title: Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE).
abstract: BACKGROUND
  This study evaluated various remission criteria in abatacept plus methotrexate (MTX)-treated patients with early rheumatoid arthritis (RA). We aimed to investigate the time to, and sustainability of, remission, and to evaluate the relationship between remission, function and structure.
  
  
  METHODS
  Post hoc analyses were performed from the 12-month, double-blind period of the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE) in patients with early RA (≤2 years) and poor prognostic factors, comparing abatacept plus MTX (n = 210) versus MTX alone (n = 209).
  
  
  RESULTS
  At month 12, Disease Activity Score 28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index and Boolean remission rates were, for abatacept plus MTX versus MTX alone: 47.6 % versus 27.3 %, 33.3 % versus 12.4 %, 34.3 % versus 16.3 %, and 23.8 % versus 5.7 %, respectively. Cumulative probability demonstrated higher proportions achieving first remission and first sustained remission for abatacept plus MTX versus MTX alone (e.g., 23.3 % [95 % confidence interval (CI): 17.6, 29.1] vs 12.9 % [8.4, 17.5] for first SDAI remission over 0-6 months). For patients in SDAI remission at month 3, mean Health Assessment Questionnaire-Disability Index at month 12 was 0.20 versus 0.50 for abatacept plus MTX versus MTX alone. Mean changes in radiographic score from baseline to month 12 were minimal for patients in SDAI remission at month 3 in both groups, while less structural damage progression was seen, 0.75 versus 1.35, respectively, for abatacept plus MTX versus MTX alone for patients with moderate/high disease activity at month 3 (adjusted mean treatment difference: -0.60 [95 % CI: -1.11, -0.09; P < 0.05]).
  
  
  CONCLUSIONS
  High proportions of abatacept plus MTX-treated patients achieved stringent remission criteria. Remission was associated with long-term functional benefit; dissociation was seen between clinical and structural outcomes for abatacept. These findings highlight the impact of reaching stringent remission targets early, on physical function and structural damage, in MTX-naïve biologic-treated patients.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT00122382. Registered 19 July 2005.
authors.affiliation: Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2nd Department of Medicine, Hietzing Hospital, Waehringer Guertel 18-20, Vienna, A-1090, Austria. josef.smolen@wienkav.at.
authors.forename: Josef S
authors.initials: JS
authors.lastname: Smolen
authors.affiliation: Schön-Klinik, Hamburg-Eilbek, Hamburg, Germany. wollenhaupt@rheumatologikum.de.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Wollenhaupt
authors.affiliation: Hospital Clinico Universitario, Santiago de Compostela, Spain. juan.jesus.gomez-reino.carnota@sergas.es.
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Gomez-Reino
authors.affiliation: Clinica Reumatologica, Università Politecnica delle Marche, Ancona, Italy. walter_grassi@yahoo.it.
authors.forename: Walter
authors.initials: W
authors.lastname: Grassi
authors.affiliation: Bristol-Myers Squibb, Rueil-Malmaison, France. corine_gaillez@hotmail.com.
authors.forename: Corine
authors.initials: C
authors.lastname: Gaillez
authors.affiliation: Docs International, Nanterre, France. poncet.coralie@gmail.com.
authors.forename: Coralie
authors.initials: C
authors.lastname: Poncet
authors.affiliation: Bristol-Myers Squibb, Rueil-Malmaison, France. manuela.lebars@bms.com.
authors.forename: Manuela
authors.initials: M
authors.lastname: Le Bars
authors.affiliation: Skeletal Biology and Engineering Research Center, Department of Development and Regeneration KU Leuven; Rheumatology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Rene
authors.initials: R
authors.lastname: Westhovens
mesh_terms: D000069594:Abatacept / Q000008:administration & dosage*; D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis* / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000069594:Abatacept; D008727:Methotrexate