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. 2023 Sep;42(9):2321-2334.
doi: 10.1007/s10067-023-06649-x. Epub 2023 Jun 14.

Subcutaneous abatacept for the treatment of rheumatoid arthritis in routine clinical practice in Germany, Austria, and Switzerland: 2-year retention and efficacy by treatment line and serostatus

Rieke Alten  1 , Hans-Peter Tony  2 , Bettina Bannert  3 , Hubert Nüßlein  4 , Christiane Rauch  5 , Sean E Connolly  6 , Melanie Chartier  7 , Karissa Lozenski  6 , Roland Hackl  8 , Adrian Forster  9 , Peter Peichl  10
Affiliations

Subcutaneous abatacept for the treatment of rheumatoid arthritis in routine clinical practice in Germany, Austria, and Switzerland: 2-year retention and efficacy by treatment line and serostatus

Rieke Alten et al. Clin Rheumatol. 2023 Sep.

Abstract

Introduction/objectives: The ASCORE study on treatment for rheumatoid arthritis (RA) showed better retention and clinical response rates for abatacept as first-line versus later-line therapy. This post hoc analysis of ASCORE assessed 2-year retention, efficacy, and safety of subcutaneous (SC) abatacept in Germany, Austria, and Switzerland.

Methods: Adults with RA who initiated SC abatacept 125 mg once weekly were assessed. Primary endpoint was abatacept retention rate at 2 years. Secondary endpoints: proportions of patients with low disease activity (LDA)/remission per Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (≤ 3.2), Simplified Disease Activity Index (≤ 11), and Clinical Disease Activity Index (≤ 10). Outcomes were analyzed by treatment line and serostatus.

Results: For the pooled cohort, the 2-year abatacept retention rate was 47.6%; retention was highest in biologic-naïve patients (50.5% [95% confidence interval 44.9, 55.9]). Patients seropositive for both anti-citrullinated protein antibody (ACPA) and rheumatoid factor (RF; + / +) at baseline had a higher 2-year abatacept retention rate than patients with single seropositivity for either APCA or RF or double-seronegativity (- / -), irrespective of treatment line. At 2 years, a higher proportion of patients who were biologic-naïve were in LDA/remission than patients with one or ≥ two prior biologics.

Conclusion: A higher proportion of patients with + / + RA (compared with - / - RA) had abatacept retention after 2 years. Early identification of patients with seropositive RA may facilitate a precision-medicine approach to RA treatment, leading to a higher proportion of patients in LDA/remission.

Trial registration number: NCT02090556; date registered: March 18, 2014 (retrospectively registered). Key Points • This post hoc analysis of a German-speaking subset of European patients with RA from the global ASCORE study (NCT02090556) showed that retention of SC abatacept within this subset was 47.6%, with good clinical outcomes after 2 years. • Patients with double-seropositive RA (ACPA and RF positive) had higher retention of abatacept than patients with double-seronegative RA (ACPA and RF negative). Retention and clinical responses were highest for patients who were biologic-naïve compared with patients who had one or ≥ two prior biologic treatments. • These real-world data may be useful for clinicians in informing individualized treatment pathways for patients with RA, and fostering superior disease control and clinical outcomes.

Keywords: Abatacept; Clinical response; Retention; Rheumatoid arthritis; Serostatus; bDMARD.

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Conflict of interest statement

RA has received consulting fees from AbbVie, Bristol Myers Squibb, Celltrion, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and Roche; and has received grant/research support from Bristol Myers Squibb, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and Roche. BB, PP, AF, and HN declare no competing interests. CR (at time of analysis), MC, SEC, RH, and KL are employees of and shareholders in Bristol Myers Squibb. H-PT has received consulting fees from AbbVie, Bristol Myers Squibb, Chugai, Galapagos, Gilead, Janssen, Lilly, Novartis, and Roche.

Figures

Fig. 1
Fig. 1
Patient disposition for post hoc analysis population. aAll exclusions were from the Germany cohort: prior abatacept use/not initiated with subcutaneous abatacept, n = 9; age/sex missing, n = 1; abatacept intake date missing, n = 1
Fig. 2
Fig. 2
Proportion of patients with subcutaneous abatacept retention over 2 years by treatment linea, for a) the pooled cohort, b) Germany, c) Austria, and d) Switzerland. aPatients who switched to IV abatacept during the 2 years were discontinued and are not included here. bData for Switzerland ≥ two prior biologics treatment group not presented to maintain confidentiality due to small patient population. CI, confidence interval; IV, intravenous; m, number of patients censored; n, number of patients at risk
Fig. 3
Fig. 3
Proportion of patients with subcutaneous abatacept retention over 2 years by baseline RF/ACPA serostatus and treatment line, for a) the pooled cohort, and b) Germany. Patients with missing data for baseline RF/ACPA status are excluded. Patients with time to discontinuation greater than 2 years are censored at day 729. Data for Austria and Switzerland are not presented due to low patient numbers. + / + , ACPA + and RF + ; + / − , ACPA + or RF + ; − / − , ACPA − and RF − ; ACPA, anti-citrullinated protein antibody; CI, confidence interval; KM, Kaplan–Meier; RF, rheumatoid factor
Fig. 4
Fig. 4
Clinical outcomes with subcutaneous abatacept over 2 years. aRemission < 2.6; LDA ≥ 2.6 to ≤ 3.2. bRemission ≤ 2.8; LDA ≤ 10. cRemission ≤ 3.3; LDA ≤ 11. CDAI, Clinical Disease Activity Index; DAS28 (ESR), Disease Activity Score in 28 joints based on the erythrocyte sedimentation rate; LDA, low disease activity; m, number of patients in LDA or remission; n, number of patients with complete data at 2 years; SDAI, Simplified Disease Activity Index
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