16 results on '"Garlo K."'
Search Results
2. WCN23-0141 A PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF ALXN2050, A COMPLEMENT FACTOR D INHIBITOR, IN IMMUNOGLOBULIN A NEPHROPATHY OR PROLIFERATIVE LUPUS NEPHRITIS (LN)
- Author
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Bapat, A., primary, Garlo, K., additional, Rice, K., additional, and Najafian, N., additional
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- 2023
- Full Text
- View/download PDF
3. POSA380 Qualitative Development of Surveys to Assess Real-World Patient and Caregiver Perspectives of Atypical Hemolytic Uremic Syndrome Treatment Preferences and Impact
- Author
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Wang, Y, primary, Chladek, M, additional, Garlo, K, additional, Lloyd-Price, L, additional, Symonds, T, additional, Gasteyger, C, additional, and Tomazos, I, additional
- Published
- 2022
- Full Text
- View/download PDF
4. Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults.
- Author
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Barbour, T, Scully, M, Ariceta, G, Cataland, S, Garlo, K, Heyne, N, Luque, Y, Menne, J, Miyakawa, Y, Yoon, S-S, Kavanagh, D, 311 Study Group Members, Barbour, T, Scully, M, Ariceta, G, Cataland, S, Garlo, K, Heyne, N, Luque, Y, Menne, J, Miyakawa, Y, Yoon, S-S, Kavanagh, D, and 311 Study Group Members
- Abstract
INTRODUCTION: Atypical hemolytic uremic syndrome (aHUS) is a rare, complex, multisystem disease of dysregulated complement activity, characterized by progressive thrombotic microangiopathy (TMA), acute kidney injury, and multiorgan dysfunction, which often progresses to chronic kidney disease. Results from the prospective clinical trial of ravulizumab (NCT02949128) reveal rapid resolution of TMA in patients with aHUS, with sustained efficacy and safety in a 26-week initial evaluation period. METHODS: The aim of this analysis was to characterize the long-term efficacy and the safety profile of ravulizumab in adults with aHUS who had completed the initial evaluation period of the trial. Complete TMA response, hematologic and kidney functions, and safety were evaluated for all patients available for follow-up in the extension period (median follow-up: 76.7 weeks; range: 0.6-118.3). This trial included a total of 58 patients, 49 of whom entered the extension period. RESULTS: A total of 4 additional patients achieved complete TMA response during the follow-up period. Normalization of platelet count, serum lactate dehydrogenase (LDH), and hemoglobin observed in the 26-week initial evaluation period was sustained until the last available follow-up, as were the improvements in the estimated glomerular filtration rate (eGFR) and patient quality of life. All efficacy endpoints were correlated with the sustained inhibition of complement C5. Most adverse events (AEs) occurred early during the initial evaluation period and decreased substantially during the extension period. No patient developed a meningococcal infection or died during the extension period. CONCLUSION: This analysis reveals that ravulizumab administered every 8 weeks is efficacious with an acceptable safety profile for the long-term treatment of adults with aHUS and provides additional clinical benefit beyond 6 months of treatment.
- Published
- 2021
5. PRO19 THE IMPACT OF ECULIZUMAB ON HOSPITALIZATION AND LENGTH OF STAY IN PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME: A US CLAIMS DATABASE ANALYSIS
- Author
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Tomazos, I., primary, Garlo, K., additional, Faria, C., additional, Wang, Y., additional, Chen, P., additional, and Laurence, J.C., additional
- Published
- 2020
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- View/download PDF
6. Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults
- Author
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Thomas Barbour, Marie Scully, Gema Ariceta, Spero Cataland, Katherine Garlo, Nils Heyne, Yosu Luque, Jan Menne, Yoshitaka Miyakawa, Sung-Soo Yoon, David Kavanagh, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Eric Rondeau, Hermann Haller, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Barbour T., Scully M., Ariceta G., Cataland S., Garlo K., Heyne N., Luque Y., Menne J., Miyakawa Y., Yoon S.-S., Kavanagh D., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Campistol J.M., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Le Quintrec M., Jeantet G., Fumie I., Rondeau E., Haller H., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., Wong E.K.S., Institut Català de la Salut, [Barbour T] Kidney Care, The Royal Melbourne Hospital, Melbourne, Australia. [Scully M] Department of Haematology, University College London Hospitals, London, UK. [Ariceta G] Servei de Nefrologia Pediàtrica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Cataland S] Division of Hematology, The Ohio State University Medical Center, Columbus, Ohio, USA. [Garlo K] Clinical Development, Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA. [Heyne N] Section of Nephrology and Hypertension, Tübingen University Hospital, Tübingen, Germany, Vall d'Hebron Barcelona Hospital Campus, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, The Royal Melbourne Hospital, University College London Hospitals (UCLH), Vall d'Hebron University Hospital [Barcelona], Ohio State University [Columbus] (OSU), Universitätsklinikum Tübingen - University Hospital of Tübingen, Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), Seoul National University Hospital, and Newcastle University [Newcastle]
- Subjects
medicine.medical_specialty ,Thrombotic microangiopathy ,[SDV]Life Sciences [q-bio] ,Hemic and Lymphatic Diseases::Hematologic Diseases::Anemia::Anemia, Hemolytic::Hemolytic-Uremic Syndrome::Hemic and Lymphatic Diseases::Hematologic Diseases::Atypical Hemolytic Uremic Syndrome [DISEASES] ,030232 urology & nephrology ,Renal function ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,030204 cardiovascular system & hematology ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,03 medical and health sciences ,0302 clinical medicine ,afecciones patológicas, signos y síntomas::procesos patológicos::atributos de la enfermedad::enfermedades raras [ENFERMEDADES] ,Clinical Research ,Internal medicine ,Atypical hemolytic uremic syndrome ,Medicine ,complement ,Adverse effect ,Complement component 5 ,business.industry ,Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Rare Diseases [DISEASES] ,atypical hemolytic uremic syndrome ,Acute kidney injury ,diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,medicine.disease ,Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,ravulizumab ,Diseases of the genitourinary system. Urology ,3. Good health ,enfermedades hematológicas y linfáticas::enfermedades hematológicas::anemia::anemia hemolítica::síndrome hemolítico-urémico::enfermedades hematológicas y linfáticas::enfermedades hematológicas::síndrome hemolítico urémico atípico [ENFERMEDADES] ,kidney failure ,thrombotic microangiopathy ,Clinical trial ,Nephrology ,Avaluació de resultats (Assistència sanitària) ,hemolytic uremic syndrome ,RC870-923 ,Síndrome hemolíticourèmica - Tractament ,Malalties rares ,business ,Kidney disease - Abstract
Hemolytic uremic syndrome; Kidney failure; Ravulizumab Síndrome hemolítico urémico; Insuficiencia renal; Ravulizumab Síndrome hemolític urèmic; Insuficiència renal; Ravulizumab Introduction Atypical hemolytic uremic syndrome (aHUS) is a rare, complex, multisystem disease of dysregulated complement activity, characterized by progressive thrombotic microangiopathy (TMA), acute kidney injury, and multiorgan dysfunction, which often progresses to chronic kidney disease. Results from the prospective clinical trial of ravulizumab (NCT02949128) reveal rapid resolution of TMA in patients with aHUS, with sustained efficacy and safety in a 26-week initial evaluation period. Methods The aim of this analysis was to characterize the long-term efficacy and the safety profile of ravulizumab in adults with aHUS who had completed the initial evaluation period of the trial. Complete TMA response, hematologic and kidney functions, and safety were evaluated for all patients available for follow-up in the extension period (median follow-up: 76.7 weeks; range: 0.6–118.3). This trial included a total of 58 patients, 49 of whom entered the extension period. Results A total of 4 additional patients achieved complete TMA response during the follow-up period. Normalization of platelet count, serum lactate dehydrogenase (LDH), and hemoglobin observed in the 26-week initial evaluation period was sustained until the last available follow-up, as were the improvements in the estimated glomerular filtration rate (eGFR) and patient quality of life. All efficacy endpoints were correlated with the sustained inhibition of complement C5. Most adverse events (AEs) occurred early during the initial evaluation period and decreased substantially during the extension period. No patient developed a meningococcal infection or died during the extension period. Conclusion This analysis reveals that ravulizumab administered every 8 weeks is efficacious with an acceptable safety profile for the long-term treatment of adults with aHUS and provides additional clinical benefit beyond 6 months of treatment.
