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  1. Article ; Online: Ravulizumab 100 mg/mL formulation reduces infusion time and frequency, improving the patient and caregiver experience in the treatment of atypical haemolytic uraemic syndrome.

    Dixon, Bradley P / Sabus, Ashley

    Journal of clinical pharmacy and therapeutics

    2022  Volume 47, Issue 7, Page(s) 1081–1087

    Abstract: What is known and objective: The C5 inhibitor eculizumab is the standard of care for treatment of atypical haemolytic uraemic syndrome (aHUS). Ravulizumab, a next-generation C5 inhibitor, was engineered to have a longer terminal half-life than ... ...

    Abstract What is known and objective: The C5 inhibitor eculizumab is the standard of care for treatment of atypical haemolytic uraemic syndrome (aHUS). Ravulizumab, a next-generation C5 inhibitor, was engineered to have a longer terminal half-life than eculizumab. We describe practical benefits of the advanced ravulizumab 100 mg/mL formulation.
    Comment: Use of ravulizumab results in fewer maintenance infusions per year (25%-50%) compared with eculizumab. Maintenance infusion time of ravulizumab 100 mg/mL is 2-4 times shorter than ravulizumab 10 mg/mL in all weight cohorts and approximately half that of eculizumab for patients weighing <40 kg. Ravulizumab 100 mg/mL requires fewer vials annually than eculizumab in most weight cohorts.
    What is new and conclusion: With ravulizumab 100 mg/mL, patients and caregivers experience fewer infusions per year and decreased annual infusion times, improving infusion experience. Infusion centres can expect corresponding decreases in resource utilization.
    MeSH term(s) Antibodies, Monoclonal, Humanized ; Atypical Hemolytic Uremic Syndrome/drug therapy ; Caregivers ; Humans
    Chemical Substances Antibodies, Monoclonal, Humanized ; ravulizumab (C3VX249T6L)
    Language English
    Publishing date 2022-03-18
    Publishing country England
    Document type Journal Article
    ZDB-ID 639006-7
    ISSN 1365-2710 ; 0269-4727
    ISSN (online) 1365-2710
    ISSN 0269-4727
    DOI 10.1111/jcpt.13642
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Hemolytic Uremic Syndrome.

    Cody, Ellen M / Dixon, Bradley P

    Pediatric clinics of North America

    2018  Volume 66, Issue 1, Page(s) 235–246

    Abstract: Hemolytic uremic syndrome (HUS) is the clinical triad of thrombocytopenia, anemia, and acute kidney injury. Classically associated with enterocolitis from Shiga toxin-producing Escherichia coli, HUS is also associated with Streptococcus pneumoniae ... ...

    Abstract Hemolytic uremic syndrome (HUS) is the clinical triad of thrombocytopenia, anemia, and acute kidney injury. Classically associated with enterocolitis from Shiga toxin-producing Escherichia coli, HUS is also associated with Streptococcus pneumoniae infections; genetic dysregulation of the alternative complement pathway or coagulation cascade; and, rarely, a hereditary disorder of cobalamin C metabolism. These share a common final pathway of a prothrombotic and proinflammatory state on the endothelial cell surface, with fibrin and platelet deposition. Much work has been done to distinguish between the different mechanisms of disease, thereby informing the optimal therapeutic interventions for each entity.
    MeSH term(s) Antibodies, Monoclonal, Humanized/therapeutic use ; Diagnosis, Differential ; Erythrocyte Transfusion ; Escherichia coli Infections/complications ; Fluid Therapy ; Hemolytic-Uremic Syndrome/diagnosis ; Hemolytic-Uremic Syndrome/etiology ; Hemolytic-Uremic Syndrome/therapy ; Humans ; Kidney Transplantation ; Plasma Exchange ; Prognosis ; Renal Dialysis ; Risk Factors ; Streptococcal Infections/complications
    Chemical Substances Antibodies, Monoclonal, Humanized ; eculizumab (A3ULP0F556)
    Language English
    Publishing date 2018-09-08
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 215711-1
    ISSN 1557-8240 ; 0031-3955
    ISSN (online) 1557-8240
    ISSN 0031-3955
    DOI 10.1016/j.pcl.2018.09.011
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Atypical Hemolytic Uremic Syndrome.

