Randomized controlled trial of pulse/synchronization cyclophosphamide/apheresis for proliferative lupus nephritis
OBJECTIVE To assess the efficacy of pulse/synchronization cyclophosphamide/apheresis in patients with proliferative lupus nephritis. METHODS Eighteen patients with Class III or IV renal biopsies and chronicity indices <6 were prospectively randomized to receive 6 courses of parenteral cyclophosph...
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| Published in: | Journal of clinical apheresis Vol. 13; no. 4; pp. 163 - 166 |
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| Main Authors: | , , , , , , |
| Format: | Journal Article |
| Language: | English |
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New York
John Wiley & Sons, Inc
1998
Wiley-Liss |
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| Abstract | OBJECTIVE
To assess the efficacy of pulse/synchronization cyclophosphamide/apheresis in patients with proliferative lupus nephritis.
METHODS
Eighteen patients with Class III or IV renal biopsies and chronicity indices <6 were prospectively randomized to receive 6 courses of parenteral cyclophosphamide over 8 months along with prednisone. Nine of these patients also received 3 daily plasmaphereses prior to each of the 6 courses of cyclophosphamide. Assessments compiled at 6 and 24 months included serum creatinine, albumin, anti DNA, 24‐hour urine protein, and C3 complement along with SLAM scores.
RESULTS
Two out of nine patients in each group evolved end stage renal disease and 3/9 patients in each group went into a renal remission at 24 months. Serum albumin, C3 complement, and SLAM scores improved in both groups, and anti‐DNA improved in the pulse/synchronization patients (P < 0.025). No intergroup comparisons were significant.
CONCLUSION
The addition of pulse/synchronization apheresis to cyclophosphamide therapy does not improve the course of patients with proliferative lupus nephritis. J. Clin. Apheresis 13:163–166, 1998. © 1998 Wiley‐Liss, Inc. |
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| AbstractList | To assess the efficacy of pulse/synchronization cyclophosphamide/apheresis in patients with proliferative lupus nephritis.
Eighteen patients with Class III or IV renal biopsies and chronicity indices <6 were prospectively randomized to receive 6 courses of parenteral cyclophosphamide over 8 months along with prednisone. Nine of these patients also received 3 daily plasmaphereses prior to each of the 6 courses of cyclophosphamide. Assessments compiled at 6 and 24 months included serum creatinine, albumin, anti DNA, 24-hour urine protein, and C3 complement along with SLAM scores.
Two out of nine patients in each group evolved end stage renal disease and 3/9 patients in each group went into a renal remission at 24 months. Serum albumin, C3 complement, and SLAM scores improved in both groups, and anti-DNA improved in the pulse/synchronization patients (P < 0.025). No intergroup comparisons were significant.
The addition of pulse/synchronization apheresis to cyclophosphamide therapy does not improve the course of patients with proliferative lupus nephritis. OBJECTIVE To assess the efficacy of pulse/synchronization cyclophosphamide/apheresis in patients with proliferative lupus nephritis. METHODS Eighteen patients with Class III or IV renal biopsies and chronicity indices <6 were prospectively randomized to receive 6 courses of parenteral cyclophosphamide over 8 months along with prednisone. Nine of these patients also received 3 daily plasmaphereses prior to each of the 6 courses of cyclophosphamide. Assessments compiled at 6 and 24 months included serum creatinine, albumin, anti DNA, 24‐hour urine protein, and C3 complement along with SLAM scores. RESULTS Two out of nine patients in each group evolved end stage renal disease and 3/9 patients in each group went into a renal remission at 24 months. Serum albumin, C3 complement, and SLAM scores improved in both groups, and anti‐DNA improved in the pulse/synchronization patients (P < 0.025). No intergroup comparisons were significant. CONCLUSION The addition of pulse/synchronization apheresis to cyclophosphamide therapy does not improve the course of patients with proliferative lupus nephritis. J. Clin. Apheresis 13:163–166, 1998. © 1998 Wiley‐Liss, Inc. |
| Author | Goldfinger, Dennis Wallace, Daniel J. Pepkowitz, Samuel H. Schroeder, Johann O. Euler, Hans H. Metzger, Allan L. Fichman, Marshal |
