Ronald F van Vollenhoven1, Roy M Fleischmann2, Daniel E Furst2, Stuart Lacey2, Patricia B Lehane2. 1. From the Unit for Clinical Therapy Research, Inflammatory Diseases, Karolinska Institute, Stockholm, Sweden; Department of Internal Medicine, University of Texas, Southwestern Medical Center, Dallas, Texas; Department of Rheumatology, University of California, Los Angeles Medical Center, Los Angeles, California, USA; Roche Products Ltd., Welwyn Garden City, UK.R.F. van Vollenhoven, MD, Chief of the Unit for Clinical Therapy Research, Inflammatory Disease, Karolinska Institute; R.M. Fleischmann, MD, Clinical Professor of Medicine, Department of Internal Medicine, University of Texas, Southwestern Medical Center; D.E. Furst, MD, Carl M. Pearson Professor of Medicine, Department of Rheumatology, University of California, Los Angeles Medical Center; S. Lacey, MSc, Statistician, Roche Products Ltd.; P.B. Lehane, PhD, Senior Clinical Development Scientist, Roche Products Ltd. ronald.van.vollenhoven@ki.se. 2. From the Unit for Clinical Therapy Research, Inflammatory Diseases, Karolinska Institute, Stockholm, Sweden; Department of Internal Medicine, University of Texas, Southwestern Medical Center, Dallas, Texas; Department of Rheumatology, University of California, Los Angeles Medical Center, Los Angeles, California, USA; Roche Products Ltd., Welwyn Garden City, UK.R.F. van Vollenhoven, MD, Chief of the Unit for Clinical Therapy Research, Inflammatory Disease, Karolinska Institute; R.M. Fleischmann, MD, Clinical Professor of Medicine, Department of Internal Medicine, University of Texas, Southwestern Medical Center; D.E. Furst, MD, Carl M. Pearson Professor of Medicine, Department of Rheumatology, University of California, Los Angeles Medical Center; S. Lacey, MSc, Statistician, Roche Products Ltd.; P.B. Lehane, PhD, Senior Clinical Development Scientist, Roche Products Ltd.
Abstract
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 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. 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.
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 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. 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.
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