Artikel
Abatacept in Combination with Non-methotrexate Disease-Modifying Antirheumatic Drugs: a Descriptive Analysis of Data From Four Studies
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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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Andrea Rubbert-Roth
- Universitätsklinikum Köln, Klinik I für Innere Medizin, Köln
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Klaus Krüger
- Praxiszentrum, München
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Reinhard Voll
- Department of Rheumatology and Clinical Immunology, Medical Center University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg
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Jürgen Rech
- Universitätsklinikum Erlangen, Medizinische Klinik 3, Rheumatologie und Immunologie, Erlangen
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Harald Louis Burkhardt
- Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik II, Rheumatologie, Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP, Frankfurt/Main
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Eugen Feist
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
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Yedid Elbez
- 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: There is a wealth of data supporting the use of abatacept in combination with MTX. However, MTX is poorly tolerated by some patients, and data on alternative conventional synthetic (cs)DMARD combinations with abatacept are scarce. This exploratory analysis assessed the available efficacy and safety data for abatacept in combination with non-MTX csDMARDs.
Methods: Data were extracted from four previously published studies: three clinical studies (ATTAIN, ASSURE, ARRIVE) and a real-world study (ACTION; cohort A [89% biologic experienced]). Patients (≥18 years) with moderate-to-severe RA received abatacept administered with one non-MTX csDMARD (hydroxychloroquine, sulfasalazine, azathioprine or leflunomide) for 6 months to 2 years (according to study). Changes from baseline in physical function assessed by HAQ-DI (all studies), DAS28 (CRP) (ATTAIN, ARRIVE and ACTION) and ACR20 response rates (ATTAIN) were described. Efficacy results for HAQ-DI and DAS28 (CRP) were pooled across clinical studies. ACTION was excluded from the pooled efficacy and safety analyses.
Results: Across the four studies, 731 patients received abatacept with one non-MTX csDMARD (hydroxychloroquine : n=152; sulfasalazine : n=123; azathioprine : n=59; leflunomide : n=397) and 2382 patients received abatacept plus MTX. Abatacept administered in combination with non-MTX csDMARDs was associated with improvements in HAQ-DI, DAS28 (CRP) and ACR20 response rates (Table 1 [Tab. 1]). In pooled analyses, for abatacept plus a non-MTX csDMARD, mean changes from baseline in HAQ-DI scores for individual csDMARDs were in the range from –0.35 to –0.49 versus –0.43 for abatacept plus MTX, and change in DAS28 (CRP) scores were in the range from –1.65 to –2.37 versus –2.04. Data from ACTION supported these findings (Table 2 [Tab. 2]). Overall rates of treatment-related AEs and treatment-related serious AEs, respectively, for abatacept plus one non-MTX csDMARD were in the range, across individual csDMARDs, of 25.0–40.0% and 0.0–25.0% (ATTAIN), 50.0–59.7% and 0.0–10.0% (ASSURE) and 28.1–46.7% and 0.0–1.5% (ARRIVE), versus 41.7% and 2.3% (ATTAIN), 55.9% and 1.7% (ASSURE), and 44.3% and 2.9% (ARRIVE) for abatacept plus MTX.
Conclusion: This analysis suggests that abatacept combined with a non-MTX csDMARD improves clinical outcomes and is well tolerated in patients with RA. Given the small numbers of patients, further analyses are needed to assess the treatment benefit conferred by specific concomitant non-MTX csDMARDs.
