Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Abatacept Demonstrates Consistent Safety and Sustained Improvements in Efficacy through 4 Years of Open-Label Treatment in Patients with An Inadequate Response to Anti-TNF Therapy
Genovese1, M. C., Schiff2, M., Luggen3, M. E., Le Bars4, M., Becker5, J. C., Aranda5, R., Elegbe5, A.
Stanford University, Palo Alto, CA,
Univ of Colorado, Denver, CO,
University of Cincinnati Medical Center, Cincinnati, OH,
Bristol-Myers Squibb, Rueil-Malmaison, France,
Bristol-Myers Squibb, Princeton, NJ,
Hospital Cochin, Descartes Univ, Paris, France
Abatacept has demonstrated sustained efficacy and consistent safety over 3 years in patients with RA and an inadequate response to anti-TNF therapy in the ATTAIN (Abatacept Trial in Treatment of Anti-TNF INadequate responders) trial1. Here we evaluate the long-term safety and efficacy of abatacept over 4 years of the open-label (OL) long-term extension (LTE) of this trial.
Patients completing the 6-month double-blind (DB) period were eligible for the LTE (abatacept ~10 mg/kg, every 4 wks plus DMARDs). Here we present interim as-observed analyses of long-term safety and efficacy. Safety was assessed monthly for all patients who received >=1 dose of abatacept during the LTE.
Clinical efficacy (ACR 20, 50 and 70 responders), disease activity status (DAS28 [CRP]-defined remission [DAS28<2.6] and Low Disease Activity State [LDAS; DAS28 <=3.2]) were evaluated quarterly to Year 3, and biannually thereafter, for patients originally randomized to abatacept.
In total, 258 and 133 patients were randomized and treated with abatacept or placebo in the DB period; 218 and 99 entered the LTE, respectively. At the time of reporting, 6 months of DB and 4 years of LTE efficacy data were available, while safety analyses were reported up to Nov 2008 (mean abatacept exposure during the DB period plus LTE=42.2 months [range=3.765.5]). Up to Nov 2008, 165 (52.1%) patients discontinued from the LTE. In the DB period vs the LTE, incidence rates for serious adverse events were 25.98 vs 19.55/100 patientyears (ptyrs), and for serious infections were 5.28 vs 3.40/100 ptyrs. There were no cases of TB or opportunistic infections in the LTE. Rates of malignancies were 3.51 vs 2.17/100 ptyrs in the DB vs LTE period. Rates of autoimmune events were 1.75 vs 1.53/100 ptyrs in the DB vs LTE period. There was a sustained improvement over 4 years of OL abatacept treatment in ACR 20 responders (Month 6=60.1%[95% CI: 53.6, 66.6] vs Year 4.5=80.9%[75.7, 86.1]). A similar pattern was observed for ACR 50 and 70 responders (Month 6=23.9%[18.2, 29.6] and 11.8%[7.5, 16.1] vs Year 4.5=45.0%[38.4, 51.7] and 23.2%[17.6, 28.8]), and for patients achieving LDAS and DAS28-defined remission (Figure).
In this trial of patients with RA and an inadequate response to anti-TNF therapy, the safety of abatacept over 4 years of the LTE was consistent with the DB period. Sustained clinical efficacy was observed in patients initially randomized to abatacept, supporting long-term use of abatacept in this patient population with refractory disease.
To cite this abstract, please use the following information:
Genovese, M. C., Schiff, M., Luggen, M. E., Le Bars, M., Becker, J. C., Aranda, R., et al; Abatacept Demonstrates Consistent Safety and Sustained Improvements in Efficacy through 4 Years of Open-Label Treatment in Patients with An Inadequate Response to Anti-TNF Therapy [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1689