gms | German Medical Science

42. Kongress der Deutschen Gesellschaft für Rheumatologie, 28. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 24. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

17.-20. September 2014, Düsseldorf

Clinical responses by baseline RA disease duration in the AMPLE (abatacept versus adalimumab comparison in biologic-naïve RA patients with background methotrexate) trial: 2-year results

Meeting Abstract

  • Michael Schiff - University of Colorado School of Medicine, Rheumatology Division, Denver, United States of America
  • M.E. Weinblatt - Brigham and Women's Hospital, Boston, United States of America
  • Robert M. Valente - Arthritis Center of Nebraska, Clinical Research/ Rheumatology, Lincoln, United States of America
  • Desiree van der Heijde - Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
  • Gustavo Citera - Instituto de Rehabilitación Psicofísca de Buenos Aires, Rheumatology, Buenos Aires, Argentina
  • Michael Maldonado - Bristol-Myers Squibb, Princeton, United States of America
  • J. Fay - Bristol-Myers Squibb, Princeton, United States of America
  • R. Fleischmann - University of Texas Southwestern Medical Center, Dallas, United States of America

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 42. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 28. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 24. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Düsseldorf, 17.-20.09.2014. Düsseldorf: German Medical Science GMS Publishing House; 2014. DocRA.11

doi: 10.3205/14dgrh136, urn:nbn:de:0183-14dgrh1362

Published: September 12, 2014

© 2014 Schiff et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Background: Disease duration has a considerable impact on treatment response with DMARDs in RA patients [1]. Those with longer disease duration respond less well to MTX compared with early RA patients. Data that informs decision making, especially early in the disease course, is of significant clinical utility when treating patients with biologic DMARDs. We assessed clinical outcomes in early RA patients (≤6 months’ disease duration) treated with subcutaneous (SC) abatacept or adalimumab compared with patients with >6 months’ disease duration, using 2-year AMPLE data.

Methods: AMPLE is a 2-year, Phase IIIb, randomized, investigator-blinded study. Biologic-naïve patients with RA and inadequate response to MTX were randomized to 125 mg SC abatacept weekly or 40 mg SC adalimumab bi-weekly, with background MTX.[REF1] Baseline disease duration (≤6 and >6 months for each treatment) was analysed in the intention-to-treat population, and the proportions of patients achieving ACR20/50/70 response, remission (defined as Clinical Disease Activity Index [CDAI] ≤2.8, Simplified Disease Activity Index [SDAI] ≤3.3, Boolean score ≤1), low disease activity (LDA; CDAI ≤10, SDAI ≤11) or improvement in physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI] >0.3) were assessed by disease duration and treatment subgroups.

Results: 646 patients were randomized and treated with SC abatacept (n=318) or adalimumab (n=328) on background MTX (71 and 70 patients with ≤6 months’ disease duration; 247 and 258 patients with >6 months’ disease duration). Baseline characteristics were balanced between the disease duration subgroups, with the exception of a higher percentage of males among patients with ≤6 months’ disease duration treated with adalimumab compared with other subgroups. Among patients with ≤6 months’ disease duration, 23.9% (SC abatacept) and 30.0% (adalimumab) of patients discontinued study treatment; 19.8% (SC abatacept) and 24.0% (adalimumab) of patients with >6 months’ disease duration discontinued. Clinical responses by disease duration at Years 1 (AMPLE primary endpoint) and 2 are summarized (Table 1 [Tab. 1]).

Conclusion: Data from this post hoc analysis of the AMPLE trial show that patients treated with effective biologic DMARDs (SC abatacept or adalimumab), whether treated early in the disease course (≤6 months) or later, achieved comparable responses across a range of clinical measures.


References

1.
Anderson JJ, Wells G, Verhoeven AC, Felson DT. Factors predicting response to treatment in rheumatoid arthritis: the importance of disease duration. Arthritis Rheum. 2000 Jan;43(1):22-9.