    Dixon, Bradley P / Gruppo, Ralph A

    Pediatric clinics of North America

    2018  Volume 65, Issue 3, Page(s) 509–525

    Abstract: Atypical hemolytic uremic syndrome is a rare life-threatening disease of unregulated complement activation. Untreated, the prognosis is generally poor; more than one-half of patients die or develop end-stage renal disease within 1 year. Atypical ... ...

    Abstract Atypical hemolytic uremic syndrome is a rare life-threatening disease of unregulated complement activation. Untreated, the prognosis is generally poor; more than one-half of patients die or develop end-stage renal disease within 1 year. Atypical hemolytic uremic syndrome is characterized by thrombotic microangiopathy with evidence of hemolysis, thrombocytopenia, and renal impairment. This systemic disease affects the kidneys, brain, heart, lungs, gastrointestinal tract, pancreas, and skin. Acquired and genetic abnormalities of complement regulation may be identified in approximately 70% of patients. Plasma therapy is generally ineffective. Eculizumab blocks terminal complement activation, prevents complement-mediated organ damage, and is currently recommended as front-line therapy.
    MeSH term(s) Antibodies, Monoclonal, Humanized/therapeutic use ; Atypical Hemolytic Uremic Syndrome/diagnosis ; Atypical Hemolytic Uremic Syndrome/etiology ; Atypical Hemolytic Uremic Syndrome/therapy ; Blood Component Transfusion ; Humans ; Plasma ; Plasmapheresis
    Chemical Substances Antibodies, Monoclonal, Humanized ; eculizumab (A3ULP0F556)
    Language English
    Publishing date 2018-05-24
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 215711-1
    ISSN 1557-8240 ; 0031-3955
    ISSN (online) 1557-8240
    ISSN 0031-3955
    DOI 10.1016/j.pcl.2018.02.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: The Role of Complement Split-products as Biomarkers for Acute Antibody-mediated Rejection of Kidney Allografts.

    Abu Jawdeh, Bassam G / Campos-Naciff, Begona / Meganathan, Karthikeyan / Steve Woodle, E / Dixon, Bradley P

    Transplantation direct

    2022  Volume 8, Issue 9, Page(s) e1366

    Abstract: Acute antibody-mediated rejection (AMR) is mediated by the activation of the classical complement system in addition to noncomplement-dependent inflammatory pathways. Complement fixation by donor-specific antibodies leads to cleavage of the complement ... ...

    Abstract Acute antibody-mediated rejection (AMR) is mediated by the activation of the classical complement system in addition to noncomplement-dependent inflammatory pathways. Complement fixation by donor-specific antibodies leads to cleavage of the complement proteins C4, C3, and C5 to produce multiple complement split-products (CSP) and the end-effector membrane attack complex, C5b-9. In this study, we investigate CSP as potential biomarkers for AMR.
    Methods: In an Institutional Review Board-approved, prospective, controlled study, CSP levels were measured in blood and urine samples from consecutive kidney transplant recipients with biopsy-proven AMR (n = 10), acute cellular rejection (ACR) (n = 5), or no rejection (n = 5). After obtaining informed consent, samples were collected at the time of biopsy (day 0) and days 15 (end of rejection treatment) and 30 postbiopsy for AMR and ACR patients. ELISA was used to measure C5a, C4d, and soluble C5b-9 concentrations in blood and urine, in addition to factor Bb (Bb) concentration in blood only. Kidney transplant histopathology was evaluated using the Banff 2013 classification. Rejection treatment and follow-up were performed per standard of care.
    Results: Blood and urine CSP levels adjusted to urine creatinine were not elevated in AMR compared to no rejection and ACR arms. There was significant variability in CSP concentration within each of the study groups.
    Conclusion: Our study does not support the utility of CSP as surrogate biomarkers of AMR; however, it is limited by the small sample size and larger studies may be warranted.
    Language English
    Publishing date 2022-08-04
    Publishing country United States
    Document type Journal Article
    ISSN 2373-8731
    ISSN 2373-8731
    DOI 10.1097/TXD.0000000000001366
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Clinical Safety and Efficacy of Pegcetacoplan in a Phase 2 Study of Patients with C3 Glomerulopathy and Other Complement-Mediated Glomerular Diseases.

