gms | German Medical Science

Background: Open-label clinical trials have shown that patients with RA can switch from IV to SC abatacept therapy with no efficacy loss or safety concerns [1], [2]; however, findings from single-centre, real-world studies are unclear [3], [4]. Our objective was to examine characteristics at baseline and before switching, and reasons for switching, in patients who switched from IV to SC abatacept in the real-world ACTION study.

Methods: ACTION is a 2-year, prospective, observational study of patients with moderate-to-severe RA who initiated IV abatacept across Europe and Canada. Enrolment periods: May 2008–December 2010 (biologic naïve/failed prior biologics); September 2010–December 2013 (biologic naïve); October 2011–December 2013 (failed prior biologics). This was an interim analysis of 1-year data. Assessments: baseline characteristics; reasons for switching; efficacy at the time of switch measured by EULAR response, DAS28 (ESR), DAS28 (CRP), CDAI, SDAI.

Results: 2364 patients were enrolled, 2350 were evaluable. A total of 91 patients (3.9%) switched from IV to SC abatacept during their first study year: 19 were biologic naïve, 72 had failed prior biologics at study entry. Compared with non-switchers, the switch group had numerically higher percentages of patients with BMI ≥35kg/m², ≥1 co-morbidity and ≥2 prior anti-TNF failures, and lower mean disease activity, at baseline. Most patients (62.6%) who switched did so after >6 months in the study (Figure 1 [Fig. 1]). Reasons for switching from IV to SC abatacept were available for 86 patients (94.5%; some patients had >1 reason): patient wish (53.5%), physician’s preference (24.4%), safety (9.3%), poor compliance (4.7%), efficacy (2.3%), remission (2.3%), surgery (1.2%), other (16.3%). Only 3/91 (3.3%) patients re-switched to IV abatacept; reasons were: patient wish, safety, efficacy (1 patient each). Prior to switching to SC abatacept, 64% of patients had a good/moderate EULAR response. According to mean (SD) values, disease activity before switching was moderate: DAS28 (ESR) 3.85 (1.09), DAS28 (CRP) 3.46 (1.07), CDAI 12.49 (7.70), SDAI 13.6 (8.13).[IMG1]

Conclusion: Few patients switched from IV to SC abatacept and most who did so switched after >6 months allowing them to first achieve stable disease activity. Switching from IV to SC abatacept was primarily driven by patient or physician preference for the SC formulation. The very low rate of return to IV (3.3%) suggests that switching from IV to SC abatacept had no adverse clinical impact.

Note: Original abstract © EULAR/BMJ. First presented at EULAR 2016 and published in Ann Rheum Dis (AB0371). Any reprints, promotional options, education material etc have to be done through the original source (ARD / BMJ).