| Author_xml | – sequence: 1 givenname: Daniel J. surname: Wallace fullname: Wallace, Daniel J. organization: Department of Medicine and Pathology and Laboratory Medicine, Cedars-Sinai/UCLA School of Medicine, Los Angeles, California – sequence: 2 givenname: Dennis surname: Goldfinger fullname: Goldfinger, Dennis organization: Department of Medicine and Pathology and Laboratory Medicine, Cedars-Sinai/UCLA School of Medicine, Los Angeles, California – sequence: 3 givenname: Samuel H. surname: Pepkowitz fullname: Pepkowitz, Samuel H. organization: Department of Medicine and Pathology and Laboratory Medicine, Cedars-Sinai/UCLA School of Medicine, Los Angeles, California – sequence: 4 givenname: Marshal surname: Fichman fullname: Fichman, Marshal organization: Department of Medicine and Pathology and Laboratory Medicine, Cedars-Sinai/UCLA School of Medicine, Los Angeles, California – sequence: 5 givenname: Allan L. surname: Metzger fullname: Metzger, Allan L. organization: Department of Medicine and Pathology and Laboratory Medicine, Cedars-Sinai/UCLA School of Medicine, Los Angeles, California – sequence: 6 givenname: Johann O. surname: Schroeder fullname: Schroeder, Johann O. organization: Department of Internal Medicine and Rheumatology, 2nd Medical Department, Christian Albrecht University of Kiel, Kiel, Germany – sequence: 7 givenname: Hans H. surname: Euler fullname: Euler, Hans H. organization: Department of Internal Medicine and Rheumatology, 2nd Medical Department, Christian Albrecht University of Kiel, Kiel, Germany |
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| Cites_doi | 10.7326/0003-4819-107-2-344 10.1177/096120339300200302 10.1016/S0140-6736(76)93088-9 10.1002/art.1780371212 10.1002/art.1780310701 10.1016/S0307-742X(21)00211-3 10.1016/0140-6736(92)92292-N 10.1016/0955-3886(92)90167-F 10.1002/art.1780251101 10.1016/S0049-0172(95)80017-4 10.1016/0002-9343(82)90812-9 10.1002/jca.2920040107 10.1056/NEJM199205213262101 10.2165/00003495-199754030-00005 |
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| Keywords | Kidney disease Human Immunopathology Connective tissue disease Skin disease Proliferative glomerulonephritis Urinary system disease Autoimmune disease Synchronization Chemotherapy Cyclophosphamide Oxazaphosphinane derivatives Nitrogen mustard Systemic disease Lupus erythematosus Combined treatment Disseminated Pulse sequence |
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| References | Neumann K, Wallace DJ, Azen C, Nessim S, Fichman M, Metzger AL, Klinenberg JR: Lupus in the 1980s: III. Influence of clinical variables, biopsy and treatment on the outcome of 150 patients with lupus nephritis seen at a single center. Semin Arthritis Rheum 25: 475-485, 1995. Jones JV: Plasmapheresis in systemic lupus erythematosus. Clin Rheum Dis 8: 243-260, 1982. Wallace DJ: Plasmapheresis in lupus (editorial). Lupus 2: 141-143, 1993. Lewis EJ, Hunsicker LG, Lan S-P, Rhode RD, Lachin RD: A controlled trial of plasmapheresis therapy in severe lupus nephritis. N Engl J Med 326: 1373-1379, 1992. Euler HH, Schroeder JO, Harten P, Zeuner RA, Gutschmidt HJ: Treatment-free remission in severe systemic lupus erythematosus following synchronization of plasmapheresis with subsequent pulse cyclophosphamide. Arthritis Rheum 37: 1784-1794, 1994. Boumpas DT, Austin HA, Vaughn EM, Klippel JH, Steinberg AD, Yarboro CH, Balow JE: Controlled trial of pulse methylpred-nisolone versus two regimens of pulse cyclophosphamide in severe lupus nephritis. Lancet 340: 741-745, 1992. Wallace DJ, Goldfinger D, Savage G, Nichols S, Goodman D, Fichman M, Stewart M, Klinenberg JR: Prediction value of clinical, laboratory, pathologic and treatment variables in steroid/immunosuppressive resistant lupus nephritis. J Clin Apheresis 4: 30-34, 1988. Tan EM, Cohen AS, Fries JF, Masi AT, McShane DJ, Rothfield NF, Schaller JG, Talal N, Winchester RJ: Special article: the 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 25: 1271-1277, 1982. Schroeder JO, Euler H: Recognition and management systemic lupus erythematosus. Drugs 54: 422-434, 1997. Jones JV, Cumming RH, Bucknall RC, Asplin CM, Fraser ID, Bothamley J, Davis P, Hamblin TJ: Plasmapheresis in the management of systemic lupus erythematosus? Lancet I: 709-711, 1976. Schroeder JO, Euler HE, Loffler H: Synchronization of plasmapheresis and pulse cyclophosphamide in severe systemic lupus erythematosus. Ann Intern Med 107: 344-346, 1987. Liang MM, Socher SA, Roberts WN, Esdaile JM: Measurement of systemic lupus erythematosus activity in clinical research. Arthritis Rheum 31: 817-825, 1992. Wallace DJ, Podell TE, Weiner J, Cox M, Klinenberg JR, Forouzesh S, Dubois EL: Lupus nephritis: experience with 230 patients in a private practice from 1950-1980. Am J Med 72: 209-220, 1982. Euler HH, Schroeder JO, Loffler H: Antibody depletion and cytotoxic drug therapy in systemic lupus erythematosus. Transfus Sci 13: 167-184, 1992. Schroeder JO, Schwab U, Zeuner R, Fastenrath S, Euler HH: Plasmapheresis and subsequent pulse cyclophosphamide in severe systemic lupus erythematosus. Preliminary results of the LPSG-Trial. Arthritis Rheum 40: S325, 1997. 