Soliris (eculizumab) / AstraZeneca 
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  • ||||||||||  Review, Journal:  Pegcetacoplan: First Approval. (Pubmed Central) -  Dec 22, 2021   
    Pegcetacoplan is the first C3-targeted paroxysmal nocturnal haemoglobinuria (PNH) therapy to be approved (in May 2021) in the USA, where it is indicated for the treatment of adults with PNH, including those switching from C5 inhibitor therapy with eculizumab and ravulizumab...The recommended dosage regimen of pegcetacoplan is 1080 mg twice weekly, administered as a subcutaneous infusion via an infusion pump with a ≥ 20 mL reservoir. This article summarizes the milestones in the development of pegcetacoplan leading to this first approval for the treatment of adults with PNH.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Clinical, Journal:  Thrombotic microangiopathy associated with arboviral infection: Report of 3 cases. (Pubmed Central) -  Dec 22, 2021   
    The third patient had TMA not classified as either aHUS or thrombotic thrombocytopenic purpura (TTP); he abandoned the treatment and returned to the service after 2 years for a dialysis emergency. Patients with arboviral infectious disease and changes that suggest TMA should have appropriate support to establish early diagnosis and useful treatment.
  • ||||||||||  Arzerra (ofatumumab) / Novartis, Genmab, Soliris (eculizumab) / AstraZeneca
    Retrospective data, Review:  Efficacy and Safety of Immunotherapies in Refractory Myasthenia Gravis: A Systematic Review and Meta-Analysis. (Pubmed Central) -  Dec 21, 2021   
    A total of 16 studies were included with 403 patients with refractory MG on therapies with rituximab, eculizumab, tacrolimus, and cladribine...Rituximab had a superior safety profile than eculizumab with a lower incidence of adverse events. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021236818, identifier CRD42021236818.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Clinical, Journal:  Two cases of carfilzomib-induced thrombotic microangiopathy successfully treated with Eculizumab in multiple myeloma. (Pubmed Central) -  Dec 16, 2021   
    P3
    In both patients, treatment with eculizumab over two months efficiently treated TMA without recurrence and with both patients remaining responsive months after TMA onset. Taken together, we describe two cases of TMA in MM patients on carfilzomib-combination treatment, showing similar courses of this severe adverse reaction, with good responses to two months of eculizumab treatment.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Journal:  Eculizumab in the treatment of neuromyelitis optica spectrum disorder. (Pubmed Central) -  Dec 1, 2021   
    Eculizumab, a humanized monoclonal antibody against the terminal complement component 5, was shown to significantly reduce the risk of NMOSD relapse in a Phase III placebo-controlled trial. Based on this, eculizumab (Soliris) was the first drug to be formally approved for the treatment of anti-AQP4-antibody positive NMOSD in 2019.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Relapsed Refractory Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Following COVID-19 Vaccination () -  Nov 24, 2021 - Abstract #ASH2021ASH_6820;    
    Intravenous Cyclophosphamide 750 mg/m 2 was also added every 3 weeks...Additionally, cases of relapsed aTTP have been described following only the BNT162B2 (Pfizer-BioNTech) vaccine (Maayan, Kirgner et al...2021). This is the first case, to our knowledge, reported in the literature of aTTP following vaccination with Moderna's mRNA-1273 vaccine.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Ultomiris IV (ravulizumab IV) / AstraZeneca
    Is Nature Truly Healing Itself? Spontaneous Remissions and Clonal Replacement in Paroxysmal Nocturnal Hemoglobinuria () -  Nov 24, 2021 - Abstract #ASH2021ASH_6604;    
    Once available, he was started on eculizumab and later continued on ravulizumab...PNH spontaneous remissions are rare events. In addition to be replaced by polyclonal hematopoiesis, PIGA clones may be swept by CHIP lesions in myeloid genes (e.g. ASXL1 ) characterized by improved fitness advantage in a process of Darwinian selection.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Searching for Service and Accessibility Excellence in Paroxysmal Nocturnal Hemoglobinuria in Canada: The Epic Program () -  Nov 24, 2021 - Abstract #ASH2021ASH_6360;    
    We have characterized the patient journeys of a cohort of patients followed at our centers, and have identified gaps and potential areas for improvement. The variability and delay in assessment for PNH may be attributed to the diverse backgrounds of the participants, first presentation abroad, year of symptom presentation, and availability of high-sensitivity flow cytometry, which is the diagnostic gold standard.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Empaveli (pegcetacoplan SC) / Apellis, SOBI
    Cost per Responder Analysis for Pegcetacoplan and Eculizumab in the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria () -  Nov 24, 2021 - Abstract #ASH2021ASH_6180;    
    P1, P2a, P
