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13 Subcutaneous ocrelizumab in multiple sclerosis: benefit-risk profile from the OCARINA clinical development program

jnnp · 2025-11-26 · canonical JSON source

5 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction OCARINA I ( NCT03972306) and II (NCT05232825) show that subcutaneous (SC) ocrelizumab (OCR) 920 mg has a similar benefit-risk profile to intravenous (IV) OCR 600 mg in people with (Pw) relapsing and primary progressive multiple sclerosis (RMS/PPMS).Methods In OCARINA I, PwRMS/PPMS transitioned to SC OCR 920 mg after dose escalation to assess safety, tolerability, and serum neurofilament light chain (sNfL) level. In OCARINA II, OCR-naive PwRMS/PPMS patients were randomized to OCR IV or SC, and all later received SC OCR; endpoints included safety and efficacy.Results In OCARINA I (n=118), patients experienced adverse events (AEs; n=105, 89.0%), serious AEs (SAEs; n=11, 9.3%), and injection reactions (IRs; n=70, 59.3%). In OCARINA II (n=233), patients experienced AEs (n=175, 75.1%), SAEs (n=6, 2.6%), and IRs (n=120, 51.5%). SC OCR showed near-complete suppression of MRI and relapse activity up to week 48, with B-cell depletion maintained via IV/SC routes. sNfL levels were decreased via IV/SC routes.Conclusions SC OCR has shown similar clinical/MRI outcomes to IV OCR, with a sustained reduction of sNFL. It was well tolerated, with no new safety concerns.jay.azmi@roche.com