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AB0531 Real-world efficacy and safety of abatacept treatment for RA: 12-month interim analysis of the action study
  1. H. Nüßlein1,
  2. R. Alten2,
  3. M. Galeazzi3,
  4. H.M. Lorenz4,
  5. D. Boumpas5,
  6. M.T. Nurmohamed6,
  7. W.G. Bensen7,
  8. G.R. Burmester8,
  9. H.H. Peter9,
  10. F. Rainer10,
  11. K. Pavelka11,
  12. M. Chartier12,
  13. C. Poncet13,
  14. C. Rauch14,
  15. M. Le Bars15
  1. 1University of Erlangen, Internistische Schwerpunktpraxis, Nürnberg
  2. 2Schlosspark-Klinik Univ Medicine, Berlin, Germany
  3. 3Univ of Siena, Siena, Italy
  4. 4Univ Hospital, Heidelberg, Germany
  5. 5Panepistimio Kritis, Rethymnon, Greece
  6. 6VU Univ Medical Center/Jan van Breeman Research Institute, Amsterdam, Netherlands
  7. 7McMaster Univ, Ontario, Canada
  8. 8Charité-Universitätsmedizin, Berlin
  9. 9Univ of Freiburg, Freiburg, Germany
  10. 10Hospital Barmherzige Brueder, Graz, Austria
  11. 11Institute of Rheumatology, Prague, Czech Republic
  12. 12Chiltern International, Neuilly
  13. 13Docs International, Sèvres, France
  14. 14Bristol-Myers Squibb, Munich, Germany
  15. 15Bristol-Myers Squibb, Rueil-Malmaison, France


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

  1. Nüßlein H et al. Ann Rheum Dis 2011.

  2. Genovese M et al. N Engl J Med 2005;353:1114–23.

  3. Kremer et al. Annals Internal Med 2006;144:865-76;

  4. Schiff M et al. Int J Clin Rheumatol 2010;5:581–91; Nüßlein H et al Ann Rheum Dis 2011;70(Suppl 3):464.

  5. Leffers HC et al. Ann Rheum Dis 2011;70:1216-22.

  6. Gomez-Reino J et al. Arthr Res Ther 2006;8:R29.

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

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