Enspryng (satralizumab-mwge) / Roche - LARVOL DELTA

Real-world safety of satralizumab in neuromyelitis optica spectrum disorder: a FAERS-based risk stratification study. (PubMed, J Neurol) - "This real-world study highlights clinically relevant safety signals of satralizumab in NMOSD, identifies vulnerable patient subgroups, and supports risk-adapted monitoring strategies in neurological practice."

Journal • Real-world evidence • Retrospective data • CNS Disorders • Infectious Disease • Nephrology • Neuromyelitis Optica Spectrum Disorder • Pneumococcal Infections • Pneumonia • Rare Diseases • Respiratory Diseases • Septic Shock • IL6R

BEST-NMOSD: Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (clinicaltrials.gov) - P4 | N=540 | Not yet recruiting | Sponsor: Massachusetts General Hospital | N=160 ➔ 540

Enrollment change • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

EVALUATING THE ECONOMIC VALUE OF MONOCLONAL ANTIBODIES FOR AQP4+ NMOSD IN THE US USING ATTACK-FREE SURVIVAL OVER A 5-YEAR HORIZON (ISPOR 2026) - "This comparative economic assessment provides payer-relevant evidence on the long-term value of monoclonal antibody therapies for AQP4+ NMOSD in the US and may help guide clinical and reimbursement decisions."

CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Pregnancy Outcomes and Disease Activity in Women With NMOSD and MOGAD (AAN 2026) - "47/64 women (73.4%; n=30 AQP4-Ab+,n=2 AQP4-Ab-, n=15 MOGAD) were therapy exposed at conception: 31/64 (48.4%) to anti-CD20, 10/64 (15.6%) to azathioprine, 2/64 (3.1%) to glatirameracetate and one each (1.6%) to satralizumab, inebilizumab and tocilizumab...In patients with at least three-months follow-up, 14/56 (25.0%) relapsed in the first-year postpartum (n=7/36 (19.4%) AQP4-Ab+: 1/7 (14.3%) pretreated with azathioprine, 3/7 (42.9%) with rituximab and 3/7 (42.9%) untreated; n=7/18 (38.9%) MOGAD: 1/7 (14.3%) pretreated with azathioprine, 3/7 (42.9%) with rituximab and 3/7 (42.9%) untreated). Our findings provide valuable insights into pregnancies in women with NMOSD/MOGAD, with low disease activity in pregnancy and increase postpartum. Newborns were generally healthy with increased number of SGA"

Clinical • CNS Disorders • Genetic Disorders • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Small for Gestational Age • Solid Tumor

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab to Prevent Relapses in Neuromyelitis Optica Spectrum Disorder (NMOSD) (AAN 2026) - "BEST-NMOSD is the first comparative effectiveness trial comparing all approved NMOSD DMTs to rituximab. The primary endpoint combines efficay and safety, allowing for a holistic comparison of treatments. This reflects real-world decisions and this study will deliver actionable results for patients, physicians, and regulatory authorities."

Clinical • CNS Disorders • Depression • Inflammation • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Ophthalmology • Optic Neuritis • Rare Diseases

Comparative analysis of adverse event reporting signals between Satralizumab and Inebilizumab in neuromyelitis optica spectrum disorder: A pharmacovigilance study using the FDA Adverse Event Reporting System. (PubMed, Intractable Rare Dis Res) - "This signal detection study highlights distinct adverse event reporting profiles for these biologics and offers insights that may inform clinical monitoring and personalized treatment strategies in NMOSD. Further studies with rigorous prospective designs are recommended to validate these findings and elucidate the mechanisms underlying the observed adverse events."

Adverse events • Journal • CNS Disorders • Immunology • Infectious Disease • Inflammation • Nephrology • Neuromyelitis Optica Spectrum Disorder • Novel Coronavirus Disease • Pain • Pneumonia • Rare Diseases • Respiratory Diseases • Urology

Progress in the Treatment of Neuromyelitis Optica Spectrum Disorder: From Pathogenic Insights to Biologics. (PubMed, Intern Med) - "Recently, biologics such as complement inhibitors (eculizumab and ravulizumab), IL-6 receptor inhibitors (satralizumab), and B-cell-depleting agents (inebilizumab and rituximab) have been successively introduced. Drugs have different mechanisms of action, administration, and side effect profiles; therefore, treatment selection should be individualized. This review summarizes the recent progress in this field."

