gms | German Medical Science

Introduction: Retention and effectiveness of IV abatacept over 6 months for patients with RA enrolled in the real-world ACTION study [1] (2008–2013) are presented.

Methods: ACTION is a 2-year, international, non-interventional cohort of patients with RA who initiated IV abatacept in three periods: A, May 2008–December 2010 (biologic naïve or failed prior biologics); B, September 2010–December 2013 (biologic naïve only); and C, December 2011–December 2013 (failed prior biologics), follow-up ongoing. Data from different cohorts were pooled, as patient baseline characteristics were comparable for each treatment line. Abatacept retention over 6 months was estimated by Kaplan–Meier; patients were censored at date of last available data. Safety is reported for enrolled patients up to August 2014; incidence rates (IR) calculated based on patient exposure in follow-up.

Results: 2343 patients were evaluable (Cohorts A, 1131; B, 550; C, 662); 672 (28.7%) were biologic naïve and 1671 (71.3%) had failed ≥1 prior biologic: 726 failed 1 biologic and 945 ≥2 biologics. Differences between biologic-naïve patients and patients who failed prior biologics included: mean age (59.9 vs 57.0 years), RA duration (7.2 vs 12.1 years), CRP (1.66 vs 2.12 mg/dL), HAQ-DI (1.37 vs 1.50), erosive disease (58.1 vs 71.7%), use of abatacept monotherapy (16.5 vs 25.4%) and median dose of concomitant corticosteroids (5.0 vs 7.5 mg/day). Retention rates decreased with increasing number of previous biologics (Figure 1 [Fig. 1]). During 3371 patient-years of follow-up, there were 335 serious AEs in 174/2359 (7.4%) patients with 56 discontinuations and 22 deaths (2 due to opportunistic infections: Pneumocystis jiroveci; multi-organ failure including Candida infection). Sixty-nine patients had serious infections (IR: 2.05/100 patient-years), including 1 case of latent TB and 3 non-TB opportunistic infections (cytomegalovirus, Candida and P. jiroveci). Twenty-one patients had malignancies (2 pre-existing; IR: 0.62/100 patient-years), 17 had serious cardiac disorders, 12 had serious vascular disorders and 19 had serious hypersensitivity reactions.

Conclusion: Findings of the real-world ACTION study are consistent with previous clinical experience and demonstrate the benefits and safety of IV abatacept in a large cohort. These data confirm the trend of abatacept demonstrating improved retention and clinical outcomes when used in earlier lines of RA treatment.

Note: This abstract was first presented at the EULAR Congress, 10–13 June 2015, Rome, Italy (AB0477) and published in the corresponding supplement of Ann Rheum Dis.