Background We previously presented 6-month (mth) results of a prospective, non-interventional study with IV abatacept (ABA);1 here we show the efficacy, safety and retention rate (RR) results of a 12-mth planned interim analysis including 65% of the enrolled cohort.
Objectives To evaluate RR, efficacy and safety of ABA in RA patients (pts) treated in routine clinical practice.
Methods ACTION (AbataCepT In rOutiNe clinical practice) is a non-interventional, longitudinal study in ABA-treated RA pts. RR (Kaplan–Meier estimation; pts not reaching the timepoint were censored at the last infusion date available) and disease activity (DAS28 [ESR and/or CRP], CDAI, for pts with available data) are reported. Safety was assessed in all pts, and reported up to Aug 2011.
Results 1138/1114 pts were enrolled/evaluable. At 12 mths 65% of pts had reached the timepoint or discontinued, and were available for this analysis. Mean (SD) baseline characteristics were: age 56.5 (12.6) years (yrs); disease duration 11.0 (8.9) yrs;RF+ 69.2%; anti-CCP+ 65.2%; 70.0% with erosions; 89.4% had failed ≥1 biologic; 21.2% had received ABA monotherapy; 73.8% had concomitant corticosteroids. The 12-mth overall RR (95% CI) was 70.7% (67.5, 73.7); 81.6% (71.8, 88.5) in biologic-naïve pts, 69.4% (66.0, 72.7) in pts who had previously failed a biologic. 251 pts discontinued. Efficacy is shown in table 1.
Ninety-five SAEs were reported in 54/1138 (4.7%) pts (20 discontinuations): 8 deaths (4 due to serious infections), 19 serious infections, 8 malignancies, 5 cardiac and 3 vascular disorders. No TB, but one opportunistic infection was reported (Pneumocystis jiroveci).
Conclusions These long-term data confirm abatacept’s clinical effectiveness, safety and RR in RA pts with long-term, erosive disease. These data are consistent with previous RCTs findings,2,3 the preliminary 6-mth findings,1,4 and national registry data for abatacept and other biologics.5,6
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Disclosure of Interest H. Nüßlein Consultant for: Bristol-Myers Squibb, R. Alten Grant/Research support from: BMS, Merck Pharma GmbH, Wyeth Pharmaceuticals, Pfizer, Consultant for: Abbott Laboratories, Horizon Pharma, Merck Pharma GmbH, Nitec Pharma GmbH, Novartis Pharmaceuticals Corporation, Roche, Speakers Bureau: Abbott Laboratories, BMS, Horizon Pharma, Merck Pharma GmbH, Novartis Pharmaceuticals Corporation, Roche, M. Galeazzi: None Declared, H. Lorenz Grant/Research support from: Wyeth, Consultant for: Bristol-Myers Squibb, Wyeth/Pfizer, Essex, MSD, UCB, Chugai, Roche, Abbott, D. Boumpas: None Declared, M. Nurmohamed Grant/Research support from: BMS, MSD, Roche, Abbott, Pfizer and UCB, Consultant for: BMS, MSD, Roche, Abbott, Pfizer and UCB, Speakers Bureau: BMS, MSD, Roche, Abbott, Pfizer and UCB, W. Bensen Grant/Research support from: 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. Burmester Grant/Research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Speakers Bureau: Bristol-Myers Squibb, H. Peter: None Declared, F. Rainer: None Declared, K. Pavelka Consultant for: Roche, Abbott, MSD, Speakers Bureau: Pfizer, MSD, M. Chartier: None Declared, C. Poncet: None Declared, C. Rauch Employee of: Bristol-Myers Squibb, M. Le Bars Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb