Rheumatoid Arthritis Drug Maintains Strong Safety Profile

Article

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

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.

Related Videos
male pharmacist using digital tablet during inventory in pharmacy | Image Credit: sofiko14 - stock.adobe.com
Pharmacist holding medicine box in pharmacy drugstore. | Image Credit: I Viewfinder - stock.adobe.com
Pharmacy Drugstore Checkout Cashier Counter | Image Credit: Gorodenkoff - stock.adobe.com
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk - stock.adobe.com
Capsules medicine and white medicine bottles on table | Image Credit: Satawat - stock.adobe.com
Human cell or Embryonic stem cell microscope background | Image Credit: Anusorn - stock.adobe.com
Concept of health care, pharmaceutical business, drug prices, pharmacy, medicine and economics | Image Credit: Oleg - stock.adobe.com
Biosimilar pharmaceutical drug bottle on blue background. | Image Credit: Carl - stock.adobe.com
Pharmaceutical manufacture background with glass bottles with clear liquid on automatic conveyor line. | Image Credit: wacomka - stock.adobe.com
Bottle and scattered pills on color background, top view | Image Credit: New Africa - stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.