A new study has revealed that early treatment with ocrelizumab significantly reduces disease activity and long-term progression in patients with early-stage relapsing-remitting multiple sclerosis (RRMS).1 Early treatment of multiple sclerosis (MS) reduces disease activity and the risk of long-term disease progression.2
The ENSEMBLE study (NCT03085810) evaluated the 4-year effectiveness and safety of ocrelizumab as a first-line therapy in treatment-naive patients with recently diagnosed RRMS. The study enrolled 678 treatment-naive participants, aged 18–55, diagnosed with RRMS within three years, with Expanded Disability Status Scale (EDSS) scores ≤3.5 and ≥1 clinically reported relapse or ≥1 signs of brain inflammatory activity on MRI in the previous 12 months.
Patients received intravenous ocrelizumab (600 mg) every 24 weeks, and outcomes were monitored for 192 weeks. Key measures included the proportion of patients achieving no evidence of disease activity (NEDA-3), annualized relapse rates (ARR) and MRI findings.
At 192 weeks, the results demonstrated that:
- 66.4% of participants achieved NEDA-3.
- 90.9% experienced no relapses.
- 90.9% showed no MRI activity.
- 81.8% exhibited no 24-week confirmed disability progression.
The adjusted ARR was low at 0.020. Neurofilament light chain (NfL) levels normalized by week 48 and remained stable throughout the study. The safety profile of ocrelizumab was consistent with previous research, with no unexpected adverse effects reported.
Although the single-arm design limited the study by the lack of a parallel group for comparison, these findings emphasize the importance of early intervention in MS and support the role of ocrelizumab in reducing the disease burden in newly diagnosed patients.
References:
1. Hartung HP, Â Benedict RHB, Berger T, et al. Ocrelizumab in Early-Stage Relapsing-Remitting Multiple Sclerosis. Neurology. 2024;104:Epub
2. Kavaliunas A, Manouchehrinia A, Stawiarz L, et al. Importance of early treatment initiation in the clinical course of multiple sclerosis. Mult Scler. 2017;23:1233–1240. d:
Disclosures: This article was created by the touchNEUROLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
