Artikel
The Use of Conventional Synthetic DMARDs in Patients with RA Enrolled in ACTION, a 2-Year, Observational Study of Abatacept in Routine Clinical Practice
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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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Hanns-Martin Lorenz
- Universitätsklinikum Heidelberg, Medizinische Klinik V, Sektion Rheumatologie, Heidelberg
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Hubert Nüßlein
- University of Erlangen-Nuremberg, Nuremberg
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Mauro Galeazzi
- University of Siena, Rheumatology Section, Siena, Italy
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Frederico Navarro
- Hospital Univesitario Virgen Macarena, Seville, Spain
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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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Julia Heitzmann
- Excelya, Boulogne-Billancourt, 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: ACTION (AbataCepT In rOutiNe clinical practice; NCT02109666) is a 2-year, international, observational study of patients (≥18 years) with moderate-to-severe RA who initiated IV abatacept in routine clinical practice. Here we compared conventional synthetic (cs)DMARD use and 2-year abatacept retention rates in biologic-naïve patients enrolled in ACTION with those who were biologic experienced at enrolment.
Methods: Enrolment into ACTION took place between May 2008 and December 2013. In this analysis, csDMARD use prior to and at abatacept initiation, and crude 2-year abatacept retention rates, were compared in biologic-naïve and biologic-experienced patients. Time to abatacept discontinuation was estimated by Kaplan–Meier analysis and compared between groups using a log-rank test. Safety analyses were also conducted.
Results: 2350/2364 (99.4%) patients enrolled in ACTION were evaluable for the 2-year analysis (673 [28.6%] biologic naïve and 1677 [71.4%] biologic experienced). Of the biologic-experienced patients, 728 (43.4%) had received 1 and 949 (56.6%) had received ≥2 previous biologics. Prior to abatacept initiation, mean (SD) number of previous csDMARDs in the biologic-naïve versus biologic-experienced groups, respectively, was 1.11 (0.98) versus 1.60 (1.25) (MTX: 621 [92.3%] versus 1552 [92.5%] patients, p=0.856; leflunomide: 278 [41.3%] versus 951 [56.7%] patients, p<0.001; hydroxychloroquine/chloroquine: 229 [34.0%] versus 681 [40.6%] patients, p=0.003 and sulfasalazine 148 [22.0%] versus 578 [34.5%] patients, p<0.001). Abatacept was initiated as monotherapy in 112 (16.6%) versus 427 (25.5%; p<0.001) patients and with concurrent csDMARD(s) in 561 (83.4%) versus 1250 (74.5%) patients in the biologic-naïve versus biologic-experienced groups, respectively (MTX ± any other csDMARD: 436/561 [77.7%] versus 947/1250 [75.8%]; MTX alone: 358/561 [63.8%] versus 829/1250 [66.3%] patients; MTX plus other csDMARD(s): 78/561 [13.9%] versus 118/1250 [9.4%] patients). Changes in csDMARD use with abatacept over 2 years are shown in the Figure. Switch from monotherapy to combination with csDMARDs or vice versa was observed in <4.0% and <10% of patients, respectively. Overall crude retention rates (95% CI) at 2 years were 54.5% (50.5, 58.3) for biologic-naïve patients, 50.2% (46.3, 53.9) for patients with 1 previous biologic and 41.3% (38.0, 44.6) for patients with ≥2 previous biologics (log-rank test p<0.001). (Figure 1 [Fig. 1])
Conclusion: At enrolment, biologic-naïve versus biologic-experienced patients had failed fewer csDMARDs and were less likely to have initiated abatacept as monotherapy. Over 2 years, a small proportion of patients switched from abatacept monotherapy to combination therapy or vice versa, with similar patterns in biologic-naïve and -experienced groups.
