Artikel
ASCORE, a 2-year, observational, prospective study of subcutaneous abatacept for rheumatoid arthritis in clinical practice: 6-month interim analysis of the German cohort
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Autoren
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Rieke H.-E. Alten
- Schlossparkklinik, Akademisches Lehrkrankenhaus der Charité – Universitätsmedizin Berlin, Innere Medizin II, Rheumatologie, Klinische Immunologie und Osteologie, Berlin
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X. Mariette
- Paris-Sud University, Paris, France
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M. H. Buch
- University of Leeds and Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
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Roberto Caporali
- Reumatologian, Dipartimento di Area Medica, Pavia, Italien
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Rene-Marc Flipo
- Centre Hospitalier Régional Universitaire de Lille, Lille, France
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Adrian Forster
- Schulthess Klinik, Zürich, Schweiz
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Hedley Griffiths
- University Hospital Geelong, Geelong, Australien
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M. T. Nurmohamed
- VU Univ Medical Center/Jan van Breeman Research Institute, Amsterdam, The Netherlands
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Yusuf Patel
- Hull Royal Infirmary, Hull, Großbritannien
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Peter Peichl
- Evangelisches Krankenhaus, Wien, Österreich
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Raimon Sanmarti
- Hospital Clínic de Barcelona, Barcelona, Spanien
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Hubert Nüßlein
- University of Erlangen-Nuremberg, Nuremberg
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Coralie Chauvet
- DOCS, Nanterre, France
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Julia Heitzmann
- Excelya, Boulogne-Billancourt, France
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C Rauch
- Bristol-Myers Squibb, München
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S. E. Connolly
- Bristol-Myers Squibb, Princeton, USA
| Veröffentlicht: | 5. Februar 2019 |
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Gliederung
Text
Background: ASCORE (NCT02090556) is an ongoing, prospective, non-interventional, multicentre study of SC abatacept in patients with RA across ten countries. To provide a local perspective, this analysis presents the 6-month (6M) interim retention rates and clinical outcomes by biologic (b)DMARD treatment line from the German cohort.
Methods: German patients (≥18 years) with active, moderate-to-severe RA, who initiated SC abatacept 125 mg weekly, were enrolled between February 2013 and February 2017 in two cohorts: biologic-naïve patients and patients who had failed ≥1 prior bDMARD. Patient and disease characteristics at SC abatacept initiation were recorded. The 6M retention rate (95% CI) of SC abatacept was estimated by Kaplan-Meier analysis. Good/moderate EULAR response rates based on DAS28 (ESR, otherwise CRP), low disease activity (LDA) or remission according to DAS28 (ESR), CDAI, SDAI and Boolean criteria were assessed.
Results: 900/2943 patients enrolled in ASCORE were from Germany; of these, 873 (97.0%) were evaluable: 283 (32.4%) were biologic naïve, 242 (27.7%) had failed 1 and 348 (39.9%) had failed ≥2 prior biologics. At baseline, patients with later vs earlier treatment lines had longer disease duration; disease activity and the proportion of patients who were RF+/anti-CCP+ were similar across treatment lines; CRP was higher in biologic-naïve vs -failure patients; 97/185 (52.4%) biologic-naïve patients had erosive disease vs 90/161 (55.9%) or 150/232 (64.7%) who had received 1 or ≥2 prior bDMARDs, respectively. Probability of overall abatacept retention at 6M was 0.89 (95% CI: 0.87, 0.91) and was similar across treatment lines (Figure). At 6M, 91 patients had discontinued abatacept (inefficacy, n=46 [50.5%]; safety, n=39 [42.9%]). At 6M, good/moderate EULAR response rates were 83.7%, 77.8% and 77.3% for biologic-naïve patients and patients with 1 and ≥2 prior bDMARD failures, respectively. DAS28 (ESR), CDAI or SDAI LDA/remission, or Boolean remission rates were higher with earlier vs later treatment lines. The safety profile was consistent with IV abatacept studies [1], [2] Figure 1 [Fig. 1].
Conclusion: In routine clinical practice in Germany, overall 6M retention of SC abatacept was high and similar to IV abatacept studies [1], [2]. Better response rates were achieved with abatacept as an earlier treatment line. Good/moderate EULAR response rates at 6M were consistently >75% irrespective of treatment line.
References
- 1.
- Nüßlein HG, Alten R, Galeazzi M, Lorenz HM, Boumpas D, Nurmohamed MT, Bensen WG, Burmester GR, Peter HH, Rainer F, Pavelka K, Chartier M, Poncet C, Rauch C, Bars ML. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord. 2014 Jan 11;15:14. DOI: 10.1186/1471-2474-15-14
- 2.
- Nüßlein HG, Alten R, Galeazzi M, Lorenz HM, Nurmohamed MT, Bensen WG, Burmester GR, Peter HH, Peichl P, Pavelka K, Chartier M, Poncet C, Rauch C, Le Bars M. Efficacy and prognostic factors of treatment retention with intravenous abatacept for rheumatoid arthritis: 24-month results from an international, prospective, real-world study. Clin Exp Rheumatol. 2016 May-Jun;34(3):489-99.
