AB0532 Effect of prior therapy on the efficacy and safety of abatacept: 6-month analysis of the action study

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 References Genovese M et al. N Engl J Med 2005;353:1114–23. Nußlein H et al. Ann Rheu