Background Patients (pts) with RA may be able to switch from IV to SC abatacept with no loss of efficacy or safety concerns, but data are inconclusive.1–4 In the ACTION (AbataCepT In rOutiNe clinical practice; NCT02109666) study, a 1-year interim analysis showed that switching had no adverse clinical effect.5
Objectives To examine treatment patterns and explore abatacept formulation switching over 2 years in ACTION.
Methods ACTION is a 2-year, prospective, observational study of pts with moderate-to-severe RA who initiated IV abatacept in Europe and Canada between May 2008 and December 2013. Assessments in biologic-naïve and biologic-failure pts were: baseline characteristics, rates of and reasons for switching (IV to SC), and re-switching to IV over 2 years. Descriptive data were generated: mean (SD) for continuous variables and n (%) for categorical variables. Rates of switching were estimated by Kaplan–Meier analysis. Cohorts were pooled to analyse further pts who switched owing to low numbers.
Results In the ACTION cohort, 2350/2364 pts (99.4%) were evaluable for this analysis (673 [28.6%] biologic naïve, 1677 [71.4%] biologic failure). A total of 729 (43.4%) biologic-failure pts had received 1, and 948 (56.6%) had received ≥2 previous biologics. Baseline characteristics in biologic-naïve and biologic-failure pts, respectively, were: mean (SD) age 59.9 (12.7) and 56.9 (12.5) years; RA duration 7.2 (8.22) and 12.1 (9.13) years; 496 (73.7%) and 1379 (82.2%) were women; 621 (92.3%) and 1552 (92.5%) had received prior MTX; and 533 (79.2%) and 1386 (82.6%) had received corticosteroids. Over 2 years, 195 pts switched from IV to SC abatacept (57 biologic naïve, 138 biologic failure; Fig.). Reasons for switching were available for 172 pts (51 biologic naïve, 121 biologic failure; some had >1 reason); biologic naïve/biologic failure: pt wish 54.9%/62.0%, physician choice 31.4%/19.8%, safety 5.9%/9.9%, remission/major improvement 3.9%/5.0%, poor compliance 0%/4.1%, lack of efficacy 2.0%/3.3%, surgery 2.0%/0.8%, weight adjustment 2.0%/0%, other 49.0%/36.4%. Only eight pts (2.6%) re-switched to IV abatacept (2 biologic naïve, 6 biologic failure). Reasons for re-switching were: pt wish (n=4), lack of efficacy (n=4), safety issue (n=1) and other (n=2).
Conclusions Less than 5% of pts who switched formulation from IV to SC abatacept in real-world clinical practice re-switched to the IV formulation, suggesting that switching has no adverse clinical impact. A change in formulation was mainly due to pt wish, reflecting their involvement in decision-making.
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Disclosure of Interest R. Alten Grant/research support from: Bristol-Myers Squibb, Speakers bureau: Bristol-Myers Squibb, H.-M. Lorenz Consultant for: AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, SOBI, Medac, Novartis, Janssen-Cilag, Astra-Zeneca, Pfizer, Actelion, X. Mariette Grant/research support from: Biogen, Pfizer, UCB, Consultant for: Bristol-Myers Squibb, LFB, Pfizer, GSK, UCB, H. Nüßlein Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, M. Galeazzi: None declared, F. Navarro Grant/research support from: Pfizer, MSD, AbbVie, Bristol-Myers Squibb, Roche, Consultant for: Pfizer, MSD, Roche, UCB, AbbVie, Bristol-Myers Squibb, Jansen, Lilly, Speakers bureau: Pfizer, MSD, Roche, UCB, AbbVie, Bristol-Myers Squibb, M. Chartier Employee of: Bristol-Myers Squibb, J. Heitzmann: None declared, C. Rauch Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, M. Le Bars Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb