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  • The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial

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Clinical and epidemiological research
Extended report
The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial
  1. M Schiff1,
  2. C Pritchard2,
  3. J E Huffstutter3,
  4. V Rodriguez-Valverde4,
  5. P Durez5,
  6. X Zhou6,
  7. T Li6,
  8. K Bahrt6,
  9. S Kelly6,
  10. M Le Bars7,
  11. M C Genovese8
  1. 1
    University of Colorado, Denver, Colorado, USA
  2. 2
    Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA
  3. 3
    Arthritis Associates, Hixson, Tennessee, USA
  4. 4
    Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain
  5. 5
    Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
  6. 6
    Bristol-Myers Squibb, Princeton, New Jersey, USA
  7. 7
    Bristol-Myers Squibb, Rueil-Malmaison, France
  8. 8
    Stanford University, Palo Alto, California, USA
  1. Correspondence to Dr M Schiff, University of Colorado, 5400 South Monaco Street, Greenwood Village, CO 80111, USA; Lmschiff{at}aol.com

Abstract

Objective: To assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout.

Methods: In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 (C-reactive protein; CRP) of 5.1 or greater. “Washout” patients discontinued anti-TNF therapy 2 months or longer pre-screening; “direct-switch” patients began abatacept (∼10 mg/kg) at their next scheduled anti-TNF therapy dose.

Results: 1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (⩾1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index ⩾0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4).

Conclusion: Abatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice.

Trial registration number: NCT00124982.

https://doi.org/10.1136/ard.2008.099218

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    Footnotes

    • Funding This study was funded and sponsored by Bristol-Myers Squibb, Princeton, New Jersey, USA, who was responsible for the study design, collection, analysis and interpretation of the data as well as the decision to publish. Editorial assistance was provided by Medicus International and funded by Bristol-Myers Squibb, Princeton, New Jersey, USA.

    • Competing interests Declared. MS has received research grants and consulting fees from Bristol-Myers Squibb, Roche, Abbott and Centocor; CP has received speaking fees from Genentech, Bristol-Myers Squibb and Centocor; JEH has received grant support from BMS and Genentech, and speaking fees from BMS, Centocor, Genentech, Lilly and Pfizer; VR-V has received speaking fees from Wyeth and was on the advisory committee for Schering-Plough; XZ is an employee of Bristol-Myers Squibb; TL, SK and MLB are employees of Bristol-Myers Squibb and have stock options; MG has received research grants and consulting fees from Bristol-Myers Squibb, Genentech, Roche, Biogen-Idec, Abbott, Amgen, Wyeth, Centocor, Pfizer and Merk Serono.

    • Ethics approval The study was conducted in accordance with the Declaration of Helsinki and was approved by local institutional review boards.

    • Patient consent Obtained.