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Combination Therapy with Pulse Cyclophosphamide plus Pulse Methylprednisolone Improves Long-Term Renal Outcome without Adding Toxicity in Patients with Lupus Nephritis

Gabor G. Illei, MD; Howard A. Austin III, MD; Marianna Crane, NP; Lee Collins, MS; Mark F. Gourley, MD; Cheryl H. Yarboro, RN; Ellen M. Vaughan, MSN; Takashi Kuroiwa, MD; Carol L. Danning, MD; Alfred D. Steinberg, MD; John H. Klippel, MD; James E. Balow, MD; and Dimitrios T. Boumpas, MD
[+] Article and Author Information

From Arthritis and Rheumatism Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases and Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland; Washington Hospital Center, Washington, D.C.; and Mitretek Systems, McLean, Virginia.


Acknowledgments: The authors thank Dr. Robert Wesley for expert statistical help; Dr. Dorothy E. Scott, Dr. John C. Davis Jr., and the Rheumatology Fellows of the National Institutes of Health for taking care of the patients; the referring physicians for allowing them to participate in the evaluation of their patients; Frank Pucino, PharmD, for dedicated support; and the Nurses of the Day Hospital and the Rheumatology Outpatient Clinic of the Warren Magnuson Clinical Center of the National Institutes of Health.

Requests for Single Reprints: Gabor G. Illei, MD, Arthritis and Rheumatism Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, 10 Center Drive, Building 10, Room 9S-205, Bethesda, MD 20892; e-mail, illeig@exchange.nih.gov.

Current Author Addresses: Dr. Illei, Ms. Crane, Ms. Collins, and Ms. Yarboro: Arthritis and Rheumatism Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, 10 Center Drive, Building 10, Room 9S-205, Bethesda, MD 20892.

Dr. Austin, Ms. Vaughan, and Dr. Balow: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Building 10, Room 9N-222, 9000 Rockville Pike, Bethesda, MD 20892.

Dr. Gourley: Section of Rheumatology, Washington Hospital Center, Room 2A-38H, 110 Irving Street NW, Washington, DC 20010.

Dr. Kuroiwa: Third Department of Internal Medicine, Gunma University School of Medicine, 3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan.

Dr. Danning: Division of Rheumatology, Gunderson Lutheran, 1836 South Avenue, LaCrosse, WI 54601-9576.

Dr. Steinberg: Mitretek Systems, 7525 Colshire Drive, McLean, VA 22102-3481.

Dr. Klippel: Arthritis Foundation, Suite 305, 4455 Connecticut Avenue NW, Washington, DC 20008.

Dr. Boumpas: Department of Medicine, University of Crete, PO Box 1352, Heraklion 711 10, Greece.

Author Contributions: Conception and design: G.G. Illei, H.A. Austin, M. Crane, L. Collins, M.F. Gourley, C.H. Yarboro, E.M. Vaughan, T. Kuroiwa, C.L. Danning, A.D. Steinberg, J.H. Klippel, J.E. Balow, D.T. Boumpas.

Analysis and interpretation of the data: G.G. Illei, H.A. Austin, M. Crane, L. Collins, M.F. Gourley, C.H. Yarboro, E.M. Vaughan, T. Kuroiwa, C.L. Danning, A.D. Steinberg, J.H. Klippel, J.E. Balow, D.T. Boumpas.

Drafting of the article: G.G. Illei, H.A. Austin, M. Crane, L. Collins, M.F. Gourley, C.H. Yarboro, E.M. Vaughan, T. Kuroiwa, C.L. Danning, A.D. Steinberg, J.H. Klippel, J.E. Balow, D.T. Boumpas.

Critical revision of the article for important intellectual content: G.G. Illei, H.A. Austin, M.F. Gourley, C.H. Yarboro, T. Kuroiwa, C.L. Danning, A.D. Steinberg, J.H. Klippel, J.E. Balow, D.T. Boumpas.

Final approval of the article: G.G. Illei, H.A. Austin, M. Crane, L. Collins, M.F. Gourley, C.H. Yarboro, E.M. Vaughan, T. Kuroiwa, C.L. Danning, A.D. Steinberg, J.H. Klippel, J.E. Balow, D.T. Boumpas.

Provision of study materials or patients: G.G. Illei, H.A. Austin, E.M. Vaughan, C.L. Danning, J.E. Balow, D.T. Boumpas.

Statistical expertise: G.G. Illei, H.A. Austin,

Obtaining of funding: J.H. Klippel, J.E. Balow, D.T. Boumpas.

Administrative, technical, or logistic support: M. Crane, L. Collins, C.H. Yarboro, E.M. Vaughan, J.E. Balow, D.T. Boumpas.

Collection and assembly of data: G.G. Illei, H.A. Austin, M. Crane, L. Collins, C.H. Yarboro, E.M. Vaughan, T. Kuroiwa, J.E. Balow, D.T. Boumpas.


Ann Intern Med. 2001;135(4):248-257. doi:10.7326/0003-4819-135-4-200108210-00009
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Proliferative lupus nephritis is characteristically a protracted disease with a waxing and waning course (12). Open-label and controlled clinical trials have shown that cyclophosphamide is superior to corticosteroids in preserving renal function; only a minority of patients treated with cyclophosphamide reach end-stage renal disease (314). Some retrospective analyses, however, have reported a less favorable effect of pulse cyclophosphamide therapy (1517).

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Figure.
Kaplan–Meier analysis of failure of therapy with cyclophosphamide plus methylprednisolone(circles),cyclophosphamide only(squares),or methylprednisolone only(triangles).PPP

All patients entered in the study are included, regardless of length of therapy. Treatment failure was defined as death, doubling of serum creatinine concentration, or need for immunosuppressive therapy not specified in the protocol to control renal or extrarenal lupus activity, whichever occurred first. The Breslow–Gehan–Wilcoxon test was used for all comparisons. * = 0.002 vs. methylprednisolone; † = 0.24 vs. cyclophosphamide; ‡ = 0.04 vs. methylprednisolone.

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Summary for Patients

Kidney Disease in Patients with Lupus Who Are Treated with Potent Drugs that Suppress the Immune System

The summary below is from the full report titled “Combination Therapy with Pulse Cyclophosphamide plus Pulse Methylprednisolone Improves Long-Term Renal Outcome without Adding Toxicity in Patients with Lupus Nephritis.” It is in the 21 August 2001 issue of Annals of Internal Medicine (volume 135, pages 248-257). The authors are GG Illei, HA Austin III, M Crane, L Collins, MF Gourley, CH Yarboro, EM Vaughan, T Kuroiwa, CL Danning, AD Steinberg, JH Klippel, JE Balow, and DT Boumpas.

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