Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen 
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 45 Diseases   15 Trials   15 Trials   525 News 


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  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Journal:  Linking Downbeat Nystagmus and Aquaporin-4-Positive Neuromyelitis Optica: A Closer Look at Their Hidden Relationship. (Pubmed Central) -  Nov 20, 2024   
    NMO may be associated with antibodies selective for aquaporin-4 (AQP4), a water channel located within the optic nerves and spinal cord.AQP4 is distributed in the periventricular region, corpus callosum, magnocellular nuclei of the hypothalamus, and brain stem.Downbeat nystagmus (DBN) is associated with structural, metabolic, and autoimmune disorders, but is rarely reported in NMO.We treated a 33-year-old female with known AQP4-positive NMO who presented with new-onset DBN. We review the literature and discuss possible mechanisms and lesion locations hypothetically responsible for the symptoms and signs.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma, Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Review, Journal:  Neuromyelitis optica spectrum disorder with ultra-longitudinally extensive transverse myelitis: A case report and literature review. (Pubmed Central) -  Nov 19, 2024   
    Simultaneously, sequential disease-modifying therapy was initiated, starting with long-term oral administration of mycophenolate mofetil, followed by cyclophosphamide, telitacicept, and Inebilizumab...Early and comprehensive evaluation of autoimmune diseases is crucial in patients with NMOSD presenting with u-LETM as the initial symptom. Prompt treatment initiation, followed by disease-modifying therapy, is essential for improving patient prognosis.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Journal:  Inebilizumab for Treatment of IgG4-Related Disease. (Pubmed Central) -  Nov 16, 2024   
    P3
    Inebilizumab reduced the risk of flares of IgG4-related disease and increased the likelihood of flare-free complete remission at 1 year, confirming the role of CD19-targeted B-cell depletion as a potential treatment for IgG4-related disease. (Funded by Amgen; MITIGATE ClinicalTrials.gov number, NCT04540497.).
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen, Amvuttra (vutrisiran) / Alnylam, Lytgobi (futibatinib) / Otsuka
    Assessing the Impact of a First-to-Market Product on the Orphan Designation Status for Subsequent Products Across the EU4 () -  Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_823;    
    However, manufacturers of second- and third-to-market products must consider factors such as the significant benefit and time of approval to successfully maintain its orphan designation status. Direct comparative data, indirect comparisons, and protocol assistance can aid in demonstrating benefit.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen, Rituxan (rituximab) / Roche
    Review, Journal:  CD19: a promising target for systemic sclerosis. (Pubmed Central) -  Oct 18, 2024   
    No difference in change of AQP4-IgG titers from baseline to time of attack was observed. Uplizna
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Trial completion date, Trial primary completion date:  Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA (clinicaltrials.gov) -  Oct 8, 2024   
    P=N/A,  N=60, Recruiting, 
    Conclusion ExTINGUISH Trial findings will immediately influence patient care while informing the design and implementation of future clinical trials in autoimmune encephalitis. Trial completion date: Aug 2032 --> Oct 2032 | Trial primary completion date: Aug 2032 --> Oct 2032
  • ||||||||||  Review, Journal:  B-cell Depletion Therapy in Pediatric Neuroinflammatory Disease. (Pubmed Central) -  Sep 20, 2024   
    B-cell depletion therapies can be safe and effective in pediatric patients. Anticipation and mitigation of common adverse effects through primary prevention strategies, close monitoring, and appropriate symptomatic management can improve safety and tolerability.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Enrollment open:  Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) -  Sep 20, 2024   
    P=N/A,  N=50, Recruiting, 
    Anticipation and mitigation of common adverse effects through primary prevention strategies, close monitoring, and appropriate symptomatic management can improve safety and tolerability. Not yet recruiting --> Recruiting
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Trial completion date, Trial primary completion date:  A Study of MT-0551 in Patients With Systemic Sclerosis (clinicaltrials.gov) -  Jul 4, 2024   
    P3,  N=80, Recruiting, 
    Trial results are expected in 2024 and aim to establish the safety and efficacy of CD19-targeted B cell depletion by inebilizumab in IgG4-RD, potentially leading to the first approved treatment for this disease. Trial completion date: Jul 2026 --> Apr 2027 | Trial primary completion date: Jun 2024 --> Mar 2025
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Journal:  A case report of AQP4-IgG-seropositive refractory neuromyelitis optica spectrum disorder patient with Sj (Pubmed Central) -  Jun 20, 2024   
    After receiving two 300?mg injections of inebilizumab, not only the symptoms of NMOSD improved significantly, but also the symptoms of concurrent SS and pancytopenia. In the cases of AQP4-IgG seropositive NMOSD who have recurrent episodes and are comorbid with other autoimmune disorders, inebilizumab may be a good choice.
