The online edition of The Journal of Rheumatology has published a study on the long-term safety of Rituxan which found that it has a consistent safety profile over time and through multiple courses over 11 years of observation. The study is the final analysis of a long-term global study.
Research was based on a pooled observed case analysis of data from patients with moderate to severe, active rheumatoid arthritis (RA) in a global clinical trial program over 11 years of observation in 3,595 patients. A previously published analysis found that exposure to multiple courses of RTX over 9.5 years of observation was associated with a well-tolerated safety profile.
This study represented 2,854 additional patient-years (PY) of follow-up with the inclusion of an additional 401 patients treated with RTX, pooled from an RTX RA 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, Genentech Immunology. "What we were able to do with this study was to extend the safety analysis of Rituxan on a long-term, global scale, further supporting the use of this product as a safe and well-tolerated treatment for rheumatoid arthritis."
Findings Showed That:
- The overall serious infection event (SIE) rate was 3.76/100 PY (2.71/100 PY in patients observed for > 5 yrs) and comparable with rates reported previously at 9.5 years (3.94/100 PY and 3.26/100 PY, respectively).
- Rates of AE and SAE remained similar in the RTX all-exposure, RTX longterm, and placebo populations
- Serious opportunistic infections remained rare
- Rates of cardiac events remained consistent with previous analysis and with rates in the general RA population
- No increased risk of malignancy over time was observed
Longterm Safety of Rituximab: Final Report of the Rheumatoid Arthritis Global Clinical Trial Program over 11 Years. DOI: 10.3899/jrheum.150051