Artikel
Abatacept Retention and Clinical Outcomes in German Patients with Rheumatoid Arthritis: 2-Year Results From the Real-World ACTION Study
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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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Hubert Nüßlein
- University of Erlangen-Nuremberg, Nuremberg
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Hanns-Martin Lorenz
- Universitätsklinikum Heidelberg, Medizinische Klinik V, Sektion Rheumatologie, Heidelberg
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Yedid Elbez
- Excelya, Boulogne-Billancourt, France
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Manuela Le Bars
- Bristol-Myers Squibb, Rueil-Malmaison, France
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Melanie Chartier
- Bristol-Myers Squibb, Rueil-Malmaison, France
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Christiane Rauch
- Bristol-Myers Squibb GmbH & Co. KGaA, München
| Veröffentlicht: | 4. September 2017 |
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Gliederung
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Background: The ACTION (AbataCepT In rOutiNe clinical practice; NCT02109666) study demonstrated higher abatacept retention rates in earlier versus later lines of treatment in patients with RA; however, variations by country have been noted [1]. To provide a local perspective, we compared 2-year retention rates and clinical outcomes by treatment line in the German cohort of patients enrolled in the ACTION study.
Methods: ACTION is a 2-year, prospective, observational, international study of patients (≥18 years) with moderate-to-severe RA who initiated IV abatacept in routine clinical practice. Biologic-naïve and biologic-experienced patients were enrolled between May 2008 and December 2013. In the German cohort, baseline characteristics were recorded. Crude abatacept retention rates were estimated by Kaplan–Meier analysis and clinical outcomes (EULAR response based on DAS28 [ESR, otherwise CRP]) were evaluated at 2 years and compared by treatment line.
Results: Among the overall ACTION cohort, 680 (28.8%) patients were recruited in Germany, of whom 677 (99.6%) were evaluable at 2 years. Overall, 171/677 (25.3%) patients were biologic naïve and 506/677 (74.7%) had failed ≥1 prior biologic (1 biologic: 197/506 [38.9%] patients; ≥2 biologics: 309/506 [61.1%] patients). Baseline patient characteristics are shown in the Table 1 [Tab. 1]. Overall crude abatacept retention rate (95% CI) at 2 years was 39.9% (36.0, 43.7; Figure 1 [Fig. 1]). Retention rates (95% CI) at 2 years were numerically higher with earlier treatment line: biologic naïve: 42.1% (34.3, 49.6); 1 previous anti-TNF: 41.9% (35.2, 48.5); ≥2 previous anti-TNFs: 38.1% (32.0, 44.2) (Figure 2 [Fig. 2]). For both biologic-naïve and biologic-experienced patients, respectively, discontinuation at 2 years was higher for inefficacy (37/69 [53.6%] and 134/207 [64.7%]) than for safety reasons (23/69 [33.3%] and 55/207 [26.6%]). Good/moderate EULAR response rates (95% CI) at 2 years were numerically higher in biologic-naïve (85.4% [75.4, 95.4]) than biologic-experienced patients (1 previous anti-TNF: 78.0% [67.4, 88.5]; ≥2 previous anti-TNFs: 80.9% [71.5, 90.2]).
Conclusion: In this German cohort, earlier line of treatment was associated with better abatacept retention and clinical outcomes at 2 years, consistent with previous real-world findings [1], [2].No new safety events were reported.
