AB0361 ASCORE, A 2-YEAR, OBSERVATIONAL, PROSPECTIVE MULTICENTRE STUDY OF SUBCUTANEOUS ABATACEPT FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE: 1-YEAR INTERIM ANALYSIS
Authors: Rieke Alten, Xavier Mariette, Maya Buch, Roberto Caporali, Rene-Marc Flipo, Adrian Forster, Michael Nurmohamed, Yusuf Patel, Peter Peichl, Raimon Sanmarti, Melanie Chartier, Julia Heitzmann, Christiane Rauch, Sean Connolly
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> ASCORE (Abatacept [ABA] SubCutaneOus in Routine clinical practicE; ClinicalTrials.gov: NCT02090556) is an ongoing, 2-year, observational, prospective, multicentre study of patients (pts) with RA initiating SC ABA in routine clinical practice. <h3>Objectives</h3> To present for the first time 1-year interim retention rates and clinical outcomes by previous biologic (b)DMARD exposure. <h3>Methods</h3> Pts (≥18 years) with moderate-to-severe RA, who initiated SC ABA 125 mg weekly, were enrolled (Mar 2013–Jan 2017) across 10 countries in two cohorts: biologic-naïve pts and those who had failed ≥1 prior bDMARD. Pt and disease characteristics were recorded. ABA retention rates (95% CI) were estimated at 1 year by Kaplan–Meier analysis. Good/moderate EULAR response rates based on DAS28 (ESR, otherwise CRP), LDA or remission according to DAS28 (ESR; ≤3.2), SDAI (≤11), CDAI (≤10) and Boolean criteria were assessed at 1 year. <h3>Results</h3> A total of 2843/2949 enrolled pts were evaluable: 1162 (40.9%) were biologic naïve; 740 (26.0%) had failed 1 and 941 (33.1%) had failed ≥2 prior biologics. At baseline, pts with a higher vs lower number of prior bDMARDs had longer disease duration and greater presence of erosive disease vs pts who were biologic-naïve; CRP was higher in biologic-naïve vs -failure pts; disease activity was similar across treatment exposures. Overall SC ABA retention (95% CI) at 1 year was 65.3% (63.4, 67.0); retention was higher in pts receiving ABA as a first vs later bDMARD (71.1% [68.3, 73.7] in biologic-naïve pts vs 61.9% [58.2, 65.4] and 60.7% [57.4, 63.8] in those with 1 and ≥2 prior biologic failures, respectively; Figure). At 1 year, 943 pts had discontinued ABA: 465/936 [49.7%] due to inefficacy and 218/936 [23.3%] due to safety (data unavailable, n=9/943). Among pts continuing ABA at 1 year, good/moderate EULAR response rates for pts who were biologic-naïve and those with 1 and ≥2 prior biologic failures were 81.0%, 70.0% and 66.4%, respectively. Corresponding rates for LDA outcomes were also higher with ABA as an earlier vs later bDMARD. The safety profile was similar across patient cohorts and consistent with real-world IV ABA studies.<sup>1,2</sup> <h3>Conclusion</h3> In routine clinical practice, overall retention of SC abatacept at 1 year was around 65% and comparable with that of IV abatacept.<sup>2</sup> Among pts continuing abatacept at 1 year, good/moderate EULAR response rates were consistently &gt;65% irrespective of prior bDMARD exposure. Better retention and clinical response rates were achieved with abatacept earlier in bDMARD treatment history. <h3>References</h3> [1] Nüßlein HG, et al. Clin Exp Rheumatol2016;34:489–99. [2] Alten R, et al. RMD Open2017;3:e000538. <h3>Acknowledgement</h3> Professional medical writing: Fiona Boswell, PhD, Caudex; funding: Bristol-Myers Squibb <h3>Disclosure of Interests</h3> Rieke Alten Grant/research support from: Bristol-Myers Squibb, Speakers bureau: Bristol-Myers Squibb, Xavier Mariette Consultant for: Honorarium from Bristol-Myers Squibb, GlaxoSmithKline, Gilead, Janssen, Pfizer, UCB, Maya Buch Grant/research support from: Pfizer LTD, UCB, Consultant for: AbbVie, Eli Lilly, EMD Serono, Pfizer Ltd., Sanofi, Roberto Caporali Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Roche, Genzyme, Lilly, MSD, Pfizer, UCB, Rene-Marc Flipo Consultant for: Advisory board: Bristol-Myers Squibb, Adrian Forster Consultant for: Consultant for Pfizer, MSD, Grünenthal, Novartis and Roche, Michael Nurmohamed Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi and UCB, Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi and UCB, Yusuf Patel: None declared, Peter Peichl Speakers bureau: Speaker: Eli Lilly, Pfizer, Bristol-Myers Squibb, Raimon Sanmarti Grant/research support from: Research support: Bristol-Myers Squibb, Speakers bureau: Speakers bureau: Bristol-Myers Squibb, Melanie Chartier Employee of: Bristol-Myers Squibb, Julia Heitzmann Employee of: Employee of Excelya which received funding from Bristol-Myers Squibb as contract research organization for this study., Christiane Rauch Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Sean Connolly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb