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

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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.


Ann Intern Med. 2001;135(4):S29. doi:10.7326/0003-4819-135-4-200108210-00003
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What is the problem and what is known about it so far?

Lupus is a disease of the immune system that can damage many body organs. Damage to the kidneys from this disease is known as lupus nephritis. Lupus nephritis is difficult to treat and can return even if initial treatment is successful. If left untreated, lupus nephritis can progress to complete kidney failure. Patients with kidney failure need kidney transplantation or hemodialysis (a procedure in which a special machine filters the blood). Treatment of lupus nephritis often includes two powerful drugs that suppress the immune system: methylprednisolone and cyclophosphamide. Both of these drugs can have serious side effects. An earlier study showed that cyclophosphamide, either alone or in combination with methylprednisolone, was more effective than methylprednisolone alone in the short term (< 5 years). At the end of 5 years, patients who received the combination seemed to do better than the other groups, but these results were not clear cut. It is not known what happens after 5 years to patients treated with these drugs.

Why did the researchers do this particular study?

To find out whether patients with lupus nephritis do best in the long term (beyond 5 years) if they are treated with cyclophosphamide alone, methylprednisolone alone, or a combination of the two drugs.

Who was studied?

The researchers studied 82 patients with lupus nephritis who participated in a 1986–1990 study comparing the effects of treatment with cyclophosphamide alone, methylprednisolone alone, and the two drugs in combination.

How was the study done?

The researchers followed the patients from the time they enrolled in the study through August 1999. They collected information on whether treatment failed (defined as blood tests that showed worsening kidney function, the need for additional drugs to treat the lupus nephritis, or death) and whether serious side effects of the drugs occurred.

What did the researchers find?

Treatment was less likely to fail in patients who were initially treated with cyclophosphamide, alone or in combination with methylprednisolone, than in patients initially treated with methylprednisolone alone. Among patients who completed their original treatment, the rate of worsening kidney function was lower in those who took cyclophosphamide plus methylprednisolone. Similar numbers of side effects occurred in all three groups.

What were the limitations of the study?

Many of the patients changed treatment during the study, so the results are not as definitive as they might be. Some experts believe it would have been better if the researchers looked for development of kidney failure as the main outcome.

What are the implications of the study?

Over the long term, patients with lupus nephritis who receive cyclophosphamide, either alone or in combination with methylprednisolone, appear to do better than patients treated with methylprednisolone alone. Adding methylprednisolone to cyclophosphamide therapy appears to provide more benefit than cyclophosphamide alone but does not increase the patient's risk for adverse events.

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