Non-inferiority of Rituximab versus OCrelizumab in Multiple Sclerosis (ROC-MS)-an individual participant data...

Area of Science:

• Neurology
• Immunology
• Clinical Trials

Background:

• Ocrelizumab (OCR) is a standard treatment for multiple sclerosis (MS).
• Rituximab (RTX), another anti-CD20 antibody, shows potential for similar efficacy and safety but requires higher-quality comparative data.
• Existing evidence comparing RTX and OCR is limited to retrospective studies with conflicting results.

Purpose of the Study:

• To conduct a prospective meta-analysis (PMA) using individual participant data (IPD) from four randomized controlled trials (RCTs).
• To compare the non-inferiority of RTX versus OCR in treating relapsing-remitting multiple sclerosis (RRMS).
• To provide robust evidence guiding treatment choices between RTX and OCR for MS.

Main Methods:

• Harmonizing core outcomes across four RCTs (OVERLORD-MS, DanNORMS, Noisy Rebels, TRIO).
• Analyzing IPD from 1109 RRMS patients (660 on RTX, 449 on OCR).
• Assessing primary outcome of relapse from month 6 to 24, alongside secondary clinical, patient-reported, radiological, biomarker, and safety outcomes.

Main Results:

• Patient recruitment is ongoing, with two sites completed as of October 2025.
• The collaborative initiative (ROC-MS) aims to provide precise estimates and increase statistical power.
• Anticipated results in 2028 will offer robust evidence on RTX vs. OCR efficacy and safety.

Conclusions:

• The ROC-MS collaboration will yield high-quality evidence on RTX and OCR for RRMS.
• This PMA will enhance precision for outcome estimates and rare event assessment.
• Findings will inform clinical decision-making for MS treatment selection.