    Dixon, Bradley P / Greenbaum, Larry A / Huang, Liwei / Rajan, Sandeep / Ke, Chunlei / Zhang, Yiwei / Li, Li

    Kidney international reports

    2023  Volume 8, Issue 11, Page(s) 2284–2293

    Abstract: Introduction: Dysregulated complement activation is likely the primary driver of disease in C3 glomerulopathy (C3G) and contributes to other complement-mediated diseases, including immunoglobulin A nephropathy (IgAN), lupus nephritis (LN), and primary ... ...

    Abstract Introduction: Dysregulated complement activation is likely the primary driver of disease in C3 glomerulopathy (C3G) and contributes to other complement-mediated diseases, including immunoglobulin A nephropathy (IgAN), lupus nephritis (LN), and primary membranous nephropathy (PMN). No complement inhibitors are proven to halt disease progression in these diseases. Pegcetacoplan, a targeted C3 and C3b inhibitor, may mitigate complement-mediated kidney damage in C3G and other glomerular diseases in which complement may have a pathogenic role.
    Methods: This open-label, phase 2, 48-week study evaluated the preliminary efficacy and safety of subcutaneous pegcetacoplan for patients with complement-mediated glomerular diseases. The primary end point was proteinuria reduction, measured as 24-hour urine protein-to-creatinine ratio. Secondary end points included remission status, changes in estimated glomerular filtration rate (eGFR), and pharmacodynamic biomarkers. Treatment-emergent adverse events (TEAEs) were monitored.
    Results: Efficacy results for the C3G cohort are reported herein, along with safety results for the study population. In the C3G cohort, mean proteinuria reduction from baseline to week 48 was 50.9% in the intent-to-treat (ITT) population (
    Conclusion: Pegcetacoplan may provide therapeutic benefit for C3G and has a favorable safety profile across the 4 glomerular diseases studied.
    Language English
    Publishing date 2023-08-25
    Publishing country United States
    Document type Journal Article
    ISSN 2468-0249
    ISSN (online) 2468-0249
    DOI 10.1016/j.ekir.2023.08.033
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  6. Article ; Online: Urine Complement Factor Ba Is Associated with AKI in Critically Ill Children.

    Stenson, Erin K / Edelstein, Charles L / You, Zhiying / Miyazaki-Anzai, Shinobu / Thurman, Joshua M / Dixon, Bradley P / Zappitelli, Michael / Goldstein, Stuart L / Akcan Arikan, Ayse / Kendrick, Jessica

    Kidney360

    2023  Volume 4, Issue 3, Page(s) 326–332

    MeSH term(s) Humans ; Child ; Complement Factor B ; Critical Illness ; Prospective Studies ; Biomarkers ; Acute Kidney Injury
    Chemical Substances Complement Factor B (EC 3.4.21.47) ; Biomarkers
    Language English
    Publishing date 2023-02-10
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ISSN 2641-7650
    ISSN (online) 2641-7650
    DOI 10.34067/KID.0000000000000077
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Corrigendum to "The long-acting C5 inhibitor, ravulizumab, is effective and safe in pediatric patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment." Kidney Int. 2021;100:225-237.

