Retention of subcutaneous abatacept for the treatment of rheumatoid arthritis: real-world results from the ASCORE study: an international 2-year observational study

Rieke Alten, Xavier Mariette, René-Marc Flipo, Roberto Caporali, Maya H Buch, Yusuf Patel, Sara Marsal, Raimon Sanmartí, Michael T Nurmohamed, Hedley Griffiths, Peter Peichl, Bettina Bannert, Melanie Chartier, Sean E Connolly, Karissa Lozenski, Christiane Rauch, Rieke Alten, Xavier Mariette, René-Marc Flipo, Roberto Caporali, Maya H Buch, Yusuf Patel, Sara Marsal, Raimon Sanmartí, Michael T Nurmohamed, Hedley Griffiths, Peter Peichl, Bettina Bannert, Melanie Chartier, Sean E Connolly, Karissa Lozenski, Christiane Rauch

Abstract

Objectives: To evaluate retention, efficacy, and safety of subcutaneous (SC) abatacept over 2 years in patients with moderate-to-severe RA in the Abatacept SubCutaneOus in Routine clinical practicE (ASCORE) study.

Methods: Patients with RA who initiated SC abatacept 125 mg once weekly were enrolled in the international, observational, prospective multicentre ASCORE study into biologic-naïve or ≥ 1 prior biologic failure cohorts.

Primary endpoint: abatacept retention rate at 2 years. Secondary endpoints: proportion of patients with good/moderate EULAR response rates based on DAS28 (ESR), low disease activity and/or remission according to DAS28 (ESR; ≤ 3.2/ < 2.6), SDAI (≤ 11/ ≤ 3.3), CDAI (≤ 10/ ≤ 2.8), and Boolean criteria. Retention rate by baseline serostatus was evaluated post hoc.

Results: Overall, 47% of patients remained on abatacept for 2 years, irrespective of treatment line. Higher abatacept retention rates were associated with lower prior biologic exposure. Generally, clinical outcomes showed that the proportion of patients with low disease activity/remission was higher in biologic-naïve patients (vs biologic-failure) and similar in those with 1 and ≥ 2 prior biologic failures. In patients on treatment at 2 years, good/moderate EULAR response rates of ~ 80% were consistently noted irrespective of prior biologic exposure. Across treatment lines, retention was greater in patients with seropositive (vs seronegative) RA. Patients with rheumatoid factor/anti-citrullinated protein antibody single-positive RA who were bio-naïve had higher retention than patients who were bio-experienced.

Conclusions: In the ASCORE study, SC abatacept retention was 47% at 2 years with good clinical outcomes and was well-tolerated in the real-world setting. Abatacept retention and clinical response rates were higher in patients who received abatacept as an earlier- versus later-line biologic drug treatment and in those with seropositive RA.

Trial registration: ClinicalTrials.gov, NCT02090556.

Keywords: Abatacept; Biological therapy; Retention; Rheumatoid arthritis.

Conflict of interest statement

CR, MC, KL, and SEC are employees and shareholders of Bristol Myers Squibb. BB, YP, and PP have no competing interests. SMB declares consulting/grant/research support/speaker fees from AbbVie, Bristol Myers Squibb, Gilead/Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, and UCB. MHB declares consulting/grant/research support from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, Pfizer, Roche, Sanofi, and UCB. RC declares consulting and speaker fees from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Gilead/Galapagos, Eli Lilly, MSD, Pfizer, Roche, Sanofi, and UCB. R-MF declares consulting and speaker fees from AbbVie, Bristol Myers Squibb, Eli Lilly, MSD, Pfizer, Roche-Chugai, and Sanofi. HG declares consulting/research support/speaker fees from AbbVie, Gilead, Pfizer, and Roche. XM declares honoraria from Bristol Myers Squibb, Galapagos, Gilead, GSK, Janssen, Novartis, Pfizer, and UCB. MN declares consulting/grant/research support/speaker fees from AbbVie, Bristol Myers Squibb, Celgene, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, and Sanofi. RS declares consulting/grant support from AbbVie, Bristol Myers Squibb, Fresenius, Gebro Pharma, Gilead/Galapagos, Eli Lilly, Pfizer, Roche, Sandoz, and Sanofi. RA declares speaker fees from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Galapagos, Gilead, Eli Lilly, Novartis, Pfizer, and Roche. Consulting fees from Celltrion, Galapagos, Gilead, Eli Lilly, and Novartis. Research support from Bristol Myers Squibb, Galapagos, Gilead, Novartis, and Pfizer.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Patient disposition. aPatients with no recorded date of consent or date of visit 1. IV, intravenous
Fig. 2
Fig. 2
Proportion of patients with subcutaneous abatacept retention over 2 years by treatment linea: A overall, B biologic-naïve, and C ≥ 1 prior biologic failure.b aPatients who switched to IV abatacept during the 2 years were discontinued and are not included. bFirst line or more data present combined data from patients with 1 and ≥ 2 failures of prior biologic treatment, as further stratification would result in small patient numbers. Panels B and C reproduced from Alten R, et al. EULAR Virtual Congress 2021; 3 June 2021; oral presentation OP0180 (with permission from the authors). CI, confidence interval; KM, Kaplan–Meier; IV, intravenous; RA, rheumatoid arthritis
Fig. 3
Fig. 3
Clinical outcomes at 2 years by treatment line. DAS28, Disease Activity Score in 28 joints; CDAI, Clinical Disease Activity Index; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; SDAI, Simplified Disease Activity Index
Fig. 4
Fig. 4
SDAI and CDAI A LDA/remission and B remission at 2 years by serostatus and treatment line (last observation carried forward). Figure reproduced from Alten R, et al. EULAR Virtual Congress 2021; 3 June 2021; oral presentation OP0180 (with permission from the authors). CDAI, Clinical Disease Activity Index; LDA, low disease activity; RA, rheumatoid arthritis; SDAI, Simplified Disease Activity Index

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