- Published
- 2021
7. Efficacy and Safety of Ravulizumab in IgA Nephropathy: A Phase 2 Randomized Double-Blind Placebo-Controlled Trial.
- Author
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Lafayette R, Tumlin J, Fenoglio R, Kaufeld J, Pérez Valdivia MA, Wu MS, Susan Huang SH, Alamartine E, Kim SG, Yee M, Kateifides A, Rice K, Garlo K, and Barratt J
- Published
- 2024
- Full Text
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8. Ravulizumab in Atypical Hemolytic Uremic Syndrome: An Analysis of 2-Year Efficacy and Safety Outcomes in 2 Phase 3 Trials.
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Dixon BP, Kavanagh D, Aris ADM, Adams B, Kang HG, Wang E, Garlo K, Ogawa M, Amancha P, Chakravarty S, Heyne N, Kim SH, Cataland S, Yoon SS, Miyakawa Y, Luque Y, Muff-Luett M, Tanaka K, and Greenbaum LA
- Abstract
Rationale & Objective: Atypical hemolytic uremic syndrome (aHUS) is a rare form of thrombotic microangiopathy (TMA) caused by complement dysregulation. Ravulizumab is a C5i approved for the treatment of aHUS. This analysis assessed long-term outcomes of ravulizumab in adults and pediatric patients with aHUS., Study Design: This analysis reports 2-year data from 2 phase 3, single-arm studies., Setting & Participants: One study included C5i-naïve adults (NCT02949128), and the other included 2 cohorts of pediatric patients (C5i-naïve and those who switched to ravulizumab from eculizumab [pediatric switch patients]; NCT03131219)., Exposure: Patients received intravenous ravulizumab every 4-8 weeks, with the dose depending on body weight., Outcomes: The primary endpoint in the studies of C5i-naïve patients was complete TMA response, which consisted of platelet count normalization, lactate dehydrogenase normalization, and ≥25% improvement in serum creatinine concentrations from baseline, at 2 consecutive assessments ≥4 weeks apart., Analytical Approach: All analyses used descriptive statistics. No formal statistical comparisons were performed., Results: In total, 86 and 92 patients were included in efficacy and safety analyses, respectively. Complete TMA response rates over 2 years were 61% and 90% in C5i-naïve adults and pediatric patients, respectively. The median increase in estimated glomerular filtration rate from baseline was maintained over 2 years in C5i-naïve adults (35 mL/min/1.73 m
2 ) and pediatric patients (82.5 mL/min/1.73 m2 ). Most adverse events and serious adverse events occurred during the first 26 weeks. No meningococcal infections were reported. Improvement in the Functional Assessment of Chronic Illness Therapy - Fatigue score achieved by 26 weeks was maintained over 2 years., Limitations: Limitations were the small sample of pediatric switch patients and limited availability of genetic data., Conclusions: Long-term treatment with ravulizumab is well tolerated and associated with improved hematologic and renal parameters and quality of life in adults and pediatric patients with aHUS., (© 2024 The Authors.)- Published
- 2024
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9. Treatment preference and quality of life impact: ravulizumab vs eculizumab for atypical hemolytic uremic syndrome.
