A potential therapy for lupus nephritis when other medications fail
- Histopathologic and Clinical Outcome of Rituximab Treatment in Patients with Cyclophosphamide-Resistant Proliferative Lupus Nephritis
- Arthritis & Rheumatism, Volume 56, Number 4, April 2007, pp. 1263-1272
What is the topic?
Lupus nephritis (kidney disease) is a serious complication of lupus. The standard treatment is usually a combination of steroids and either mycophenolate mofetil (CellCept) or cyclophosphamide (Cytoxan)®. Most patients eventually respond well to one or a combination of these treatments, but there are some who do not, and they are at risk for further kidney damage and loss of the kidneys.
What did the researchers hope to learn?
Researchers in Sweden tested to see if providing rituximab (Rituxan®) in combination with cyclophosphamide (CYC) would be a safe and effective therapy for lupus nephritis patients who had previously not responded to CYC.
Who was studied?
The researchers studied seven women with lupus who had severe kidney disease and who had not responded to previous therapy with CYC. All seven were taking prednisone at the time the study began, and all had a kidney biopsy at the start of the study to determine the level of tissue damage.
How was the study conducted?
The seven study participants each received rituximab (four doses total), steroids, and CYC over a 23-day period. After the final treatment with rituximab, the patients were put back on the same dose of prednisone they had been using before the study began, with the option to taper this down if their condition improved.
What did the researchers find?
The researchers found that rituximab, in combination with CYC, was effective in treating lupus nephritis in patients who had previously not responded to CYC. Six months after their treatment with rituximab and CYC, all seven patients showed improvement in blood tests, urine measurements and in a repeat kidney biopsy. Three of the patients reached a complete remission, and one had a partial remission. Six of the seven patients were able to reduce the dose of prednisone after the combined rituximab/CYC treatment.
What were the limitations of the study?
This study only involved seven patients and there was no treatment to compare this one to. It might have been that, despite not yet improving on CYC alone, this final CYC treatment would have had the same effect as rituximab plus CYC. A much larger study with a comparison to alternative treatment will be needed in order to verify this very preliminary report.
What do the results mean for you?
This study adds to a number of other small, preliminary studies in which rituximab has looked like it might be a potential new treatment for lupus -- and one that may work even when other treatments have failed. However larger studies which compare rituximab to alternative treatments would be needed to verify these preliminary observations. Two larger studies are going on now, one for general lupus symptoms and another for lupus kidney disease and it is important to wait for these studies to be evaluated before drawing conclusions about rituximab.