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Rituximab Does Not Improve Safety Profile of RA Treatment

More frequent serious adverse events when adding rituximab to methotrexate and TNF inhibitor

MONDAY, April 4 (HealthDay News) -- Combining rituximab with a tumor necrosis factor (TNF) inhibitor and methotrexate (MTX) in patients with rheumatoid arthritis (RA) does not offer any safety improvement, according to a study published in the March issue of Arthritis & Rheumatism.

Maria W. Greenwald, M.D., from the Desert Medical Advances in Palm Desert, Calif., and colleagues assessed the safety profile of combining rituximab with TNF inhibitor and MTX in patients with active RA. Fifty-one participants receiving a stable dose of MTX and TNF inhibitor for 12 weeks or more were randomized to receive two infusions of 500 mg of rituximab or placebo. The main study end point was the proportion of patients who developed one or more serious infections up to week 24.

The investigators found that 55 percent of patients in the rituximab group developed infections, compared to 61 percent in the placebo group. In the rituximab group, one patient had a serious infection, three had Grade 3 infections, and two had serious adverse effects (SAEs) compared with none in the placebo group. Neither group had Grade 4, fungal, or opportunistic infections or tuberculosis. At week 24, an American College of Rheumatology (ACR) 20 percent improvement response was achieved by 30 percent of the rituximab group and 12 percent of the placebo group, and ACR50 in 12 and 6 percent, respectively.

"SAEs were numerically more frequent in the rituximab group and there was no clear evidence of an efficacy advantage in patients receiving rituximab in combination with a TNF inhibitor and MTX," the authors write.

Several authors disclosed financial relationships with Biogen Idec and Roche, which also funded the study.

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