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Methods: Pts on background immunosuppressants and corticosteroids were randomized to placebo (PLA) or RTX (1000 mg IV on days 1, 15, 168, and 182). Adverse events (AEs), serious AEs (SAEs), deaths, and antibodies to RTX (HACAs) were recorded from screening to wk 78, or to termination visits. HACA responses were measured at baseline and every 3 mo. Immunoglobulin (Ig) levels were measured at baseline and days 112, 168, 308, 364, 455, and 546.
Results: Eighty-eight PLA and 169 RTX pts were included in the safety-evaluable populations. AEs and SAEs were comparable between PLA and RTX groups. Infection and infestation treatment-emergent SAEs were higher in the PLA than in the RTX group (18.2% vs 11.2%). Rates of infections were 227 and 224 events/100 pt-yr (patient-years) for PLA and RTX. Rates of serious infections were 16.7 and 13.6 events/100 pt-yr for PLA and RTX. Herpes virus infection-related AEs occurred in 8 (9.1%) pts in the PLA group vs 26 (15.4%) in the RTX group. The % of pts with infusion-related AEs during course 1 was comparable between groups, but during course 2 a higher % of RTX-treated pts had infusion-related AEs. HACAs were present in 3 (3.4%) and 48 (28.4%) pts in the PLA and RTX groups. At the 4th infusion, 11 (22.9%) of the 48 HACA+ RTX-treated pts experienced an infusion-related AE (1 SAE), vs 14 (11.0%) of the HACA- RTX-treated pts. Neutropenia occurred in 6 RTX pts. Four cases of serum sickness (1 serious) occurred in the RTX group. At any time during the study, IgG levels were below the lower limit of normal (LLN) in 8.5% of PLA, and 6.3% of RTX pts. IgM levels were below the LLN in 9.7% of the PLA group, and 28.7% of the RTX group. Mean IgG levels did not significantly change in the RTX group during the trial. Low Ig levels did not correlate with serious infectious AEs.
Conclusion: The numbers of pts who developed AEs and SAEs were comparable between the PLA and RTX groups. Whereas overall infection rates were also comparable, infectious SAEs were higher in PLA. The percent of pts with infusion reactions was similar between groups after the 1st and 2nd infusions, however, more pts experienced infusion reactions in the RTX group after the 3rd and 4th infusions. No clear associations were observed between HACAs and safety. Herpes viral infections, neutropenia, and serum sickness occurred more frequently in the RTX group.
Disclosure: J. T. Merrill, Genentech , 5, Genentech , 2 ; D. J. Wallace, None; K. M. Latinis, Genentech , 2, Genentech , 5, Genentech, Centocor , 6 ; T. O. Utset, Genentech , 5 ; R. Furie, Genentech, Roche, Biogen Idec, 2, Genentech, Roche, Biogen Idec, 5, Genentech, Roche, Biogen Idec, 6 ; C. M. Neuwelt, Genentech, Biogen IDEC, Roche, 2, Genentech and Biogen IDEC Inc., 8 ; R. J. Looney, Genentech, Biogen IDEC, Roche, 5 ; H. Hsieh, Genentech , 3 ; B. Wagner, Genentech , 3 ; P. Brunetta, Genentech , 3 .