- Author
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Mauch TJ, Chladek MR, Cataland S, Chaturvedi S, Dixon BP, Garlo K, Gasteyger C, Java A, Leguizamo J, Lloyd-Price L, Pham TP, Symonds T, Tomazos I, and Wang Y
- Subjects
- Adult, Humans, Child, Middle Aged, Quality of Life, Antibodies, Monoclonal, Humanized, Complement Inactivating Agents therapeutic use, Complement Inactivating Agents adverse effects, Atypical Hemolytic Uremic Syndrome drug therapy, Atypical Hemolytic Uremic Syndrome chemically induced
- Abstract
Aim: Ravulizumab and eculizumab are complement C5 inhibitors approved for the treatment of atypical hemolytic uremic syndrome (aHUS). Ravulizumab requires less frequent infusions than eculizumab, which may reduce treatment burden. This study investigated patients' treatment preferences and the impact of both treatments on patient and caregiver quality of life. Materials & methods: Two surveys were conducted (one for adult patients with aHUS and one for caregivers of pediatric patients with aHUS) to quantitatively assess treatment preference and the patient- and caregiver-reported impact of ravulizumab and eculizumab on quality of life. Patients were required to have a diagnosis of aHUS, to be currently receiving treatment with ravulizumab and to have received prior treatment with eculizumab. Participants were recruited via various sources: the Alexion OneSource™ patient support program, the Rare Patient Voice recruitment agency, the aHUS Foundation and directly via a clinician involved in the study. Results: In total, 50 adult patients (mean age: 46.5 years) and 16 caregivers of pediatric patients (mean age: 10.1 years) completed the surveys. Most adult patients (94.0%) and all caregivers reported an overall preference for ravulizumab over eculizumab; infusion frequency was one of the main factors for patients when selecting their preferred treatment. Fewer patients reported disruption to daily life and the ability to go to work/school due to ravulizumab infusion frequency (4.0% and 5.7%, respectively) than eculizumab infusion frequency (72.0% and 60.0%), with similar results for caregivers. Conclusion: Adult patients and caregivers of pediatric patients indicated an overall preference for ravulizumab than eculizumab for the treatment of aHUS, driven primarily by infusion frequency. This study contributes to the emerging real-world evidence on the treatment impact and preference in patients with aHUS.
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- 2023
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10. Atypical Hemolytic Uremic Syndrome Treated With Ravulizumab or Eculizumab: A Claims-Based Evaluation of Health Care Resource Utilization and Clinical Outcomes in the United States.
- Author
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Wang Y, Al-Dakkak I, Garlo K, Ong ML, Tomazos I, and Mahajerin A
- Abstract
Rationale and Objective: Ravulizumab and eculizumab have shown efficacy for the treatment of atypical hemolytic uremic syndrome (aHUS), but real-world evidence for ravulizumab is limited owing to its more recent approval. This real-world database study examined outcomes for adult patients switching to ravulizumab from eculizumab and patients treated with individual treatments., Study Design: A retrospective, observational study using the Clarivate Real World Database., Setting and Population: US health-insurance billing data (January 2012 to March 2021) of patients aged 18 years or older with ≥1 diagnosis relevant to aHUS, ≥1 claim for treatment with eculizumab or ravulizumab, and no evidence of other indicated conditions., Exposures: Treatment-switch (to ravulizumab after eculizumab), ravulizumab-only, and eculizumab-only cohorts were examined., Outcomes: Clinical procedures, facility visits, health care costs, and clinical manifestations., Analytical Approach: Paired-sample statistical testing compared the mean numbers of claims for each group 0-3 months before (preindex period) and 0-3 months and 3-6 months after (postindex period) the index date (point of initiation with a single treatment or treatment switch)., Results: In total, 322 patients met the eligibility criteria at 3-6 months postindex in the treatment-switch (n=65), ravulizumab-only (n=9), and eculizumab-only (n=248) cohorts. The proportions of patients with claims for key clinical procedures continued to be small after treatment switch and were small (0%-11%) across all cohorts at 3-6 months postindex. Inpatient visits were reduced in the postindex period across all cohorts. At 3-6 months after treatment switch, patients reported fewer claims for outpatient, private practice, and home visits and lower median health care costs. The proportions of patients with claims for clinical manifestations of aHUS were generally reduced in the postindex period compared with those of the preindex period., Limitations: Low patient numbers receiving ravulizumab only., Conclusions: The health-insurance claims data showed a reduced health care burden for US adult patients after treatment with ravulizumab or eculizumab for treatment of aHUS., (© 2023 The Authors.)
