Soliris (eculizumab) / AstraZeneca 
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 85 Diseases   26 Trials   26 Trials   4615 News 


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  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    METHODOLOGY OF AN INTERNATIONAL MULTI-CENTER RETROSPECTIVE REVIEW OF TRANSPLANT-ASSOCIATED THROMBOTIC MICROANGIOPATHY (TA-TMA) BY THE TA-TMA WORKING GROUP () -  May 13, 2022 - Abstract #EHA2022EHA_2434;    
    Patients who had a positive biopsy, were diagnosed with TA-TMA or aHUS, or had received eculizumab following alloHCT were considered to have definite TA-TMA...Conclusion This is the first multi-center comprehensive retrospective study to evaluate TA-TMA with a formalized process for independent local and central adjudication to verify TA-TMA diagnosis. The large cohort of TA-TMA cases identified in this study should enable validation of current and future diagnostic criteria, improve our understanding of prognostic/risk factors, and enhance awareness of this disease.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Ultomiris IV (ravulizumab IV) / AstraZeneca
    OUTCOMES IN HOSPITALIZED PATIENTS WITH COMPLEMENT MEDIATED THROMBOTIC MICROANGIOPATHY () -  May 13, 2022 - Abstract #EHA2022EHA_2258;    
    We believe early diagnosis and initiation of therapy might avoid adverse outcomes. Large, long-term and prospective studies evaluating diagnostic criteria, therapy and outcomes in CM-TMA are warranted.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Ultomiris IV (ravulizumab IV) / AstraZeneca, Empaveli (pegcetacoplan SC) / Apellis, SOBI
    A MATCHING-ADJUSTED INDIRECT COMPARISON OF THE EFFICACY OF PEGCETACOPLAN USING PRINCE TRIAL DATA VERSUS RAVULIZUMAB AND ECULIZUMAB IN COMPLEMENT-NAÏVE PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA () -  May 13, 2022 - Abstract #EHA2022EHA_1142;    
    P3
    Patients receiving PEG also showed significant improvements in LDH normalization (35.6% compared to RAV, p<0.001; 39.6% compared to ECU, p<0.001), Hb stabilization (28.2% compared to RAV, p<0.001; 31.7% compared to ECU, p<0.001), and transfusion avoidance (22.6% compared to RAV, p<0.001; 30.1% compared to ECU, p<0.001; Figure 1 ). Conclusion In the absence of head-to-head comparisons, this unanchored MAIC study shows that PEG is more efficacious versus RAV and ECU in complement inhibitors treatment naïve PNH patients in terms of significant improvements across all evaluated endpoints, Hb stabilization, LDH improvement, LDH normalization and transfusion avoidance.
  • ||||||||||  Empaveli (pegcetacoplan SC) / Apellis, SOBI
    PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA TREATED WITH PEGCETACOPLAN SHOW IMPROVEMENTS IN D-DIMER NORMALIZATION AND DECREASE IN INCIDENCE OF THROMBOSIS () -  May 13, 2022 - Abstract #EHA2022EHA_1141;    
    P3
    Methods PEGASUS enrolled adult patients with PNH with prior suboptimal response to eculizumab (ECU) despite stable ECU treatment (≥3 months) and hemoglobin (Hb) levels <10.5 g/dL at screening...PRINCE compared PEG treatment (n=35; 1080 mg sc 2x weekly) in complement-inhibitor-naïve patients to patients receiving control treatment (CTRL; excluding complement-inhibitors i.e., ECU/ravulizumab; n=18)...In PRINCE, D-dimer normalization in the PEG arm increased from 51% (baseline, n=18) to 67% (Week 8, n=18) and increased further to 68% (n=19) at Week 26 (Table 1). Conclusion Overall, these results demonstrate that PEG treatment can increase D-dimer normalization and reduces incidence of thrombotic events in patients with PNH who are complement-inhibitor naïve or remained anemic after ECU treatment, suggesting that PEG treatment is as effective as ECU in these outcomes.
