RESEARCH - The 6-month safety and efficacy of Orencia in patients with RA who underwent washout after anti-TNF therapy or were directly switched to Orencia: ARRIVE

[Guest guest]

Ann Rheum Dis. Published Online First: 15 December 2008.

doi:10.1136/ard.2008.099218

--------------------------------------------------------------------------------

Extended Report

The 6-month safety and efficacy of abatacept in patients with

rheumatoid arthritis who underwent a washout after anti-TNF therapy or

were directly switched to abatacept: the ARRIVE trial

H Schiff 1*, Pritchard 2, J.Eugene Huffstutter 3,

e -Valverde 4, Durez 5, Xianhuang Zhou 6,

Li 6, Bahrt 6, Sheila 6, a Le Bars 7 and

Mark C Genovese 8

1 University of Colorado, Denver, CO, United States

2 Rheumatology Specialty Center, Willow Grove, PA, United States

3 Arthritis Associates, Hixson, TN, United States

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, NJ, United States

7 Bristol-Myers Squibb, Rueil-Malmaison, France

8 Stanford University, Palo Alto, CA, United States

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

and a DAS28 (CRP) of 5.1. 'Washout' patients discontinued anti-TNF

therapy 2 months pre-screening; 'direct-switch' patients began

abatacept (~10 mg/kg) at their next scheduled anti-TNF therapy dose.

Results: In total, 1046 patients were treated (449 washout, 597

direct-switch; baseline characteristics were similar between groups).

At 6 months, adverse events ([AEs] 78.0 vs 79.2%), serious AEs (SAEs;

11.1 vs 9.9%) and discontinuations due to AEs (3.8 vs 4.0%) and SAEs

(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; LDAS, 22.5 vs 22.3%; DAS28-defined remission,12.0

vs 13.7%), physical function (HAQ-DI 0.22 improvement; 46.3 vs 47.1%)

and health-related QoL (mean change in SF-36 scores; PCS, 5.5 vs 6.1;

MCS, 4.8 vs 5.4).

Conclusion: Abatacept demonstrated acceptable safety and tolerability,

and clinically meaningful efficacy over 6 months in patients with an

inadequate response to anti-TNF therapy. Results were comparable

regardless of whether there was a washout or not, supporting

direct-switching from anti-TNF therapy to abatacept as an option in

clinical practice.

http://ard.bmj.com/cgi/content/abstract/ard.2008.099218v1?papetoc

Not an MD