Soliris (eculizumab) / AstraZeneca 
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 85 Diseases   29 Trials   29 Trials   4783 News 


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  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Bexsero (meningococcal group B vaccine) / GSK
    Clinical, Journal:  Eculizumab impairs Neisseria meningitidis serogroup B killing in whole blood despite 4CMenB vaccination of PNH patients. (Pubmed Central) -  May 15, 2021   
    Anti-MenB IgG was able to bind to the bacterial surface and initiate complement activation; however, inhibition of the membrane attack complex formation completely blocked whole blood-mediated killing of MenB. This would suggest that, despite 4CMenB vaccination, PNH patients taking C5 inhibitors are not sufficiently protected against MenB infection, which is in line with the fact that vaccinated PNH patients still experience meningococcal infections.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Review, Journal:  Antiphospholipid syndrome: complement activation, complement gene mutations and therapeutic implications. (Pubmed Central) -  May 15, 2021   
    Finally, analogous to classic complement-mediated diseases such as atypical hemolytic uremic syndrome, a subset of patients with APS may be at increased risk for development of CAPS due the presence of germline variants in genes crucial for complement regulation. Together, these data make complement inhibition an attractive and potentially life-saving therapy to mitigate morbidity and mortality in severe thrombotic APS and CAPS.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Zarzio (filgrastim biosimilar) / Novartis, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    [VIRTUAL] PAROXYSMAL NOCTURNAL HEMOGLOBINURIA’S HUMANISTIC AND ECONOMIC BURDEN IN PATIENTS RECEIVING C5 INHIBITORS IN EUROPE () -  May 13, 2021 - Abstract #EHA2021EHA_1982;    
    Despite the clinical benefit for PNH patients (pts), real world evidence studies indicate that pts treated with C5 inhibitors eculizumab (ECU) and ravulizumab (RAV) experience continued impairment in productivity and overall quality-of-life (QoL), and that a significant proportion of pts, besides being anemic continues to experience fatigue and other symptoms.1 Aims Assess the burden of illness in European PNH pts currently treated with C5 inhibitors, from a clinical, humanistic and economic perspective...Total work productivity impairment was 29%[±32] (ECU: 48%[±34], RAV: 19%[±23]). Conclusion This burden of illness interim analysis among European PNH pts indicates a substantial unmet need in regards to economic burden and QoL as the results show relevant work-related productivity loss, diminished ability to work, limitations in daily life activities, and reduced QoL, despite treatment with ECU or RAV.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Zarzio (filgrastim biosimilar) / Novartis
    [VIRTUAL] TRIAL IN PROGRESS: QUANTIFYING THE HUMANISTIC AND SOCIOECONOMIC BURDEN OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA IN THE COMMODORE BURDEN OF ILLNESS STUDY () -  May 13, 2021 - Abstract #EHA2021EHA_1209;    
    Worldwide access to the C5 inhibitor eculizumab is hindered by the unavailability of treatment, and in places where treatment is approved, cost of treatment, reimbursement issues, infrastructure, or patient restrictions may further impede access (Risitano et al, Am J Hematol...Results Final results are expected in spring 2022. Conclusion The COMMODORE BOI study aims to characterize current PNH treatment via quantification of the humanistic and socioeconomic burden at the patient, healthcare system, and societal level to enhance the evidence base for treatment and decision-making in this community.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    [VIRTUAL] SAFETY OF RAVULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA: STUDY 301/302 2-YEAR RESULTS () -  May 13, 2021 - Abstract #EHA2021EHA_1188;    
    P3
    Of these, 214 were complement C5 inhibitor-experienced having received eculizumab prior to switching to ravulizumab in the extension period...More than 90% of pts in both studies continued ravulizumab treatment beyond the 2-year data cut of the extension periods. Conclusion Ravulizumab was well tolerated in pts with PNH who were complement C5 inhibitor therapy naïve or experienced, with no new safety signals reported up to 2 years of treatment.
