Background The ACTION (NCT02109666) study was designed to provide prospective, real-world data on abatacept (ABA) retention in patients (pts) with RA.
Objectives To assess the retention rate and to identify prognostic factors of ABA retention in the overall ACTION population and by treatment line over 2 yrs.
Methods ACTION is a 2-yr, international, observational study of pts with RA who initiated IV ABA as first- or as second-/further-line biologic therapy in routine clinical practice. Biologic-naïve and biologic-failure pts were enrolled during three periods between May 2008 and December 2013. The primary endpoint was crude ABA retention rate over 2 yrs (Kaplan–Meier plot). Prognostic factors (p≤0.2) from univariate analyses with no colinearity, clinically relevant variables and known risk factors were entered into a multivariate model; factors with p≤0.1 were retained by backward selection. EULAR response was compared by Fisher's exact test.
Results In the ACTION cohort, 2350/2364 enrolled pts were evaluable for analysis; 673 (28.6%) were biologic naïve and 1677 (71.4%) had failed biologic treatment. Most biologic-failure pts (56.6%) had previously received ≥2 biologics. Some expected differences in baseline characteristics were observed between groups; mean (SD) RA duration was shorter (7.2 [8.2] vs 12.1 [9.1] yrs; p<0.001), more pts had RA for ≤2 yrs (35.7 vs 9.0%; p<0.001) and fewer pts had radiographic erosions (58.2 vs 71.5%; p<0.001) for biologic-naïve vs biologic-failure pts. At Yr 2, the overall retention rate was 47.9% (95% CI 45.7, 50.0). The retention rate was higher in biologic-naïve vs biologic-failure pts (54.5 vs 45.2%; p<0.001) and in pts with 1 vs ≥2 previous biologics (Fig). Reasons for discontinuation were comparable between groups; main reasons were lack of efficacy (61.4 vs 67.7%) and safety (21.3 vs 21.2%). RF and anti-citrullinated protein antibody (ACPA) seropositivity were prognostic factors for higher retention in biologic-naïve (p=0.030) and biologic-failure pts (p=0.028); other positively impacting factors were diabetes mellitus (p=0.044; biologic naïve); geographic location (p<0.001; biologic naïve) and ABA combination therapy (p<0.001; biologic failure). Only Pt Global Assessment (p=0.009; biologic failure) predicted lower retention. Among pts continuing ABA, a greater proportion of biologic-naïve vs biologic-failure pts had a good/moderate EULAR response (90.7 vs 81.6%; p=0.005) and RF/ACPA seropositivity was associated with a better response (p=0.002). There were no new safety signals.
Conclusions In this first prospective, international, non-interventional research evaluating the long-term IV abatacept retention, RF and ACPA seropositivity were predictors of 2-yr higher retention and better outcomes. Higher retention rates may be achievable with earlier vs later initiation of abatacept treatment, consistent with prior findings from a pooled analysis of EU and Canadian registries.1
Iannone F et al. Clin Rheumatol (2016): doi:10.1007/s10067–016–3505–5.
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, AstraZeneca, 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, Y. Elbez: 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