Enspryng (satralizumab-mwge) / Roche - LARVOL DELTA

Satralizumab treatment in adults with aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorder in clinical practice. (PubMed, Mult Scler J Exp Transl Clin) - "Satralizumab was effective and well tolerated in patients with NMOSD, including those who switched from previous treatments due to inadequate disease control and/or intolerance. These real-world outcomes align with long-term safety and efficacy findings from the Phase III SAkura trials."

Journal • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Inebilizumab: Pediatric Case Series in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder. (PubMed, Pediatr Neurol) - "This study adds to the literature because it shows that in our cohort inebilizumab was a safe medication for pediatric patients with NMOSD and prevented further relapses."

Journal • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Rare Diseases

Consensus recommendations for the diagnosis and management of neuromyelitis optica spectrum disorder: A Saudi expert panel review. (PubMed, Mult Scler Relat Disord) - "This expert consensus provides evidence-based guidance for the diagnosis and management of NMOSD in Saudi Arabia, striking a balance between clinical evidence and expert opinion where data gaps exist. It emphasises individualised care, antibody testing, and long-term immunosuppressive strategies while highlighting the need for further research on treatment duration and failure criteria."

Journal • Review • CNS Disorders • Immunology • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Evaluation of the Efficacy and Safety of Satralizumab in a Pregnant NMOSD Patient With AQP4/MOG-IgG Dual Seropositive: A Case Report. (PubMed, Ann Clin Transl Neurol) - "With traditional treatment of corticosteroids and mycophenolate mofetil, her vision gradually recovered and overall condition stabilized. When fertility is desired, the selection of disease-modifying therapy must carefully balance effectiveness and safety. In such cases, satralizumab may serve as a viable option, supported by promising real-world data."

Journal • CNS Disorders • Immunology • Inflammation • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Solid Tumor

SHIELD DMD: A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2027 ➔ Jun 2028

Trial completion date • Duchenne Muscular Dystrophy • Genetic Disorders • Muscular Dystrophy • Pediatrics

What is in the Neuromuscular Junction Literature? (PubMed, J Clin Neuromuscul Dis) - "The role of thymectomy in older patients with MG is considered. The medical treatment section addresses corticosteroid regimens, intravenous immunoglobulin as maintenance therapy, a phase 3 study of the recently approved neonatal Fc receptor (FcRN) blocker nipocalimab, use of complement inhibitors and FcRN blockers in general, regimens for efgartigimod, and positive studies on the interleukin-16 receptor monoclonal antibody (Ab) satralizumab and the CD19 B-cell-depleting monoclonal Ab inebilizumab."

Journal • Review • CNS Disorders • Myasthenia Gravis • Ophthalmology • Thyroid Eye Disease • IL16

Real-World Investigation of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disease. (PubMed, Ann Clin Transl Neurol) - "Satralizumab demonstrated superior efficacy in reducing NMOSD relapse rates compared to conventional immunosuppressants while maintaining a comparable safety profile."

Journal • Real-world evidence • CNS Disorders • Hematological Disorders • Infectious Disease • Nephrology • Neuromyelitis Optica Spectrum Disorder • Neutropenia • Rare Diseases • Respiratory Diseases • Septic Shock • IL6R

Double-negative NMOSD: from case report to a proposed diagnostic and therapeutic algorithm. (PubMed, BMC Neurol) - "This case underscores the therapeutic potential of anti-IL-6 drugs for DN-NMOSD, especially when anti-CD20 therapies fail. It highlights the heterogeneity of DN-NMOSD and the need for novel biomarkers, such as GFAP, tau, and IL-6, to better understand disease mechanisms and guide targeted treatments. A structured therapeutic approach, starting with anti-CD20 drugs and progressing to anti-IL-6 agents if ineffective, may optimize outcomes in this poorly understood condition."

