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

SONATA-MS: Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P=N/A | N=1800 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New trial • CNS Disorders • Multiple Sclerosis

Operetta III: A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - P3 | N=25 | Not yet recruiting | Sponsor: Hoffmann-La Roche | Phase classification: P2 ➔ P3 | Initiation date: Aug 2026 ➔ Oct 2026

Phase classification • Trial initiation date • CNS Disorders • Multiple Sclerosis

Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model. (PubMed, Health Technol Assess) - "Fingolimod, glatiramer acetate, interferon beta-1a, interferon beta-1b and peginterferon beta-1a were associated with an increased treatment discontinuation (29 studies, 13 interventions)...Data in highly active relapsing-remitting multiple sclerosis were available for fingolimod, ocrelizumab, alemtuzumab, cladribine, interferon beta, autologous haematopoietic stem cell treatment and placebo...60. See the NIHR Funding and Awards website for further award information."

Clinical • Journal • Review • CNS Disorders • Inflammation • Multiple Sclerosis

OCARINA 3: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis (clinicaltrials.gov) - P1 | N=75 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

Ocrelizumab: Pediatric First Approval. (PubMed, Paediatr Drugs) - "In May 2026, the intravenous infusion formulation of ocrelizumab (OCREVUS®) was approved in the USA for the treatment of relapsing-remitting MS (RRMS) in pediatric patients 10 years of age and older who weigh 25 kg or more. This article summarizes the milestones in the development of ocrelizumab leading to this first pediatric approval for RRMS."

Journal • Review • CNS Disorders • Multiple Sclerosis • Pediatrics • CD20

Network meta-analysis of triple immunosuppressive therapies and standard of care for induction of remission of active lupus nephritis. (PubMed, Lupus) - "In indirect pairwise comparisons, patients who received SOC+Tacrolimus compared to SOC+Rituximab (2.30 [1.27 to 4.20]), SOC+Anifrolumab (1.98 [1.07 to 3.52]), SOC+Ocrelizumab (1.81 [1.12 to 2.82]), and SOC+Abatacept (1.78 [1.07 to 2.91]) had significantly higher PRR...SOC+Belimumab, SOC+Obinutuzumab, SOC+Voclosporin and SOC+Tacrolimus ranked as effective therapies inducing PRR with SUCRA probability scores between 61.14% and 95.12%. Risk ratios of SAE and SIE were not significantly different among the immunosuppressive therapies.ConclusionIn patients with LN, induction therapies of SOC with calcineurin inhibitors had the highest relative benefit achieving remission of LN."

Clinical • Journal • Retrospective data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Anti-CD20 associated enterovirus meningoencephalitis: A narrative review with two illustrative cases. (PubMed, Mult Scler J Exp Transl Clin) - "Of 42 cases, 34 were associated with rituximab and eight with ocrelizumab...IVIg or subcutaneous immunoglobulin (SCIg) was used in 36 cases, steroids in seven, fluoxetine in six, pocapavir in two, pleconaril in two, and ribavirin/favipiravir in one...CSF PCR aids diagnosis, though alternative specimens may be required. Early IVIg and investigational antivirals may be considered."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Multiple Sclerosis • Nephrology • Oncology • Ophthalmology • Pain • Renal Disease

PORTAMENTO: A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) (clinicaltrials.gov) - P2 | N=193 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Oct 2030 ➔ Mar 2030 | Trial primary completion date: Jan 2027 ➔ Sep 2026 | Recruiting ➔ Active, not recruiting

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

Subcutaneous Ocrelizumab for the Treatment of Relapsing Forms of Multiple Sclerosis: A Budget Impact Model. (PubMed, Pharmacoecon Open) - "Ocrelizumab SC may be a cost-saving and resource-efficient option for HA/RES RMS management in Italy. By reducing administration time while maintaining the established clinical profile of the intravenous (IV) formulation of ocrelizumab, its adoption can enhance hospital efficiency and deliver meaningful budgetary savings."

HEOR • Journal • CNS Disorders • Multiple Sclerosis

OSSIA: A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Genentech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis

Ocrevus Zunovo for MS: Mixed Methods (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Northwestern University

New trial • CNS Disorders • Multiple Sclerosis

Real-World Experience of Transition from Intravenous to Subcutaneous Ocrelizumab in Multiple Sclerosis (EAN 2026) - "Transitioning from IV to SC Ocrelizumab was safe, well-tolerated, and associated with high patient satisfaction and substantial logistical benefits in real-world clinical practice."

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

From Intravenous to Subcutaneous Ocrelizumab in a High-Volume Infusion Center: A Time-and-Motion–Informed Capacity and Service-Flow Analysis (EAN 2026) - "Transitioning from IV to SC ocrelizumab yields substantial procedural efficiencies and frees infusion-unit capacity. The care-time dividend enables expanded access to complex therapies without additional staff or infrastructure, positioning SC ocrelizumab as a structural efficiency tool in MS care"

CNS Disorders • Multiple Sclerosis

Relative increase of memory B-cell subsets under s.c. B-cell-depleting therapies in multiple sclerosis. (PubMed, Front Immunol) - "We identified a higher percentage of memory B cells in s.c. Ocre and Ofa B cell-depleted pwMS and pwMS who switched their anti-CD20 therapy from i.v. Ocre to s.c. Ofa injection. Further analysis will be needed to investigate how these observations link to safety and efficacy profiles of the different anti-CD20 therapies."