Journal • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • IL6

NMOSD Treatment Patterns in the Era of Approved Biologics: An Analysis from the SPHERES Registry (AAN 2026) - "Objective: Since 2019, four biologic therapies have been approved to prevent relapses in patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) and aquaporin-4 antibodies (AQP4-IgG+): eculizumab, inebilizumab, ravulizumab, and satralizumab (A-BIOs). This study showed a predominant first-line rituximab use followed by A-BIOs; nearly half needed a second-line therapy or higher. We showed a preponderance of rituximab use in earlier lines of therapy, while A-BIOs, specifically inebilizumab, satralizumab, and eculizumab, were used more often as second or higher lines of therapy. Given accumulating disability with repeated attacks, these findings support earlier approved biologic use to prevent relapses."

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

Pipeline Therapies in Autoimmune Encephalitis (AAN 2026) - "Novel biological and cellular therapies that modulate cytokine signaling, complement activation, and autoreactive lymphocyte survival are currently being explored.Design/ We conducted a literature search of 45 ongoing and completed trials, case reports and cohort studies evaluating IL-6 inhibitors (tocilizumab, satralizumab), FcRn antagonists (efgartigimod, rozanolixizumab), complement inhibitors (eculizumab), and advanced therapies such as bortezomib, telitacicept, and CAR-T cell therapy. Next-generation therapies targeting IL-6, FcRn, and complement pathways, along with plasma cell directed and cellular therapies, are emerging therapies in AE management. Early data suggest favorable tolerability and immunologic response, though larger controlled studies are needed to define efficacy, safety, and optimal patient selection."

CNS Disorders • Immunology

A Real-world Study of the Effectiveness and Safety of Ravulizumab in AQP4-Ab+ NMOSD Patients with Suboptimal Response to Satralizumab in Japan - Interim Analysis (AAN 2026) - "Findings from this interim analysis suggest that the switch from satralizumab to ravulizumab induces clinical stability accompanied by changes in B cell subsets."

Clinical • IO biomarker • Real-world • Real-world evidence • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • CD27

Safety and Efficacy of Satralizumab in Patients with Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD): Results from the Phase 3 METEOROID Trial (AAN 2026) - No abstract available

Clinical • P3 data • CNS Disorders • Solid Tumor

Efficacy and Safety of IL-6 Inhibitors in Neuromyelitis Optica Spectrum Disorder (NMOSD): A Network Meta-analysis (AAN 2026) - "Tocilizumab and Satralizumab significantly reduce relapse risk and maintain efficacy at 96 weeks versus control, without increasing serious adverse events. Further large-scale trials are needed to compare IL-6 inhibitors directly, assess long-term safety, and optimize dosing strategies for NMOSD patients."

Retrospective data • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Clinical Practice Experience With Satralizumab in NMOSD: Impact on Pain, Polypharmacy, and Glucocorticoid Reduction (AAN 2026) - "At initiation, 96% were receiving oral prednisolone; other frequently used drugs included antacids (96%), osteoporosis agents (86%), and analgesics (65%). In routine clinical practice, satralizumab is associated with improved pain, reduced medication use, and successful GC tapering while maintaining relapse control. These findings suggest that IL-6 receptor inhibition may not only prevent relapses but also mitigate polypharmacy and improve quality of life in patients with NMOSD."

Clinical • CNS Disorders • Immunology • Neuralgia • Neuromyelitis Optica Spectrum Disorder • Osteoporosis • Pain • Rare Diseases • IL6

Tocilizumab and Satralizumab in MOGAD: Real-world Outcomes for Relapse Prevention (AAN 2026) - "Anti-IL6R therapy may be useful for attack-prevention in MOGAD and can be considered as an empiric treatment option while results from prospective, randomized placebo-controlled clinical trials are awaited."

Clinical • Real-world • Real-world evidence • CNS Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rheumatoid Arthritis • Solid Tumor

BN45398: A study to check the effect of satralizumab in children and adolescents living with Duchenne muscular dystrophy, to check if it is safe and also how it affects the different parts of the body and how it is eliminated from the body (SHIELD DMD) (clinicaltrialsregister.eu) - P1/2 | N=28 | Active, not recruiting | Sponsor: F. Hoffmann-La Roche AG | Recruiting ➔ Active, not recruiting

Enrollment closed • Duchenne Muscular Dystrophy • Genetic Disorders • Muscular Dystrophy • Pediatrics

Long-term effectiveness and safety of satralizumab for neuromyelitis optica spectrum disorder in a real-world clinical setting in Japan: A 2.5-year final analysis of a multicenter medical chart review (The SAkuraBeyond Study). (PubMed, Mult Scler) - "The real-world relapse-free rate at 2.5 years was 91.8% (ARR = 0.03) in satralizumab-treated patients with AQP4[+] NMOSD, supporting the relapse-preventive effect of satralizumab without new safety concerns."

