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AB0532 Effect of prior therapy on the efficacy and safety of abatacept: 6-month 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. 4University 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

Abstract

Background Randomized controlled trials have demonstrated the long-term efficacy and favourable safety of abatacept (ABA) in RA patients (pts).1 Previously we reported 6-month (mth) results of an interim analysis of German and Canadian pts enrolled in this study.2

Objectives Evaluate the effect of prior therapy on retention rate,efficacy and safety of ABA in RA pts treated in routine clinical practice in Europe and Canada.

Methods ACTION (AbataCepT In rOutiNe clinical practice) is a non-interventional, prospective, longitudinal study in ABA-treated RA pts. Here we present the 6-mth planned interim analysis in pts from all participating countries. Retention rates (Kaplan–Meier estimation) are reported for subgroups of pts failing ≥1 anti-TNF agents and by reason for previous failure. Safety was assessed in all pts and reported up to Aug 2011.

Results 1138/1114 pts were enrolled/evaluable; 86% of pts had reached mth 6 or discontinued ABA within 6 mths at time of analysis. Mean (SD) baseline characteristics were: age 56.5 (12.6) years (yrs); disease duration 11.0 (8.9) yrs; female 81.1%; RF+ 69.2%. Overall 6-mth retention rate (95% CI) was 88.6% (86.4, 90.4), 93.0% (85.9, 96.6) in pts who failed DMARDs and 88.1% (85.7, 90.0) in pts who failed biologic agents. Of 978 pts who failed prior biologics, 49.1% and 50.2% failed 1 or ≥2 anti-TNF agents, respectively, and 26.6%, 46.5% and 22.0% failed the previous biologic due to primary or secondary inefficacy or safety/tolerance, respectively. Retention rates (95% CI) were 89.2% (85.8, 91.8) and 86.7% (83.1, 89.5) in pts who failed 1 or ≥2 anti-TNF agents, respectively, and 84.4% (79.0, 88.6), 90.3% (86.9, 92.8), and 85.1% (79.1, 89.5) in pts who failed due to primary inefficacy, secondary inefficacy or safety/tolerance, respectively. 95 SAEs were reported in 54/1138 (4.7%) pts (20 discontinuations): 8 deaths including 4 due to serious infections, 19 serious infections, 8 malignancies, 5 cardiac disorders and 3 vascular disorders. No TB but one event of opportunistic infection was reported (Pneumocystis jiroveci).

Conclusions This long-term observational study of abatacept in RA pts in a real-life setting demonstrates similar retention rates at 6 mths independent of number or reason for failure of prior anti-TNF agents. Overall retention rate was consistent with data reported in interventional and real-life studies with abtacept.3,4

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

  2. Nußlein H et al. Ann Rheum Dis 2011;70(Suppl 3):464. Poster FRI0359.

  3. Genovese M et al. Ann Rheum Dis 2008;57:547–54.

  4. Schiff M et al. Int J Clin Rheumatol 2010;5:581–91.

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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