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  • Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy

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Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy
  1. M C Genovese1,
  2. M Schiff2,
  3. M Luggen3,
  4. J-C Becker4,
  5. R Aranda4,
  6. J Teng4,
  7. T Li4,
  8. N Schmidely5,
  9. M Le Bars5,
  10. M Dougados1,6
  1. 1
    Stanford University, Division of Immunology and Rheumatology, 1000 Welch Road #203, Palo Alto, CA, 94304, USA
  2. 2
    Denver Arthritis Clinic, Denver, CO, USA
  3. 3
    University of Cincinnati Medical Center, Cincinnati, OH, USA
  4. 4
    Bristol-Myers Squibb, Princeton, NJ, USA
  5. 5
    Bristol-Myers Squibb, Rueil-Malmaison, France
  6. 6
    Hopital Cochin, Descartes University, Paris, France
  1. Dr Mark Genovese, Stanford University, Division of Immunology and Rheumatology, 1000 Welch Road #203, Palo Alto, CA, 94304, USA; genovese{at}stanford.edu

Abstract

Objective: To evaluate the safety and efficacy of abatacept during 2 years of the ATTAIN (Abatacept Trial in Treatment of Anti-TNF INadequate responders) trial in patients with rheumatoid arthritis.

Methods: Patients completing the 6-month, double-blind period were eligible to enter the long-term extension; patients received abatacept ∼10 mg/kg, plus disease-modifying antirheumatic drugs. Safety and efficacy (American College of Rheumatology (ACR) criteria responses, DAS28 (C-reactive protein), HAQ-DI, SF-36, Medical Outcomes Study Sleep Problems Index, fatigue VAS) were assessed through 2 years.

Results: 317 patients (218 from the abatacept and 99 from the placebo group) entered and 222 (70%) completed 18 months of long-term extension treatment. The incidence and type of adverse events were consistent between the double-blind and cumulative (double-blind plus long-term extension) periods. Rates of serious adverse events were 25.6 and 23.4 per 100 patient-years in the double-blind versus cumulative period. At 6 months and 2 years, using non-responder analyses, ACR responses in abatacept-treated patients were: ACR 20, 59.4% and 56.2%; ACR 50, 23.5% and 33.2%; ACR 70, 11.5% and 16.1%; HAQ-DI responses were 54.4% and 47.9%. At 6 months and 2 years, using post-hoc as-observed analyses, the percentage of patients (95% confidence interval) achieving DAS28 (C-reactive protein) low disease activity score (⩽3.2) and DAS28 (C-reactive protein)-defined remission (<2.6) increased from 18.3% (13.0, 23.5) to 32.0% (24.6, 39.4) and 11.1% (6.8, 15.3) to 20.3% (13.9, 26.6). Clinically meaningful improvements in SF-36, pain, fatigue and sleep problems were also maintained throughout the 2 years of abatacept treatment.

Conclusion: No unique safety observations were reported during open-label exposure. Improvements in the signs and symptoms of rheumatoid arthritis, physical function and health-related quality of life observed after 6 months, were maintained throughout the 2 years in this population with difficult-to-treat disease.

Trial registration number: NCT00124982.

https://doi.org/10.1136/ard.2007.074773

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    Footnotes

    • Competing interests: None.

    • The Food and Drug Administration registration number for this clinical trial is NCT00124982.