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).

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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.

References

1. Keystone EC, et al. Ann Rheum Dis 2012;71:857–61.

2. Mueller R, et al. Arthritis Rheumatol 2015;67(Suppl. 10):651–52.

3. Reggia R, et al. J Rheumatol 2015;42:193–5.

4. Monti S, et al. J Rheumatol 2015;42:1993–4.

5. Alten R, et al. Ann Rheum Dis 2016;75(Suppl. 2):202.

References

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