Rituxan Clinical Data
In the pivotal placebo-controlled trial, a significantly higher proportion of patients treated with one course of Rituxan achieved an ACR response vs placebo at 6 months1
- Primary end point for response was ACR20*: 51% for Rituxan vs 18% for placebo1
Efficacy over 5 courses in open-label extension
Care should be exercised in interpreting open-label results, due to the inability to minimize bias.
A within-group, pooled completer analysis was conducted in a subset of TNFi nonresponders from Rituxan clinical trials who responded to an initial course of therapy (≥20% improvement in swollen and tender joints) with subsequent courses given no more frequently than every 16 weeks. Each course consisted of 2 x 1000 mg of Rituxan as IV infusions 2 weeks apart. Efficacy was determined 24 weeks following each course. All points include at least 5 courses and 6-month data for each course.2
Adapted from Keystone ACR 2010.
REFLEX radiographic data at 2 years
Of the Rituxan patients who had no progression during the first year, 87% also had no progression the second year.3
A total of 520 patients were enrolled in the study. 311 were randomized to rituximab plus MTX and 209 to placebo plus MTX; 3 patients were randomized but did not receive treatment. 468 patients (281 rituximab patients and 187 placebo patients) were included in the REFLEX ITT population, and had a baseline film at screening and at least one postbaseline radiograph. A total of 197 rituximab and 135 placebo patients had radiographs at both baseline and Week 104. The baseline characteristics and measures of disease activity were similar in both treatment groups and were similar to those of the original ITT population.4
Adapted from Cohen et al 2010.
Patients were eligible for rescue therapy at 4 months. At 2 years, 82% of the placebo population had received at least 1 course of Rituxan.4
IMPORTANT SAFETY INFORMATIONInfections:
- Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Rituxan-based therapy
- Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure)
- In the pooled, placebo-controlled studies, 39% of patients in the Rituxan group experienced an infection of any type compared to 34% of patients in the placebo group
- The most common infections were nasopharyngitis, upper respiratory tract infections, urinary tract infections, bronchitis, and sinusitis
- The incidence of serious infections was 2% in the Rituxan treated patients and 1% in the placebo group
Patient Case History: Sustained efficacy over multiple courses
Dr. James Loveless hosts a presentation exploring a Rituxan Patient Case History and pivotal data on the safety and efficacy of Rituxan.
- Cohen SB, Emery P, Greenwald MW, et al; for the REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793-2806. doi:10.1002/art.22025.
- Keystone E, Fleischmann RM, Emery P, Dougados M, Williams S, Reynard M. Multiple courses of rituximab produce sustained efficacy in patients with rheumatoid arthritis with an inadequate response to one or more TNF inhibitor(s). Presented at: The American College of Rheumatology Annual Scientific Meeting; November 6-11, 2010, Atlanta, Georgia.
- Cohen SB, Keystone E, Genovese MC, et al. Continued inhibition of structural damage over 2 years in patients with rheumatoid arthritis treated with rituximab in combination with methotrexate. Ann Rheum Dis. 2010;69(6):1158-1161.