Journal • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases • GFAP

EQ-5D Utility Trends in NMOSD: Impact of Time and Disability (ISPOR-EU 2025) - "EQ-5D utilities have increased significantly during long-term Satralizumab treatment. Patients who had higher baseline utility sustained better HRQoL outcomes, while disease progression, measured by EDSS, was associated with reduced utility. These findings underscore the importance of early intervention in preserving HRQoL in NMOSD."

CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Efficacy and Safety of Modern Biologics Compared to Conventional Therapies in AQP-4 Positive Neuromyelitis Optica Spectrum Disorder: A Fully AI-Automated Targeted Literature Review (ISPOR-EU 2025) - "Eculizumab, satralizumab, and inebilizumab showed significantly reduced annualized relapse rates (84-98%) compared to rituximab (74-100%) and traditional immunosuppressants (33-96%). Modern biologics show significantly better safety profile and superior efficacy in preventing relapses in adult AQP4-positive NMOSD patients compared to conventional therapies. The AI-based automated literature review by our in-house toolkit demonstrates the power of AI in performing complete reviews within 2-3 hours compared to a few weeks by manual processes. The AI pathways and efficacy comparison with manual processes will be presented."

Clinical • Review • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

SATISFY-JP Trial: Satralizumab, an Anti-Interleukin-6 Receptor Antibody, for Pulmonary Arterial Hypertension with an Activated Immune-Responsive Phenotype: Primary Results from the Phase II Trial (AHA 2025) - "In a subgroup of PAH patients identified by high serum IL-6 levels, the anti-IL-6 receptor antibody satralizumab improved PVR at 24 weeks. The results of this trial support the validity of a novel precision medicine strategy."

P2 data • Cardiovascular • Heart Failure • Pulmonary Arterial Hypertension • Respiratory Diseases • Rheumatology • IL6R

A real-world study of satralizumab in the treatment of neuromyelitis optica spectrum disorder (NMOSD) (ChiCTR) - P=N/A | N=140 | Not yet recruiting | Sponsor: Xi'an No.1 Hospital; Xi'an No.1 Hospital

New trial • Real-world evidence • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Decrease in Urinary Tract Infections Following Switch From Anti-Interleukin-6 Monoclonal Antibody to Ravulizumab in a Patient With Neuromyelitis Optica Spectrum Disorder (NMOSD): A Case Report. (PubMed, Cureus) - "Satralizumab is an anti-interleukin-6 (IL-6) monoclonal antibody used for the treatment of neuromyelitis optica spectrum disorder (NMOSD). This case highlights the potential increased susceptibility to recurrent UTIs associated with anti-IL-6 monoclonal antibody therapy. Clinicians should monitor for recurrent UTIs in NMOSD patients treated with satralizumab and consider alternative treatments, such as C5 complement inhibitors, if infections persist."

Journal • CNS Disorders • Infectious Disease • Nephrology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Respiratory Diseases • Septic Shock • IL6

Consolidated financial highlights (Core results) (Chugai Press Release) - "Of revenue, sales were ¥794.6 billion (an increase of 5.9% year on year). Domestic sales exceeded the levels of the same period of the previous fiscal year due to the increase in the sales of new products Phesgo and PiaSky, and the mainstay products Vabysmo, Hemlibra, and Enspryng, despite the effects of the NHI drug price revisions and the market penetration of generic drugs."

Commercial • Breast Cancer • CNS Disorders • Colorectal Cancer • Hemophilia A • Inflammation • Lupus • Ophthalmology • Paroxysmal Nocturnal Hemoglobinuria • Rheumatoid Arthritis

Neuromyelitis optica spectrum disorder (NMOSD): Recent advances and insights from Taiwan. (PubMed, J Formos Med Assoc) - "Acute relapses are managed with high-dose intravenous methylprednisolone, often combined with plasma exchange in severe attacks (EDSS ≥4 or visual acuity <0.1). For maintenance therapy, azathioprine or mycophenolate mofetil, either as monotherapy or combined with corticosteroid, is recommended. More recently, monoclonal antibodies including inebilizumab and satralizumab have been reimbursed in Taiwan under strict National Health Insurance regulations, restricted to AQP4-IgG-seropositive patients with high disease severity refractory to oral immunotherapy. This review provides an updated overview of NMOSD diagnosis and treatment, with emphasis on the characteristics of Taiwanese patients."

