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NKF 2007 Spring Clinical Meetings Abstracts
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DE NOVO EVERY-OTHER-WEEK (Q2W) DARBEPOETIN ALFA ADMINISTRATION IN PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD): HEMOGLOBIN (HB) LEVELS ON INITIATION OF THERAPY Reshma Kewalramani, Chao-Yin Chen, and Preston Klassen. Amgen Inc., Thousand Oaks, CA, USA. Darbepoetin alfa is an erythropoiesis-stimulating protein (ESP) that can be administered at extended dosing intervals to achieve and maintain Hb levels in study patients with CKD not receiving dialysis. A combined analysis of two de novo Q2W darbepoetin alfa dosing studies was conducted. In the 24-week study 1 (Suranyi et al, Am J Nephrol. 2003), 85% of all subjects achieved the primary endpoint of Hb within 11-13 g/dL. In the 18-week study 2 (Silver et al. ASN 2005), 92% of subjects achieved the primary endpoint of Hb ≥11 g/dL. The integrated post-hoc analysis presented here was conducted to assess the occurrence of Hb excursions above 13 g/dL during initiation of Q2W darbepoetin alfa therapy. Patients were enrolled if they were ≥18 years, had Hb levels <11 g/dL, and were iron replete (Studies 1&2), and had CrCl <40 mL/min but were not receiving dialysis (Study 1) or eGFR ≥15 and ≤60 mL/min/1.73 m2 (Study 2). Subjects initiated Q2W darbepoetin alfa at 0.75 mcg/kg, with subsequent doses titrated to achieve a Hb level between 11 and 13 g/dL. Enrolled subjects (N=203) were white (56%) and/or female (60%), and were mean (SD) 65 (15) years of age. N = 203 Subjects with ≥1 Hb measurement n (%) 95% CI above 13 g/dL Within 4 weeks 1 (0%) 0%, 3% Within 6 weeks 2 (1%) 0%, 4% Within 8 weeks 11 (5%) 3%, 9% Q2W darbepoetin alfa achieved the Hb primary endpoints in the majority of subjects, and in this post-hoc analysis, we demonstrate that de novo Q2W darbepoetin alfa dosing can achieve Hb target ranges with minimal excursions above 13 g/dL during the initiation phase of therapy.
IMPACT OF CO-INSURANCE ON OUT-OF-POCKET COST BURDEN FOR PATIENTS WITH CHRONIC KIDNEY DISEASE Reshma Kewalramani1 Michelle Gleeson2, Denise Globe1, Vaishali Patel1, Martin Zagari1, Suellen Curkendall2 1 Amgen, Thousand Oaks, CA, USA 2 Cerner LifeSciences, Beverly Hills, CA, USA. Purpose: Compared out-of-pocket cost (OOP$) burden for CKD patients with versus without co-insurance. Methods: Data for years 2002 through 2004 were obtained from a managed care database that captures person-specific clinical utilization and expenditures. In each year, these data represent ~ 6 million insured employees and their dependents. Patients who had 2 diagnoses of CKD at least 30 days apart were selected. Comparison groups were patients with diabetes (without CKD) and adult enrollees with an insurance claim. Total annual per-patient OOP$ were calculated as sum of copayments, coinsurance and deductibles for all claims. OOP$ were compared for patients whose benefit plans required in-network coinsurance with patients whose plans did not require any coinsurance. Results: The proportion of patients with CKD who made coinsurance payments for their erythropoietic therapy increased from 4% in 2002 to 27% in 2004. OOP payments for patients in co-insurance design plans were nearly twice that of patients not in co-insurance plans (Table 1). Table 1. Annual Patient OOOP $ by Coinsurance Benefit Design Patient cohorts No Coinsurance Coinsurance (in network) th th Mean (75 , 90 ) Mean (75th, 90th) CKD Cohorts CKD w/o diabetes 759 (948, 1582) 2022 (2527, 4035) CKD with diabetes 902 ( 1218, 1773) 2276 (3082, 4476 ) Control Cohorts Diabetes (w/o CKD) 532 (693, 1100) 1,384 (1846, 2880) All Utilizers 243 (303, 569) 749 (1105, 2017) Conclusions: CKD patients are spending more for healthcare than the average patient and more than patients with diabetes. OOP expenses are significantly higher for patients with insurance plans requiring coinsurance. The trend toward coinsurance requirements may limit the affordability of necessary treatments for patients with CKD.
