Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Jiangsu Hansoh Pharma, Amgen - LARVOL DELTA

Phase 2B ExTINGUISH Trial Aims to Assess Efficacy of Inebilizumab for NMDAR Encephalitis (NeurologyLive) - "In the study, participants (target enrollment of 116) from across the United States and Europe will receive first-line immunotherapies before randomization to either inebilizumab or placebo. Outcomes will be measured at 6, 16, 24, 32, and 96 weeks, with comprehensive neurophysological tests and cognitive screening tools being used at the final 96-week time point...The trial is enrolling participants in that age group and plans to continue accepting patients who have experienced new onset of NMDAR encephalitis within the past 3 months."

Clinical protocol • Immunology

Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Amgen | Trial completion date: Oct 2032 ➔ Jul 2033

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

Safety and Efficacy of Inebilizumab in IgG4-Related Disease Across Various Participant Demographics: Subgroup Analysis from the MITIGATE Study (EULAR 2025) - P3 | "*Flare-free, treatment-free complete remission is defined as the absence of evident disease activity at week 52; defined as an IgG4-RD Responder Index score of 0 or determination by the investigator that no disease activity is present on the basis of physical, laboratory, pathology, or other evidence), no AC-determined flare during the RCP of the trial, and no treatment for flare or disease control beyond the protocol required prednisone taper. The MITIGATE trial demonstrated that participants across various demographic subgroups derived similar clinical benefits with INEB treatment, making INEB a potentially effective and broadly applicable treatment choice for patients with IgG4-RD."

Clinical • Inflammation

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

Early Onset and Durability of Efficacy in Inebilizumab-treated Participants with IgG4 Related Disease: Post Hoc Analyses from the Phase 3 MITIGATE Trial (EULAR 2025) - P3 | "Analysis of MITIGATE trial data demonstrates that inebilizumab treatment provides significant benefit as soon as 91 days following treatment initiation, and continues to provide benefit during the second year of treatment, in patients with IgG4-RD."

Clinical • P3 data • Retrospective data • Inflammation

A Study of MT-0551 in Patients With Systemic Sclerosis (clinicaltrials.gov) - P3 | N=80 | Active, not recruiting | Sponsor: Mitsubishi Tanabe Pharma Corporation | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2025 ➔ Aug 2025

Enrollment closed • Trial primary completion date • Immunology • Scleroderma • Systemic Sclerosis

Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders. (PubMed, BioDrugs) - "Recently, four monoclonal antibodies (mAbs) were granted Food and Drug Administration approval for aquaporin-4 antibody (AQP4-IgG)-seropositive NMOSD treatment: eculizumab, inebilizumab, satralizumab, and ravulizumab. We explore the role of these preventative mAbs for NMOSD management by reviewing the efficacy, safety, mechanisms of action, and administration of these agents, and compare them to rituximab and traditional immunosuppressants. We discuss therapy selection and the clinical challenges of therapeutic management, including medication adherence, therapeutic monitoring strategies, economic considerations, and medication accessibility, while managing therapy failure and indications for transitioning to alternative therapies."

Journal • Review • CNS Disorders • Immunology • 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

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

A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

THE THIRD BIOLOGICS LICENSE APPLICATION OF XINYUE (INEBILIZUMAB INJECTION) WAS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (iis.aastocks.com) - "The board of directors (the 'Board') of Hansoh Pharmaceutical Group Company Limited (the 'Company' and together with its subsidiaries, the 'Group') is pleased to announce that, on May 29, 2025, the third biologics license application ('BLA') of XINYUE...(inebilizumab Injection) (the 'Product') has been accepted by the National Medical Products Administration (the 'NMPA'), which is for the treatment of generalized myasthenia gravis (gMG) in adult patients."

China filing • Myasthenia Gravis

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Amgen

New P2 trial • CNS Disorders • Myasthenia Gravis

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

Relapses during treatment with monoclonal antibodies targeting B-cells in NMOSD. (PubMed, J Neurol) - "Attack frequency and cumulative disability before mAb initiation are important predictors for relapses during targeted B-cell mAb treatment for NMOSD. Future therapeutic strategies should focus on preventing clustered attacks to reduce the likelihood of mAb treatment failure."

