Subsequent Courses of Treatment
Open-label studies suggest consistent and lasting results from one course to the next
Results at 6-month end points in an uncontrolled, open-label, ongoing extension trial with Rituxan
Completer analysis of a subset of Rituxan patients who responded to an initial course of therapy (>20% improvement in swollen and tender joints). Data derived from Keystone et al.6
Care should be exercised in interpreting open-label results due to the inability to minimize bias.
Safety and efficacy of subsequent courses have not been established in controlled clinical trials.
Evaluate patients at the first signs of the return of disease activity
In extension trials, most patients received a subsequent course of Rituxan after 6 months upon the return of disease activity
- In the open-label extension trial, the median interval between the first and second course was 37.9 weeks6
- Criteria for receiving subsequent courses of Rituxan included active disease, defined as ≥8 swollen joints and ≥8 tender joints
The safety of subsequent courses of therapy appears similar to that seen with the initial course5
- Among the total subsequent-course population of 1053 patients who received at least 1 course of Rituxan:
- 25% had at least 1 low IgM and 6% at least 1 low IgG.6 The clinical consequences of decreases inimmunoglobulin levels in RA patients treated with Rituxan are unclear2
- In an ongoing, uncontrolled study with a limited number of patients who received up to 4 courses of Rituxan7:
- A slight upward trend was observed in the rate of infections after 4 courses; however, the rate of serious infections remained stable with repeated treatment
