PMID- 18383390
OWN - NLM
STAT- MEDLINE
DCOM- 20080521
LR  - 20211027
IS  - 0004-3591 (Print)
IS  - 0004-3591 (Linking)
VI  - 58
IP  - 4
DP  - 2008 Apr
TI  - Results of a two-year followup study of patients with rheumatoid arthritis who 
      received a combination of abatacept and methotrexate.
PG  - 953-63
LID - 10.1002/art.23397 [doi]
AB  - OBJECTIVE: To evaluate the efficacy, radiographic changes, and safety of 
      abatacept and methotrexate therapy through 2 years in a long-term extension of a 
      previously published 1-year study. METHODS: Patients who received placebo during 
      year 1 were switched to abatacept. Patients taking abatacept continued to take 
      it. Efficacy and safety were assessed through 2 years. RESULTS: Of 539 patients 
      enrolled in the initial 1-year study, 488 completed 1 year of the long-term 
      extension (2% discontinued for lack of efficacy). At 2 years, patients taking 
      abatacept had maintained their responses on the American College of Rheumatology 
      (ACR) improvement criteria and the Disease Activity Score in 28 joints (DAS28; 
      using the C-reactive protein [CRP] level), as well as their physical function 
      (according to the Health Assessment Questionnaire [HAQ] disability index [DI]) 
      and health-related quality of life (HRQOL; assessed with the Short Form 36 
      [SF-36] health survey), that were observed at the end of the double-blind period 
      (year 1 versus year 2 values were 81.9% versus 80.3% for ACR 20% improvement, 
      25.4% versus 30.9% for a DAS28 [CRP] of <2.6, 71.8% versus 66.8% for the HAQ DI, 
      and 9.7 versus 10.6 and 7.3 versus 7.2, respectively, for the mean change in the 
      physical and mental components summary scores of the SF-36). In the abatacept 
      group, post hoc analysis demonstrated further inhibition of radiographic 
      progression during year 2 (57% reduction in mean change of total score in year 2 
      versus year 1; P<0.0001), and minimal radiographic progression was observed (mean 
      change in total score from baseline was 1.1 and 1.6 at year 1 and 2, 
      respectively). Rates of adverse events (AEs) and severe AEs were consistent 
      throughout the cumulative period. CONCLUSION: The improvements in signs and 
      symptoms, physical function, and HRQOL observed after 1 year of abatacept 
      treatment were maintained through 2 years of treatment. This durability was 
      accompanied by a safety profile consistent with that in the double-blind portion 
      of the study. Radiographic progression was further inhibited in year 2 compared 
      with year 1, suggesting an increasing effect of abatacept on the inhibition of 
      structural damage in year 2.
FAU - Kremer, Joel M
AU  - Kremer JM
AD  - Center for Rheumatology, Albany Medical College, Albany, New York 12206, USA. 
      jkremer@joint-docs.com
FAU - Genant, Harry K
AU  - Genant HK
FAU - Moreland, Larry W
AU  - Moreland LW
FAU - Russell, Anthony S
AU  - Russell AS
FAU - Emery, Paul
AU  - Emery P
FAU - Abud-Mendoza, Carlos
AU  - Abud-Mendoza C
FAU - Szechinski, Jacek
AU  - Szechinski J
FAU - Li, Tracy
AU  - Li T
FAU - Teng, Julie
AU  - Teng J
FAU - Becker, Jean-Claude
AU  - Becker JC
FAU - Westhovens, Rene
AU  - Westhovens R
LA  - eng
SI  - ClinicalTrials.gov/NCT00048568
GR  - 18475/ARC_/Arthritis Research UK/United Kingdom
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Rheum
JT  - Arthritis and rheumatism
JID - 0370605
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Immunoconjugates)
RN  - 7D0YB67S97 (Abatacept)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Abatacept
MH  - Adult
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/diagnostic imaging/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Health Status
MH  - Humans
MH  - Immunoconjugates/therapeutic use
MH  - Male
MH  - Methotrexate/*therapeutic use
MH  - Middle Aged
MH  - Quality of Life
MH  - Radiography
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2008/04/03 09:00
MHDA- 2008/05/22 09:00
CRDT- 2008/04/03 09:00
PHST- 2008/04/03 09:00 [pubmed]
PHST- 2008/05/22 09:00 [medline]
PHST- 2008/04/03 09:00 [entrez]
AID - 10.1002/art.23397 [doi]
PST - ppublish
SO  - Arthritis Rheum. 2008 Apr;58(4):953-63. doi: 10.1002/art.23397.