title: Patient-Reported Outcomes From a Two-Year Head-to-Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis.
abstract: To report 2-year patient-reported outcomes (PROs) from the head-to-head Abatacept versus Adalimumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate (MTX) (AMPLE) trial.
  
  
  
  AMPLE was a phase IIIb, randomized, investigator-blinded trial. Biologic-naive patients with rheumatoid arthritis (RA) and an inadequate response to MTX were randomized to subcutaneous (SC) abatacept (125 mg/week) or adalimumab (40 mg every 2 weeks) with background MTX. PROs (pain, fatigue, ability to perform work, and ability to perform daily activities) were compared up to year 2 for patients in each treatment group, as well as those who achieved low disease activity at both years 1 and 2 (responders) and those who did not (nonresponders).
  
  
  
  A total of 646 patients were randomized and treated with SC abatacept (n = 318) or adalimumab (n = 328). Baseline characteristics were balanced between the 2 treatment arms. Comparable improvements in PROs were observed in the abatacept and adalimumab groups over 2 years, with both groups achieving clinically meaningful improvements in PROs from baseline. At year 2, fatigue improved by 23.4 mm and 21.5 mm on a 100-mm visual analog scale with abatacept and adalimumab, respectively. Clinical responders achieved greater improvements in PROs than nonresponders.
  
  
  
  In biologic-naive patients with active RA, despite prior MTX, treatment with SC abatacept or adalimumab with background MTX resulted in comparable improvements in PROs, which were highly correlated with physician-reported clinical response end points.
authors.affiliation: University of Texas Southwestern Medical Center, Dallas.
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.affiliation: Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Weinblatt
authors.affiliation: University of Colorado, Denver.
authors.forename: Michael
authors.initials: M
authors.lastname: Schiff
authors.affiliation: Dinesh Khanna, MD: University of Michigan, Ann Arbor.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Khanna
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Maldonado
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey.
authors.forename: Anagha
authors.initials: A
authors.lastname: Nadkarni
authors.affiliation: University of California at Los Angeles.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
mesh_terms: D000069594:Abatacept / Q000627:therapeutic use*; D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000069594:Abatacept; D000068879:Adalimumab