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Rituximab Infection Risk in Daily Practice Same As in Trials

Rheumatoid arthritis patients with underlying illness and immunodeficiency at higher risk

FRIDAY, Sept. 24 (HealthDay News) -- The rate of severe infections in rheumatoid arthritis (RA) patients treated with rituximab (RTX) in daily practice is similar to that seen in controlled clinical trials of the drug, according to research published in the September issue of Arthritis & Rheumatism. The study also identifies patient characteristics which are associated with an increased risk of these infections.

Jacques-Eric Gottenberg, M.D., of the Université de Strasbourg in France, and colleagues conducted a review of the AutoImmunity and Rituximab registry set up by the French Society of Rheumatology. The objective of the current study was to assess the incidence of and risk factors for severe infections occurring in RA patients treated with RTX.

The researchers found that a total of 82 severe infections were documented in 78 patients, equivalent to 5.0 severe infections per 100 patient-years; this rate is similar to that previously reported in the controlled setting of RTX clinical trials. Patients with chronic lung disease and/or cardiac insufficiency and extra-articular manifestations of RA had significantly increased odds of having a severe infection (odds ratios, 3.0 and 2.9, respectively), as did patients with low IgG levels before RTX treatment (odds ratio, 4.9).

"We suggest measuring serum Ig concentrations and checking for vaccination against pneumococcal infections before the first infusion of RTX, since a minority of patients might already have a low serum IgG level," the authors write.

The French AutoImmunity and Rituximab registry receives unrestricted educational grant support from Roche, which markets rituximab outside of the United States. Many of the study authors disclosed financial relationships with pharmaceutical and/or medical device companies, including Roche.

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