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Safety of biologic therapies following rituximab treatment in rheumatoid arthritis patients
  1. Mark C Genovese (genovese{at}stanford.edu)
  1. Stanford University, United States
    1. Ferdinand C Breedveld (f.c.breedveld{at}lumc.nl)
    1. Leiden University, Netherlands
      1. Paul Emery (p.emery{at}leeds.ac.uk)
      1. Leed Teaching Hospitals Trust and the University of Leeds, United Kingdom
        1. Stanley Cohen (arthdoc{at}aol.com)
        1. Metroplex Clinical Research Center, United States
          1. Edward Keystone (edkeystone{at}mtsinai.on.ca)
          1. University of Toronto, Canada
            1. Eric L Matteson (matteson.eric{at}mayo.edu)
            1. Mayo Clinic of Medicine, United States
              1. Yvette Baptiste (yvette.baptiste{at}roche.com)
              1. Roche Products Ltd, United Kingdom
                1. Akiko Chai (chai.akiko{at}gene.com)
                1. Genentech, Inc., United States
                  1. Laura Burke (laura.burke{at}roche.com)
                  1. Roche Products Ltd, United Kingdom
                    1. William Reiss (reiss.william{at}gene.com)
                    1. Genentech, Inc., United States
                      1. Marianne Sweetser (marianne.sweetser{at}biogenidec.com)
                      1. Biogen Idec, United States
                        1. Tim M Shaw (tim.shaw{at}roche.com)
                        1. Roche Products Ltd, United Kingdom

                          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.

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