Alten, Rieke, Burkhardt, Harald, Feist, Eugen, Krueger, Klaus, Rech, Juergen, Rubbert-Roth, Andrea, Voll, Reinhard E., Elbez, Yedid and Rauch, Christiane (2018). Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res. Ther., 20. LONDON: BMC. ISSN 1478-6362

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Abstract

Background: Methotrexate (MTX) remains the anchor drug in rheumatoid arthritis (RA) treatment, but is poorly tolerated or contraindicated in some patients. There is a wealth of data supporting the use of abatacept in combination with MTX, but data on alternative conventional synthetic disease-modifying antirheumatic drug (csDMARD) combinations with abatacept are scarce. Methods: In this post-hoc exploratory analysis, efficacy and safety data were extracted from abatacept RA studies in which combination with csDMARDs other than MTX was permitted: three interventional trials (ATTAIN, ASSURE, and ARRIVE) and one real-world study (ACTION). Patients with moderate-to-severe RA received abatacept in combination with MTX, hydroxychloroquine, sulfasalazine, azathioprine, or leflunomide for 6 months to 2 years according to the study design. Change from baseline in physical function (Health Assessment Questionnaire-Disability Index (HAQ-DI); all studies) and 28-joint Disease Activity Score (C-reactive protein) (DAS28 (CRP); ATTAIN, ARRIVE, and ACTION), American College of Rheumatology response rates (ATTAIN), and safety were assessed for individual and pooled csDMARD combinations for each trial. A meta-analysis was also performed on pooled data for HAQ-DI and DAS28 (CRP) across interventional trials. Results: Across all four studies, 731 patients received abatacept plus one non-MTX csDMARD (hydroxychloroquine n = 152; sulfasalazine n = 123; azathioprine n = 59; and leflunomide n = 397) and 2382 patients received abatacept plus MTX. Mean changes from baseline in HAQ-DI scores for abatacept plus MTX (all csDMARDs pooled) vs abatacept plus a nonMTX csDMARD were -0.54 vs -0.44 (ATTAIN), -0.43 vs -0.43 (ASSURE), and -0.39 vs -0.36 (ARRIVE). Mean changes from baseline in DAS28 (CRP) and ACR response rates were also similar with abatacept plus MTX or non-MTX csDMARDs. Data for individual non-MTX csDMARDs (pooled across studies) and real-world data were consistent with these findings. Rates of treatment-related adverse events and serious adverse events, respectively, for abatacept plus one non-MTX csDMARD vs abatacept plus MTX were 35.7% vs 41.7% and 2.4% vs 2.3% (ATTAIN), 58.0% vs 55.9% and 4.2% vs 1.7% (ASSURE), and 38.1% vs 44.3% and 0.6% vs 2.9% (ARRIVE). Conclusions: Abatacept in combination with non-MTX csDMARDs is clinically effective and well tolerated in patients with moderate-to-severe RA, providing similar benefits to those seen with abatacept plus MTX.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Alten, RiekeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burkhardt, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Feist, EugenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krueger, KlausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rech, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rubbert-Roth, AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Voll, Reinhard E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Elbez, YedidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rauch, ChristianeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-199216
DOI: 10.1186/s13075-017-1488-5
Journal or Publication Title: Arthritis Res. Ther.
Volume: 20
Date: 2018
Publisher: BMC
Place of Publication: LONDON
ISSN: 1478-6362
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ACTIVE RHEUMATOID-ARTHRITIS; RADIOGRAPHIC PROGRESSION; SUBCUTANEOUS ABATACEPT; INADEQUATE RESPONSE; PROGNOSTIC-FACTORS; DOUBLE-BLIND; INHIBITION; EFFICACY; SAFETY; LEFLUNOMIDEMultiple languages
RheumatologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/19921

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