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Clinical response and tolerability to abatacept in patients with rheumatoid arthritis previously treated with infliximab or abatacept: open-label extension of the ATTEST Study
  1. Michael Schiff1,
  2. Mauro Keiserman2,
  3. Christine Codding3,
  4. Suthin Songcharoen4,
  5. Alberto Berman5,
  6. Sauithree Nayiager6,
  7. Cristina Saldate7,
  8. Richard Aranda8,
  9. Jean-Claude Becker8,
  10. Marleen Nys9,
  11. Manuela le Bars10,
  12. Diane Moniz Reed8,
  13. Coralie Poncet11,
  14. Maxime Dougados12
  1. 1Department of Rheumatology, University of Colorado School of Medicine, Denver, Colorado, USA
  2. 2Pontificial Catholic University, School of Medicine, Porto Alegre, Brazil
  3. 3Health Research of Oklahoma, Oklahoma City, Oklahoma, USA
  4. 4Arthritis and Osteoporosis Center, Flowood, Mississippi, USA
  5. 5Centro Medico Privado de Reumatologia, Tucuman, Argentina
  6. 6St Augustine's Hospital, Durban, South Africa
  7. 7Centro de Investigacion del Noroeste, Tijuana, Mexico
  8. 8Bristol-Myers Squibb, Princeton, New Jersey, USA (at time of study)
  9. 9Bristol-Myers Squibb, Braine L’Alleud, Belgium
  10. 10Bristol-Myers Squibb, Rueil-Malmaison, France
  11. 11Docs International, Issy les Moulineaux, France
  12. 12Paris-Descartes University, Medicine Faculty, Cochin Hospital, Paris, France
  1. Correspondence to Michael Schiff, Department of Rheumatology, University of Colorado, 5400 South Monaco Street, Greenwood Village, CO 80111, USA; lmschiff{at}aol.com

Abstract

Objective To assess the efficacy and safety of abatacept in biological-naive patients with rheumatoid arthritis and an inadequate response to methotrexate treated in the long-term extension (LTE) of the ATTEST trial.

Methods Patients randomly assigned to abatacept, placebo or infliximab completing the 1-year double-blind period were eligible to receive abatacept ~10 mg/kg in the open-label LTE. Efficacy to year 2 is presented for patients randomly assigned to abatacept or infliximab who switched to open-label abatacept. Safety data are presented for all patients entering LTE regardless of double-blind treatment.

Results Of 431 patients randomly assigned, 79.8% remained on abatacept at year 2. At years 1 and 2, 19.7% and 26.1% of abatacept and 13.3% and 28.6% of infliximab-to-abatacept patients achieved disease activity score 28-defined remission (<2.6). Safety with abatacept during the cumulative study period was consistent with the double-blind experience, with no increase in adverse event incidence following the switch to abatacept.

Conclusion In methotrexate-inadequate responders, abatacept efficacy was maintained over 2 years. For infliximab-to-abatacept patients, efficacy improvements were seen in year 2 after patients switched to abatacept. Switching directly from infliximab to abatacept was well tolerated. These data demonstrate that abatacept provides sustained responses and consistent safety, suggesting that switching from infliximab to abatacept is a viable treatment option.

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Footnotes

  • Funding This study was sponsored, and editorial support funded, by Bristol-Myers Squibb.

  • Competing interests MS, MD and MK have received grant support and consulting fees from Bristol-Myers Squibb. SS has received grant support from Bristol-Myers Squibb. RA, J-CB, MN, MlB and DMR are employees and stock-holders of Bristol-Myers Squibb. CC, AB, SN and CS have no conflict of interest to declare.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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