Artikel
Retention Rates and Clinical Outcomes in Cohorts of Patients (Biologic Naïve or Failed Prior Biologics) Treated with Intravenous Abatacept in a Real-World Setting: 6-Month Results from the ACTION Study
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Veröffentlicht: | 1. September 2015 |
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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.
References
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- Nüßlein HG, Alten R, Galeazzi M, Lorenz HM, Boumpas D, Nurmohamed MT, Bensen WG, Burmester GR, Peter HH, Rainer F, Pavelka K, Chartier M, Poncet C, Rauch C, Bars ML. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord. 2014 Jan 11;15:14. DOI: 10.1186/1471-2474-15-14