Background Initial results from the real-world ACTION study suggest that abatacept (ABA) is clinically effective and well tolerated in pts with RA, with good pt retention over 12 mths.1
Objectives To assess retention rates and the effectiveness of IV ABA over 24 mths in the ACTION study.
Methods ACTION is a 2-yr, international (Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Greece, Italy, the Netherlands), non-interventional cohort of pts with RA who initiated IV ABA between May 2008 and January 2011. ABA retention (and 95% CI) over 24 mths was estimated by Kaplan–Meier and stratified by previous RA therapy. The proportion of pts achieving a moderate or good EULAR response was assessed in pts on ABA at 24 mths (as observed). Safety is reported for all enrolled pts.
Results 1137 pts were enrolled and 1131 pts were evaluable; 122 (10.8%) patients were biologic-naïve and 1009 (89.2%) had failed ≥1 prior biologic agent (out of which, 487/1009 [48.3%] failed 1 anti-TNF and 504/1009 [50.0%] ≥2 anti-TNFs, while 18/1009 [1.8%] failed non anti-TNFs only). Baseline characteristics were similar, but disease duration was numerically shorter in biologic-naïve pts versus pts failing ≥1 prior biologic agent (7.0 vs 11.8 yrs). The overall retention rate (95% CI) at 24 mths was 54.4% (51.3, 57.4). Retention rates at 24 mths were higher in biologic-naïve pts (63.2% [53.2, 71.6]) and pts who failed 1 prior anti-TNF (60.6% [55.9, 64.9]) versus pts failing ≥2 prior anti-TNFs (46.7% [42.0, 51.2]) (Figure). The retention rate was 49.2% (44.0, 54.1) in pts who had failed 2 previous anti-TNFs (n=410) and 35.5% (25.4, 45.7) in pts who failed 3 previous anti-TNFs (n=94). More pts discontinued in later lines of treatment for inefficacy (23.9% in biologic-naïve pts and 35.7% in pts failing ≥1 prior biologic agent) than intolerance/safety (7.0% and 10.6%, respectively). A good or moderate EULAR response was achieved in 95.0% of biologic-naïve pts (n=20) and in 80.2% of pts failing ≥1 prior biologic agent (n=283). There were 111 serious adverse events in 63/1137 (5.5%) pts (28 discontinuations) and 12 deaths, including 4 due to serious infections (sepsis [4 mths after last ABA infusion; pt was receiving tocilizumab]; Pneumocystis jiroveci [4 mths after last ABA infusion, pt had deep vein thrombosis]; pneumonia and urosepsis unrelated to ABA). Serious infections occurred in 26 pts and there were 12 malignancies, 5 serious cardiac disorders and 1 serious hypersensitivity reaction. No TB occurred and 2 opportunistic infections were reported (Cytomegalovirus and P. jiroveci).
Conclusions In this real-world setting study, more than 50% of patients retained IV abatacept over 2 years. Higher long-term retention rates were observed when abatacept was initiated earlier in the course of RA. In ACTION, IV abatacept was clinically effective and well tolerated in a broad range of bioexperienced patients.
Nüβlein H, et al. Arthritis Rheum 2012;64(Suppl10):S199.
Disclosure of Interest H. Nüβlein Consultant for: Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis and Roche, Speakers bureau: Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis and Roche, R. Alten Grant/research support: BMS, Speakers bureau: BMS, M. Galeazzi: None declared, H.-M. Lorenz Consultant for: BMS, Speakers bureau: BMS, M. Nurmohamed Grant/research support: The Jan van Breemen Research Institute has received research grants from Roche, Abbott, Pfizer, UCB and BMS, Consultant for: Roche, Schering-Plough, BMS, UCB, Wyeth, Pfizer and MSD, Speakers bureau: Abbott, Roche, Pfizer and BMS, W. Bensen Grant/research support: Abbott, Amgen, BMS, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, Sanofi-Aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth, Consultant for: Abbott, Amgen, BMS, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, Sanofi-Aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth, Speakers bureau: Abbott, Amgen, BMS, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, Sanofi-Aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth, G.-R. Burmester Grant/research support: Clinical trials for BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, Abbott, Pfizer, MSD, Roche, UCB, H.-H. Peter: None declared, K. Pavelka Grant/research support: MSD, Pfizer, Amgen, AbbVie, Roche, Consultant for: MSD, Pfizer, Amgen, AbbVie, Roche, M. Chartier Consultant for: BMS, C. Poncet Consultant for: BMS, C. Rauch Employee of: BMS, M. Le Bars Shareholder of: BMS, Employee of: BMS