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Clinical and MRI Outcomes of Ocrelizumab in Early RRMS Over 4 Years

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The following is a summary of “Ocrelizumab in Early-Stage Relapsing-Remitting Multiple Sclerosis: The Phase IIIb ENSEMBLE 4-Year, Single-Arm, Open-Label Trial,” published in the December 2024 issue of Neurology by Hartung et al.  


Early treatment of multiple sclerosis (MS) can reduce disease activity and long-term progression. However, limited data on the effectiveness of ocrelizumab in people with early relapsing-remitting MS (RRMS) is studied.  

Researchers conducted a prospective study to evaluate ocrelizumab’s 4-year effectiveness and safety in people with early-stage RRMS.  

They involved 678 individuals aged 18-55 years with early-stage RRMS (disease duration ≤3 years, Expanded Disability Status Scale [EDSS] score ≤3.5) and a history of relapses or MRI signs of brain inflammation. Participants received 600 mg of intravenous ocrelizumab every 24 weeks. Effective measures included the proportion of people with no evidence of disease activity (NEDA-3), confirmed disability progression (CDP) over 24 weeks, and annualized relapse rate (ARR), among other measures. Cognitive status, patient-reported outcomes, and neurofilament light chain (NfL) levels were also assessed.  

The results showed that at week 192, 66.4% of participants had NEDA-3, 85.0% had no MRI activity, 90.9% had no relapses, and 81.8% had no CDP over 24 weeks. The adjusted ARR was 0.020 (95% CI 0.015–0.027). The NfL levels were reduced to and remained within the healthy donor range by week 48 and continued to stay within this range by week 192. No new or unexpected safety signals were observed.  

They concluded that ocrelizumab demonstrated favorable long-term effectiveness and safety as a first-line treatment for people with early-stage RRMS.  

Source: neurology.org/doi/10.1212/WNL.0000000000210049

The post Clinical and MRI Outcomes of Ocrelizumab in Early RRMS Over 4 Years first appeared on Physician's Weekly.


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