Rheumatoid Arthritis Drug Maintains Strong Safety Profile

Rheumatoid arthritis treatment remains consistently well tolerated over long-term evaluation.

A treatment for rheumatoid arthritis continued to show strong results over the course of a multi-year safety evaluation.

In a study recently published in The Journal of Rheumatology evaluating the long-term safety of Rituxan, the rheumatoid arthritis drug maintained a consistent safety profile over time and through multiple courses over 11 years of observation. The study comes as a final installment to the long-term global study.

Researchers studied 3595 patients with moderate-to-severe, active RA in a global clinical trial program over 11 years. A previously published study found that over the course of 9.5 years, the Rituxan regimen maintained a well-tolerated safety profile.

The current study represented 2854 additional patient-years of follow-up with the inclusion of an additional 401 patients treated with Rituxan, pooled from an open-label prospective study.

“The results of this study reinforce what is already known about the safety profile of Rituxan,” said Ani John, senior medical science director at Genentech Immunology. “What we were able to do with this study was to extend the safety analysis of Rituxan on a long-term, global scales, further supporting the use of this product as a safe and well-tolerated treatment for rheumatoid arthritis.”

Findings from the study demonstrated that the overall serious infection event rate was 3.76/100 patient years and comparable with rates reported previously at 9.5 years. Additionally, rates of adverse events and serious adverse events remained similar in the Rituxan all-exposure, Rituxan long-term, and placebo populations, while serious opportunistic infections remained rare.

Rates of cardiac events were consistent with previous findings and with rates in the general RA population. No increased risk of malignancy was noted over time.