Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) / Roche, Halozyme - LARVOL DELTA

Findings from the OLIKOS Study: B-Cell Concentrations in Patients with Relapsing Multiple Sclerosis Switching from Intravenous Anti-CD20 Therapies to Ofatumumab (ACTRIMS Forum 2026) - P3 | "Ocrelizumab (OCR) and rituximab (RTX) are typically administered intravenously (IV) every 6 months, whereas ofatumumab (OMB) is administered subcutaneously (SC) via autoinjector pen once per month... After switching to OMB, B-cell concentrations were below LLN across all subgroups and all time points (Months 6 and 12). This suggests a more stable pharmacodynamic effect with OMB treatment, leading to a more consistent and sustained effect on B-cell concentration which may be due to the more frequent dosing (once per month) of OMB compared to OCR/RTX (every 6 months)."

Clinical • CNS Disorders • Multiple Sclerosis

No Evidence of Disease Activity in Treatment-Naive People With Relapsing Multiple Sclerosis Treated With Intravenous or Subcutaneous Ocrelizumab: Findings of the OPERA (10 Years) and OCARINA II (2 Years) Studies (ACTRIMS Forum 2026) - P3 | "Treatment with ocrelizumab led to rapid and substantial control of disease activity in TN pwRMS regardless of the route of administration. Near-complete and sustained suppression of disease activity was observed in TN patients continuing treatment for up to 10 years."

CNS Disorders • Infectious Disease • Multiple Sclerosis

Intravenous and Subcutaneous Ocrelizumab Lead to Sustained Reductions in Serum Neurofilament Light Chain Levels in Treatment-Naive People With Multiple Sclerosis (ACTRIMS Forum 2026) - P3 | "In TN patients, IV and SC ocrelizumab induced a rapid and significant reduction in serum NfL, which was sustained in patients treated for up to 6.5 years. These findings demonstrate that ocrelizumab effectively controls neuroaxonal damage when used as a first-line therapy, regardless of the route of administration."

CNS Disorders • Multiple Sclerosis • NEFL

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants With Relapsing Multiple Sclerosis: RESHAPE Study Design (ACTRIMS Forum 2026) - P3 | "This study will provide scientific evidence comparing the benefit-risk profile of remibrutinib in pwRMS who transition from ocrelizumab versus those who continue treatment with ocrelizumab."

Clinical • CNS Disorders • Inflammation • Multiple Sclerosis

Real World Safety and Adverse Events of Ocrelizumab in MS (ACTRIMS Forum 2026) - "Ocrelizumab demonstrated a favorable long-term safety profile in this large real-world MS cohort. Infusion reactions were generally mild, and malignancy incidence remained comparable to background population rates. Cytopenias were frequent but mostly transient, with few grade ≥3 cases."

Adverse events • Clinical • Real-world • Real-world evidence • Breast Cancer • CNS Disorders • Genetic Disorders • Gynecologic Cancers • Hematological Malignancies • Infectious Disease • Multiple Sclerosis • Nephrology • Neutropenia • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Urology • Vulvar Cancer

Ocrelizumab/Hyaluronidase Subcutaneous Injection in the Outpatient Clinic Setting: Real-World Clinic Experience (ACTRIMS Forum 2026) - "OCR SC subcutaneous injection administered in the clinic setting maintains high satisfaction, tolerability, and convenience over 6 months. These patient-reported outcomes support the integration of OCR SC into clinical care by improving the patient experience and increasing access to treatment."

Clinical • Real-world • Real-world evidence • CNS Disorders • Multiple Sclerosis

BI26 More than skin deep: a case of eosinophilic fasciitis in a patient with relapsing-remitting multiple sclerosis. (PubMed, Br J Dermatol) - "Her disease remains well controlled on methotrexate 15 mg once weekly. While the development of eosinophilic fasciitis in this case was presumed to be idiopathic, to our knowledge, this is the first case of eosinophilic fasciitis developing in the setting of long-term ocrelizumab use."

Journal • CNS Disorders • Dermatology • Eosinophilia • Hematological Disorders • Hematological Malignancies • Immunology • Mood Disorders • Multiple Sclerosis • Oncology • Pain • Rheumatology • Scleroderma • Systemic Sclerosis • CRP

SurfSubQ: A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS) (clinicaltrials.gov) - P=N/A | N=842 | Recruiting | Sponsor: Hoffmann-La Roche | N=349 ➔ 842 | Trial completion date: Nov 2026 ➔ Mar 2028 | Trial primary completion date: Nov 2026 ➔ Mar 2028

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

PORTAMENTO: A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) (clinicaltrials.gov) - P2 | N=182 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis

First cancer medicine available in private hospitals (NZ Doctor) - "Pharmac has made decisions to: Fund new, more convenient options for medicines already funded as IV (into a vein) infusions: Subcutaneous ocrelizumab (Ocrevus SC) for multiple sclerosis...Faricimab (Vabysmo) for diabetic macular oedema and wet age-related macular degeneration (eye conditions)....Bevacizumab (Avastin) for people with eye conditions."

