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SAT0106 Predictors of Retention with Abatacept in Patients Who have Failed One or More Biologic Agents: Results from the International, Real-World 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. 1Internistische Schwerpunktpraxis, Nürnberg
  2. 2Schlosspark-Klinik University Medicine, Berlin, Germany
  3. 3University of Siena, Siena, Italy
  4. 4University Hospital, Heidelberg, Germany
  5. 5University of Crete and IMBB-FORTH, Heraklion, Greece
  6. 6VU Univ Medical Center/Jan van Breeman Research Institute, Amsterdam, Netherlands
  7. 7St Josephs Hospital and McMaster University, Hamilton, Canada
  8. 8Charité-Universitätsmedizin, Berlin
  9. 9University 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 Anti-cyclic citrullinated peptide (CCP) status was reported previously as predictive of abatacept response.1 Predictors of retention with abatacept have not been published previously.

Objectives To identify predictors of abatacept retention after failing ≥1 biologic agent.

Methods ACTION is an ongoing, 2-year, international, non-interventional, prospective cohort including patients with RA treated with IV abatacept.2,3 Patients from Canada, Germany, Greece and Italy, where patient numbers were sufficient to explore between-country effects, were included. At data cut-off (February 2012), all patients had 1-year follow up (interim analysis). Abatacept discontinuations were reported by the investigator at any time point during follow up. Socio-demographics, disease characteristics and medical history at abatacept initiation, and previous and concomitant treatments were deemed potential predictive variables. Clinically relevant variables and those with p≤0.2 (univariate analysis) were entered into a multivariate Cox proportional-hazards regression model, adjusted for clustered data from one investigator. Using backwards selection, variables with p≤0.1 were retained in the final model.

Results Overall, 865/999 (86.6%) patients who had failed ≥1 biologic agent (98% failed anti-TNF) were included. In the multivariate model, patients (n=834) had a significantly lower risk of abatacept discontinuation if they were anti-CCP positive (p<0.001; hazard ratio [HR]=0.55 [95% CI: 0.40, 0.75]), failed <2 anti-TNF agents (p=0.005 vs ≥2 anti-TNFs; 0.71 [0.56, 0.90]) and had a cardiac comorbidity at abatacept initiation (p=0.009; 0.48 [0.28, 0.83]). Patients in Greece and Italy were less likely to discontinue than patients in Germany (p<0.001 vs Germany; Greece 0.30 [0.16, 0.58]; Italy 0.50 [0.33, 0.76]; Canada 1.04 [0.78, 1.40]). There were no interactions or effects of C-reactive protein level, rheumatoid factor status, type of previous anti-TNF failure, infection at initiation and abatacept monotherapy. Sensitivity analysis, including all variables significant in univariate analysis, was consistent.

Conclusions In this first report of real-world predictors of abatacept patient retention, anti-CCP positivity and failing <2 prior anti-TNF agents were associated with higher retention. Differences in retention between some countries may reflect specificities in healthcare systems and populations. Abatacept, a biologic agent with no contraindications or special warnings for cardiac comorbidity, seems to be a good option for these patients.

References

  1. Gottenberg JE, et al. Ann Rheum Dis 2012;71:1815-9;

  2. Nüßlein H, et al. Ann Rheum Dis 2011;70(Suppl.3):464;

  3. Nüßlein H, et al. Arthr Rheum 2012;64(Suppl10):S199

Disclosure of Interest H. Nüßlein Consultant for: Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis, Roche, Speakers bureau: Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis, Roche, R. Alten Grant/research support from: Bristol-Myers Squibb, 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, Bristol-Myers Squibb, Horizon Pharma, Merck Pharma GmbH, Novartis Pharmaceuticals Corporation, Roche, M. Galeazzi: None Declared, H. Lorenz Speakers bureau: Bristol-Myers Squibb, D. Boumpas Grant/research support from: Unconditional educational grant support, M. Nurmohamed Grant/research support from: The Jan van Breemen Research Institute has received research grants from Bristol-Myers Squibb, MSD, Roche, Abbott, Pfizer, UCB, Consultant for: Bristol-Myers Squibb, MSD, Roche, Abbott, Pfizer, UCB, Employee of: Jan van Breemen Research Institute, VU University Medical Center, Speakers bureau: Bristol-Myers Squibb, MSD, Roche, Abbott, Pfizer, UCB, W. Bensen Grant/research support from: Abbott, Amgen, Bristol-Myers Squibb, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, sanofi aventis, Schering, Takeda, UCB, Warner Chilcott, Wyet, Consultant for: Abbott, Amgen, Bristol-Myers Squibb, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, sanofi aventis, Schering, Takeda, UCB, Warner Chilcott, Wyet, Speakers bureau: Abbott, Amgen, Bristol-Myers Squibb, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, sanofi aventis, Schering, Takeda, UCB, Warner Chilcott, Wyet, G. Burmester Grant/research support from: Bristol-Myers Squibb, Abbott, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, Abbott, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, Abbott, Pfizer, MSD, Roche, UCB, H.-H. Peter Speakers bureau: Pfizer Germany, F. Rainer: None Declared, K. Pavelka Consultant for: Roche, Abbott, MSD, Amgen, Speakers bureau: Pfizer, MSD, UCB, Bristol-Myers Squibb, M. Chartier Consultant for: Bristol-Myers Squibb, C. Poncet Consultant for: Bristol-Myers Squibb, C. Rauch Employee of: Bristol-Myers Squibb, M. Le Bars Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb

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