    Ariceta, Gema / Dixon, Bradley P / Kim, Seong Heon / Kapur, Gaurav / Mauch, Teri / Ortiz, Stephan / Vallee, Marc / Denker, Andrew E / Kang, Hee Gyung / Greenbaum, Larry A

    Kidney international

    2023  Volume 104, Issue 1, Page(s) 205

    Language English
    Publishing date 2023-05-20
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 120573-0
    ISSN 1523-1755 ; 0085-2538
    ISSN (online) 1523-1755
    ISSN 0085-2538
    DOI 10.1016/j.kint.2023.04.010
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    Zs.A 797: Show issues Location:
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  8. Article ; Online: Comorbidity of inflammatory bowel disease with atypical hemolytic uremic syndrome in pediatric patients.

    Shin, H Stella / Nester, Carla M / Dixon, Bradley P

    Clinical nephrology. Case studies

    2019  Volume 7, Page(s) 35–40

    Abstract: Atypical hemolytic uremic syndrome (aHUS) is a form of thrombotic microangiopathy mediated by dysregulation of the alternative complement pathway. Complement-amplifying conditions such as respiratory and gastrointestinal infections, pregnancy, malignancy, ...

    Abstract Atypical hemolytic uremic syndrome (aHUS) is a form of thrombotic microangiopathy mediated by dysregulation of the alternative complement pathway. Complement-amplifying conditions such as respiratory and gastrointestinal infections, pregnancy, malignancy, and systemic autoimmune diseases such as systemic lupus erythematosus have been associated with the clinical manifestation of aHUS. Inflammation of the gastrointestinal tract is a potent stimulus for complement activation, and we describe a series of three pediatric patients with aHUS and comorbidity of inflammatory bowel disease (IBD). In two of the three cases, the diagnosis of aHUS preceded the diagnosis of IBD, perhaps suggesting a mechanistic link between complement dysregulation and thrombotic microangiopathy in the gastrointestinal tract and the ensuing inflammatory changes of IBD.
    Language English
    Publishing date 2019-06-25
    Publishing country Germany
    Document type Case Reports
    ISSN 2196-5293
    ISSN (online) 2196-5293
    DOI 10.5414/CNCS109511
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  9. Article ; Online: Treatment preference and quality of life impact: ravulizumab vs eculizumab for atypical hemolytic uremic syndrome.

    Mauch, Teri J / Chladek, Michael R / Cataland, Spero / Chaturvedi, Shruti / Dixon, Bradley P / Garlo, Katherine / Gasteyger, Christoph / Java, Anuja / Leguizamo, Jorge / Lloyd-Price, Lucy / Pham, Tan P / Symonds, Tara / Tomazos, Ioannis / Wang, Yan

    Journal of comparative effectiveness research

    2023  Volume 12, Issue 9, Page(s) e230036

    Abstract: Aim: ...

    Abstract Aim:
    MeSH term(s) Adult ; Humans ; Child ; Middle Aged ; Atypical Hemolytic Uremic Syndrome/drug therapy ; Atypical Hemolytic Uremic Syndrome/chemically induced ; Quality of Life ; Antibodies, Monoclonal, Humanized ; Complement Inactivating Agents/therapeutic use ; Complement Inactivating Agents/adverse effects
    Chemical Substances ravulizumab (C3VX249T6L) ; eculizumab (A3ULP0F556) ; Antibodies, Monoclonal, Humanized ; Complement Inactivating Agents
    Language English
    Publishing date 2023-07-29
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2023-0036
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Editorial: Autoantibodies in Kidney Diseases.

    Marchbank, Kevin J / Frazer-Abel, Ashley / Dragon-Durey, Marie-Agnes / Dixon, Bradley P

    Frontiers in immunology

    2020  Volume 11, Page(s) 591338

    MeSH term(s) Autoantibodies/immunology ; Autoimmune Diseases/etiology ; Autoimmune Diseases/metabolism ; Autoimmune Diseases/pathology ; Autoimmunity ; Disease Management ; Disease Susceptibility ; Humans ; Kidney Diseases/etiology ; Kidney Diseases/metabolism ; Kidney Diseases/pathology
    Chemical Substances Autoantibodies
    Language English
    Publishing date 2020-09-16
    Publishing country Switzerland
    Document type Editorial ; Introductory Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2020.591338
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