Real-World Data Show Switch to Subcutaneous Ocrelizumab Well Tolerated

Real-world data from the CONFIDENCE study found that switching from intravenous to subcutaneous ocrelizumab was well tolerated in patients with relapsing and primary progressive multiple sclerosis (MS). Investigators presented the findings at the 10th Joint ACTRIMS-ECTRIMS Meeting (MSToronto2026), held October 21-23, 2026, in Toronto, Ontario, Canada.¹

The analysis was led by Ingo Kleiter, MD, a professor consultant at Josef-Hospital Bochum, in Germany. Subcutaneous ocrelizumab, coformulated with recombinant human hyaluronidase, was developed as an alternative to the original intravenous formulation, which the FDA approved in 2017 as the first and only disease-modifying therapy for primary progressive MS.^1,2

CONFIDENCE (ML39632, EUPAS22951) is an ongoing real-world study that included patients with relapsing MS (n = 236) and primary progressive MS (n = 60) who switched from intravenous ocrelizumab or other disease-modifying therapies to the subcutaneous formulation between July 22, 2024, and October 10, 2025. Mean time since diagnosis was 9.32 years for the relapsing cohort and 4.16 years for the primary progressive cohort. At the time treatment began, 68.4% of patients with relapsing MS had an Expanded Disability Status Scale (EDSS) score of 0 to 3.5, and 78.0% of patients with primary progressive MS had a score of 0 to 5.5.¹

Of the 296 total patients, 293 switched from intravenous ocrelizumab and 3 switched from other therapies. Patient preference was the primary driver of the switch (67.9%), followed by physician preference due to capacity constraints (17.6%).

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On the subcutaneous formulation, the time-adjusted adverse event (AE) rate was 37.0 events per 100 patient-years, and no new safety signals were identified. Injection site reactions occurred in 2 patients with relapsing MS (none with primary progressive MS), all non-serious and mild to moderate in intensity. Serious infections remained infrequent (relapsing MS, 0.8%; primary progressive MS, 1.7%). One fatal AE, sepsis, occurred in the relapsing MS group; its relationship to ocrelizumab treatment was not assessed.

Ocrelizumab was first approved by the FDA in March 2017 as Ocrevus, a CD20-targeted monoclonal antibody given by intravenous infusion every 6 months. It was the first and only disease-modifying therapy approved for primary progressive MS, based on the phase 3 ORATORIO trial, alongside the phase 3 OPERA I and OPERA II trials in relapsing MS.²

A subcutaneous formulation, Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq), followed with FDA approval in September 2024 as the first and only twice-yearly, approximately 10-minute subcutaneous injection for both relapsing and primary progressive MS. That approval was based on the phase 3 OCARINA II trial, which enrolled 236 patients with relapsing or primary progressive MS and found subcutaneous ocrelizumab non-inferior to the IV formulation on pharmacokinetic exposure, with comparable control of MRI lesion activity and a safety profile consistent with the IV formulation.^3,4

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REFERENCES
1. Kleiter I, Buttmann M, Weber MS, Meuth SG, Walter S, Ziemssen T. Real-world experience of switching from intravenous to subcutaneous ocrelizumab in people with relapsing and primary progressive MS: data from the CONFIDENCE study. Abstract 1706. Presented at: 10th Joint ACTRIMS-ECTRIMS Meeting (MSToronto2026); October 21-23, 2026; Toronto, Ontario, Canada.
2. FDA approves Genentech's OCREVUS (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis. News release. Genentech. Published March 28, 2017. Accessed October 21, 2026. https://www.gene.com/media/press-releases/14657/2017-03-28/fda-approves-genentechs-ocrevus-ocrelizu
3. FDA approves Ocrevus Zunovo as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis. News release. Genentech. Published September 13, 2024. Accessed October 21, 2026. https://www.gene.com/media/press-releases/15036/2024-09-13/fda-approves-ocrevus-zunovo-as-the-first
4. Positive Phase III results for Genentech's Ocrevus (ocrelizumab) twice a year, 10-minute subcutaneous injection in patients with multiple sclerosis. News release. Genentech. Published July 12, 2023. Accessed October 21, 2026. https://www.businesswire.com/news/home/20230712019800/en/Positive-Phase-III-Results-for-Genentechs-Ocrevus-ocrelizumab-Twice-a-Year-10-Minute-Subcutaneous-Injection-in-Patients-With-Multiple-Sclerosis