Rheumatoid arthritis: new trial confirms long-term safety of rituximab

The biological therapy rituximab (MabThera) can be safe when used for the long-term treatment of rheumatoid arthritis says new evidence published in the Journal of Rheumatology.
Data was analysed from people with moderate to severe active rheumatoid arthritis who were enrolled in a clinical trial programme spanning 11 years. A total of 3,595 people were given an average of four courses of rituximab over 11 years, of whom 1,246 people had more than five years of follow-up. A group of 818 people receiving a placebo were included in the analysis too.

Key findings
• The overall serious infection event was low and comparable with rates previously reported;
• Infection rates were unaffected by the development of low immunoglobulin levels, and serious opportunistic infections were rare;
• Rates of cardiac events were consistent with rates in the general rheumatoid arthritis population and with previous analysis;
• No increased risk of malignancy over time was seen.

Rituximab is designed to remove B-cells (a subset of white blood cells that play an important role in rheumatoid arthritis) and help reduce the inflammation that causes joint pain and swelling. It is currently licensed for the treatment of rheumatoid arthritis, vasculitis, lupus and dermatomyositis.

“This final report demonstrates that rituximab remains well tolerated over time and multiple courses,” the researchers say. “No new safety risks were identified and there was no increase in the rate of any types of adverse events with prolonged exposure to rituximab during 11 years of observation.”

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