Background/Purpose: ACTION (NCT02109666) was the first prospective international non-interventional study designed to provide long-term real-world data on abatacept retention in patients (pts) with RA. The 1-y interim analyses of ACTION were reported previously.¹

Methods: ACTION is a 2-y observational study of pts with moderate-to-severe RA who initiated IV abatacept as first- or second/further-line biologic therapy in routine clinical practice in Europe and Canada (May 2008–Dec 2013). Here we report the primary outcome of the study, ie 2-y crude abatacept retention rate with 95% CI (overall and by treatment line), estimated by Kaplan–Meier analysis. Additional study outcomes were crude retention rates by participating country, prognostic factors of retention, identifed by backward selection method in multivariate models, and EULAR response by treatment line and RF/anti-citrullinated protein antibody (ACPA) seropositivity, compared by Fisher’s exact test.

Results: In total, 2350/2364 enrolled pts were evaluable for analysis: 673 (28.6%) biologic naïve and 1677 (71.4%) biologic failures. Some expected differences in baseline characteristics were seen between groups and were reported previously.² The 2-y retention rate was 47.9% (95% CI 45.7, 50.0) in the overall population, and was higher in biologic-naïve (54.5% [50.4, 58.3]) vs -failure pts (45.2% [42.7, 47.7]; p<0.001); main reasons for abatacept discontinuation were lack of efficacy (61.4 vs 67.7%) and safety (21.3 vs 21.2%).² By country, overall retention rates were 37.5–66.7%; rates were highest in Belgium (66.7%) and Austria (60.5%). Retention rates were higher in biologic-naïve vs ‑failure pts (Figure). Predictors of higher abatacept retention² included: RF/ ACPA seropositivity (p=0.030 biologic naïve; p=0.028 biologic failure); diabetes (p=0.044 biologic naïve); geographic location, Canada, Spain and Italy vs Germany (p<0.001 biologic naïve); and abatacept combination therapy (p<0.001 biologic failure). Only high Patient Global Assessment, ie ≥70, (p=0.009 biologic failure) predicted lower retention. At 2 y, a greater proportion of biologic-naïve vs -failure pts had good/moderate EULAR response (p=0.005); RF and/or ACPA seropositivity was associated with a significantly better response (p=0.007)].² Conclusion: In a real-world setting, higher abatacept retention rates were achieved by biologic-naïve vs -failure pts. Consistent with other reports,³ geographic location impacted 2-y abatacept retention even in analyses adjusted for patients’ baseline characteristics. RF and ACPA seropositivity were predictors of higher retention and better outcomes independent of treatment line. These results are consistent with the 1-y ACTION data.¹ 1. Nüßlein HG, et al. BMC Musculoskelet Disord 2015;16:176. 2. Alten R, et al. Ann Rheum Dis 2017; DOI: 10.1136/annrheumdis-2017-eular.1375 (abstr. #FRI0245). 3. Iannone F, et al. Clin Rheumatol 2017;36:773–9.