In Study 7, overall survival estimates at 5 years were 58% vs. 46% for R-CHOP and CHOP, respectively.

Rheumatoid Arthritis (RA)

The efficacy and safety of Rituxan were evaluated in 517 patients with active disease who were receiving methotrexate and had a prior inadequate response to at least one TNF inhibitor. Patients were ≥ 18 years, diagnosed with RA according to American College of Rheumatology (ACR) criteria and had at least 8 swollen and 8 tender joints. Patients received 2 doses of either Rituxan 1000 mg or placebo as an IV infusion on days 1 and 15, in combination with continued methotrexate 10-25 mg weekly.

Efficacy was assessed at 24 weeks. Glucocorticoids were given IV as premedication prior to each Rituxan infusion and orally on a tapering schedule from baseline through Day 16.

The proportions of Rituxan (1000 mg) treated patients achieving ACR 20, 50, and 70 responses in this study is shown in Table 5.

Table 5
ACR Responses at Week 24 in Placebo-Controlled Study
(Percent of Patients) (Modified Intent-to-Treat Population)

Improvement was also noted for all components of ACR response following treatment with Rituxan, as shown in Table 6.

Table 6
Components of ACR Response
(Modified Intent-to-Treat Population)

The time course of ACR 20 response for this study is shown in Figure 1. Although both treatment groups received a brief course of IV and oral glucocorticoids, resulting in similar benefits at week 4, higher ACR 20 responses were observed for the Rituxan group by week 8 and were maintained through week 24 after a single course of treatment (2 infusions) with Rituxan. Similar patterns were demonstrated for ACR 50 and 70 responses.

Figure 1
ACR 20 Responses Over 24 Weeks

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