Reimbursement • Diabetic Macular Edema • Multiple Sclerosis • Retinal Disorders • Wet Age-related Macular Degeneration

Workforce and Environmental Impact of Home-Based vs. Hospital-Based Administration of Second-Line MS Therapies in the Netherlands: A Comparative Analysis of Personnel Time and Carbon Footprint (ISPOR-EU 2025) - "This analysis examines the workforce burden and environmental impact of administering second-line disease-modifying treatments (DMTs) for relapsing-remitting multiple sclerosis (RRMS) in the Netherlands, comparing personnel time requirements and the estimated carbon footprint across different routes and settings. Data were drawn from the MICRO-MARS study involving patients treated with hospital-based intravenous ocrelizumab or natalizumab, or home-based oral cladribine or subcutaneous ofatumumab... Home-based DMT administration requires less workforce input and produces lower CO₂e emissions per administration than hospital-based administration. On an annual basis, the workforce advantage remains, but the CO₂e benefit may be offset when accounting for differences in treatment frequency."

Clinical • CNS Disorders • Multiple Sclerosis

Microcosting Analysis of Oral, Subcutaneous, and Intravenous Second-line Multiple Sclerosis Treatments Administered at Home or in Hospital (ISPOR-EU 2025) - "Patients received either nurse-administered ocrelizumab or natalizumab intravenously (IV) at the hospital, or self-administered cladribine (oral) or ofatumumab (subcutaneous; SC) at home... Home-based administration of RRMS treatments (oral or SC) was associated with lower healthcare and non-healthcare costs compared to hospital-based IV therapies. Including overhead costs would likely widen this difference further. Administration costs should be considered alongside drug costs in cost-effectiveness analyses of RRMS therapies, as they may influence comparative value assessments."

Clinical • HEOR • CNS Disorders • Multiple Sclerosis

Cost Savings From Patient Preference-Based Allocation of High-Efficacy Therapies for MS: Evidence From Switzerland (ISPOR-EU 2025) - "Based on estimated real-world HET utilization (66% ocrelizumab i.v., 21% ofatumumab, 9% natalizumab i.v., 4% natalizumab s.c.) and 7,067 patients, treatment-related HET-costs reached EUR 149 million... This CMA shows that pen-at-home administration - favored by most patients - can offer substantial cost savings compared to more resource-intensive regimens. These findings suggest that educating patients about administration options may support preference-aligned treatment choices and improve resource efficiency."

Clinical • HEOR • CNS Disorders • Multiple Sclerosis

Economic and Organizational Impact of Subcutaneous Ocrelizumab in French Daily Hospitals (ISPOR-EU 2025) - "Implementing SC could save hospital time, increase hospital capacity, patient throughput, and potentially also boost revenue. Even with a 20% increase in patient numbers, considerable nurse and chair hours would remain available for other activities."

Clinical

Budget Impact Analysis of Subcutaneous Ocrelizumab for Relapsing Multiple Sclerosis in Italy: A Hospital Perspective (ISPOR-EU 2025) - "The introduction of OCR-SC in Italy can save hospital resources by reducing drug administration time. Enhanced adherence and persistence associated with ocrelizumab, combined with its established efficacy, may further contribute to reducing costs related to relapses and disease progression."

Clinical • HEOR • CNS Disorders • Multiple Sclerosis

Assessing the Socioeconomic Value of Ocrelizumab Subcutaneous for Treating Relapsing Multiple Sclerosis in the Evolving Treatment Landscape in the United Kingdom (ISPOR-EU 2025) - "Indirect costs included productivity losses to patients (due to short term absence, long term absence and early retirement) and informal care. The socioeconomic value of ocrelizumab subcutaneous versus ublituximab and ofatumumab was approximately £188 million and £44 million, respectively... The results presented show that reducing MS progression can result in patients going back to work and requiring less informal care. This analysis highlights the importance of considering the societal perspective when assessing the benefit of anti-CD20 medicines in RMS to the wider society."

CNS Disorders • Multiple Sclerosis

Switch from intravenous anti-CD20 therapy to subcutaneous ofatumumab in patients with relapsing MS: results from the OLIKOS study. (PubMed, J Neurol) - P3 | "The findings indicate efficacy and safety are maintained following a switch from IV anti-CD20 to SC ofatumumab with improved treatment satisfaction."

