Background Since 2007, IV abatacept has been available in Europe for use in combination with MTX in adults with moderate-to-severe RA failing ≥1 anti-TNF. From 2010 onwards, abatacept was approved for use in patients (pts) failing conventional synthetic (cs)DMARDs (i.e. first-line biologic). In Canada, IV abatacept has been available as mono- or combination therapy for DMARD-failing pts since 2006. An observational study in a single US clinic demonstrated a shift in prescription trends for abatacept over time, towards earlier use in the RA treatment paradigm and in pts with less erosive disease.1
Objectives To investigate how the pt population of the real-world ACTION study, in which pts with RA received IV abatacept, has changed over time.
Methods ACTION is a 2-year, international, non-interventional cohort of pts with RA who initiated IV abatacept: Cohort A, enrolled May 2008 to December 2010 (biologic naïve or failed prior biologics [majority]); Cohort B, enrolled September 2010 to December 2013 (biologic naïve only; post-approval in Europe); and Cohort C, enrolled December 2011 to December 2013 (failed prior biologic). Participating countries varied by cohort. Pt characteristics are reported. Categories were compared using the chi-square test, or the Fisher exact test for small pt numbers; scores and other quantitative variables were analysed using the Kruskal–Wallis test.
Results Overall, 2359 pts were enrolled (1137, 553 and 669 in Cohorts A, B and C, respectively); 675 (28.6%) pts were biologic naïve and 1684 (71.4%) had failed prior biologics; 672 and 1671 were included in this analysis, respectively. Pt characteristics for the two cohorts are shown (see Table). Comparing pts who had failed prior biologics in Cohort A versus Cohort C, those in Cohort C were older, had longer disease duration, were more frequently anti-cyclic citrullinated peptide (anti-CCP) seropositive, more frequently initiated abatacept monotherapy, with a trend for more failed biologic (b)DMARDS, but had lower DAS28 (CRP) and HAQ-DI, and had failed fewer csDMARDS; fewer differences were observed when comparing biologic-naïve pts in Cohort A versus Cohort B, although pts in Cohort B had lower DAS28 (CRP) and were more likely to be anti-CCP seropositive. The proportions of pts with co-morbidities were similar across the cohorts.
Conclusions In this real-world setting, differences over time between enrolment cohorts of pts with RA receiving IV abatacept reflect the changes in clinical practice. Over time, lower pt baseline DAS28 (CRP) and HAQ-DI indicate improved access to biologics for pts with less active disease; more pts with anti-CCP seropositivity indicates increased treatment of pts with poor prognostic factors; more pts failing ≥3 bDMARDs despite awareness of the acceptable safety profile of abatacept across all treatment lines reflects access to an increasing range of biologics.
Schiff M, et al. Int J Clin Rheumatol 2010;5:581–91.
Disclosure of Interest H. Nüβlein Consultant for: Bristol-Myers Squibb, Abbvie, Chugai, UCB, Wyeth, Pfizer, MSD, Novartis and Roche, Speakers bureau: Bristol-Myers Squibb, Abbvie, Chugai, UCB, Wyeth, Pfizer, MSD, Novartis and Roche, R. Alten Grant/research support from: Bristol-Myers Squibb, Speakers bureau: Bristol-Myers Squibb, M. Galeazzi: None declared, H.-M. Lorenz Consultant for: Bristol-Myers Squibb, Speakers bureau: Bristol-Myers Squibb, A. Cantagrel Grant/research support from: Pfizer, UCB, Roche, Chugai, Speakers bureau: Bristol-Myers Squibb, Pfizer, Chugai, Abbvie, Nordic-Pharma, Fabre, MSD, Novartis, M. Chartier Consultant for: Bristol-Myers Squibb, C. Poncet Consultant for: Bristol-Myers Squibb, Employee of: DOCS, C. Rauch Employee of: Bristol-Myers Squibb, M. Le Bars Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb