Enspryng (satralizumab-mwge) / Roche - LARVOL DELTA

BEST-NMOSD: Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (clinicaltrials.gov) - P4 | N=160 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P4 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

VISION BLURRED BY UNSEEN DIAGNOSIS: A CASE REPORT OF NEUROMYELITIS OPTICA SPECTRUM DISEASE AND SYSTEMIC LUPUS ERYTHEMATOSUS-UNRAVELLING NEUROAUTOIMMUNITY, CORRELATION OR COINCIDENCE (EULAR 2025) - "Treatment with steroids and Rituximab (RTX) led to mild visual improvement (left eye: 8/10; right eye: 2/10) and normalization of platelets (PLT: 326×10^3). Maintenance therapy with RTX and Azathioprine prevented relapses over a two-year follow-up period and MRI showed right optic nerve atrophy without new lesions...NMOSD first-line treatments include biologics such as Eculizumab (anti-C5a), Inebilizumab (anti-CD19), Satralizumab (anti-IL-6) and plasma exchange [1]. In contrast, CNS Lupus is treated with cyclophosphamide and RTX for refractory cases...Optic neuritis, while prominent in NMOSD, is rare in SLE, potentially delaying diagnosis and treatment. Early recognition and targeted therapy of the dominant disease are vital to preventing irreversible damage and improving outcomes, emphasizing the need for further research into these intersecting conditions."

Case report • Clinical • Cardiovascular • CNS Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Macular Edema • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pulmonary Arterial Hypertension • Rare Diseases • Solid Tumor • Systemic Lupus Erythematosus • Thrombocytopenia

SAkuraSun: A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) (clinicaltrials.gov) - P3 | N=8 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Sep 2029 ➔ Dec 2029 | Trial primary completion date: Mar 2027 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Rare Diseases

Anti-IL-6R antibody treatment changes microglial phenotype in AQP4 peptide-immunized mice, leading to suppression of myelitis severity. (PubMed, J Neuroimmunol) - "Satralizumab, an anti-interleukin-6 receptor (anti-IL-6R) antibody, has been proven in previous studies to reduce the frequency and severity of relapses in patients with NMOSD. Mice treated with MR16-1 showed a greater percentage of CD11c+ microglia in the spinal cord, along with upregulated expression of phagocytosis-related genes. Blockade of IL-6R by anti-IL-6R antibodies may suppress the severity of myelitis by increasing CD11c+ microglia and enhancing phagocytic function in AQP4 peptide-immunized mice."

Journal • Preclinical • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • ITGAX

Neuromyelitis optica spectrum disorder in Latin America: a global data share initiative. (PubMed, Mult Scler Relat Disord) - "Most frequent treatment received in the analyzed population was rituximab (56.7 %), followed by azathioprine (28 %). Despite the availability of novel therapeutic options such as satralizumab, eculizumab, and inebilizumab, these were used in <5 % of AQP4-IgG-positive patients The study helps to understand how patients are being treated in the region and to develop educational and access strategies to improve patients care."

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

Extrapolation of Impact on Individual Patient Outcomes in Neuromyelitis Optica Spectrum Disorder (NMOSD) Due to Relapse Reduction From Ravulizumab and Other Novel Biologic Treatments (ISPOR 2025) - "OBJECTIVES: Extrapolate the long-term impact of ravulizumab, satralizumab, and inebilizumab on individual outcomes resulting from relapse reduction in patients with anti-aquaporin-4 antibody-positive (AQP4-Ab+) NMOSD. This research estimates the consequence of relapses experienced by patients with AQP4-Ab+ NMOSD for 3 approved treatment options and placebo/supportive care, illustrating a substantial risk of permanent disability even with biologic treatment. Timely treatment with the most effective preventive therapy may avoid irrevocable deterioration in NMOSD symptoms."

Clinical • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Ophthalmology • Pain • Rare Diseases

Clinical analysis of satralizumab-induced neuromyelitis optica spectrum disorder patients (JSNE 2025) - No abstract available

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

Examination of the usefulness of the satralizumab patient support program "Circle" for NMOSD patients (JSNE 2025) - No abstract available

Clinical • Neuromyelitis Optica Spectrum Disorder

Interleukin-6 in neuroimmunological disorders: Pathophysiology and therapeutic advances with satralizumab. (PubMed, Autoimmun Rev) - "Phase III clinical trials have already validated the safety and efficiency of satralizumab in treating neuromyelitis optica spectrum disorders (NMOSD) and acetylcholine receptor (AChR) seropositive generalized myasthenia gravis (gMG). This review aims to elucidate the pathophysiological role of IL-6, and explore the clinical implications of satralizumab in neuroimmunological diseases, providing insights into its potential therapeutic applications."

