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SAT0246 Correlation of Clinical Response with Patient-Reported Outcomes in the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve RA Patients with Background Methotrexate) Trial: 2-Year Results
  1. R. Fleischmann1,
  2. M. Weinblatt2,
  3. M. Schiff3,
  4. D. Khanna4,
  5. M. Maldonado5,
  6. A. Nadkarni5,
  7. J. Fay5,
  8. D. Furst6
  1. 1University of Texas Southwestern Medical Center, Dallas
  2. 2Brigham & Women's Hospital, Boston
  3. 3University of Colorado, Denver
  4. 4University of Michigan, Ann Arbor
  5. 5Bristol-Myers Squibb, Princeton
  6. 6University of California at Los Angeles, Los Angeles, United States


Background RA is a progressively debilitating disease that decreases health-related quality of life and increases functional limitation of daily living activities. Year 1 and 2 data from the 2-year head-to-head AMPLE study showed comparable improvements and similar onset of response with subcutaneous (SC) abatacept (ABA) and adalimumab (ADA) on background MTX across multiple clinical measures and patient-reported outcomes (PROs).1,2 It is important to understand the association between clinical responses and improvements in pain, fatigue and the ability to perform work and daily activities.

Objectives To use 2-year data from the AMPLE trial to examine correlations between clinical response, including stringent remission parameters, and PROs.

Methods AMPLE is a Phase IIIb, randomized, investigator-blinded study. Biologic-naïve patients (pts) with RA and an inadequate response to MTX were randomized to SC 125 mg ABA weekly or 40 mg ADA bi-weekly, with background MTX. The proportions of pts achieving low disease activity (LDA; Clinical Disease Activity Index [CDAI] ≤10, Simplified Disease Activity Index [SDAI] ≤11) or remission (CDAI ≤2.8, SDAI ≤3.3, Boolean score ≤1) were assessed. PROs were analysed for pts who obtained these clinical responses at both Years 1 and 2 (“responders”) and those who did not (“non-responders”). Pain and fatigue were measured by 100-mm visual analogue scales (VAS). Work productivity was assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire. The Activity Limitation Questionnaire measured the number of days pts were unable to perform usual activities during the prior 30 days.

Results 646 pts were randomized and treated with SC ABA (n=318) or ADA (n=328) on background MTX. Baseline characteristics were balanced between the two treatment arms. Across multiple measures, greater improvements were observed in pain, fatigue, work time and activity in those achieving LDA or remission (Table 1).

Table 1

Conclusions Achievement of clinical remission and LDA was associated with greater improvements in PROs (pain, fatigue and the ability to perform work and daily activities) than pts who did not achieve clinical response. Pts treated with SC abatacept and adalimumab over 2 years had comparable responses.


  1. Schiff M, et al. Ann Rheum Dis 2013;73:86–94,

  2. Fleischmann R, et al. Arthritis Rheum 2013;65(Suppl 10):S183.

Disclosure of Interest R. Fleischmann Grant/research support: Abbvie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Dynavax, Genzyme, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Xoma, Consultant for: Abbvie, Amgen, AstraZeneca, BMS, Celgene, Janssen, Eli Lilly, Pfizer, Roche, Sanofi-Aventis, UCB, M. Weinblatt Grant/research support: BMS, Crescendo Bioscience, UCB, Consultant for: BMS, Crescendo Bioscience, UCB, Abbvie, Roche, Janssen, M. Schiff Consultant for: Bristol-Myers Squibb, Abbvie, Speakers bureau: Bristol-Myers Squibb, Abbvie, D. Khanna Consultant for: BMS, M. Maldonado Shareholder of: BMS, Employee of: BMS, A. Nadkarni Shareholder of: BMS, Employee of: BMS, J. Fay Shareholder of: BMS, Employee of: BMS, D. Furst Grant/research support: Abbvie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: Abbvie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: Abbvie, Actelion, UCB

DOI 10.1136/annrheumdis-2014-eular.2113

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