FRI0235 Adherence to the recommended dosing regimen of abatacept: results from the international, real-world action study
Authors: H. Nüßlein, R. Alten, M. Galeazzi, H. M. Lorenz, D. Boumpas, M. T. Nurmohamed, W. G. Bensen, G. R. Burmester, H.-H. Peter, F. Rainer, K. Pavelka, M. Chartier, C. Poncet, C. Rauch, M. Le Bars
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> In real-life, dosage increases are often described with biologic agents.<sup>1</sup> 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,<sup>2</sup> 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.<sup>3,4</sup> <h3>Objectives</h3> To assess adherence to the recommended dosing regimen of abatacept over the first 6 mths of treatment in ACTION. <h3>Methods</h3> 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). <h3>Results</h3> 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. <h3>Conclusions</h3> 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. <h3>References</h3> Ariza-Ariza R, et al. <i>Rheumatology</i> 2007;<b>46</b>:529-32; Abatacept EU SmPC; Nüßlein H, et al. <i>Arthr Rheum</i> 2012;<b>64</b>(Suppl10):S199; Nüßlein H, et al. <i>Ann Rheum Dis</i> 2011;<b>70</b>(Suppl.3):464 <b>Disclosure of Interest</b>: 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