Thursday, September 10, 2015

Journal of Rheumatology: Longterm Safety of Rituximab in Treatment of RA

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As someone who has received rituximab infusions in the past, my interest was piqued when I saw this published online August 15 in the Journal of Rheumatology: Longterm Safety of Rituximab: Final Report of the Rheumatoid Arthritis Global Clinical Trial Program over 11 Years; By Ronald F. van Vollenhoven, Roy M. Fleischmann, Daniel E. Furst, Stuart Lacey, and Patricia B. Lehane
Objective. Final evaluation of the longterm safety of rituximab (RTX) in rheumatoid arthritis (RA) up to 11 years. 
Methods. Pooled observed case analysis of data from patients with moderate to severe, active RA in a global clinical trial program. 
Results. As of September 2012, 3595 patients received a mean of 4 courses (range 1–20) of RTX over 11 years [14,816 patient-years (PY)]. Of these, 1246 patients had > 5 years of followup (8970 PY). A pooled placebo population (n = 818) was included in the analysis. 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). SIE rates continued to be similar before and during/after development of low immunoglobulin levels, and serious oppor- tunistic 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. 
Conclusion. This final report demonstrates that RTX remains well tolerated over time and multiple courses. No new safety risks were identified and there was no increase in the rate of any types of adverse events with prolonged exposure to RTX during 11 years of observation......Continue reading here.
(J Rheumatol First Release August 15 2015; doi:10.3899/jrheum.150051) ran a good article explaining the specifics of the clinical trial:

Rituximab Safe for Up to 11 Years in Rheumatoid Arthritis
Janis C. Kelly
September 01, 2015 
Rituximab had a consistent safety profile through multiple courses used in treating rheumatoid arthritis (RA) during 11 years of observation and was not associated with excess infection rates, cardiac events, or malignancies, researchers report in an article published online August 15 in the Journal of Rheumatology. 
The analysis "affords rheumatologists a higher level of confidence" in the safety of prolonged and repeated peripheral B cell depletion in treatment of RA, Ronald F. van Vollenhoven, MD, from the Unit for Clinical Therapy Research, Inflammatory Diseases, the Karolinska University Hospital, Stockholm, Sweden, and colleagues write. 
The authors report a pooled observed case analysis of 3595 patients with moderate to severe RA from a global clinical trial program. Patients had received a mean of four courses of rituximab (RTX). The placebo population included 818 patients (1107 patient-years.......Continue reading here. (Requires creating a free account.)
While this case analysis examined the safety of rituximab use in the treatment of rheumatoid arthritis, and not primary Sjogren's syndrome; still I find this to be good news for ongoing research in B-cell depletion therapy use for autoimmune diseases.

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