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

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

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) - "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

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

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) - "No reproduction, re-use or transcription for any commercial purpose or use of the content is permitted without the written permission of the authors. Permission for re-use must be obtained directly from the authors."

Clinical • P3 data • Hepatology • Inflammation

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

Inebilizumab Treatment in a Patient with Co-occurring AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder and Myasthenia Gravis: A Case Report and Literature Review (P12-8.012). (PubMed, Neurology) - "Song has nothing to disclose. Author has nothing to discloseAuthor has nothing to disclose."

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

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

A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis. (PubMed, N Engl J Med) - P3 | "In participants with acetylcholine receptor antibody-positive or muscle-specific kinase antibody-positive generalized myasthenia gravis, inebilizumab improved function and reduced disease severity. (Funded by Amgen; MINT ClinicalTrial.gov number, NCT04524273.)."

Journal • P3 data • CNS Disorders • Cough • Immunology • Infectious Disease • Myasthenia Gravis • Nephrology • Pain • Respiratory Diseases

HANSOH PHARMA ANNOUNCES THE SECOND BIOLOGICS LICENSE APPLICATION OF XINYUE (INEBILIZUMAB INJECTION) ACCEPTED BY NMPA FOR THE TREATMENT OF IGG4-RD (Hansoh Pharma Press Release) - "On March, 4, 2025, Hansoh Pharmaceutical Group Co., Ltd...announces that Second Biologics License Application of XINYUE (Inebilizumab Injection) has been accepted by the National Medical Products Administration (the 'NMPA'), which is for the treatment ofimmunoglobulin G4-related disease (IgG4-RD). On February 8, 2025, this new indication has been included in the Priority Review and Approval Procedure by the NMPA."

China filing • Priority review • Immunology • Inflammation

The Evolution of Anti-CD20 Treatment for Multiple Sclerosis: Optimization of Antibody Characteristics and Function. (PubMed, CNS Drugs) - "Initial apparent success with rituximab in MS and neuromyelitis optica spurred development of the anti-CD20 monoclonal antibody (mAb) therapies ocrelizumab, ofatumumab, and ublituximab as well as the anti-CD19 mAb inebilizumab...Glycoengineering of the mAbs ublituximab and inebilizumab enhances ADCC and can overcome the reduced responses to mAb-mediated B-cell depletion associated with certain genetic polymorphisms. Other strategies for therapeutic targeting of CD20, including brain shuttle antibodies (e.g., RO7121932), bispecific antibodies, chimeric antigen receptor T-cell therapies, and antibody-drug conjugates, are in active clinical development and may be future treatment approaches in MS and other B-cell-mediated autoimmune diseases."

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

MINT Trial 26-Week Data Show Inebilizumab for gMG Is Effective and Safe (AJMC) - P3 | N=238 | MINT (NCT04524273) | Sponsor: Amgen | "Comparing outcomes between adult patients living with generalized myasthenia gravis (gMG) who received inebilizumab (Uplizna; Amgen) and those who received placebo, the humanized monoclonal antibody produced superior efficacy and safety results through week 26 of the MINT trial (NCT04524273), according to topline results presented at the recent MDA Clinical & Scientific Conference....Changes from baseline in MG-ADL and QMG scores in the combined population were –4.2 (95% CI, –2.9 to –1.0; P < .01) in the treatment group vs –2.2 in the placebo group and –4.8 (95% CI, –3.8 to –1.2; P < .001) vs –2.3, respectively."

P3 data • Myasthenia Gravis

Evaluation of the efficacy and safety of Inebilizumab in the treatment of isolated aquaporin4 antibody seropositive optic neuritis: a multicenter, prospective, non-randomized, positive-controlled clinical trial (ChiCTR) - P=N/A | N=60 | Not yet recruiting | Sponsor: Second Affiliated Hospital of Zhejiang University School of Medicine; Second Affiliated Hospital of Zhejiang University School of Medicine

New trial • Ocular Inflammation • Ophthalmology • Optic Neuritis

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) - No abstract available

Clinical • P3 data • Retrospective data • Inflammation

Specific use results study of inebilizumab in NMOSD (5th interim analysis): Safety and efficacy (JSNE 2025) - No abstract available

Clinical • Neuromyelitis Optica Spectrum Disorder

Safety and Efficacy of Inebilizumab in IgG4-Related Disease Across Various Participant Demographics: Subgroup Analysis from the MITIGATE Study (EULAR 2025) - No abstract available

Clinical • Inflammation

Clinical characteristics of 5 cases of neuromyelitis optica spectrum disorder (NMOSD) treated with inebilizumab (JSNE 2025) - No abstract available

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

Study of 4 cases of NMOSD treated with inebilizumab at our hospital (JSNE 2025) - No abstract available

Clinical • Neuromyelitis Optica Spectrum Disorder

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

Neuromyelitis Optica Spectrum Disorder

UPLIZNA (INEBILIZUMAB-CDON) SIGNIFICANTLY IMPROVES GENERALIZED MYASTHENIA GRAVIS SYMPTOMS IN ACETYLCHOLINE RECEPTOR AUTOANTIBODY-POSITIVE PATIENTS OVER 52 WEEKS (PRNewswire) - P3 | N=238 | MINT (NCT04524273) | Sponsor: Amgen | "Amgen...today announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of UPLIZNA (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG). The results demonstrated durable and sustained efficacy of UPLIZNA in patients with acetylcholine receptor autoantibody-positive (AChR+) gMG with two doses a year, following an initial loading dose. Findings will be presented as a late-breaking oral presentation during the American Academy of Neurology (AAN) Annual Meeting on April 8, 2025, in San Diego...Regulatory filing activities are underway with submission anticipated to be complete in H1 2025."

Filing • P3 data • Myasthenia Gravis

IgG4-related disease: lessons from the first 20 years. (PubMed, Rheumatology (Oxford)) - "Both glucocorticoids and B cell depletion are effective at inducing remission in IgG4-RD in most patients. The optimal approach to the use of these agents is now being defined in clinical trials."

Journal • Review • Endocrine Disorders • Fibrosis • Immunology • Inflammation • Oncology • Pancreatitis • Rheumatology

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

Summary Gastro Digest: Can Inebilizumab change the management of IgG4-related Disease? (PubMed, Gastroenterology) - No abstract available

Journal • Inflammation