Treating newly diagnosed systemic lupus erythematosus patients with Rituxan (rituximab) is safe and effective, according to a study that followed a small group of patients over several years.
A key finding was that Rituxan reduced the patients’ use of corticosteroids, which is good news because long-term steroid use can cause numerous side effects. In fact, several studies hypothesize that steroid treatment is the main cause of damage in lupus.
The research, “The use of rituximab in newly diagnosed patients with systemic lupus erythematosus: long-term steroid saving capacity and clinical effectiveness,” was published in the journal Lupus Science and Medicine.
Earlier investigations have shown that Rituxan prevents lupus flare-ups and keeps patients’ steroid use low up to three years after a diagnosis. To see if the effects held up in the long run, researchers at Blesa University Hospital in Spain and University College London Hospitals in the United Kingdom followed 16 newly diagnosed female lupus patients for up to seven years.
The patients, most of whom did not have kidney disease, were compared with three previously assessed patients who had received conventional treatment. To make the comparison more valid, researchers matched Rituxan and control patients according to ethnicity, age, symptoms, disease duration, and follow-up period.
They followed the women for a median of 4.5 years. All patients who received Rituxan had joint problems. Eleven had skin issues, three had serositis — inflammation of membranes lining the lungs, heart, abdomen, and inner abdominal organs — and two had kidney disease. None had gastrointestinal or central nervous system symptoms.
Rituxan-treated patients averaged 2.63 flare-ups and controls four flare-ups. The difference was not statistically significant.
Anti-double stranded DNA antibodies are a common feature of lupus. The study showed that Rituxan-treated patients had significantly higher levels of the autoantibodies before treatment than conventionally treated patients.
Levels fell in both groups during the study. After 18 months, Rituxan-treated patients had significantly lower levels than before their treatment started. Both groups maintained low levels of the autoantibodies five years after treatment began.
The Rituxan group also had a higher rate of red blood cell sedimentation — a blood test that can reveal inflammatory activity — than before treatment. And the group had lower levels of C3, an important immune system factor.
Both the Rituxan-treated patients and controls had normal levels of blood cell sedimentation. C3 levels rose only in the Rituxan-treated patients.
The biggest difference between the groups was in corticosteroid use. Four Rituxan-treated patients never had to use steroids. The cumulative dose of the steroids among the 11 Rituxan-treated patients whom researchers assessed was 4,745.67 mg at 60 months.
Among the controls, the average cumulative dose was 12,553.92 mg, demonstrating that the biological treatment spared patients from a significant amount of steroid exposure.
The study also reported no major infections or serious side effects in patients given Rituxan.