The Reflex Study: Prevention of Joint Structural Damage at 1 Year with Rituximab in Rheumatoid Arthritis Patients with an Inadequate Response to One or More TNF Inhibitors

Summary

Previous reports of the Reflex Study 6-month data with rituximab (RTX) indicated that this selective CD20+ B cell targeted therapy can inhibit the radiographic progression of joint structural damage in RA patients with longstanding resistance to one or more TNF inhibitors [Cohen et al. Arthritis Rheum in press).

  • rheumatoid arthritis clinical trials

Previous reports of 6-month data with rituximab (RTX) indicated that this selective CD20+ B cell targeted therapy can inhibit the radiographic progression of joint structural damage in RA patients with longstanding resistance to one or more TNF inhibitors (Cohen et al, Arthritis Rheum in press). This study extends those findings to report results at week 56 regarding the efficacy of RTX plus MTX versus MTX alone on joint structural damage in RA patients with inadequate response to one or more TNF inhibitors.

The mean change in the total Genant-modified Sharp score in the placebo group was 2.31 compared with 1.0 in the RTX group (p = 0.0043). Significant differences were also seen in ES and JSN changes. The proportion of patients with no change in ES was significantly (p = 0.045) higher in the RTX + MTX group (61%) versus the placebo + MTX group (52%).

This is the first study to show that in RA patients refractory to 1 or more TNF inhibitors, treatment with RTX can prevent radiographically documented joint structural damage, which reinforces previous data that supports the use of RTX as an effective, innovative treatment for RA.

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