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

SAFETY AND EFFICACY OF INEBILIZUMAB IN IGG4 RELATED DISEASE IN PARTICIPANTS WITH PANCREATIC AND BILIARY INVOLVEMENT: RESULTS FROM THE PHASE 3 MITIGATE TRIAL (DDW 2025) - P3 | No abstract available

Clinical • P3 data • Inflammation

Inebilizumab specific use survey in NMOSD (5th interim analysis): safety and efficacy (JSNE 2025) - No abstract available

Clinical • Neuromyelitis Optica Spectrum Disorder

A study of four cases of NMOSD treated with inebilizumab at our hospital (JSNE 2025) - No abstract available

Clinical • Neuromyelitis Optica Spectrum Disorder

Clinical characteristics of five cases of neuromyelitis optica spectrum disorder (NMOSD) treated with inebilizumab (JSNE 2025) - No abstract available

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

Inebilizumab specific use survey in NMOSD (5th interim analysis): Oral steroid use status (JSNE 2025) - No abstract available

Neuromyelitis Optica Spectrum Disorder

Safety and efficacy of inebilizumab in IgG4 related disease in participants with pancreatic, biliary, and hepatic involvement: results from the phase 3 MITIGATE trial (EASL 2025) - P3 | "Analysis of IgG4-RD patients with pancreas and hepatobiliary involvement from the MITIGATE trial demonstrates the benefit and safety of CD19-targeted B cell depletion by INEB in this cohort."

Clinical • P3 data • Back Pain • Hepatology • Infectious Disease • Inflammation • Musculoskeletal Pain • Nephrology • Novel Coronavirus Disease • Pain • Respiratory Diseases

AMGEN REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS (PRNewswire) - "TEPEZZA (teprotumumab-trbw) sales decreased 10% year-over-year to $381 million in the first quarter, primarily driven by 9% lower volume and 8% from a decrease in inventory levels, partially offset by higher net selling price; KRYSTEXXA (pegloticase) sales were flat year-over-year at $236 million in the first quarter, as 11% volume growth was offset by 10% from a decrease in inventory levels; UPLIZNA (inebilizumab-cdon) sales increased 14% year-over-year to $91 million in the first quarter, primarily driven by volume growth; TAVNEOS (avacopan) sales increased 76% year-over-year to $90 million in the first quarter, primarily driven by volume growth....TEZSPIRE (tezepelumab-ekko) sales increased 65% year-over-year to $285 million in the first quarter, driven by volume growth."

Sales • ANCA Vasculitis • Asthma • Gout • Immunology • Neuromyelitis Optica Spectrum Disorder • Ophthalmology • Thyroid Eye Disease

Management of IgG4-related cholangitis: diagnosis, therapy, and long-term surveillance. (PubMed, Gastroenterol Rep (Oxf)) - "Steroid-sparing agents for remission induction and maintenance therapy comprise immunomodulators, such as azathioprine, as well as B-cell depletion therapies, such as rituximab. This review provides a structured clinical overview of the diagnosis, differential diagnosis, and therapy, including novel therapeutic options, such as inebilizumab, for this rare yet severe condition. A key focus is on long-term surveillance strategies, which include laboratory tests, imaging (contrast-enhanced magnetic resonance imaging/magnetic resonance cholangiopancreatography, ultrasound, endosonography), and, particularly in patients with fibrotic bile duct strictures, endoscopy (endoscopic retrograde cholangiopancreatography, cholangioscopy)."

Journal • Review • Cholestasis • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Pancreatitis

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

Phase 3 Myasthenia Gravis Inebilizumab Trial (MINT): Efficacy Data in AChR+ Generalized MG Subpopulation Through Week-52 (AAN 2025) - "Background The data will be presented at the AAN conference on April 8. Objective Design/Methods Results Conclusions"

Clinical • Late-breaking abstract • P3 data • CNS Disorders • Myasthenia Gravis

UPLIZNA (INEBILIZUMAB-CDON) IS NOW THE FIRST AND ONLY FDA-APPROVED TREATMENT FOR IGG4-RELATED DISEASE (PRNewswire) - "Amgen...announced today that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD)....The approval of UPLIZNA for IgG4-RD is supported by data from the MITIGATE trial, the first randomized, double-blind, placebo-controlled trial conducted in IgG4-RD. This trial demonstrated the potential of UPLIZNA to decrease disease activity by reducing flares in patients, while maintaining its efficacy and established safety profile....This is the second approved indication for UPLIZNA..."

FDA approval • Immunology • Inflammation