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FRI0235 Adherence to the recommended dosing regimen of abatacept: 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. 3Univ of Siena, Siena, Italy
  4. 4Univ 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 In real-life, dosage increases are often described with biologic agents.1 Intravenous (IV) abatacept should be administered by patient body weight (10 mg/kg) 2 and 4 weeks (wks) after the first infusion and every 4 wks thereafter,2 totalling 8 infusions over the first 6 months (mths). No adjustments to this schedule are recommended. Abatacept retention rates, efficacy and safety over 12 mths in ACTION have been reported previously.3,4

Objectives To assess adherence to the recommended dosing regimen of abatacept over the first 6 mths of treatment in ACTION.

Methods ACTION is an ongoing, 2-year, international, non-interventional, prospective cohort of RA patients treated with IV abatacept. All patients on abatacept treatment for ≥6 mths, and with infusion data available at initiation and at 6 mths, were considered in this analysis. Good adherence to treatment was defined as correct dose by patient body weight and number of actual-to-recommended infusions within the range 80–120% (i.e. 7–9 infusions).

Results 783/1120 (69.9%) patients received abatacept ≥6 mths and had infusion data available at initiation and 6 mths. The majority had established RA and failed ≥1 anti-TNF agent (87.5%). Of 774 patients with body weight data available at initiation, 87.6% received the recommended initial dose, 6.5% a lower dose and 5.9% a higher dose than recommended. Good adherence to the abatacept treatment schedule (7–9 infusions) was found in 670/783 (85.6%) patients. Over 6 mths, 34.0% of patients received 7 infusions, 50.1% received 8 infusions and 1.5% had 9 infusions. Change in dosage over time was assessed in 680/774 patients with data available at both initiation and 6 mths. The majority of patients (86.6%) maintained the recommended dosage over time. 500/680 (73.5%) patients received abatacept at the recommended dose for their weight (10 mg/kg) and at the recommended treatment schedule (7–9 infusions) over 6 mths.

Conclusions In the real-world ACTION study, adherence to the recommended treatment regimen of abatacept over 6 mths was good. Few patients received changes in dose and/or frequency of administration over this time period.

References

  1. Ariza-Ariza R, et al. Rheumatology 2007;46:529-32;

  2. Abatacept EU SmPC;

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

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

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, Wyeth, Consultant for: Abbott, Amgen, Bristol-Myers Squibb, Janssen, Merck, Lilly, Novartis, Pfizer, Proctor and Gamble, Roche, sanofi aventis, Schering, Takeda, UCB, Warner Chilcott, Wyeth, Speakers bureau: Abbott, Amgen, Bristol-Myers Squibb, 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, 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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