerning populations underrepresented in clinical trials.
This study aimed to evaluate the safety and effectiveness of ocrelizumab in Hispanic/Latino people with multiple sclerosis (pwMS).
Prospective longitudinal observational study including pwMS who received at least one dose of ocrelizumab between June 2018 and October 2023.
A total of 305 pwMS (223 relapsing-remitting MS (RRMS), 29 secondary progressive MS (SPMS), and 53 primary progressive MS (PPMS)), 67% female, mean age 38.7, mean disease duration 7 years, and median Expanded Disability Status Scale (EDSS) 2.0 (range 0-7). Median follow-up under ocrelizumab 29.5 (range 6-65) months. Only 1 patient had a relapse, 12-week-confirmed disability worsening was observed in 12.4% of the full cohort. Survival analysis showed higher risk of 12-week-confirmed disability worsening in SPMS compared with RRMS and PPMS ( = 0.0009). Magnetic resonance imaging (MRI) activity was significantly reduced from baseline across all disease phenotypes. Serious infections were observed in 4.6%, and two patients died during follow-up (one serious COVID-19 and one metastatic cancer). Notably, 22 pregnancies were reported, with 11 newborns and 6 pregnancies still on course.
This study supports the effectiveness of ocrelizumab in a real-world cohort of individuals from traditionally underrepresented groups, such as the Latin American population, with a consistent safety profile in patients receiving care at a specialized MS Unit.
需要开展真实世界研究，以拓展我们对临床试验中代表性不足人群的认识。
本研究旨在评估奥瑞珠单抗在西班牙裔/拉丁裔多发性硬化症患者（pwMS）中的安全性和有效性。
前瞻性纵向观察性研究，纳入2018年6月至2023年10月期间接受至少一剂奥瑞珠单抗的pwMS患者。
共有305例pwMS患者（223例复发缓解型多发性硬化症（RRMS）、29例继发进展型多发性硬化症（SPMS）和53例原发进展型多发性硬化症（PPMS）），67%为女性，平均年龄38.7岁，平均病程7年，扩展残疾状态量表（EDSS）中位数为2.0（范围0 - 7）。奥瑞珠单抗治疗的中位随访时间为29.5个月（范围6 - 65个月）。仅1例患者复发，12.4%的全部队列患者观察到12周确认的残疾恶化。生存分析显示，与RRMS和PPMS相比，SPMS患者12周确认的残疾恶化风险更高（P = 0.0009）。所有疾病表型的磁共振成像（MRI）活动均较基线显著降低。4.6%的患者发生严重感染，随访期间有2例患者死亡（1例死于严重COVID - 19，1例死于转移性癌症）。值得注意的是，报告了22例妊娠，其中11例已分娩，6例仍在妊娠中。
本研究支持奥瑞珠单抗在来自传统上代表性不足群体（如拉丁裔人群）的真实世界队列中的有效性，在专科多发性硬化症治疗单元接受治疗的患者中具有一致的安全性。