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- 2023
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11. Correction to: Exploratory Prognostic Biomarkers of Complement-Mediated Thrombotic Microangiopathy (CM-TMA) in Adults with Atypical Hemolytic Uremic Syndrome (aHUS): Analysis of a Phase III Study of Ravulizumab.
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Cammett TJ, Garlo K, Millman EE, Rice K, Toste CM, and Faas SJ
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- 2023
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12. Exploratory Prognostic Biomarkers of Complement-Mediated Thrombotic Microangiopathy (CM-TMA) in Adults with Atypical Hemolytic Uremic Syndrome (aHUS): Analysis of a Phase III Study of Ravulizumab.
- Author
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Cammett TJ, Garlo K, Millman EE, Rice K, Toste CM, and Faas SJ
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- Humans, Adult, Prognosis, Complement System Proteins, Biomarkers, Atypical Hemolytic Uremic Syndrome diagnosis, Atypical Hemolytic Uremic Syndrome drug therapy, Atypical Hemolytic Uremic Syndrome complications, Thrombotic Microangiopathies diagnosis, Thrombotic Microangiopathies drug therapy, Thrombotic Microangiopathies complications
- Abstract
Background: Clinically validated biomarkers for monitoring of patients with complement-mediated thrombotic microangiopathy (CM-TMA) including atypical hemolytic uremic syndrome (aHUS) are unavailable. Improved characterization of biomarkers in patients with aHUS may inform treatment and monitoring for patients with CM-TMA., Methods: This analysis used data collected from 55/56 (98.2 %) adult patients with aHUS enrolled in the global Phase III study of ravulizumab (NCT02949128). Baseline (pre-treatment) patient serum, plasma and urine biomarker levels were compared with the maximum observed levels in normal donors and evaluated for associations with pre-treatment plasma exchange/infusion and dialysis status. Biomarkers were also assessed for associations with key clinical measures at baseline and with changes at 26 and 52 weeks from treatment initiation via linear regression analyses., Results: Complement-specific urine levels (factor Ba and sC5b-9) were elevated in >85 % of patients and are significantly associated with pre-treatment kidney dysfunction. Baseline levels of other evaluated biomarkers were elevated in >70 % of patients with aHUS, except for plasma sC5b-9 and serum sVCAM-1. Lower levels of urine complement markers at baseline are significantly associated with improvements in total urine protein and estimated glomerular filtration rate at 26 and 52 weeks of treatment. Clinical assessment of complement activation by a receiver operating characteristic analysis of Ba and sC5b-9 was more sensitive and specific in urine matrix than plasma., Conclusion: This analysis identified a set of biomarkers that may show utility in the prognosis of CM-TMA, including their potential for measuring and predicting response to anti-C5 therapy. Further studies are required to enhance patient risk stratification and improve management of these vulnerable patients., Clinical Trials Registration: NCT02949128, ClinicalTrials.gov., (© 2022. The Author(s).)
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- 2023
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13. Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults.
- Author
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Barbour T, Scully M, Ariceta G, Cataland S, Garlo K, Heyne N, Luque Y, Menne J, Miyakawa Y, Yoon SS, and Kavanagh D
- Abstract
Introduction: Atypical hemolytic uremic syndrome (aHUS) is a rare, complex, multisystem disease of dysregulated complement activity, characterized by progressive thrombotic microangiopathy (TMA), acute kidney injury, and multiorgan dysfunction, which often progresses to chronic kidney disease. Results from the prospective clinical trial of ravulizumab (NCT02949128) reveal rapid resolution of TMA in patients with aHUS, with sustained efficacy and safety in a 26-week initial evaluation period., Methods: The aim of this analysis was to characterize the long-term efficacy and the safety profile of ravulizumab in adults with aHUS who had completed the initial evaluation period of the trial. Complete TMA response, hematologic and kidney functions, and safety were evaluated for all patients available for follow-up in the extension period (median follow-up: 76.7 weeks; range: 0.6-118.3). This trial included a total of 58 patients, 49 of whom entered the extension period., Results: A total of 4 additional patients achieved complete TMA response during the follow-up period. Normalization of platelet count, serum lactate dehydrogenase (LDH), and hemoglobin observed in the 26-week initial evaluation period was sustained until the last available follow-up, as were the improvements in the estimated glomerular filtration rate (eGFR) and patient quality of life. All efficacy endpoints were correlated with the sustained inhibition of complement C5. Most adverse events (AEs) occurred early during the initial evaluation period and decreased substantially during the extension period. No patient developed a meningococcal infection or died during the extension period., Conclusion: This analysis reveals that ravulizumab administered every 8 weeks is efficacious with an acceptable safety profile for the long-term treatment of adults with aHUS and provides additional clinical benefit beyond 6 months of treatment., (© 2021 Published by Elsevier, Inc., on behalf of the International Society of Nephrology.)