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115 ONCE-WEEKLY (QW) DARBEPOETIN ALFA ADMINISTRATION IN ERYTHROPOIESIS-STIMULATING PROTEIN (ESP)-NAÏVE PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD): HEMOGLOBIN (HB) LEVELS WITHIN THE FIRST 8 WEEKS OF THERAPY Reshma Kewalramani, Chao-Yin Chen, and Preston Klassen. Amgen Inc., Thousand Oaks, CA, USA. Darbepoetin alfa is an ESP that can be administered at a variety of intervals to achieve and maintain Hb levels in study patients with CKD not receiving dialysis. The analysis presented here was conducted to assess Hb levels during the first 8 weeks of subcutaneous QW darbepoetin alfa therapy in ESP-naïve CKD patients. The primary analysis has been published previously (Locatelli et al, Kidney Int, 2001). Patients were enrolled if they were ≥18 years of age, had Hb levels <11 g/dL, had CrCl <30 mL/min but were not receiving dialysis, and were iron replete. Subjects initiated QW darbepoetin alfa at 0.45 mcg/kg, with subsequent doses titrated to achieve a Hb level between 11 and 13 g/dL. The primary endpoint was the proportion of subjects who achieved at least one Hb measurement ≥1 g/dL from baseline and ≥11 g/dL during the first 24 weeks of therapy. Subjects who initiated QW darbepoetin alfa (N=129) were white (95%) and/or male (54%), and were mean (SD) 60 (15) years of age. Of the subjects receiving QW darbepoetin alfa, 93% achieved the primary endpoint. N = 129 Subjects with ≥1 Hb measurement n (%) 95% CI above 13 g/dL Within 4 weeks 1 (1%) 0%, 4% Within 6 weeks 2 (2%) 0%, 5% Within 8 weeks 10 (8%) 4%, 14% De novo QW darbepoetin alfa dosing achieved the Hb primary endpoint in the majority of subjects, and in this ad hoc analysis, we demonstrate that the Hb target range was achieved by subjects with few excursions above 13 g/dL during the first 8 weeks of therapy.
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LEUKOPENIA IN RENAL TRANSPLANT RECIPIENTS, RISK FACTORS AND COMPLICATIONS Ali R Khan, MD1, Anita Patel, MD1, Moushen AlHakeem, MD1, Mariella Goggins, MD1, Ravi Parasuraman, MD1, Vanji Karthikeyan, MD1 and K K Venkat, MD1. 1Nephrology, Henry Ford Hospital, Detroit, MI, United States. Purpose: Leukopenia and neutropenia in solid organ transplant recipients has not been well reported. The effect of these conditions on patient and allograft outcomes is also unclear. This study was designed to identify risk factors for leukopenia and to define complications and patient outcomes. Methods: Retrospective chart analysis was done of 864 patients who received a renal transplant from January 1996 to April 2006 and were followed at our institution. Patients who developed leukopenia (L) (WBC count < 3500/mm3) were selected and further classified as having mild leukopenia (ML WBC- 3.5-2 K/ mm3 )and severe leukopenia (SL WBC 2 K/ mm3 ). Logistic regression analysis was performed to define associations between leukopenia and several transplant factors. Results: 144 (17%) of the patients had leukopenia of whom 15.3% had neutropenia. 31% of patients developed infections, of these 55% were CMV infections. 16 developed bacterial infections. 6.9% of patients died of sepsis. In a univariate logistic regression model, factors associated with risk of SL were CMV infection, EBVpositive serology and acute rejection episodes. Immunosuppression (IS) regimens in various combinations, bactrim, valgancyclovir, gancyclovir,donor/recipient CMV IgG status and age were not associated with SL. In a multivariate model acute rejection (Odds Ratio 10.07, P<0.001) and neupogen use were the most significant associations with S ( Odds Ratio 4.47, P<0.005). Conclusions: Leukopenia is a significant disorder affecting the management of solid organ transplant recipients. Our study reveals a significant causal relationship between SL, and acute rejection. Surprisingly, IS medications were not associated with leukopenia regardless of dosage. this study highlights the need for closer monitoring in this subset of patients to reduce morbidity and mortality associated with leukopenia.
