Ocrelizumab Subcutaneous Administration: Further Characterization of the Benefit–Risk Profile from the OCARINA II Study and Patient Preferences
Scott Newsome1, Lawrence Goldstick2, Krzysztof Selmaj3, Ewa Krzystanek4, Dusanka Zecevic5, Catarina Figueiredo5, Susanne Clinch6, Caroline Giacobino5, Jay Azmi6, Diego Centonze7
1Johns Hopkins University School of Medicine, Baltimore, MD, USA, 2Department of Neurology and Rehabilitation Waddell Center for Multiple Sclerosis, University of Cincinnati, College of Medicine, Cincinnati, OH, USA, 3Centrum Neurologii, Łódź, Poland, 4Department of Neurology, School of Health Sciences in Katowice, Medical University of Silesia, Katowice, Poland, 5F. Hoffmann-La Roche Ltd, Basel, Switzerland, 6Roche Products Ltd, Welwyn Garden City, UK, 7Unit of Neurology, IRCCS Neuromed, Pozzilli (IS), Italy
Objective:
To further characterize the benefit–risk profile of ocrelizumab (OCR) subcutaneous (SC) based on updated efficacy/safety data, and new patient-reported outcomes (PROs) from OCARINA II (NCT05232825), at the clinical cut-off date (CCOD; up to September 2024).
Background:
OCARINA II showed that OCR SC 920 mg (co-formulated with rHuPH20) has a similar benefit–risk profile to OCR IV 600 mg in people with RMS/PPMS (PwRMS/PwPPMS).
Design/Methods:
OCR-naive PwRMS/PwPPMS (18‒65 years; EDSS: 0–6.5) were randomized 1:1 to receive OCR IV 600 mg or OCR SC 920 mg during the controlled period. At Week (W)24, all patients (OCR IV/SC and OCR SC/SC arms) could enter the treatment phase with OCR SC up to W96. Endpoints included EDSS, relapses, safety and PROs (Multiple Sclerosis Treatment Preference Questionnaire [MSTPQ]; Patient Preference Questionnaire [PPQ]).
Results:
OCR SC resulted in near-complete suppression of relapse activity up to W48; 97.2% (OCR SC/SC) vs 98.1% (OCR IV/SC) of patients were relapse-free. Safety data in the OCR SC all-exposure group (December 2023, CCOD): adverse event (AE), 75.1%; serious AE, 2.6%; injection reaction (IR), 51.5% (local IR, 50.2% and systemic IR, 11.6%). All IRs were non-serious and mild/moderate in intensity; 74.1% resolved, mostly ≤3 days. No treatment-emergent antidrug antibodies to OCR were reported; 0.4% incidence of treatment-emergent anti-rHuPH20 antibodies. Small decreases in mean immunoglobulin G and M levels were observed in both arms.
At W48, the MSTPQ showed that among participants previously treated for MS, 81.6% preferred OCR; 98.1% were satisfied/very satisfied with OCR. According to the PPQ, where patients experienced both OCR IV and SC, 80.4% preferred SC administration.
W72 efficacy/safety data will be presented.
Conclusions:
Subcutaneous administration of ocrelizumab continues to show efficacy and safety similar to the well-established IV route of administration at the CCOD. Patients preferred and expressed a high level of satisfaction with the subcutaneous route of administration.
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