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OP0180 IMPACT OF RF AND ANTI-CITRULLINATED PROTEIN ANTIBODY SEROSTATUS ON 2-YEAR RETENTION OF ABATACEPT IN PATIENTS WITH RA
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  1. R. Alten1,
  2. X. Mariette2,
  3. R. M. Flipo3,
  4. R. Caporali4,5,
  5. M. H. Buch6,7,
  6. Y. Patel8,
  7. R. Sanmartí9,
  8. S. Marsal10,
  9. M. T. Nurmohamed11,
  10. H. Griffiths12,
  11. P. Peichl13,
  12. B. Bannert14,
  13. A. Forster15,
  14. M. Chartier16,
  15. S. Connolly17,
  16. Y. Elbez18,
  17. C. Rauch19,
  18. V. Khaychuk20,
  19. K. Lozenski21
  1. 1Schlosspark-Klinik University, Department of Internal Medicine, Rheumatology, Berlin, Germany
  2. 2Université Paris-Saclay, AP-HP, Hospital Bicêtre, Department of Rheumatology, Paris, France
  3. 3Centre Hospitalier Universitaire de France, Department of Rheumatology, Lille, France
  4. 4University of Milan, Department of Clinical Sciences and Community Health, Milan, Italy
  5. 5G. Pini Hospital, Clinical Rheumatology Unit, Milan, Italy
  6. 6University of Leeds, Leeds Institute for Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom
  7. 7University of Manchester, Division of Musculoskeletal & Dermatological Sciences, Manchester, United Kingdom
  8. 8Hull Royal Infirmary, Rheumatology, Hull, United Kingdom
  9. 9Hospital Clinic de Barcelona, Rheumatology Department, Barcelona, Spain
  10. 10Hospital Universitari Vall d’Hebron, Rheumatology, Barcelona, Spain
  11. 11ARC Amsterdam University Hospitals – VU University Medical & Reade, Department of Rheumatology, Amsterdam, Netherlands
  12. 12University Hospital Geelong, Barwon Rheumatology Service, Geelong, Australia
  13. 13Evangelical Hospital, Department of Internal Medicine, Vienna, Austria
  14. 14Universitätsspital Basel, Rheumatologische Universitätsklinik, Basel, Switzerland
  15. 15Schulthess Klinik, Department of Rheumatology, Zürich, Switzerland
  16. 16Bristol Myers Squibb, Non-Registrational Data Generation, Rueil-Malmaison, France
  17. 17Bristol Myers Squibb, Global Drug Development, Princeton, United States of America
  18. 18Deepscover, Biostatistics, Puteaux, France
  19. 19Bristol Myers Squibb, Medical Immunology & Fibrosis, Munich, Germany
  20. 20Bristol Myers Squibb, US Medical Immunology and Fibrosis, Princeton, United States of America
  21. 21Bristol Myers Squibb, Immunology and Fibrosis, Princeton, United States of America

Abstract

Background: Up to 50% of patients with RA discontinue DMARD treatment within 18 months.1 However, up to 20% of patients who fail multiple treatments may have a good treatment response to another therapy.1 Predictive biomarkers, such as RF and anti-citrullinated protein antibodies (ACPAs), may be useful to stratify patients with RA to the most appropriate treatment.1 ASCORE (Abatacept SubCutaneOus in Routine Clinical PracticE; NCT02090556) was a 2-year, observational, prospective, multicentre study of SC abatacept for the treatment of RA in routine clinical practice.2

Objectives: To determine if RF/ACPA serostatus and treatment line impact abatacept retention in patients with RA in a post hoc analysis of ASCORE.

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 abatacept retention rate at 2 years in a subset of patients with RF/ACPA serostatus data (n=1748) from the ASCORE study (N=2892; as observed). Baseline (BL) serostatus groups examined by treatment line were: RF/ACPA double positive (+/+) RA, RF/ACPA single positive (RF+/ACPA– or RF–/ACPA+) RA (data not shown) and RF/ACPA double negative (–/–) RA. Last observation carried forward (LOCF) analyses were used to assess change from BL and measures of disease remission (DAS28 [CRP] <2.6, CDAI ≤2.8, and SDAI ≤3.3) in patients with +/+ RA versus –/– RA.

Results: BL demographic and disease characteristics were similar across serostatus groups and treatment lines (Table 1). Mean age was 57.1 and 57.8 years for +/+ RA and –/– RA, respectively. Mean DAS28 (CRP) was 4.7 and 4.8 for +/+ RA and –/– RA, respectively. In patients with +/+ RA, abatacept retention was greater when given as first-line treatment (57% vs 48% when given as ≥ second-line) (Figure 1). Retention was similar in patients with –/– RA regardless of treatment line. After 2 years, mean (SE) change from BL (LOCF) in DAS28 (CRP) was –1.41 (0.06) and –0.97 (0.09) for patients with +/+ and –/– RA, respectively. For patients with +/+ RA, mean (SE) change from BL in DAS28 (CRP) was –1.62 (0.08) for those in whom abatacept was first-line and –1.19 (0.08) for those in whom abatacept was ≥ second-line. For patients with –/– RA, mean (SE) change from BL in DAS28 (CRP) was –1.03 (0.13) for those in whom abatacept was first-line and –0.93 (0.12) for those in whom abatacept was ≥ second-line. Remission rates (LOCF) were significantly (p<0.0001) higher in patients with +/+ RA vs –/– RA respectively: DAS28 (CRP) 38.4% (n=393) versus 19.3% (n=62); CDAI 50.6% (n=513) versus 33.0% (n=107); and SDAI 49.5% (n=497) versus 32.5% (n=102).

Table 1.

BL demographics and disease characteristics by RF/ACPA status

Conclusion: In this real-world analysis, patients with +/+ RA treated with first-line abatacept had higher retention than patients receiving abatacept as a ≥ second-line therapy. Remission rates on abatacept were higher in patients with +/+ RA versus –/– RA. These results support early treatment with abatacept and highlight the importance of further evaluating precision medicine approaches in RA.

References: [1]Smolen JS, et al. Ann Rheum Dis 2020;79:685–699.

[2]Alten R, et al. Ann Rheum Dis 2019;78(suppl 2):A1639.

Acknowledgements: Professional medical writing and editorial assistance was provided by Lindsay Craik 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 & 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 & Dohme, Pfizer, Roche, Samsung Bioepis, Sanofi, UCB, Consultant of: Galapagos, Gilead, Janssen, Lilly, Merck Sharp & 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 & Dohme, Pfizer, Roche, Sanofi, Consultant of: AbbVie, Bristol Myers Squibb, Gebro, Lilly, Merck Sharp & Dohme, Pfizer, Roche, Sanofi, Grant/research support from: Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer, Sara Marsal Speakers bureau: Bristol Myers Squibb, Celgene, Pfizer, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol Myers Squibb, Celgene, Galapagos, Merck Sharp & Dohme, Pfizer, Roche, Sanofi, UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, Janssen, Merck Sharp & 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 & 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, Sean Connolly 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, Vadim Khaychuk Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Karissa Lozenski Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb

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