    Conclusion : Based on the treatment response observed in PEGASUS, the NNT and cost to achieve good or good-to-complete response was lower for pegcetacoplan-treated patients than eculizumab-treated patients, according to EBMT consensus-based hematological response categories. PNH treatment with pegcetacoplan allowed more patients to achieve EBMT defined good-to-complete response and better overall response and is a more efficient use of spending with lower cost per responder in all response categories.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    A Challenging Case of Atypical Hemolytic Uremic Syndrome in a Young African American Patient () -  Nov 24, 2021 - Abstract #ASH2021ASH_6161;    
    Our case emphasizes the importance of having low threshold for testing for aHUS in patients with mHTN and TMA, especially in African American patients where malignant HTN is known to happen more commonly, and to notice the subtle hints that may help in this distinction, such as profound hemolysis or thrombocytopenia out of proportion to what one would expect from mHTN alone. Early recognition of aHUS may save a patient's kidney.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Ultomiris IV (ravulizumab IV) / AstraZeneca
    Real-World Ravulizumab Dosing Patterns Among Patients with Paroxysmal Nocturnal Hemoglobinuria in a US Population () -  Nov 24, 2021 - Abstract #ASH2021ASH_6134;    
    Additionally, the mean dose received during the maintenance phase was higher than the label-recommended dose of 3,300 mg in more than one-quarter of patients (≥60 - <100 kg). The deviations from label-recommended dosing regimens-especially dosages exceeding recommendations-suggest that in some patients, PNH is not controlled by ravulizumab.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Clinical, PK/PD data, Journal:  Eculizumab Pharmacokinetics and Pharmacodynamics in Patients With Neuromyelitis Optica Spectrum Disorder. (Pubmed Central) -  Nov 24, 2021   
    P3
    The approved eculizumab dosing regimen (900/1,200 mg) for adults with aquaporin-4-IgG-positive NMOSD is confirmed by rigorous quantitative model-based analysis of exposure-response. The data demonstrate that eculizumab's mechanism of action translates into clinical effect by achieving rapid, complete, and sustained terminal complement inhibition.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Journal:  Eculizumab as a Treatment for Hyper-Haemolytic and Aplastic Crisis in Sickle Cell Disease. (Pubmed Central) -  Nov 21, 2021   
    Prompt recognition and treatment with eculizumab are paramount in those who fail steroid and intravenous immunoglobulin treatment. Treatment of hyper-haemolytic and aplastic crisis in sickle cell disease with eculizumab offers therapeutic benefit.A high index of suspicion for hyper-haemolytic crisis and aplastic crisis should be maintained in those with haemolytic features as well as reticulocytopenia in the setting of sickle cell disease.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Clinical, PK/PD data, Journal:  Eculizumab Pharmacokinetics and Pharmacodynamics in Patients With Generalized Myasthenia Gravis. (Pubmed Central) -  Nov 21, 2021   
    P3
    Clinical efficacy and tolerability were consistent across the eculizumab exposure range. Rigorous, quantitative, model-based exposure-response analysis of serum eculizumab concentration and response data demonstrated that the approved eculizumab dosing (900/1,200 mg) for adults with anti-AChR antibody-positive refractory gMG rapidly achieved complete inhibition of terminal complement activation and provided sustained clinical efficacy across the eculizumab exposure range.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Journal:  Eculizumab and aHUS: to stop or not. (Pubmed Central) -  Nov 21, 2021   
    This association should be considered in patients with MAS who develop disproportionate anemia, thrombocytopenia, and lactate dehydrogenase increase, or have multiorgan failure. No abstract available
  • ||||||||||  cemdisiran (ALN-CC5) / Alnylam, Regeneron, pozelimab (REGN3918) / Regeneron
    Enrollment open, Trial completion date, Trial primary completion date, Combination therapy:  Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy (clinicaltrials.gov) -  Nov 15, 2021   
    P2,  N=12, Recruiting, 
    Results suggest that among patients previously treated with eculizumab, clinical, hematological, and quality of life endpoints were better for patients who received the C3 complement inhibitor pegcetacoplan vs. patients who received ravulizumab, a C5 complement inhibitor. Not yet recruiting --> Recruiting | Trial completion date: Jul 2023 --> Oct 2024 | Trial primary completion date: Jun 2022 --> Sep 2022
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Journal:  Cellular changes in eculizumab early responders with generalized myasthenia gravis. (Pubmed Central) -  Nov 11, 2021   
    Our data suggest complement inhibition with ECU modulates the adaptive immunity in patients with MG, consistent with preclinical data showing changes in complement-mediated signaling by T- and antigen-presenting cells. These findings extend our understanding of ECU's mechanism of action when treating patients with MG.