Journal • Review • CNS Disorders • Inflammation • Myasthenia Gravis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • IL6 • IL6R

How Satralizumab changed treatment strategy in NMOSD - Real World Evidence from Japan (JSNE 2025) - "Co-sponsored by Chugai Pharmaceutical Co., Ltd."

Clinical • HEOR • Real-world • Real-world evidence • Neuromyelitis Optica Spectrum Disorder

Analysis of infection rates in neuromyelitis optica spectrum disorder: Comparing satralizumab treatment in SAkuraMoon, post-marketing, and US-based health claims data. (PubMed, Mult Scler Relat Disord) - P3 | "Infection rates were consistently lower in satralizumab-treated patients compared with US-RWD. Trial Registration: NCT04660539(SAkuraMoon), NCT02028884(SAkuraSky), NCT02073279(SAkuraStar)."

HEOR • Journal • P4 data • CNS Disorders • Infectious Disease • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Septic Shock

Potential drug targets for Neuromyelitis optica spectrum disorders (NMOSD): A Mendelian randomization analysis. (PubMed, PLoS One) - "Increased levels of plasma CLEC11A and SERPINA1 are correlated with an elevated risk of NMOSD, whereas elevated levels of plasma PF4V1 and CSF FAM3B are associated with a decreased risk of NMOSD. The opposing effects of risk or protective proteins suggest synergistic targeting could improve efficacy beyond current immunosuppressive regimens. Nonetheless, clinical trials are required to confirm the findings."

Biomarker • Journal • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • IL6 • SERPINA1

Clinical characteristics of 11 NMOSD cases with extended satralizumab dosing intervals (JSNE 2025) - No abstract available

Clinical • Neuromyelitis Optica Spectrum Disorder

Very-late-onset neuromyelitis optica spectrum disorder: a case report and review. (PubMed, Front Neurol) - "We report the case of a 92-year-old patient with NMOSD who was admitted to our hospital; hers is currently the oldest reported case of NMOSD globally. The onset occurred after COVID-19 vaccination, and the patient responded well to treatment with satralizumab."

Journal • CNS Disorders • Immunology • Infectious Disease • Neuromyelitis Optica Spectrum Disorder • Novel Coronavirus Disease • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases

Satralizumab after inebilizumab treatment in a patient with recurrent neuromyelitis optica spectrum disorder: A case report. (PubMed, Medicine (Baltimore)) - "In patients with clinical episodes of NMOSD that recur despite treatment with a B-cell-depleting agent, satralizumab may help alleviate myelitis-associated pain. Further investigations are warranted to establish IL-6 as a therapeutic target for the treatment of neuropathic pain, and may help address the unmet medical need in the management of NMOSD-associated neuropathic pain. As exemplified by the present case, individualized management, and therapy for patients with NMOSD are essential. Our case report provides new ideas for the management of patients with refractory NMOSD and patients with subsequent severe neuropathic pain."

Journal • CNS Disorders • Immunology • Inflammation • Neuralgia • Neuromyelitis Optica Spectrum Disorder • Pain • Rare Diseases • IL6

Patient Preferences for Treatment Features in Neuromyelitis Optica Spectrum Disorder (NMOSD): Results From a Discrete Choice Experiment (DCE) (P7-8.013). (PubMed, Neurology) - "To quantify preferences and predict treatment choices between ravulizumab and other approved treatments (eculizumab, inebilizumab, satralizumab) among US adults with anti-aquaporin-4 antibody-positive (AQP4-Ab+) NMOSD. Conway has received research support from Biogen. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff."

Journal • CNS Disorders • Infectious Disease • Meningococcal Infections • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Effectiveness of satralizumab in a real-world clinical setting in Japan: Interleukin-6 receptor inhibition in neuromyelitis optica spectrum disorder: A six-month interim analysis of a multicenter medical chart review. (PubMed, Mult Scler Relat Disord) - "The 6-month relapse-free rate after satralizumab treatment was 96.6 %. Satralizumab use permitted dose reduction of concomitant oral GC and immunosuppressants over 26-weeks."

