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.

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 ( approximately 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) (> or =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 > or =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.

• Authors: M Schiff, C Pritchard, J E Huffstutter, V Rodriguez-Valverde, P Durez, X Zhou, T Li, K Bahrt, S Kelly, M Le Bars, M C Genovese
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 68 Issue 11 Pg. 1708-14 (Nov 2009) ISSN: 1468-2060 [Electronic] England
• PMID: 19074911 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Biomarkers
• Immunoconjugates
• Tumor Necrosis Factor-alpha
• Abatacept
• C-Reactive Protein

Topics

• Abatacept
• Adult
• Aged
• Antirheumatic Agents (adverse effects, therapeutic use)
• Arthritis, Rheumatoid (blood, drug therapy)
• Autoimmune Diseases (chemically induced)
• Biomarkers (blood)
• C-Reactive Protein (metabolism)
• Female
• Humans
• Immunoconjugates (adverse effects, therapeutic use)
• Male
• Middle Aged
• Neoplasms (chemically induced)
• Opportunistic Infections (chemically induced)
• Quality of Life
• Severity of Illness Index
• Treatment Failure
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)