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Ann Rheum Dis 2009;68:1894-1897 doi:10.1136/ard.2008.101675
  • Clinical and epidemiological research
  • Concise report

Safety of biological therapies following rituximab treatment in rheumatoid arthritis patients

  1. M C Genovese1,
  2. F C Breedveld2,
  3. P Emery3,
  4. S Cohen4,
  5. E Keystone5,
  6. E L Matteson6,
  7. Y Baptiste7,
  8. A Chai8,
  9. L Burke7,
  10. W Reiss8,
  11. M Sweetser9,
  12. T M Shaw7
  1. 1
    Stanford University School of Medicine, Palo Alto, California, USA
  2. 2
    Leiden University Medical Center, Leiden University, Leiden, The Netherlands
  3. 3
    Leeds Teaching Hospitals Trust, the University of Leeds, Leeds, UK
  4. 4
    Metroplex Clinical Research Center, Dallas, Texas, USA
  5. 5
    University of Toronto, Toronto, Canada
  6. 6
    Mayo Clinic of Medicine, Rochester, Minnesota, USA
  7. 7
    Roche Products Ltd, Welwyn Garden City, UK
  8. 8
    Genentech, Inc, South San Francisco, California, USA
  9. 9
    Biogen Idec, Inc, Cambridge, Massachusetts, USA
  1. Correspondence to Dr M C Genovese, Division of Rheumatology, Stanford University Medical Center, 1000 Welch Road, Suite 203, Palo Alto, CA 94304, USA; genovese{at}stanford.edu
  • Accepted 14 December 2008
  • Published Online First 20 January 2009

Abstract

Objective: To assess the safety of biological disease-modifying antirheumatic drugs (DMARD) in rheumatoid arthritis (RA) patients following rituximab.

Methods: RA patients who participated in an international rituximab clinical trial programme were included. Patients who had received one or more rituximab courses and entered safety follow-up (SFU) were permitted additional biological DMARD. Serious infection events (SIE) were collected.

Results: Of 185 of 2578 patients who entered SFU and received another biological DMARD, 88.6% had peripheral B-cell depletion at the time of initiation of another biological agent. Thirteen SIE (6.99 events/100 patient-years) occurred following rituximab but before another biological DMARD and 10 SIE (5.49 events/100 patient-years) occurred following another biological DMARD. SIE were of typical type and severity for RA patients. 153 had received one or more tumour necrosis factor inhibitor(s). No fatal or opportunistic infections occurred.

Conclusions: In this analysis, treatment with biological DMARD after rituximab was not associated with an increased serious infection rate. Sample size with limited follow-up restricts definitive conclusions.

Footnotes

  • Funding This report was sponsored by F Hoffmann-La Roche Ltd, Biogen Idec, Inc and Genentech, Inc. A portion of this work (Stanford University) was supported in part by a grant (5 M01 RR000070) from the National Center for Research Resources, National Institutes of Health.

  • Competing interests Declared. MCG has received speaker fees and research grant support from Roche and has served as a consultant for Roche, Biogen Idec and Genentech. FCB has received consulting and speaker fees from Roche. EK has received consulting and speaker fees from Roche and Genentech and research grants from Roche. PE has received consulting and speaker fees and research grants from Roche; he is the arc Professor of Rheumatology of the Academic Unit of Musculoskeletal Disease at Leeds University. SC has received consulting and speaker fees and research grants from Genentech, Inc. ELM has received consulting fees and research grants from Biogen Idec. YB, LB and TMS are employees and own shares in Roche Products Ltd. MS is an employee and owns shares in Biogen Idec. AC and WR are employees and own shares in Genentech, Inc.

  • Role of the study sponsors: Data collection was co-sponsored by F Hoffmann-La Roche Ltd, Biogen Idec, Inc and Genentech, Inc. Statistical analyses were conducted by qualified statisticians who were employees of the sponsors. All the authors had access to and involvement in the interpretation of the data and input into the content of this manuscript (supervised by MCG).

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