Journal • CNS Disorders • Multiple Sclerosis

CN46182: Study of an On-Body Injection System for Home Use of Ocrelizumab in People with Multiple Sclerosis (clinicaltrialsregister.eu) - P2/3 | N=15 | Not yet recruiting | Sponsor: F. Hoffmann-La Roche AG

New P2/3 trial • CNS Disorders • Multiple Sclerosis

OCARINA 3: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: Hoffmann-La Roche

New P1 trial • CNS Disorders • Multiple Sclerosis

BA45841: A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic effects of Subcutaneous Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis (clinicaltrialsregister.eu) - P1/2 | N=6 | Not yet recruiting | Sponsor: F. Hoffmann-La Roche AG

New P1/2 trial • CNS Disorders • Multiple Sclerosis

Comparative Efficacy of B-Cell-Targeted Biologic therapies in Lupus Nephritis: A Bayesian Network Meta-Analysis (EULAR 2026) - "Eligible studies evaluated rituximab, belimumab, ocrelizumab, obinutuzumab, or anifrolumab added to SOC in adults with active class III/IV LN and reported complete renal response (CRR) between weeks 52 and 104...Obinutuzumab and belimumab appear to provide the most consistent late renal responses, though findings are based on indirect comparisons rather than head-to-head trials. These results support individualized biologic selection based on timing of response, durability, and strength of evidence, and highlight the need for direct comparative studies."

Retrospective data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus

Applying a phenotype-driven diagnostic algorithm to suspected hypersensitivity reactions to biologicals: a real-world experience (EAACI 2026) - "The implicated biologicals were infliximab (n=3), tocilizumab, certolizumab, ixekizumab, omalizumab, mepolizumab, and ocrelizumab (n=1 each)...A third confirmed case involved an exuberant local injection-site reaction (>10 cm) with positive ST to subcutaneous infliximab (Remsima®) and negative ST to the intravenous formulation (Zessly®); Remsima® was maintained while awaiting switch to adalimumab, due to mild symptoms and dosing convenience...Conclusion In this real-world tertiary center experience, one-third of suspected HSR to biologicals were confirmed, including severe reactions and suspected excipient allergy. A structured diagnostic pathway supported accurate diagnosis, guided safe re-exposure or switching strategies and remains essential to optimize biologic therapy management."

Clinical • Real-world • Real-world evidence • Immunology • Inflammation

Transitioning from intravenous to subcutaneous ocrelizumab in a high-volume infusion center: A time-and-motion-informed capacity and service-flow analysis. (PubMed, Mult Scler Relat Disord) - "Transitioning from IV to SC ocrelizumab yields substantial procedural efficiencies and frees infusion-unit capacity. The care-time dividend enables expanded access to complex therapies without additional staff or infrastructure, positioning SC ocrelizumab as a structural efficiency tool in MS care."

Journal • CNS Disorders • Multiple Sclerosis • Oncology

The Clock Starts at Discharge: Reducing Delays In Multiple Sclerosis Patient Care (CMSC 2026) - "Implementing a multidisciplinary, integrated care approach—including a structured inpatient-to-outpatient referral pathway and in-clinic treatment options—substantially accelerates access to neuroimmunology consultation and DMT initiation. These strategies facilitate earlier treatment, potentially improving disease outcomes and optimizing care delivery in MS patients. Further refinement of such pathways may yield additional benefits in managing MS and related conditions."

Clinical • CNS Disorders • Multiple Sclerosis

Artificial Intelligence Literacy and Self-Care Behaviors In People with Multiple Sclerosis: A Cross-Sectional Study (CMSC 2026) - "Most had (RRMS) (67.2%, N=119), onset 18–30y (53.1%, N=94), low disability (EDSS 0–1: 64.9%, N=115), in treatment with natalizumab (19.8%, N=35) and ocrelizumab (14.7%, N=26)... AIL plays a relevant role in enhancing SC symptom understanding among pwMS. AI Educational interventions targeting AI literacy, facilitated by MS nurses, may support patient empowerment and improve disease management in all SC subdimensions."

Observational data • CNS Disorders • Multiple Sclerosis

Case Report: Marburg variant of multiple sclerosis and review of its complicated treatment. (PubMed, Front Immunol) - "Escalation to high-dose cyclophosphamide resulted in radiologic stabilization but was limited by severe, refractory cytopenia. Given persistent disease activity and intolerance to infusion-based therapy, transition from ocrelizumab to subcutaneous ofatumumab was planned as a pragmatic maintenance strategy; however, treatment initiation was delayed. The patient subsequently experienced rapid clinical deterioration marked by recurrent aspiration events and functional decline, ultimately leading to death following transition to comfort-focused care. This case highlights the therapeutic challenges of Marburg MS, including treatment-limiting toxicity, logistical barriers to anti-CD20 therapy, and the critical importance of timely, individualized immunosuppressive strategies."

Journal • Review • CNS Disorders • Hematological Disorders • Multiple Sclerosis

Analysis of CD20-Directed Cytolytic Antibody Treatment Switches to Ocrelizumab and Hyaluronidase In Patients with Multiple Sclerosis (MS) (CMSC 2026) - "Patients were 68% female, 73% Caucasian, 27% minority populations, who transitioned from ocrelizumab (83%), ofatumumab (9%), rituximab (7%) and ublituxumab (1%)... Switching from a CD20-directed cytolytic antibody to ocrelizumab and hyaluronidase, was largely driven by patient preference and convenience. The majority of patients on ocrelizumab and hyaluronidase, experienced no disease activity and infrequent adverse events."

Clinical • CNS Disorders • Multiple Sclerosis • CD20

Efficacy and Safety of Remibrutinib after Switching from Ocrelizumab In Participants with Relapsing Multiple Sclerosis: RESHAPE Study Design (CMSC 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 • Multiple Sclerosis