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Safety of biologic therapies following rituximab treatment in rheumatoid arthritis patients

Genovese MC et al. Ann Rheum Dis published online 20.01.2009
(doi:10.1136/ard.2008.101675)

Objective: To assess the safety of biologic agents in RA patients following treatment with rituximab.

Methods: Included were RA patients from an international rituximab clinical trial who received ≥ 1 course of rituximab and withdrew from the treatment phase of the study. This follow-up study was designed to assess the safety under treatment, where additional biologic DMARDs were permitted. Serious infection events were collected.

Results: Out of 2'578 patients, 185 entered the safety follow-up period and received another biologic DMARD. At the time of initiation of another biologic agent, the majority of patients (88.6%) still had peripheral B-cell depletion. 153 of these patients had received ≥ 1 TNF-inhibitor. Following rituximab, but prior to another biologic DMARD 13 serious infection events (6.99 events/100 patient-years) occurred in the 185 patients. 10 serious infection events (5.49 events/100 patient-years) occurred following another biological DMARD. The type of the serious infection events was typical for RA patients, while there were no fatal or opportunistic infections.

Conclusions: Treatment with a biologic DMARD after rituximab was not associated with an increased rate of serious infection. The positive signals from this study are to be interpreted in consideration of the small sample size with limited follow-up.

Comments: Treatment with biologic DMARD after peripheral B-cell depletion from rituximab represents an issue of concern with regard to the risk of infection. This study, although limited in size and duration, suggests that the infection rates as well as the type of infection is not altered under biologic DMARD's in RA patients who had at least one course of rituximab before taking other biologic drugs. Definitive conclusions about safety, however are not yet possible. Longer follow-up in a larger test cohorts will be necessary. The best opportunity to get a real life estimate with regard to infection events in continued biologic treatment after rituximab will be best extracted from national large patient registries.

Beat A. Michel

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