AI Article Synopsis
- The study investigates the safety and effectiveness of ocrelizumab in Hispanic/Latino individuals with multiple sclerosis (MS), highlighting the need for real-world data from underrepresented populations in clinical trials.
- Out of 305 participants, the majority had relapsing-remitting MS, and the results showed minimal relapses and a significant reduction in MRI activity, with only 12.4% experiencing confirmed disability worsening.
- While the treatment was largely safe, with a low rate of serious infections and a consistent profile of outcomes, the study confirms ocrelizumab's effectiveness in this demographic at a specialized MS center.
Article Abstract
Background: Real-world studies are needed to expand our knowledge concerning populations underrepresented in clinical trials.
Objective: This study aimed to evaluate the safety and effectiveness of ocrelizumab in Hispanic/Latino people with multiple sclerosis (pwMS).
Methods: Prospective longitudinal observational study including pwMS who received at least one dose of ocrelizumab between June 2018 and October 2023.
Results: 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.
Conclusion: 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.
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| http://dx.doi.org/10.1177/13524585241309835 | DOI Listing |
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