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Safety of Rituximab at 11 Years of Observation

Studying infection, cardiac events, and malignancies

Publish date:: August 24, 2015

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 (RTX) during 11 years of observation, according to a study of 3,595 patients with rheumatoid arthritis. Researchers found:

• At 11 years, overall serious infection event (SIE) rates were comparable with rates reported at 9.5 years.

• SIE rates continued to be similar before and during/after development of low immunoglobulin levels.

• Serious opportunistic infections remained rare.

• Rates of cardiac events remained consistent with previous analysis and with rates in the general rheumatoid arthritis population.

• No increase in malignancy over time was seen.

Citation: van Vollenhoven RF, Fleischmann RM, Furst DE, Lacey S, Lehane PB. Longterm safety of Rituximab: final report of the rheumatoid arthritis global clinical trial program over 11 Years. [Published online ahead of print August 15, 2015]. J Rheumatol. doi: 10.3899/jrheum.150051.

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