  • ||||||||||  Empaveli (pegcetacoplan SC) / Apellis, SOBI
    NORMALIZATION OF HEMATOLOGIC AND HEALTH-RELATED QUALITY OF LIFE MARKERS IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA TREATED WITH PEGCETACOPLAN AND BASELINE HEMOGLOBIN AT OR ABOVE 10 G/DL () -  May 13, 2022 - Abstract #EHA2022EHA_1131;    
    P1, P3
    PEGASUS enrolled patients with Hb levels <10.5g/dL at screening despite stable eculizumab (ECU) treatment (≥3 months)...PRINCE compared PEG treatment (1080mg sc 2x weekly) in complement-inhibitor naïve patients with PNH and Hb levels below the lower limits of normal (males: ≤13.6g/dL; females: ≤12.0g/dL) to control treatment (CTRL; excluding complement-inhibitors i.e., ECU/ravulizumab)...Overall, these results suggest PEG can be efficacious long-term in patients with less severe anemia, regardless of prior complement-inhibitor treatment, resulting in further clinical improvements in markers of hemolysis and QoL. The safety profile of PEG was consistent with results from previous studies.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    PAROXYSMAL NOCTURNAL HEMOGLOBINURIA AND THROMBOSIS: A MULTICENTRIC RETROSPECTIVE STUDY () -  May 13, 2022 - Abstract #EHA2022EHA_1101;    
    Of the eight patients who developed thrombosis at diagnosis, six received eculizumab and to-date they have not had a new thrombotic episode [median time of f/u 22 months (range 12 - 179)]...The antithrombotic therapy that was used was acenocoumarol following a short course of low molecular weight heparin...Conclusion CONCLUSIONS Thrombotic events occur in a significant percentage of patients with PNH, often in unusual anatomical sites. Ongoing treatment with complement inhibitors has significantly contributed to the reduction of thrombotic events and consequently the increase in patient survival.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Reviewing atypical Hemolytic Uremic Syndrome in a portuguese terciary hospital (Exhibition) -  May 13, 2022 - Abstract #ISTH2022ISTH_1520;    
    In all cases the onset was abrupt, mainly identified by analytical changes and few clinical relavants signs, despite fluctuating neurological symptoms in two patients. One patient had a previous asymptomatic Coronavirus Disease 2019.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Early use of eculizumab in patient with pregnancy-associated atypical haemolytic-uraemic syndrome (Exhibition) -  May 13, 2022 - Abstract #ISTH2022ISTH_1148;    
    not applicable Conclusion(s): Our case presents the importance of interdisciplinary cooperation in pregnancy-associated TMA. Early administration of eculizumab probably saved our critically ill patient, and maintenance treatment contributed to the success of kidney transplantation.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Classification of Japanese patients with aHUS treated with eculizumab by a diagnostic scoring system (Exhibition) -  May 13, 2022 - Abstract #ISTH2022ISTH_1053;    
    In patients who had medical record after eculizumab treatment, 96% of patients fulfilled Criterion 1, 83% of patients fulfilled Criterion 2, and 30% of patients fulfilled Criterion 3. Higher percentages of patients with impaired renal function, younger onset and no underlying diseases were observed in the population who fulfilled Criterion 3.
  • ||||||||||  Zolgensma (onasemnogene abeparvovec-xioi) / Novartis
    Journal:  Child Neurology: Pathologically Confirmed Thrombotic Microangiopathy Caused by Onasemnogene Abeparvovec Treatment for Spinal Muscular Atrophy. (Pubmed Central) -  May 12, 2022   
    She was diagnosed with TMA and received an increased dose of prednisolone, antihypertensives, diuretics, packed red blood cell and platelet transfusion, a single dose of eculizumab, 4 cycles of plasmapheresis, and intermittent and continuous hemodialysis...She can hold her posture against gravity and has neither dysphagia nor respiratory disturbance, but mild hypertension persists. Physicians should be vigilant regarding TMA as a severe side effect of onasemnogene abeparvovec treatment, especially when thrombocytopenia, hemolytic anemia, increased lactate dehydrogenase, or acute kidney injury is present.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, Vaxzevria (ChAdOx1-S recombinant) / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Journal:  Treatment of vaccine-induced immune thrombotic thrombocytopenia (VITT). (Pubmed Central) -  May 12, 2022   
    We discuss the controversial issue of whether heparin, which often inhibits VITT antibody-induced platelet activation, is harmful in the treatment of VITT. We also describe a case of "long VITT," describing the treatment challenges resulting from platelet-activating anti-PF4 antibodies that persisted for more than 9 months.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Journal:  Hemolytic paroxysmal nocturnal hemoglobinuria: 20 years of medical progress. (Pubmed Central) -  May 9, 2022   
    New anti-C5 agents reproduce the safety and efficacy of eculizumab, with improved patient convenience, while proximal complement inhibitors have been developed to address C3-mediated extravascular hemolysis, aiming to eventually improve hematological response. This review will describe the spectacular medical progress in PNH of the last 20 years, as well as the risks and benefits of a novel approach.
