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43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

Treatment Effects and Minimal Clinically Important Differences in Patient-Reported Outcomes Following Treatment and Withdrawal of Abatacept, Methotrexate or Combination Therapy in Patients with Early Rheumatoid Arthritis

Meeting Abstract

  • D. Furst - University of California at Los Angeles, Los Angeles, United States of America
  • Vivian Bykerk - Weill Cornell Medical College, New York, United States of America
  • Gerd-Rüdiger Burmester - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
  • Bernard Combe - Montpellier University, Montpellier, France
  • Tom Huizinga - Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
  • E Alemao - Bristol-Myers Squibb, Princeton, United States
  • D. Wong - Bristol-Myers Squibb, Princeton, United States of America
  • Paul Emery - Johns Hopkins University, Baltimore, United States

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. DocRA.33

doi: 10.3205/15dgrh200, urn:nbn:de:0183-15dgrh2000

Published: September 1, 2015

© 2015 Furst et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at



Introduction: Early biologic use can improve long-term control of RA [1], [2]. Minimal clinically important differences (MCIDs) in patient-reported outcomes (PROs) that are of particular importance to patients with RA, such as pain, fatigue and physical function, can provide benchmarks for intervention. In the AVERT (Assessing Very Early Rheumatoid arthritis Treatment) trial in anti-cyclic citrullinated peptide 2 seropositive (CCP2+) patients with early RA, significantly more patients receiving SC abatacept (ABA) + MTX than patients receiving MTX achieved DAS28 (CRP) <2.6 after 12 months of treatment and 6 months after rapid withdrawal of all RA therapy [3]. In AVERT, we investigated the overall treatment effect on PROs and the percentage of patients achieving MCIDs during treatment (baseline to Month 12) and ≤6 months after treatment withdrawal.

Methods: Patients were MTX naïve, anti-CCP2+, ≥18 years old, with active synovitis, DAS28 (CRP) ≥3.2, disease onset ≤2 years. Patients were randomized to weekly ABA (125 mg) + MTX, ABA (125 mg) or MTX. All RA treatments (biologic agent, MTX and steroids) were withdrawn after 12 months in patients with DAS28 (CRP) <3.2. In this post hoc analysis, overall treatment effect and treatment differences among ABA + MTX or ABA or MTX patients were obtained. The approach used a longitudinal repeated-measures model including fixed categorical effects of treatment, visit month and prior corticosteroid use as well as the continuous fixed covariate of baseline value. The percentage of patients achieving MCIDs was analysed.

Results: A total of 351 patients were enrolled (119 ABA + MTX, 116 ABA, 116 MTX). ABA + MTX had statistically significant effects on fatigue and SF-36 physical component summary (PCS) score versus MTX alone during the treatment period (Table 1 [Tab. 1]). Numerically greater percentages of patients being treated with ABA + MTX achieved MCIDs than ABA or MTX alone. In all groups, treatment withdrawal provided continued benefits but at reduced magnitude.

Conclusion: Clinically meaningful improvements and significant benefits were seen in physical function and fatigue over 12 months in an anti-CCP2+, early RA cohort treated with abatacept + MTX. Continued beneficial effects were observed at the group level up to 6 months even after all RA drugs were abruptly withdrawn.

Note: This abstract was first presented at the EULAR Congress, 10–13 June 2015, Rome, Italy (AB0446) and published in the corresponding supplement of Ann Rheum Dis.


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