  • ||||||||||  Ultomiris (ravulizumab-cwvz) / AstraZeneca
    Retrospective data, Review, Journal:  Network Meta-analysis of Ravulizumab and Alternative Interventions for the Treatment of Neuromyelitis Optica Spectrum Disorder. (Pubmed Central) -  May 9, 2024   
    Thus, it stands as an effective method to reduce the disability rates and improve the daily living ability of patients with NMOSD. In the absence of head-to-head randomized controlled trials, NMA results suggest ravulizumab, a C5 inhibitor, is likely to be more effective in preventing NMOSD relapse in patients with AQP4-Ab+ NMOSD when compared with other treatments having different methods of action.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Enrollment open:  N-MOmentum LT: Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) (clinicaltrials.gov) -  Apr 25, 2024   
    P4,  N=30, Recruiting, 
    In the absence of head-to-head randomized controlled trials, NMA results suggest ravulizumab, a C5 inhibitor, is likely to be more effective in preventing NMOSD relapse in patients with AQP4-Ab+ NMOSD when compared with other treatments having different methods of action. Not yet recruiting --> Recruiting
  • ||||||||||  Review, Journal:  Disease-modifying treatments for neuromyelitis optica spectrum disorder in the context of a new generation of biotherapies. (Pubmed Central) -  Mar 30, 2024   
    Since 2015, evidence has accumulated to support off-label biotherapies (rituximab and tocilizumab) and to approve satralizumab, inebilizumab, eculizumab, and ravulizumab...The current consensus proposes positioning the approved drugs as first-line treatments for newly-diagnosed patients and as alternative therapies in case of failure of historical treatment. Yet, there has been limited acceptance in practice due to high drug prices.
  • ||||||||||  topiramate / Generic mfg.
    The Remarkable Efficacy of Topiramate in Treating Oscillopsia in Neuromyelitis Optica Spectrum Disorder: A Video Case Report (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_4268;    
    Further work in the larger geographically diverse collaborative cohort will explore the potential impact of race/ethnicity and other sociodemographic factors on early access to NMOSD specialist care and its impact on disease outcomes. Medications such as memantine, gabapentin, and topiramate have been explored for treating oscillopsia in MS patients...Inebilizumab infusion was started after discharge...Topiramate demonstrated efficacy in NMO-associated oscillopsia in our case, along with the case recently published on Neurology reporting dramatic response of oscillopsia to topiramate in a MS patient, suggesting it could be a promising medication for this debilitating condition.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
    Matching-adjusted Indirect Comparison of Current Treatments for NMOSD and Evaluation of Long-term Effectiveness (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_4266;    
    Additionally, treatment with inebilizumab yields better results for expected life years and quality adjusted life years compared to either satralizumab or eculizumab. Relative efficacy and discontinuation were the key drivers of the results.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Downbeat Nystagmus in Patient with AQP4-positive Neuromyelitis Optica (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_3461;    
    AQP4-specific T cells are distributed throughout the CNS, with characteristic patterns of increased infiltration in NMO. These regions commonly include the optic nerves and the medulla.NMO involves the brainstem, particularly the area postrema, leading to nausea, vomiting, or hiccups.
  • ||||||||||  Journal:  Impact of neuromyelitis optica spectrum disorder on employment and income in the United States. (Pubmed Central) -  Feb 20, 2024   
    These regions commonly include the optic nerves and the medulla.NMO involves the brainstem, particularly the area postrema, leading to nausea, vomiting, or hiccups. We provide a structured analysis of the impact of NMOSD on employment, work hours, and income in the United States, demonstrating its major effect on the livelihoods of patients and their caregivers.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen, Rituxan (rituximab) / Roche
    A Broken Brain (San Diego Convention Center, Area E (Hall A-B2, Ground Level)) -  Feb 20, 2024 - Abstract #ATS2024ATS_5933;    
    She is now decannulated but continues to have catatonia. Early diagnosis for autoimmune encephalitis should always be considered in young females who present with psychosis and neurological symptoms with no prior history of mental disorders.
  • ||||||||||  Uplizna (inebilizumab) / Mitsubishi Tanabe, Amgen, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
    Review, Journal:  Advances in the long-term treatment of neuromyelitis optica spectrum disorder. (Pubmed Central) -  Feb 5, 2024   
    We will also discuss the extension trials of each of these medications and what lead to their approval in AQP4-IgG seropositive NMOSD patients. We will then examine treatments in the pipeline for adult and pediatric NMOSD patients and conclude with discussions on treatment considerations in pregnant patients and how to approach treatment of NMOSD patients during COVID.
  • ||||||||||  FDA event, Journal:  An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021). (Pubmed Central) -  Jan 30, 2024   
    The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.
  • ||||||||||  Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
    Enrollment closed, Trial completion date, Trial primary completion date:  MINT: Myasthenia Gravis Inebilizumab Trial (clinicaltrials.gov) -  Jan 8, 2024   
    P3,  N=238, Active, not recruiting, 
    Four preventive immunotherapies have now been approved for AQP4-IgG-positive NMOSD in many regions of the world: eculizumab, Recruiting --> Active, not recruiting | Trial completion date: Mar 2029 --> Nov 2027 | Trial primary completion date: Oct 2024 --> May 2024
  • ||||||||||  Uplizna (inebilizumab) / Mitsubishi Tanabe, Amgen
    Journal:  Inebilizumab reduces neuromyelitis optica spectrum disorder risk independent of FCGR3A polymorphism. (Pubmed Central) -  Dec 17, 2023   
    Previously, the F allele polymorphism at amino acid 158 of the FCGR3A gene (F158) was shown to decrease IgG-binding affinity and reduce rituximab (anti-CD20) efficacy for NMOSD attack prevention. In contrast, our current findings from inebilizumab-treated NMOSD patients indicate similar clinical outcomes between those with F158 and V158 allele genotypes.