  • ||||||||||  Uplizna (inebilizumab) / Horizon Therapeutics, Mitsubishi Tanabe, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
    Health Resource Utilization (HRU) and Cost of Care (CoC) in Neuromyelitis Optica Spectrum Disorders in the US (Gaylord National Resort & Convention Center - Prince George's Exhibit Hall) -  May 9, 2022 - Abstract #CMSC2022CMSC_106;    
    Highly active disease adds significant cost and resource utilization. New NMOSD indicated drugs that reduce attack frequency, hospitalization and disability accrual may positively impact HRU and lifetime CoC.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Preclinical, Review, Journal:  Role of Complement System in Kidney Transplantation: Stepping From Animal Models to Clinical Application. (Pubmed Central) -  May 6, 2022   
    We will discuss the involvement of the different complement components in kidney ischemia-reperfusion injury, delayed graft function, allograft rejection, and chronic allograft injury. We will also introduce the existing and upcoming attempts to improve allograft outcomes in animal models and in the clinical setting by targeting the complement system.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Eculizumab for Adult Patients With Atypical Haemolytic-Uremic Syndrome: Full Dataset Analysis of Post-Marketing Surveillance in Japan (Mini-Orals Hall) -  May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_1136;    
    CONCLUSION The percentages of patients who met effectiveness endpoints were similar to the interim analysis [ 3 ], yet the percentages of patients who met complete TMA responses were lower than in clinical trials [ 4 ]; the disparity in these outcomes could be attributed to the differences between clinical and real-world studies. This PMS analysis further demonstrated the safety and effectiveness of eculizumab in Japanese patients with aHUS in a real-world setting.
  • ||||||||||  Comirnaty (tozinameran) / Pfizer, Fosun Pharma, BioNTech, Soliris (eculizumab) / AstraZeneca
    A Rare Case of Secondary Haemolytic Uremic Syndrome after ANTI-SARS-COV-2 Vaccination (Mini-Orals Hall) -  May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_1014;    
    METHOD We report the case of a 17-year-old woman, who presented at our emergency department with fever, dyspnoea, acute kidney injury AKI III with anuria, hypertension, severe anaemia, no diarrhoea, severe thrombocytopaenia and myocarditis, about 2 weeks after the first administration of SARS-CoV-2 vaccine (Comirnaty) and recent exposition to SARS-CoV-2 positive individual...After 2 months of eculizumab, she was still oliguric, requiring renal replacement therapy...After metabolic therapy with hydroxocobalamin, she gradually recovered diuresis and partially renal function without need for replacement therapy...Moreover, our patient turned out to be an extremely rare case of HUS secondary to cobalamin C deficiency, that is generally diagnosed in early infancy and show typically neurological symptoms (absent in our case). Probably, the mRNA-based vaccine acted like ‘a second hit’, but existing predisposition should always be investigated including also the less frequent forms.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca, valnivudine (FV-100) / Hepion Pharma
    Ex Vivo C5B9 Deposition Test as a Diagnostic and Monitoring Tool For Primary and Transplantation Associated AHUS (Mini-Orals Hall) -  May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_894;    
    We now demonstrated that the ex vivo C5b9 deposition test is also useful for HSC associated aHUS and for aHUS recurrence after kidney transplantation suggesting that it could be a useful diagnostic tool for any type of CM aHUS. These results expand the spectrum of patients that would benefit from a better diagnostic and treatment monitoring procedure.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    GENE EXPRESSION PROFILES OF PERITUBULAR CAPILLARITIS IN CHRONIC ANTIBODY-MEDIATED REJECTION (Hall S01) -  May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_549;    
    In biopsies with diffuse ptc significant higher gene expressions were found in the ABMR gene set [63/55–83 versus 32/27–52; (median/IQR); P = 0.012], the ABMR exhaust gene set (390/245–609 versus 245/128–358; P = 0.022), the Eculizumab gene set (180/143–339 versus 65/57–133; P = 0.0027) and the TCMR gene set (48/40–75 versus 25/19–35; P = 0.001)...FIGURE 1: Immunohistochemical assessment in KT biopsies. FIGURE 1: Immunohistochemical assessment in KT biopsies.