RESEARCH - Safety of biologic therapies following rituximab treatment in RA patients

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Ann Rheum Dis. Published Online First: 20 January 2009.

doi:10.1136/ard.2008.101675

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Concise Report

Safety of biologic therapies following rituximab treatment in

rheumatoid arthritis patients

Mark C Genovese 1*, Ferdinand C Breedveld 2, Emery 3, Stanley

Cohen 4, Keystone 5, L Matteson 6, Yvette Baptiste 7,

Akiko Chai 8, Burke 7, Reiss 8, nne Sweetser 9 and

Tim M Shaw 7

1 Stanford University, United States

2 Leiden University, Netherlands

3 Leed Teaching Hospitals Trust and the University of Leeds, United Kingdom

4 Metroplex Clinical Research Center, United States

5 University of Toronto, Canada

6 Mayo Clinic of Medicine, United States

7 Roche Products Ltd, United Kingdom

8 Genentech, Inc., United States

9 Biogen Idec, United States

Abstract

Objective: To assess safety of biologic disease-modifying

antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients

following rituximab treatment.

Methods: RA patients who participated in an international rituximab

clinical trial program were included. Patients who had received 1

course of rituximab and withdrew from the treatment phase of the

study, entered a safety follow-up (SFU) period, during which

additional biologic DMARDs were permitted. Serious infection events

(SIEs) were collected.

Results: Of 2578 patients, 185 entered SFU and received another

biologic DMARD as of November, 2007. The majority (88.6%) of patients

had peripheral B-cell depletion at time of initiation of another

biologic. Of the 185 patients, 153 had received 1 TNF-inhibitor(s). In

these 185, 13 SIEs (6.99 events/100 patient-years) occurred following

rituximab, but prior to another biologic DMARD, and 10 SIEs (5.49

events/100 patient-years) occurred following another biological DMARD.

SIEs were of typical type and severity for RA patients. There were no

fatal or opportunistic infections.

Conclusions: In this analysis, treatment with a biologic DMARD after

rituximab was not associated with an increased rate of serious

infection. The size of the sample with limited follow-up restricts

definitive conclusions about safety in B-cell depleted patients

receiving additional biologic DMARDs.

http://ard.bmj.com/cgi/content/abstract/ard.2008.101675v1?papetoc

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