1988; 4 1982; 25 1997; 40 1992; 340 1997; 54 1982; 72 1976; I 1995; 25 1987; 107 1997 1992; 326 1982; 8 1992; 13 1994; 37 1992; 31 1993; 2 Wallace (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB1) 1997 Jones (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB17) 1982; 8 Wallace (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB11) 1982; 72 Neumann (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB12) 1995; 25 Schroeder (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB13) 1997; 40 Euler (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB7) 1992; 13 Schroeder (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB16) 1997; 54 Boumpas (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB14) 1992; 340 Schroeder (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB8) 1987; 107 Euler (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB15) 1994; 37 Lewis (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB5) 1992; 326 Jones (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB3) 1976 Tan (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB9) 1982; 25 Gladman (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB2) 1997 Wallace (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB6) 1988; 4 Wallace (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB4) 1993; 2 Liang (10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB10) 1992; 31 |
| References_xml | – volume: 54 start-page: 422 year: 1997 end-page: 434 article-title: Recognition and management systemic lupus erythematosus publication-title: Drugs – volume: 25 start-page: 1271 year: 1982 end-page: 1277 article-title: Special article: the 1982 revised criteria for the classification of systemic lupus erythematosus publication-title: Arthritis Rheum – volume: 40 start-page: S325 year: 1997 article-title: Plasmapheresis and subsequent pulse cyclophosphamide in severe systemic lupus erythematosus. Preliminary results of the LPSG‐Trial publication-title: Arthritis Rheum – start-page: 1053 year: 1997 end-page: 1066 – volume: 326 start-page: 1373 year: 1992 end-page: 1379 article-title: A controlled trial of plasmapheresis therapy in severe lupus nephritis publication-title: N Engl J Med – volume: 2 start-page: 141 year: 1993 end-page: 143 article-title: Plasmapheresis in lupus (editorial) publication-title: Lupus – volume: I start-page: 709 year: 1976 end-page: 711 article-title: Plasmapheresis in the management of systemic lupus erythematosus? publication-title: Lancet – volume: 72 start-page: 209 year: 1982 end-page: 220 article-title: Lupus nephritis: experience with 230 patients in a private practice from 1950–1980 publication-title: Am J Med – volume: 37 start-page: 1784 year: 1994 end-page: 1794 article-title: Treatment‐free remission in severe systemic lupus erythematosus following synchronization of plasmapheresis with subsequent pulse cyclophosphamide publication-title: Arthritis Rheum – volume: 25 start-page: 475 year: 1995 end-page: 485 article-title: Lupus in the 1980s: III. Influence of clinical variables, biopsy and treatment on the outcome of 150 patients with lupus nephritis seen at a single center publication-title: Semin Arthritis Rheum – volume: 8 start-page: 243 year: 1982 end-page: 260 article-title: Plasmapheresis in systemic lupus erythematosus publication-title: Clin Rheum Dis – volume: 31 start-page: 817 year: 1992 end-page: 825 article-title: Measurement of systemic lupus erythematosus activity in clinical research publication-title: Arthritis Rheum – volume: 107 start-page: 344 year: 1987 end-page: 346 article-title: Synchronization of plasmapheresis and pulse cyclophosphamide in severe systemic lupus erythematosus publication-title: Ann Intern Med – volume: 340 start-page: 741 year: 1992 end-page: 745 article-title: Controlled trial of pulse methylpred‐nisolone versus two regimens of pulse cyclophosphamide in severe lupus nephritis publication-title: Lancet – volume: 13 start-page: 167 year: 1992 end-page: 184 article-title: Antibody depletion and cytotoxic drug therapy in systemic lupus erythematosus publication-title: Transfus Sci – volume: 4 start-page: 30 year: 1988 end-page: 34 