  • ||||||||||  BCX9930 / BioCryst, Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    [VIRTUAL] BCX9930, AN ORAL FACTOR D INHIBITOR, CONTROLS EXTRAVASCULAR HEMOLYSIS AND ALLEVIATES ASSOCIATED SYMPTOMS IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA INADEQUATELY CONTROLLED ON C5 INHIBITORS () -  May 13, 2021 - Abstract #EHA2021EHA_1183;    
    P1/2
    Results Two patients are receiving ravulizumab and 4 eculizumab (>900mg every 2 weeks in 3)...No serious or Grade 3 or 4 AEs were reported and there were no trends in safety laboratory values Conclusion Oral BCX9930 at doses up to 500mg BID was safe and generally well-tolerated over at least 58 days in PNH patients with inadequate response to a C5 inhibitor. Following initiation of BCX9930, notable improvements were observed in Hb, ARC, abundance of PNH RBC, fatigue scores and RBC transfusion requirements. Both proximal AP inhibition of Factor D and demonstrated improvements in hemolysis support future evaluation of BCX9930 monotherapy for patients who are inadequately responding to C5 inhibitors.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Zarzio (filgrastim biosimilar) / Novartis
    [VIRTUAL] ECULIZUMAB FOR TREATMENT OF TRANSPLANT-ASSOCIATED THROMBOTIC MICROANGIOPATHY IN OUR CENTRE () -  May 13, 2021 - Abstract #EHA2021EHA_788;    
    None of them responded to withdrawal of tacrolimus and most of them had concomitant infection or GvHD, which are known adverse risk factors. Begin of the disorder in our patients was later than common and less than a half happened before day 100 after the transplant. Following protocols in our centre we used TPE or rituximab while waiting for eculizumab approval in our centre. Similar to previous reports, 71% of patients reached complete response after its initiation and those who did not often died because of infection complications. However, given the small amount of patients, further studies with alleatory design are required to recommend eculizumab as an effective therapy of TA-TMA that not respond to supportive treatment and to evaluate the associated risks and prognostic factors.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Genetic justification of severe COVID-19 using a rigorous algorithm. (Pubmed Central) -  May 13, 2021   
    We also observed gender differences in ADAMTS13 and complement-related variants. In light of encouraging results by complement inhibitors, our study highlights a patient population that might benefit from early initiation of specific treatment.
  • ||||||||||  [VIRTUAL] Injection-Site Reactions in the Randomized Phase 3 PEGASUS Trial of Pegcetacoplan Compared with Eculizumab for Individuals with Paroxysmal Nocturnal Hemoglobinuria () -  May 12, 2021 - Abstract #BSH2021BSH_455;    
    P3
    Five drugs with comparable delivery to pegcetacoplan were identified and evaluated for ISR data: immunoglobulin with hyaluronidase, deferoxamine, daratumumab and hyaluronidase, certolizumab pegol, and pegfilgrastim (see Table)...ISRs were often mild or manageable and pegcetacoplan patients on average reported higher quality of life than ECU treated patients, indicating these events are likely not a barrier to treatment. Comparable trends for reported ISRs have been observed with drugs delivered similarly to pegcetacoplan; management strategies for ISRs with these drugs may potentially be useful for reactions observed with pegcetacoplan.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma, pegcetacoplan SC (APL-2 SC) / Apellis, SOBI
    [VIRTUAL] C3 Inhibition with pegcetacoplan in patients with paroxysmal nocturnal hemoglobinuria: results from the Paddock and Palomino trials () -  May 12, 2021 - Abstract #BSH2021BSH_442;    
    P1, P2a, P
    PADDOCK and PALOMINO exhibit the therapeutic potential of pegcetacoplan in the treatment of PNH and support further evaluation in the ongoing phase 3 PRINCE trial (NCT04085601) in complement inhibitor-naıve patients. LDH, lactate dehydrogenase; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; PNH, Paroxysmal Nocturnal Hemoglobinuria; RBCs, red blood cells *Population norm
  • ||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Soliris (eculizumab) / AstraZeneca
    Phase classification, Enrollment change:  DUET: The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation (clinicaltrials.gov) -  May 3, 2021   
    P3,  N=36, Completed, 
    On the basis of these data, iptacopan will be tested as monotherapy in pivotal trials investigating its haematological benefit in a broader paroxysmal nocturnal haemoglobinuria population. Phase classification: P4 --> P3 | N=20 --> 36