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

M Schiff¹, C Pritchard², J E Huffstutter³, V Rodriguez-Valverde⁴, P Durez⁵, X Zhou⁶, T Li⁶, K Bahrt⁶, S Kelly⁶, M Le Bars⁷, M C Genovese⁸

¹ University of Colorado, Denver, Colorado, USA
² Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA
³ Arthritis Associates, Hixson, Tennessee, USA
⁴ Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain
⁵ Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
⁶ Bristol-Myers Squibb, Princeton, New Jersey, USA
⁷ Bristol-Myers Squibb, Rueil-Malmaison, France
⁸ Stanford University, Palo Alto, California, USA

^{Correspondence to} Dr M Schiff, University of Colorado, 5400 South Monaco Street, Greenwood Village, CO 80111, USA; Lmschiff{at}aol.com

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.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?