Journal • Review • CNS Disorders • Hepatitis B • Immunology • Infectious Disease • Inflammation • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases

COMPARATIVE EFFICACY OF MONOCLONAL ANTIBODIES IN NMOSD: A META-ANALYSIS OF RELAPSE PREVENTION, DISABILITY OUTCOMES, AND SAFETY (WCN 2025) - "While multiple monoclonal antibodies—namely eculizumab, inebilizumab, satralizumab, and tocilizumab—have emerged as treatment options, no meta-analysis to date has compared these agents head-to-head. Direct comparison indicates that while all four monoclonal antibodies significantly reduce relapse frequency and improve disability in NMOSD, eculizumab shows a slightly higher efficacy in ARR reduction. Safety profiles are broadly similar. These findings advocate for personalized treatment strategies based on individual patient profiles"

Retrospective data • CNS Disorders

SUCCESSFUL SWITCH FROM RAVULIZUMAB TO SATRALIZUMAB IN A PATIENT WITH NMOSD EXPERIENCING PERSISTENT JOINT PAIN (WCN 2025) - "Background and Aims: Neuromyelitis optica spectrum disorder (NMOSD) treatment has evolved with the introduction of biologic agents such as eculizumab, satralizumab and ravulizumab, which have significantly improved relapse prevention. This case suggests that satralizumab may be a suitable alternative for NMOSD patients experiencing mild but persistent joint pain associated with complement inhibitors. Switching biologic agents led to symptom resolution and continued disease stability. Further case accumulation and clinical experience are needed to evaluate the safety and long-term efficacy of such transitions."

Clinical • CNS Disorders • Musculoskeletal Pain • Pain

NEW THERAPIES IN AUTOIMMUNE NEUROLOGY: FOCUS ON CAR-T CELL THERAPIES (WCN 2025) - "Anti-CD20 (rituximab), anti-CD19 (inebilizumab), anti-IL6R (satralizumab), and anti-C5 (eculizumab, ravulizumab) therapies have been successfully used in NMOSD and are now under investigation for broader indications including myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), autoimmune encephalitis, and stiff person syndrome. Together, these therapeutic innovations herald a new era in autoimmune neurology—one that seeks to match mechanistic insight with targeted, durable, and potentially curative interventions. This lecture will review current evidence supporting the use of CAR-T and other cell- and antibody-based therapies, outline the evolving treatment landscape, and discuss the promise and challenges of precision immunotherapy in autoimmune neurological disease."

CAR T-Cell Therapy • IO biomarker • CNS Disorders

Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials. (PubMed, Ophthalmol Ther) - P3 | "The SatraGO-1 and SatraGO-2 trials investigated IL-6R inhibition via satralizumab in TED. Satralizumab offers a potential disease-modifying treatment option for TED while minimizing safety risks associated with current treatments."

Journal • P3 data • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • IL6 • IL6R

Long-Term Efficacy and Safety of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder From the SAkuraMoon Open-Label Extension Study. (PubMed, Neurol Neuroimmunol Neuroinflamm) - No abstract available

Journal • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Evaluation of the Efficacy and Safety of Sattralizumab in a Pregnant NMOSD Patient with AQP4/MOG-IgG Dual Seropositive: A Case Report (ECTRIMS 2025) - "Traditional treatment of corticosteroids and mycophenolate mofetil led to gradual recovery of vision and stabilization of her overall condition. The coexistence of AQP4 and MOG antibodies in a patient with optic neuritis is an extremely rare and complex clinical scenario. When fertility is desired, the selection of therapeutic agents must be meticulously balanced between efficacy and safety. In such cases, satralizumab may serve as a viable option, offering promising effecacy and safety data."

Case report • Clinical • CNS Disorders • Immunology • Inflammation • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases • IL6

IPND 2025: Revised Consensus Criteria, Classification, and Nomenclature for Neuromyelitis Optica Spectrum Disorders (ECTRIMS 2025) - "S Mariotto served on advisory board for UCB, received received support from TSF and GJF, is site PI for clinical trials of Rozanolixizumab (UCB) and Satralizumab (Roche) in MOGAD, and received speaker honoraria from UCB, Novartis, Biogen, Sanofi, Alexion, Roche, TSF, Amgen, Dynamics...S Pittock has received personal compensation for consulting or serving on scientific advisory or data safety monitoring boards for Arialys, Astellas, F. Hoffmann-La Roche AG, Genentech, Sage Therapeutics, and UCB; his institution has received compensation for his serving as a consultant for Alexion, Amgen, Arialys, and Astellas; research support from Adimmune, Alexion, Amgen, F. Hoffmann-La Roche AG, and Genentech; and has 2 patents issued (8889102; application 12-678350; Neuromyelitis Optica Autoantibodies as a Marker for Neoplasia; and 9891219B2; application 12-573942; Methods for Treating Neuromyelitis Optica [NMO] by Administration of Eculizumab to an Individual that is Aquaporin-4..."

IO biomarker • Late-breaking abstract • CNS Disorders • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Novel Coronavirus Disease • Rare Diseases • Solid Tumor

Models to predict prognosis in an international multicenter study of myelin oligodendrocyte glycoprotein antibody-associated disease (ECTRIMS 2025) - "[Study Funded by UCB] Disclousure of interest: Dr Flanagan has served on an advisory board for UCB, has received research support from UCB, is site principal investigator for clinical trials of Rozanolixizumab and Satralizumab in MOGAD, funded by UCB and Roche, respectively...M Isabel Leite has received support for scientific and educational meetings from UCB.Dr Sean Pittock has received personal compensation for consulting or serving on scientific advisory or data safety monitoring boards for Arialys, Astellas, F. Hoffmann-La Roche AG, Genentech, Sage Therapeutics, and UCB; his institution has received compensation for his serving as a consultant for Alexion, Amgen, Arialys, and Astellas; research support from Adimmune, Alexion, Amgen, F. Hoffmann-La Roche AG, and Genentech; and has 2 patents issued (8889102; application 12-678350; Neuromyelitis Optica Autoantibodies as a Marker for Neoplasia; and 9891219B2; application 12-573942; Methods for Treating Neuromyelitis..."

Clinical • Late-breaking abstract • CNS Disorders • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Ophthalmology • Pediatrics • Rare Diseases • Solid Tumor

Real-World Study Among Nmosd Patients: A Single Tertiary Center Experience From Turkey (ECTRIMS 2025) - "Preventive therapies mainly included azathioprine (n=55), rituximab (n=15), and mycophenolate mofetil (n=7). Newer agents such as eculizumab and satralizumab were used in only 2 patients... This is the first real-world NMOSD cohort study from Turkey, demonstrating a wide clinical spectrum and diverse treatment practices. While traditional immunosuppressants remain the mainstay, the introduction of monoclonal antibodies reflects evolving strategies. These findings may guide NMOSD management in regions with similar healthcare dynamics."

Clinical • Late-breaking abstract • Real-world • Real-world evidence • CNS Disorders • Endocrine Disorders • Immunology • Infectious Disease • Myasthenia Gravis • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases

Safety and effectiveness of satralizumab in a European cohort of patients with aquaporin-4-IgG-positive neuromyelitis optica spectrum disorders (ECTRIMS 2025) - "These first real-world data from Germany/Austria underscore the effectiveness of satralizumab in patients with AQP4-IgG-positive NMOSD and show a favourable safety profile. Our results support its role in the treatment landscape for AQP4-IgG+ NMOSD."

Clinical • CNS Disorders • Hematological Disorders • Infectious Disease • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases • IL6R