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01.12.2018 | Research article | Ausgabe 1/2018 Open Access

Arthritis Research & Therapy 1/2018

Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting

Zeitschrift:
Arthritis Research & Therapy > Ausgabe 1/2018
Autoren:
Rieke Alten, Harald Burkhardt, Eugen Feist, Klaus Krüger, Juergen Rech, Andrea Rubbert-Roth, Reinhard E. Voll, Yedid Elbez, Christiane Rauch
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13075-017-1488-5) contains supplementary material, which is available to authorized users.

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 non-MTX 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.

Trial registration

ClinicalTrials.gov NCT00048581. Registered 2 November 2002.
ClinicalTrials.gov NCT00048932. Registered 11 November 2002.
ClinicalTrials.gov NCT00124982. Registered 30 June 2005.
ClinicalTrials.gov NCT02109666. Registered 8 April 2014.
Zusatzmaterial
Additional file 1: is a figure showing mean change from baseline in HAQ-DI scores in response to abatacept administered in combination with one csDMARD from the (a) ATTAIN, (b) ASSURE, and (c) ARRIVE studies (PDF 183 kb)
13075_2017_1488_MOESM1_ESM.pdf
Additional file 2: is a figure showing mean change from baseline in DAS28 (CRP) at 6 months in response to abatacept administered in combination with one csDMARD from the (a) ATTAIN and (b) ARRIVE studies (PDF 101 kb)
13075_2017_1488_MOESM2_ESM.pdf
Additional file 3: is a table presenting safety profile data of csDMARDs administered in combination with abatacept in the ATTAIN, ASSURE and ARRIVE studies (PDF 35 kb)
13075_2017_1488_MOESM3_ESM.pdf
Literatur
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