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

BEST-NMOSD: Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (clinicaltrials.gov) - P4 | N=160 | Not yet recruiting | Sponsor: Massachusetts General Hospital | Initiation date: Nov 2025 ➔ May 2026 | Trial primary completion date: Feb 2029 ➔ Jan 2030

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

Consensus Recommendations for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders (NMOSD): The MENACTRIMS Guidelines. (PubMed, CNS Drugs) - "For acute treatment: initiate high-dose intravenous methylprednisolone promptly and use plasma exchange early for severe or steroid-refractory attacks. For long-term immunotherapy, monoclonal antibodies (rituximab, inebilizumab, eculizumab, ravulizumab, satralizumab, or tocilizumab) are recommended according to availability and patient factors; conventional immunosuppressants remain alternatives when biologics are inaccessible. Guidance is provided for pediatric patients and for pregnancy and breastfeeding, including planning after ≥ 12 months of disease stability and early postpartum treatment resumption. These MENACTRIMS guidelines aim to improve NMOSD outcomes across the region by promoting accurate diagnosis and timely, effective therapy."

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

Treatment Pathways, Switching, and Barriers to Disease-Modifying Therapy in Hispanic Cohort of NMOSD (ACTRIMS Forum 2026) - "Disease-modifying therapy (DMT) exposures (rituximab, eculizumab, inebilizumab, ravulizumab, satralizumab, azathioprine, mycophenolate, interferons, glatiramer), reasons for discontinuation/switch, adherence/logistics, and EDSS trajectories were compiled. ResultsPatients cycled through a median of two DMTs (range: 1-4) before stabilization. In this largely Hispanic cohort, NMOSD treatment pathways were shaped by barriers as much as biology. Logistics failures, intolerance, and drug failure were the main reasons for switching therapies. Strikingly, nearly half of inebilizumab-treated patients experienced breakthrough relapses, diverging from trial outcomes and signaling a need for close monitoring and timely escalation."

CNS Disorders • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder

Inebilizumab for treatment of NMOSD in a Real-World Cohort: Analysis from the SPHERES Registry (ACTRIMS Forum 2026) - "Of second-line patients treated with inebilizumab, 14 had immediate prior exposure to rituximab, 3 to satralizumab, 2 to non-approved biologics, 3 to glucocorticoid steroids, 1 to immunosuppressant therapy and 1 to immunoglobulin therapy. This descriptive analysis of real-world NMOSD patients who were treated with inebilizumab offers important insights into clinical characteristics and treatment patterns. Additional analysis is being conducted to understand inebilizumab treatment persistence and long-term patient outcomes."

Clinical • Real-world • Real-world evidence • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

A Comparative Clinical Effectiveness Trial of Rituximab versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab to Prevent Relapses in Neuromyelitis Optica Spectrum Disorder (NMOSD) (ACTRIMS Forum 2026) - "BEST-NMOSD is the first comparative effectiveness trial comparing all approved NMOSD DMTs to rituximab. The primary endpoint combines efficacy and safety, allowing for a holistic comparison of treatments and reflecting real-world decisions. This study will deliver actionable results for patients, physicians, and regulatory authorities."

Clinical • CNS Disorders • Depression • Inflammation • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Ophthalmology • Optic Neuritis • Rare Diseases

Changes in Blood Cells and Complements During Relapse Prevention Therapies for Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder. (PubMed, Int J Mol Sci) - "They were divided into the following treatment groups: glucocorticoids and/or immunosuppressants (GC/IS, n = 22), inebilizumab/rituximab (anti-CD19/20, n = 13), satralizumab (anti-IL-6R, n = 22), and eculizumab/ravulizumab (anti-C5, n = 13). It also showed that anti-C5 therapy strongly suppressed total complement activity but did not affect the C3 and C4 levels or blood counts. These findings may have implications for the mode of action of the drugs and the risk of adverse drug reactions, including infections."

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

Diverticular Perforation with Normal C-reactive Protein in a Patient with Neuromyelitis Optica Spectrum Disorder Receiving Satralizumab. (PubMed, Intern Med) - "She improved with percutaneous drainage, targeted antimicrobials, and withdrawal of satralizumab, followed by transition to ravulizumab. This case suggests that satralizumab may obscure inflammatory responses, delaying recognition of gastrointestinal perforation. Normal C-reactive protein levels do not exclude complicated diverticulitis under IL-6 inhibition; early imaging and a low threshold for intervention are essential."

Journal • CNS Disorders • Gastrointestinal Disorder • Infectious Disease • Inflammation • Neuromyelitis Optica Spectrum Disorder • Pain • Rare Diseases • CRP

Biomarkers for satralizumab treatment in neuromyelitis optica spectrum disorders: a prospective case series. (PubMed, BMC Neurol) - No abstract available

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

Evaluation of the Efficacy and Safety of Satralizumab in Early-stage Optic Neuritis (ON) of Aquaporin-4 (AQP4) Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: Henan Provincial Eye Hospital; Henan Provincial Eye Hospital

New trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases