Rituximab Ineffective at Enhancing Safety, Study

According to a recent study, joining the drug rituximab with a tumor necrosis factor (TNF) inhibitor and methotrexate (MTX) in rheumatoid arthritis (RA) patients proves to be infective at enhancing safety.

The study, partially funded by Biogen Idec and Roche, was published in the March edition of Arthritis & Rheumatism and was carried out by a team of investigators from the Desert Medical Advances in Palm Desert, California.

The study was performed on fifty-one patients suffering from RA and occurred over the course of roughly twenty-four weeks. The participants of the study received a steady dose of MTX and TNF inhibitor for twelve weeks, and then were randomly selected into two groups, one of which would receive 500 mg of rituximab and one of which would receive a placebo.

Fifty-five percent of the participants in the rituximab group developed infections, as opposed to the sixty-one percent of infected participants in the placebo group. In the rituximab group, however, the infections were more serious; one participant suffered a severe infection, three participants obtained Grade 3 infections, and two participants had serious adverse effects. Participants in the placebo group suffered none of these.

Fortunately, participants in neither group suffered from Grade 4, fungal, or opportunistic infections or tuberculosis.

By the twenty-fourth week, an American College of Rheumatology (ACR) twenty percent improvement response was attained by thirty percent of the drug trial group; twelve percent of the placebo group also reached this response.

ACR50 was also achieved in twelve percent of the rituximab group and six percent of the placebo group.

Maria W. Greenwald, M.D. was among these researchers and acted as one of the authors for the study. In their report, they wrote, "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.”