- Published
- 2021
- Full Text
- View/download PDF
14. Apixaban versus No Anticoagulation in Patients Undergoing Long-Term Dialysis with Incident Atrial Fibrillation.
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Mavrakanas TA, Garlo K, and Charytan DM
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- Aged, Aged, 80 and over, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Factor Xa Inhibitors adverse effects, Female, Humans, Incidence, Intracranial Hemorrhages chemically induced, Ischemic Attack, Transient epidemiology, Ischemic Attack, Transient prevention & control, Male, Middle Aged, Pyrazoles adverse effects, Pyridones adverse effects, Renal Insufficiency, Chronic diagnosis, Renal Insufficiency, Chronic epidemiology, Retrospective Studies, Risk Assessment, Risk Factors, Stroke epidemiology, Stroke prevention & control, Thromboembolism epidemiology, Thromboembolism prevention & control, Time Factors, Treatment Outcome, United States epidemiology, Atrial Fibrillation drug therapy, Factor Xa Inhibitors therapeutic use, Pyrazoles therapeutic use, Pyridones therapeutic use, Renal Dialysis adverse effects, Renal Insufficiency, Chronic therapy
- Abstract
Background and Objectives: The relative efficacy and safety of apixaban compared with no anticoagulation have not been studied in patients on maintenance dialysis with atrial fibrillation. We aimed to determine whether apixaban is associated with better clinical outcomes compared with no anticoagulation in this population., Design, Setting, Participants, & Measurements: This retrospective cohort study used 2012-2015 US Renal Data System data. Patients on maintenance dialysis with incident, nonvalvular atrial fibrillation treated with apixaban (521 patients) were matched for relevant baseline characteristics with patients not treated with any anticoagulant agent (1561 patients) using a propensity score. The primary outcome was hospital admission for a new stroke (ischemic or hemorrhagic), transient ischemic attack, or systemic thromboembolism. The secondary outcome was fatal or intracranial bleeding. Competing risk survival models were used., Results: Compared with no anticoagulation, apixaban was not associated with lower incidence of the primary outcome: hazard ratio, 1.24; 95% confidence interval, 0.69 to 2.23; P =0.47. A significantly higher incidence of fatal or intracranial bleeding was observed with apixaban compared with no treatment: hazard ratio, 2.74; 95% confidence interval, 1.37 to 5.47; P =0.004. A trend toward fewer ischemic but more hemorrhagic strokes was seen with apixaban compared with no treatment. No significant difference in the composite outcome of myocardial infarction or ischemic stroke was seen with apixaban compared with no treatment. Compared with no anticoagulation, a significantly higher rate of the primary outcome and a significantly higher incidence of fatal or intracranial bleeding and of hemorrhagic stroke were seen in the subgroup of patients treated with the standard apixaban dose (5 mg twice daily) but not in patients who received the reduced apixaban dose (2.5 mg twice daily)., Conclusions: In patients with kidney failure and nonvalvular atrial fibrillation, treatment with apixaban was not associated with a lower incidence of new stroke, transient ischemic attack, or systemic thromboembolism but was associated with a higher incidence of fatal or intracranial bleeding., Podcast: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_05_29_CJN11650919.mp3., (Copyright © 2020 by the American Society of Nephrology.)