article-title: Prediction value of clinical, laboratory, pathologic and treatment variables in steroid/immunosuppressive resistant lupus nephritis publication-title: J Clin Apheresis – start-page: 1213 year: 1997 end-page: 1228 – volume: 107 start-page: 344 year: 1987 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB8 publication-title: Ann Intern Med doi: 10.7326/0003-4819-107-2-344 contributor: fullname: Schroeder – volume: 40 start-page: s325 year: 1997 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB13 publication-title: Arthritis Rheum contributor: fullname: Schroeder – volume: 2 start-page: 141 year: 1993 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB4 publication-title: Lupus doi: 10.1177/096120339300200302 contributor: fullname: Wallace – start-page: 709 year: 1976 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB3 publication-title: Lancet doi: 10.1016/S0140-6736(76)93088-9 contributor: fullname: Jones – start-page: 1053 volume-title: Dubois' Lupus erythematous year: 1997 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB1 contributor: fullname: Wallace – volume: 37 start-page: 1784 year: 1994 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB15 publication-title: Arthritis Rheum doi: 10.1002/art.1780371212 contributor: fullname: Euler – volume: 31 start-page: 817 year: 1992 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB10 publication-title: Arthritis Rheum doi: 10.1002/art.1780310701 contributor: fullname: Liang – volume: 8 start-page: 243 year: 1982 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB17 publication-title: Clin Rheum Dis doi: 10.1016/S0307-742X(21)00211-3 contributor: fullname: Jones – volume: 340 start-page: 741 year: 1992 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB14 publication-title: Lancet doi: 10.1016/0140-6736(92)92292-N contributor: fullname: Boumpas – start-page: 1213 volume-title: Dubois' Lupus Erythematosus year: 1997 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB2 contributor: fullname: Gladman – volume: 13 start-page: 167 year: 1992 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB7 publication-title: Transfus Sci doi: 10.1016/0955-3886(92)90167-F contributor: fullname: Euler – volume: 25 start-page: 1271 year: 1982 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB9 publication-title: Arthritis Rheum doi: 10.1002/art.1780251101 contributor: fullname: Tan – volume: 25 start-page: 475 year: 1995 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB12 publication-title: Semin Arthritis Rheum doi: 10.1016/S0049-0172(95)80017-4 contributor: fullname: Neumann – volume: 72 start-page: 209 year: 1982 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB11 publication-title: Am J Med doi: 10.1016/0002-9343(82)90812-9 contributor: fullname: Wallace – volume: 4 start-page: 30 year: 1988 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB6 publication-title: J Clin Apheresis doi: 10.1002/jca.2920040107 contributor: fullname: Wallace – volume: 326 start-page: 1373 year: 1992 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB5 publication-title: N Engl J Med doi: 10.1056/NEJM199205213262101 contributor: fullname: Lewis – volume: 54 start-page: 422 year: 1997 ident: 10.1002/(SICI)1098-1101(1998)13:4<163::AID-JCA4>3.0.CO;2-1-BIB16 publication-title: Drugs doi: 10.2165/00003495-199754030-00005 contributor: fullname: Schroeder |
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| Snippet | OBJECTIVE
To assess the efficacy of pulse/synchronization cyclophosphamide/apheresis in patients with proliferative lupus nephritis.
METHODS
Eighteen patients... To assess the efficacy of pulse/synchronization cyclophosphamide/apheresis in patients with proliferative lupus nephritis. Eighteen patients with Class III or... |
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| SubjectTerms | Adult Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Biological and medical sciences Blood Component Removal - methods Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis Cell Division - drug effects Combined Modality Therapy Cyclophosphamide - administration & dosage cyclophosphamide therapy Drug Administration Schedule Female Humans Immunosuppressive Agents - administration & dosage Lupus Nephritis - therapy Medical sciences proliferative lupus nephritis pulse/synchronization apheresis Transfusions. Complications. Transfusion reactions. Cell and gene therapy |
| Title | Randomized controlled trial of pulse/synchronization cyclophosphamide/apheresis for proliferative lupus nephritis |
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