PMID- 26473625
OWN - NLM
STAT- MEDLINE
DCOM- 20170719
LR  - 20181113
IS  - 2151-4658 (Electronic)
IS  - 2151-464X (Print)
IS  - 2151-464X (Linking)
VI  - 68
IP  - 7
DP  - 2016 Jul
TI  - Patient-Reported Outcomes From a Two-Year Head-to-Head Comparison of Subcutaneous 
      Abatacept and Adalimumab for Rheumatoid Arthritis.
PG  - 907-13
LID - 10.1002/acr.22763 [doi]
AB  - OBJECTIVE: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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.
CI  - (c) 2016 The Authors. Arthritis Care & Research published by Wiley Periodicals, 
      Inc. on behalf of the American College of Rheumatology.
FAU - Fleischmann, Roy
AU  - Fleischmann R
AD  - University of Texas Southwestern Medical Center, Dallas.
FAU - Weinblatt, Michael E
AU  - Weinblatt ME
AD  - Brigham and Women's Hospital, Boston, Massachusetts.
FAU - Schiff, Michael
AU  - Schiff M
AD  - University of Colorado, Denver.
FAU - Khanna, Dinesh
AU  - Khanna D
AD  - Dinesh Khanna, MD: University of Michigan, Ann Arbor.
FAU - Maldonado, Michael A
AU  - Maldonado MA
AD  - Bristol-Myers Squibb, Princeton, New Jersey.
FAU - Nadkarni, Anagha
AU  - Nadkarni A
AD  - Bristol-Myers Squibb, Princeton, New Jersey.
FAU - Furst, Daniel E
AU  - Furst DE
AD  - University of California at Los Angeles.
LA  - eng
SI  - ClinicalTrials.gov/NCT00929864
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Care Res (Hoboken)
JT  - Arthritis care & research
JID - 101518086
RN  - 0 (Antirheumatic Agents)
RN  - 7D0YB67S97 (Abatacept)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Abatacept/*therapeutic use
MH  - Adalimumab/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Patient Reported Outcome Measures
MH  - Treatment Outcome
PMC - PMC5094537
EDAT- 2015/10/17 06:00
MHDA- 2017/07/20 06:00
PMCR- 2016/11/03
CRDT- 2015/10/17 06:00
PHST- 2015/06/09 00:00 [received]
PHST- 2015/09/29 00:00 [revised]
PHST- 2015/10/13 00:00 [accepted]
PHST- 2015/10/17 06:00 [entrez]
PHST- 2015/10/17 06:00 [pubmed]
PHST- 2017/07/20 06:00 [medline]
PHST- 2016/11/03 00:00 [pmc-release]
AID - ACR22763 [pii]
AID - 10.1002/acr.22763 [doi]
PST - ppublish
SO  - Arthritis Care Res (Hoboken). 2016 Jul;68(7):907-13. doi: 10.1002/acr.22763.