- Published
- 2020
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15. Successful eculizumab treatment of recurrent postpartum atypical hemolytic uremic syndrome after kidney transplantation.
- Author
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Garlo K, Dressel D, Savic M, and Vella J
- Abstract
Postpartum atypical hemolytic uremic syndrome (aHUS) is a rare disorder associated with poor maternal and fetal outcomes. We describe a case of severe postpartum aHUS with recurrence in a kidney allograft after a second pregnancy. The patient had initially presented age 28 years with aHUS that developed after her first delivery. In spite of treatment with plasma exchange, she developed end-stage renal disease (ESRD) requiring years of hemodialysis before receiving a kidney transplant from a living unrelated donor. Two years later, she became pregnant again and at 26 weeks gestation she presented to our hospital with hypertension and proteinuria. Within 48 hours of delivery she developed hemolytic anemia, thrombocytopenia, and oliguric acute kidney injury (AKI) culminating in the need for dialysis. There was no response to therapeutic plasma exchange (TPE). However, treatment with eculizumab led to prompt, successful resolution of hemolysis, thrombocytopenia, and AKI. Three months after therapy was stopped, her disease relapsed causing renal failure again requiring dialysis. At that time, an allograft biopsy revealed severe thrombotic microangiopathy (TMA). Eculizumab was resumed without plasma exchange leading to resolution of aHUS and return of kidney function. Now, her baby is nearly 2 years old. She remains on maintenance eculizumab therapy 1,200 mg every 2 weeks without dialysis. She has excellent renal function with creatinine of 1.2 mg/dL, eGFR 52 mL/min/1.73 m, and proteinuria 0.35 g/day. She will likely be on eculizumab for the remainder of her life.
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- 2015
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16. Severity of Anemia Predicts Hospital Length of Stay but Not Readmission in Patients with Chronic Kidney Disease: A Retrospective Cohort Study.
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Garlo K, Williams D, Lucas L, Wong R, Botler J, Abramson S, and Parker MG
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- Adult, Aged, Aged, 80 and over, Anemia epidemiology, Female, Humans, Maine epidemiology, Male, Middle Aged, Prevalence, Renal Insufficiency, Chronic epidemiology, Retrospective Studies, Young Adult, Anemia complications, Length of Stay statistics & numerical data, Patient Readmission statistics & numerical data, Renal Insufficiency, Chronic complications
- Abstract
The aim of this study was to examine the relationship of severe anemia to hospital readmission and length of stay (LOS) in patients with chronic kidney disease (CKD) stage 3-5. Compared with the general population, patients with moderate CKD have a higher hospital readmission rate and LOS. Anemia in patients with moderate CKD is associated with higher morbidity and mortality. The influence of anemia on hospital outcomes in patients with moderate CKD has not been characterized.We conducted a retrospective cohort study at Maine Medical Center, a 606-bed academic tertiary care hospital. Patients with CKD stages 3-5 and not on dialysis admitted during February 2013 to January 2014 were eligible. Patients with end stage renal disease on hemodialysis or peritoneal dialysis, kidney transplant, acute kidney injury, gastrointestinal bleeding, active malignancy, pregnancy, and surgery were excluded. The cohort was split into severe anemia (hemoglobin ≤9 g/dL) versus a comparison group (hemoglobin >9 g /dL), and examined for differences in 30-day hospital readmission and LOS.In this study, the data of 1141 patients were included, out of which 156 (13.7%) had severe anemia (mean hemoglobin 8.1 g/dL, SD 0.8). Severe anemia was associated with increased hospital LOS (mean 6.4 (SD 6.0) days vs mean 4.5 (SD 4.0) days, P < 0.001). The difference was 1.7 day longer (95% CI 0.94, 2.45). There was no difference in readmission rate (mean 11.5% vs 10.2%, P = 0.7).Patients with moderate CKD and severe anemia are at risk for increased hospital LOS. Interventions targeting this high-risk population, including outpatient management of anemia, may benefit patient care and save costs through improved hospital outcomes.
- Published
- 2015
- Full Text
- View/download PDF
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