RT Journal Article
SR Electronic
T1 Longterm Safety of Patients Receiving Rituximab in Rheumatoid Arthritis Clinical Trials
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 558
OP 567
DO 10.3899/jrheum.090856
VO 37
IS 3
A1 RONALD F. van VOLLENHOVEN
A1 PAUL EMERY
A1 CLIFTON O. BINGHAM III
A1 EDWARD C. KEYSTONE
A1 ROY FLEISCHMANN
A1 DANIEL E. FURST
A1 KATHERINE MACEY
A1 MARIANNE SWEETSER
A1 ARIELLA KELMAN
A1 RAVI RAO
YR 2010
UL http://www.jrheum.org/content/37/3/558.abstract
AB Objective. To evaluate the longterm safety of rituximab in clinical trials in patients with rheumatoid arthritis (RA). Methods. Pooled analysis of safety data, including adverse events (AE) and infections, from patients treated with rituximab in combination with methotrexate in a global clinical trial program. Results. A total of 2578 patients with RA received at least 1 course of rituximab. Safety analyses were based on 5013 patient-years of rituximab exposure. The most frequent AE was infusion-related reactions (25% of patients during the first infusion of Course 1). Less than 1% of infusion-related reactions were considered serious. Rates of AE and serious AE (SAE; 17.85 events/100 patient-yrs, 95% CI 16.72, 19.06) were stable following each course. The overall serious infection rate was 4.31/100 patient-years (95% CI 3.77, 4.92). Infections and serious infections over time remained stable across 5 courses at 4–6 events/100 patient-years. Compared with other patients with RA and with the general US population, there was no increased risk of malignancy. Conclusion. In this longterm safety update in RA clinical trial patients, rituximab remained well tolerated over multiple courses. SAE and infections remained stable over time and by treatment course.