Clinical • Journal • CNS Disorders • Multiple Sclerosis

OCRELIZUMAB-HYALURONIDASE SUBCUTANEOUS INFUSION IN THE OUTPATIENT CLINIC SETTING: REAL-WORLD EXPERIENCE (WCN 2025) - "Background and Aims: Background: Ocrevus Zunovo (OZ) is a recently FDA-approved combination of hyaluronidase, an enzyme that increases the absorption of drugs into tissue, and ocrelizumab, a widely used disease-modifying therapy for multiple sclerosis (MS)... OZ subcutaneous infusion administered in the clinic setting is a convenient and efficient treatment option for MS patients, providing decreased patient discomfort, reducing time burdens and infusion center scheduling challenges."

Clinical • Real-world • Real-world evidence • CNS Disorders

Single-Center Retrospective Safety Analysis of People with Multiple Sclerosis Treated with Higher Efficacy Disease Modifying Therapies (ECTRIMS 2025) - " Retrospective chart review was performed for pwMS who were ⩾18 years of age and received ⩾1 dose of fingolimod (FTY), natalizumab (NTZ), ocrelizumab (OCR), ofatumumab (OFA), or rituximab (RTX) between January 01, 2013 and July 31, 2024... In this large real-world cohort, 14% of people receiving higher efficacy DMTs experienced ⩾1 SAE, with around two-thirds deemed likely or possibly related to the DMT. The most common SAEs were infections and malignancies. These findings emphasize the importance of vigilant safety monitoring and individualized therapy selection in high efficacy DMT use."

Late-breaking abstract • Retrospective data • CNS Disorders • Infectious Disease • Multiple Sclerosis

Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (MS-PEKOS) (ECTRIMS 2025) - P | "Interim data from the MS-PEKOS study suggest a lower frequency of local IRRs among patients newly treated with OMB vs OCR SC and provide valuable real-world evidence to help patients with MS and their HCPs select the optimal anti-CD20 therapy. Disclousure of interest: Ming-Hui Tai, Brandon Brown, D'Andra Parker, and Abhijit Gadkari are employees of and stockholders in Novartis Pharmaceuticals Corporation. Helen Chen, Sophie Jacobovitz, and Aaron Cortright are employees of IQVIA, a consultancy company that received funds from Novartis for the conduct of the current study."

Clinical • Late-breaking abstract • CNS Disorders • Multiple Sclerosis • Pruritus

Patient-Reported Outcomes Following the Switch to Subcutaneous Ocrelizumab in South West Wales (ECTRIMS 2025) - "Half of patients established on ocrelizumab, choose to switch to SC dosing within the first 6 months. 81% were satisfied with the switch with only 6% of patients switching back to IV, predominantly related to local injection reactions. Introduction of SC dosing has been well tolerated and appreciated by the majority of patients."

Clinical • Patient reported outcomes • CNS Disorders • Multiple Sclerosis

Subcutaneous administration of Natalizumab in relapsing-remitting multiple sclerosis: experience from a tertiary center (ECTRIMS 2025) - "Four patients switch to Ocrelizumab due to JCV seroconversion... SC-NTZ demonstrated efficacy comparable to intravenous form, with no clinical or imaging deterioration in patients who switch or started subcutaneous treatment de novo. Future studies are needed to determine if subcutaneous dosage should match the intravenous form or be adjusted."

CNS Disorders • Multiple Sclerosis

Administration time and societal impact of four different second-line MS treatments; comparing mode and location of administration (ECTRIMS 2025) - "Patients received either hospital-based intravenous (IV) ocrelizumab or IV natalizumab, or home-based subcutaneous (SC) ofatumumab or oral cladribine... The study highlights important differences in administration time for patient and HCP, reliance on informal care and productivity losses between hospital-based second-line MS treatments and home-based treatments, in favor of home-based treatments."

Clinical • CNS Disorders • Multiple Sclerosis

Patient satisfaction and neurofilament light chain levels in persons with MS following subcutaneous ocrelizumab in the prospective SurfSubQ study: baseline data (ECTRIMS 2025) - P | "SurfSubQ is the first prospective study providing RWE in pwRMS/pwPPMS treated with OCR SC on PROs and changes in sNfL using the Roche Elecsys assay. These data show high patient satisfaction with OCR SC, and physicians found NFL a useful biomarker for their daily management of pwMS."

Clinical • Multiple Sclerosis • GFAP • NEFL

Evaluating the Need of Routine Testing and Antibiotic Use in Patients Receiving Ocrelizumab (ECTRIMS 2025) - "Routine pre-infusion testing could be safely replaced with a screening questionnaire, with further tests performed in patients with specific risk factors. This would reduce inappropriate antibiotic prescribing and antimicrobial resistance risk, without compromising safety. Streamlining the process could save up to 270 hours annually at a single centre, improving patient flow and capacity."

Clinical • Infectious Disease • Nephrology • Novel Coronavirus Disease