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DE NOVO EVERY-OTHER-WEEK (Q2W) DARBEPOETIN ALFA ADMINISTRATION IN PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD): HEMOGLOBIN (HB) LEVELS ON INITIATION OF THERAPY Reshma Kewalramani, Chao-Yin Chen, and Preston Klassen. Amgen Inc., Thousand Oaks, CA, USA. Darbepoetin alfa is an erythropoiesis-stimulating protein (ESP) that can be administered at extended dosing intervals to achieve and maintain Hb levels in study patients with CKD not receiving dialysis. A combined analysis of two de novo Q2W darbepoetin alfa dosing studies was conducted. In the 24-week study 1 (Suranyi et al, Am J Nephrol. 2003), 85% of all subjects achieved the primary endpoint of Hb within 11-13 g/dL. In the 18-week study 2 (Silver et al. ASN 2005), 92% of subjects achieved the primary endpoint of Hb ≥11 g/dL. The integrated post-hoc analysis presented here was conducted to assess the occurrence of Hb excursions above 13 g/dL during initiation of Q2W darbepoetin alfa therapy. Patients were enrolled if they were ≥18 years, had Hb levels <11 g/dL, and were iron replete (Studies 1&2), and had CrCl <40 mL/min but were not receiving dialysis (Study 1) or eGFR ≥15 and ≤60 mL/min/1.73 m2 (Study 2). Subjects initiated Q2W darbepoetin alfa at 0.75 mcg/kg, with subsequent doses titrated to achieve a Hb level between 11 and 13 g/dL. Enrolled subjects (N=203) were white (56%) and/or female (60%), and were mean (SD) 65 (15) years of age. N = 203 Subjects with ≥1 Hb measurement n (%) 95% CI above 13 g/dL Within 4 weeks 1 (0%) 0%, 3% Within 6 weeks 2 (1%) 0%, 4% Within 8 weeks 11 (5%) 3%, 9% Q2W darbepoetin alfa achieved the Hb primary endpoints in the majority of subjects, and in this post-hoc analysis, we demonstrate that de novo Q2W darbepoetin alfa dosing can achieve Hb target ranges with minimal excursions above 13 g/dL during the initiation phase of therapy.
IMPACT OF CO-INSURANCE ON OUT-OF-POCKET COST BURDEN FOR PATIENTS WITH CHRONIC KIDNEY DISEASE Reshma Kewalramani1 Michelle Gleeson2, Denise Globe1, Vaishali Patel1, Martin Zagari1, Suellen Curkendall2 1 Amgen, Thousand Oaks, CA, USA 2 Cerner LifeSciences, Beverly Hills, CA, USA. Purpose: Compared out-of-pocket cost (OOP$) burden for CKD patients with versus without co-insurance. Methods: Data for years 2002 through 2004 were obtained from a managed care database that captures person-specific clinical utilization and expenditures. In each year, these data represent ~ 6 million insured employees and their dependents. Patients who had 2 diagnoses of CKD at least 30 days apart were selected. Comparison groups were patients with diabetes (without CKD) and adult enrollees with an insurance claim. Total annual per-patient OOP$ were calculated as sum of copayments, coinsurance and deductibles for all claims. OOP$ were compared for patients whose benefit plans required in-network coinsurance with patients whose plans did not require any coinsurance. Results: The proportion of patients with CKD who made coinsurance payments for their erythropoietic therapy increased from 4% in 2002 to 27% in 2004. OOP payments for patients in co-insurance design plans were nearly twice that of patients not in co-insurance plans (Table 1). Table 1. Annual Patient OOOP $ by Coinsurance Benefit Design Patient cohorts No Coinsurance Coinsurance (in network) th th Mean (75 , 90 ) Mean (75th, 90th) CKD Cohorts CKD w/o diabetes 759 (948, 1582) 2022 (2527, 4035) CKD with diabetes 902 ( 1218, 1773) 2276 (3082, 4476 ) Control Cohorts Diabetes (w/o CKD) 532 (693, 1100) 1,384 (1846, 2880) All Utilizers 243 (303, 569) 749 (1105, 2017) Conclusions: CKD patients are spending more for healthcare than the average patient and more than patients with diabetes. OOP expenses are significantly higher for patients with insurance plans requiring coinsurance. The trend toward coinsurance requirements may limit the affordability of necessary treatments for patients with CKD.
