Enspryng (satralizumab-mwge) / Roche - LARVOL DELTA

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

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

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

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

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

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

Disproportionality analysis of satralizumab in FDA adverse event reporting system and Japanese adverse drug event report: a pharmacovigilance study. (PubMed, Front Immunol) - "The adverse risks associated with satralizumab are notable. Our findings provide evidence to support risk assessment in clinical practice; however, high-quality clinical studies are still needed to validate these results and to further explore the long-term safety and efficacy of the drug."

Adverse events • Journal • CNS Disorders • Dermatology • Infectious Disease • Nephrology • Neuromyelitis Optica Spectrum Disorder • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Septic Shock

Domestic sales (Chugai Press Release) - "Specialty product sales were ¥225.8 billion (an increase of 5.8% year on year). This was primarily due to the strong sales of the mainstay product Vabysmo (an ophthalmic VEGF/Ang-2 inhibitor, anti-VEGF/anti Ang-2 humanized bispecific monoclonal antibody), Enspryng (pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody), and Hemlibra (a blood coagulation factor VIII substitute/anti-coagulation factor IXa/X humanized bispecific monoclonal antibody), as well as the favorable market penetration of the new product PiaSky (a pH dependent binding humanized anti-complement (C5) monoclonal antibody), despite the market penetration of generic drugs and the effects of the NHI drug price revisions. Meanwhile, compared to the full year forecast announced on January 30, 2025, domestic sales increased by 2.1% to ¥472.4 billion, due to the increased sales of Hemlibra, Enspryng, Vabysmo, etc."

Commercial • Age-related Macular Degeneration • Diabetic Macular Edema • Hemophilia A • Neuromyelitis Optica Spectrum Disorder • Paroxysmal Nocturnal Hemoglobinuria • Retinal Vein Occlusion

Patient Preferences for Neuromyelitis Optica Spectrum Disorder (NMOSD) Treatments: Results from a Discrete Choice Experiment Study in the USA. (PubMed, Patient) - "Respondents with AQP4-Ab+ NMOSD placed the highest importance on reducing chance of relapse, placed a high importance on reduced administration frequency, and rated the safety attributes (avoiding treatments with a risk of meningococcal infection, risk of elevated liver enzymes, and risk of other infections) as comparable to each other but less influential than relapse prevention. Respondents were more likely to select a ravulizumab-like profile over comparators. These findings can inform shared decision-making in selecting treatments."

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

Real-World Efficacy and Safety of Neuromyelitis Optica Spectrum Disorder Disease-Modifying Treatments. (PubMed, Neurol Neuroimmunol Neuroinflamm) - "Clinicians should consider using NMOSD-approved treatments given their favorable efficacy and safety profiles in the real-world setting. MMF and azathioprine should be avoided. We caution against rituximab as a default first-line given the cumulative risk of relapse, SIAEs, and TLAEs over time."

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

Meteoroid: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (clinicaltrials.gov) - P3 | N=152 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Jul 2026 ➔ Nov 2025

Monotherapy • Trial primary completion date • CNS Disorders • Solid Tumor

Anti-SRP antibody-positive polymyositis complicated by neuromyelitis optica spectrum disorder: A case report and literature review. (PubMed, Mod Rheumatol Case Rep) - "Three years later, due to recurrent numbness in the left lower limb and difficulty in reducing the PSL dose to ≤ 10 mg/day, satralizumab was initiated...Previous studies reported the coexistence of NMOSD and autoimmune diseases; however, NMOSD with PM/DM is rare. We described a case of NMOSD with anti-SRP antibody-positive PM and provided a literature review."

Journal • CNS Disorders • Immunology • Musculoskeletal Pain • Myositis • Neuromyelitis Optica Spectrum Disorder • Pain • Rare Diseases

Cellular and humoral vaccination response under immunotherapies-German consensus on vaccination strategies in neurological autoimmune diseases. (PubMed, Ther Adv Neurol Disord) - "The specific humoral and cellular response to vaccination can be compromised under alemtuzumab, azathioprine, cladribine, cyclophosphamide, CD19/CD20 antibodies (inebilizumab, ocrelizumab, ofatumumab, rituximab, ublituximab), dimethyl fumarate/diroximel fumarate, FcRn inhibitors (efgartigimod, rozanolixizumab), complement C5 inhibitors (eculizumab, ravulizumab, zilucoplan), interleukin-6 receptor antibodies (tocilizumab, satralizumab), intravenous immunoglobulins, long-term steroid administration, methotrexate, mitoxantrone, mycophenolate mofetil, tacrolimus, teriflunomide, tumor necrosis factor-α blockers, and sphingosine-1-phosphate receptor modulators (fingolimod, ozanimod, ponesimod, siponimod), as well as after autologous stem cell transplantation...However, the humoral and cellular vaccination response may be impaired under immunotherapy necessitating close monitoring. Here, we provide applicable recommendations to optimize immunization for individuals receiving..."

Journal • CNS Disorders • Immunology • Infectious Disease • Oncology • Transplantation • IL6R

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

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

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