Journal • Real-world evidence • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • IL6R

Genetic Insights from Whole Exome Sequencing on IL-6 Signaling Genes in NMOSD: Unraveling Potential Mechanisms of Inflammation and Treatment Outcomes Driven by Anti-AQP4 Status and Ethnical backgrounds (S38.009). (PubMed, Neurology) - "Variants rs3810194 and rs2878342 in FCGRT are predicted to reduce gene expression, potentially impacting the recycling rate of the anti-IL6 monoclonal antibody, Satralizumab...Author has nothing to discloseDr. Leon has nothing to disclose."

Journal • Immunology • Inflammation • Neuromyelitis Optica Spectrum Disorder • FCGRT • IL6 • IL6ST

HANDLE—a Real World Study on Satralizumab in NMOSD (ChiCTR) - P=N/A | N=100 | Not yet recruiting | Sponsor: Huashan Hospital, Fudan University; Huashan Hospital, Fudan University

New trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Satralizumab treatment in patients with AQP4-IgG-seropositive neuromyelitis optica spectrum disorder after rituximab treatment: A case series. (PubMed, J Neuroimmunol) - "In this retrospective case series, satralizumab was effective and well tolerated in patients with NMOSD who switched due to ineffectiveness and/or poor tolerability of rituximab. These outcomes align with the long-term efficacy and safety outcomes with satralizumab in the Phase III SAkura clinical trials."

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

REINFORCE: Study to Evaluate the Efficacy and Safety of Satralizumab in FSHD1 (clinicaltrials.gov) - P2 | N=46 | Active, not recruiting | Sponsor: Centre Hospitalier Universitaire de Nice | Recruiting ➔ Active, not recruiting

Enrollment closed • Muscular Dystrophy

HANDLE-a Real World Study on Satralizumab in NMOSD (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Huashan Hospital | Trial completion date: Jan 2027 ➔ Jun 2027 | Trial primary completion date: Aug 2026 ➔ Mar 2027

Real-world evidence • Trial completion date • Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Evaluating Rituximab Failure Rates in Neuromyelitis Optica Spectrum Disorder: A Nationwide Real-World Study From South Korea. (PubMed, J Clin Neurol) - "This study has confirmed the efficacy of rituximab in treating NMOSD, as evidenced by an 87% continuation rate among patients over a 4-year follow-up period. Nevertheless, the occurrence of at least one relapse in 19% of the cohort, including 11% who experienced multiple or severe relapses, and a 2% discontinuation rate due to adverse events highlight the urgent need for alternative therapeutic options."

Journal • Real-world evidence • CNS Disorders • Hematological Disorders • Infectious Disease • Neuromyelitis Optica Spectrum Disorder • Neutropenia • Rare Diseases

Satralizumab Treatment in Chinese Patients with AQP4-ab-positive Neuromyelitis Optica Specturm Disorder: A Prospective Study (AAN 2025) - "Satralizumab significantly reduces relapse rates and may improve visual function in patients with AQP4-ab-positive NMOSD."

Clinical • CNS Disorders • Infectious Disease • Nephrology • Neuromyelitis Optica Spectrum Disorder • Pneumonia • Rare Diseases • Respiratory Diseases

Patient Preferences for Treatment Features in Neuromyelitis Optica Spectrum Disorder (NMOSD): Results From a Discrete Choice Experiment (DCE) (AAN 2025) - "Objective:To quantify preferences and predict treatment choices between ravulizumab and other approved treatments (eculizumab, inebilizumab, satralizumab) among US adults with anti-aquaporin-4 antibody-positive (AQP4-Ab+) NMOSD.Background:Benefit-risk profiles and mode/frequency of administration vary among the 4 US-approved NMOSD treatments. Patients with AQP4-Ab+ NMOSD placed the highest value on reducing relapse risk and were more likely to select a ravulizumab-like profile over comparators. These findings can inform shared decision-making in selecting treatments."

Clinical • CNS Disorders • Infectious Disease • Meningococcal Infections • Neuromyelitis Optica Spectrum Disorder • Rare Diseases