POS0599 DISEASE ACTIVITY IN PATIENTS WITH RA BY SEROSTATUS AND TREATMENT LINE, FOLLOWING TREATMENT WITH ABATACEPT: RESULTS FROM AN INTERNATIONAL OBSERVATIONAL STUDY
Authors: R. Alten, X. Mariette, R. M. Flipo, R. Caporali, M. H. Buch, Y. Patel, R. Sanmartí, S. Marsal, M. T. Nurmohamed, H. Griffiths, P. Peichl, B. Bannert, A. Forster, M. Chartier, Y. Elbez, C. Rauch, K. Lozenski, V. Khaychuk
Journal: Annals of the Rheumatic Diseases (2021)

Background: RF and anti-citrullinated protein antibodies (ACPAs) are associated with a severe and aggressive disease course in patients with RA. 1 Abatacept is a selective co-stimulation modulator for the treatment of RA. 2 ASCORE ( A batacept S ub C utane O us in R outine Clinical Practic E ; NCT02090556 ) was a 2-year, observational, prospective, multicentre study of SC abatacept for the treatment of RA in routine clinical practice. 3 Objectives: To determine if serostatus and treatment line impacted disease activity in patients enrolled in the ASCORE study. Methods: Eligible patients, aged ≥18 years, with active moderate-to-severe RA (ACR/EULAR 2010 criteria) who were IV abatacept-naive and initiated SC abatacept 125 mg once weekly, were enrolled into two cohorts: biologic (b)DMARD-naive patients and those with ≥1 prior bDMARD treatment failure. This post hoc analysis assessed the mean change in disease activity (CDAI, SDAI and DAS28 [ESR]) from baseline (BL) at 6, 12, 18 and 24 months in response to treatment with abatacept. Patients were stratified by BL serostatus (all patients, RF/ACPA double positive [+/+] RA; RF/ACPA single positive [+/–; RF+/ACPA– or RF–/ACPA+] RA and RF/ACPA double negative [–/–] RA) and by line of therapy (all patients, patients receiving abatacept as a first-line or ≥ second-line therapy and those receiving abatacept following 1 or ≥2 prior bDMARDs). Overall patient data, as well as data for patients who were +/– or those who had 1 or ≥2 previous bDMARDs, are not shown. Estimates of mean difference are from t -test. Results: Among 2892 eligible patients in ASCORE, 1748 patients with RF/ACPA status available at BL were included in this analysis (1079 +/+ RA, 326 +/− RA and 343 −/− RA). After 6 months, patients with +/+ RA on first-line abatacept therapy had better improvements in CDAI and SDAI scores from BL than patients on ≥ second-line abatacept therapy (mean difference [95% CI]: –3.4 [–5.6, –1.1]; p=0.0032 and –3.9 [–6.5, –1.3]; p=0.0035, respectively); better improvements in SDAI were also seen after 12 months (mean difference [95% CI]: –3.5 [–6.5, –0.5]; p=0.0207). Changes in CDAI and SDAI scores were comparable after 18 and 24 months. At 6 and 12 months, patients with +/+ RA on first-line therapy had better improvements from BL in DAS28 (ESR) than those on ≥ second-line therapy (mean differences [95% CI]: –0.5 [–0.8, –0.2]; p=0.0002 and –0.4 [–0.7, –0.0]; p=0.0317, respectively); changes were comparable at 18 and 24 months (Figure 1). For patients on ≥ second-line therapy, at 18 months those with +/+ RA had better improvements from BL in DAS28 (ESR) than those with –/– RA (mean difference [95% CI]: –0.7 [–1.2, –0.1]; p=0.0232). For patients not stratified by line of therapy, changes in DAS28 (ESR) were comparable between the +/+ and –/– RA subgroups over time, with the exception of 6 months where patients with –/– RA had better improvements from BL compared with patients with +/+ RA (mean difference [95% CI]: –0.3 [–0.6, –0.0]; p=0.0495). Conclusion: In this real-world, post hoc analysis, patients with +/+ RA who received abatacept as a first-line therapy had greater early improvements in disease activity compared with patients who received abatacept as a ≥ second-line therapy. Improvements in disease activity at 24 months were comparable between patients who were +/+ and those who were –/–. Larger studies are needed to further corroborate these findings. References: [1]Katchamart W, et al. Rheumatol Int 2015;35:1693–1699. [2]Malmström V, et al. Nat Rev Immunol 2017;17:60–75. [3]Alten R, et al. Ann Rheum Dis 2019;78(Suppl 2):A1639. Acknowledgements: Professional medical writing and editorial assistance was provided by Rachel Rankin, PhD, at Caudex and was funded by Bristol Myers Squibb. This study was funded by Bristol Myers Squibb. Disclosure of Interests: Rieke Alten Speakers bureau: AbbVie, Bristol Myers Squibb, Gilead, Janssen, Lilly, Pfizer, Consultant of: AbbVie, Bristol Myers Squibb, Gilead, Janssen, Lilly, Pfizer, Grant/research support from: AbbVie, Bristol Myers Squibb, Gilead, Janssen, Lilly, Pfizer, Xavier Mariette Consultant of: Bristol Myers Squibb, Galapagos, Gilead, GlaxoSmithKline, Janssen, Pfizer, UCB, Rene-Marc Flipo Speakers bureau: AbbVie, Bristol Myers Squibb, Janssen, Lilly, Medac, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche-Chugai, Grant/research support from: Amgen, Janssen, Novartis, Pfizer, Roberto Caporali Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Galapagos, Gilead, Lilly, Merck Sharp &amp; Dohme, Pfizer, Roche, Samsung Bioepis, Sanofi, UCB, Consultant of: Galapagos, Gilead, Janssen, Lilly, Merck Sharp &amp; Dohme, Maya H Buch Speakers bureau: AbbVie, Consultant of: AbbVie, Eli Lilly, Gilead, Merck Serono, Pfizer, Roche, Sanofi, Grant/research support from: Gilead, Pfizer, Roche, UCB, Yusuf Patel: None declared, Raimón Sanmartí Speakers bureau: AbbVie, Bristol Myers Squibb, Gebro, Janssen, Lilly, Merck Sharp &amp; Dohme, Pfizer, Roche, Sanofi, Consultant of: AbbVie, Bristol Myers Squibb, Gebro, Lilly, Merck Sharp &amp; Dohme, Pfizer, Roche, Sanofi, Grant/research support from: Bristol Myers Squibb, Merck Sharp &amp; Dohme, Pfizer, Sara Marsal Speakers bureau: Bristol Myers Squibb, Celgene, Pfizer, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol Myers Squibb, Celgene, Galapagos, Merck Sharp &amp; Dohme, Pfizer, Roche, Sanofi, UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche, Sanofi, UCB, M.T. Nurmohamed Speakers bureau: AbbVie, Bristol Myers Squibb, Eli Lilly, Roche, Sanofi, Consultant of: AbbVie, Celgene, Celltrion, Eli Lilly, Janssen, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp &amp; Dohme, Mundipharma, Novartis, Pfizer, Roche, Sanofi, Hedley Griffiths Consultant of: AbbVie, Gilead, Janssen, Novartis, Peter Peichl: None declared, Bettina Bannert: None declared, Adrian Forster: None declared, Melanie Chartier Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Yedid Elbez Consultant of: Bristol Myers Squibb, Christiane Rauch Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Karissa Lozenski Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Vadim Khaychuk Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb