Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Alten, Rieke UNSPECIFIED UNSPECIFIED UNSPECIFIED Burkhardt, Harald UNSPECIFIED UNSPECIFIED UNSPECIFIED Feist, Eugen UNSPECIFIED UNSPECIFIED UNSPECIFIED Krueger, Klaus UNSPECIFIED UNSPECIFIED UNSPECIFIED Rech, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Rubbert-Roth, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Voll, Reinhard E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Elbez, Yedid UNSPECIFIED UNSPECIFIED UNSPECIFIED Rauch, Christiane UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language ACTIVE RHEUMATOID-ARTHRITIS; RADIOGRAPHIC PROGRESSION; SUBCUTANEOUS ABATACEPT; INADEQUATE RESPONSE; PROGNOSTIC-FACTORS; DOUBLE-BLIND; INHIBITION; EFFICACY; SAFETY; LEFLUNOMIDE Multiple languages Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19921