Artikel
Two-year retention and effectiveness of IV abatacept in real-life setting: results from the ACTION study
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Autoren
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Hubert G. Nüßlein
- Rheumatologische Schwerpunktpraxis, Nürnberg
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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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M. Galeazzi
- University of Siena, Siena, Italy
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Hanns-Martin Lorenz
- Universitätsklinikum Heidelberg, Medizinische Klinik V, Sektion Rheumatologie, Heidelberg
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M.T. Nurmohamed
- VU Univ Medical Center/Jan van Breeman Research Institute, Amsterdam, The Netherlands
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WG Bensen
- St Josephs Hospital and McMaster University, Hamilton, Canada
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Gerd-Rüdiger Burmester
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
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Hans-Hartmut Peter
- Universitätsklinikum Freiburg, Rheumatologie und Klinische Immunologie, Freiburg i. Br.
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K. Pavelka
- Institute of Rheumatology, Prague, Czech Republic
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M. Chartier
- Chiltern International, Neuilly, France
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C. Poncet
- Docs International, Sèvres, France
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C. Rauch
- Bristol-Myers Squibb, München
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Manuela Le Bars
- Bristol-Myers Squibb, Rueil-Malmaison, France
| Veröffentlicht: | 12. September 2014 |
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Gliederung
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Background: Initial results from the ACTION study suggest that abatacept is clinically effective and well tolerated in RA patients, with good patient retention over 12 months [1]. We assessed retention rates and the effectiveness of IV abatacept over 24 months.
Methods: ACTION is a 2-year, international, non-interventional cohort of RA patients who initiated IV abatacept between May 2008 and January 2011. Crude abatacept retention rates were estimated by Kaplan–Meier and stratified by previous RA therapy. The proportion of patients achieving a moderate or good EULAR response was assessed at 24 months (as observed). Safety is reported for all enrolled patients.
Results: Of 1131 evaluable patients, 122 were biologic-naïve and 1009 had failed ≥1 prior biologic (487 failed 1 anti-TNF, 504 ≥2 anti-TNFs, 18 failed non anti-TNFs only). Baseline characteristics were similar, but disease duration was numerically shorter in biologic-naïve patients versus those failing ≥1 biologic agent (7.0 vs 11.8 years). The overall retention rate (95% CI) at 24 months was 54.4% (51.3, 57.4); retention rates were higher in biologic-naïve patients and those who failed 1 anti-TNF versus patients failing ≥2 anti-TNFs (Figure 1 [Fig. 1]). More patients discontinued in later lines of treatment for inefficacy (23.9% in biologic-naïve patients, 35.7% in patients failing ≥1 prior biologic agent) than intolerance/safety (7.0% and 10.6%, respectively). Good or moderate EULAR response was achieved in 95.0% of biologic-naïve patients (n=20) and in 80.2% of patients failing ≥1 prior biologic agent (n=283). There were 111 serious adverse events in 63/1137 (5.5%) patients (28 discontinuations) and 12 deaths (4 due to serious infections: sepsis [4 months after last abatacept infusion; on tocilizumab]; Pneumocystis jiroveci [4 months after last abatacept infusion]; pneumonia and urosepsis unrelated to abatacept). Serious infections occurred in 26 patients; there were 12 malignancies, 5 serious cardiac disorders and 1 serious hypersensitivity reaction. No tuberculosis occurred and 2 opportunistic infections were reported (Cytomegalovirus and P. jiroveci).
Conclusion: In this real-world setting, >50% of patients retained IV abatacept over 2 years. Higher long-term retention rates were observed when abatacept was initiated earlier in the course of RA. IV abatacept was clinically effective and well tolerated in a broad range of bioexperienced patients.