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115 ONCE-WEEKLY (QW) DARBEPOETIN ALFA ADMINISTRATION IN ERYTHROPOIESIS-STIMULATING PROTEIN (ESP)-NAÏVE PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD): HEMOGLOBIN (HB) LEVELS WITHIN THE FIRST 8 WEEKS OF THERAPY Reshma Kewalramani, Chao-Yin Chen, and Preston Klassen. Amgen Inc., Thousand Oaks, CA, USA. Darbepoetin alfa is an ESP that can be administered at a variety of intervals to achieve and maintain Hb levels in study patients with CKD not receiving dialysis. The analysis presented here was conducted to assess Hb levels during the first 8 weeks of subcutaneous QW darbepoetin alfa therapy in ESP-naïve CKD patients. The primary analysis has been published previously (Locatelli et al, Kidney Int, 2001). Patients were enrolled if they were ≥18 years of age, had Hb levels <11 g/dL, had CrCl <30 mL/min but were not receiving dialysis, and were iron replete. Subjects initiated QW darbepoetin alfa at 0.45 mcg/kg, with subsequent doses titrated to achieve a Hb level between 11 and 13 g/dL. The primary endpoint was the proportion of subjects who achieved at least one Hb measurement ≥1 g/dL from baseline and ≥11 g/dL during the first 24 weeks of therapy. Subjects who initiated QW darbepoetin alfa (N=129) were white (95%) and/or male (54%), and were mean (SD) 60 (15) years of age. Of the subjects receiving QW darbepoetin alfa, 93% achieved the primary endpoint. N = 129 Subjects with ≥1 Hb measurement n (%) 95% CI above 13 g/dL Within 4 weeks 1 (1%) 0%, 4% Within 6 weeks 2 (2%) 0%, 5% Within 8 weeks 10 (8%) 4%, 14% De novo QW darbepoetin alfa dosing achieved the Hb primary endpoint in the majority of subjects, and in this ad hoc analysis, we demonstrate that the Hb target range was achieved by subjects with few excursions above 13 g/dL during the first 8 weeks of therapy.
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LEUKOPENIA IN RENAL TRANSPLANT RECIPIENTS, RISK FACTORS AND COMPLICATIONS Ali R Khan, MD1, Anita Patel, MD1, Moushen AlHakeem, MD1, Mariella Goggins, MD1, Ravi Parasuraman, MD1, Vanji Karthikeyan, MD1 and K K Venkat, MD1. 1Nephrology, Henry Ford Hospital, Detroit, MI, United States. Purpose: Leukopenia and neutropenia in solid organ transplant recipients has not been well reported. The effect of these conditions on patient and allograft outcomes is also unclear. This study was designed to identify risk factors for leukopenia and to define complications and patient outcomes. Methods: Retrospective chart analysis was done of 864 patients who received a renal transplant from January 1996 to April 2006 and were followed at our institution. Patients who developed leukopenia (L) (WBC count < 3500/mm3) were selected and further classified as having mild leukopenia (ML WBC- 3.5-2 K/ mm3 )and severe leukopenia (SL WBC 2 K/ mm3 ). Logistic regression analysis was performed to define associations between leukopenia and several transplant factors. Results: 144 (17%) of the patients had leukopenia of whom 15.3% had neutropenia. 31% of patients developed infections, of these 55% were CMV infections. 16 developed bacterial infections. 6.9% of patients died of sepsis. In a univariate logistic regression model, factors associated with risk of SL were CMV infection, EBVpositive serology and acute rejection episodes. Immunosuppression (IS) regimens in various combinations, bactrim, valgancyclovir, gancyclovir,donor/recipient CMV IgG status and age were not associated with SL. In a multivariate model acute rejection (Odds Ratio 10.07, P<0.001) and neupogen use were the most significant associations with S ( Odds Ratio 4.47, P<0.005). Conclusions: Leukopenia is a significant disorder affecting the management of solid organ transplant recipients. Our study reveals a significant causal relationship between SL, and acute rejection. Surprisingly, IS medications were not associated with leukopenia regardless of dosage. this study highlights the need for closer monitoring in this subset of patients to reduce morbidity and mortality associated with leukopenia.