title: Maintenance of remission following 2 years of standard treatment then dose reduction with abatacept in patients with early rheumatoid arthritis and poor prognosis.
abstract: OBJECTIVE
  To evaluate maintenance of response while reducing intravenous abatacept dose from ~10 mg/kg to ~5 mg/kg in patients with early rheumatoid arthritis (RA) who achieved disease activity score (DAS)28 (erythrocyte sedimentation rate, ESR) <2.6.
  
  
  METHODS
  This 1-year, multinational, randomised, double-blind substudy evaluated the efficacy and safety of ~10 mg/kg and ~5 mg/kg abatacept in patients with early RA with poor prognosis who had reached DAS28 (ESR) <2.6 at year 2 of the AGREE study. The primary outcome was time to disease relapse (defined as additional disease-modifying antirheumatic drugs, ≥2 courses high-dose steroids, return to open-label abatacept ~10 mg/kg, or DAS28 (C reactive protein) ≥3.2 at two consecutive visits).
  
  
  RESULTS
  108 patients were randomised (~10 mg/kg, n=58; ~5 mg/kg, n=50). Three and five patients, respectively, discontinued, and four per group returned to open-label abatacept. Relapse over time and the proportion of patients relapsing were similar in both groups (31% (~10 mg/kg) vs 34% (~5 mg/kg); HR: 0.87 (95% CI 0.45 to 1.69)). Mean steady-state trough serum concentration for the ~10 mg/kg group was 20.3-24.1 µg/mL, compared with 8.8-12.0 µg/mL for the ~5 mg/kg group.
  
  
  CONCLUSIONS
  This exploratory study suggests that abatacept dose reduction may be an option in patients with poor prognosis early RA who achieve DAS28 (ESR) <2.6 after ≥1 year on abatacept (~10 mg/kg).
  
  
  BACKGROUND
  NCT00989235.
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
authors.affiliation: Centro Médico Toluca, Metepec, México.
authors.forename: Manuel
authors.initials: M
authors.lastname: Robles
authors.affiliation: Hospital Geral de Goiânia, Goiânia, Brazil.
authors.forename: Antonio Carlos
authors.initials: AC
authors.lastname: Ximenes
authors.affiliation: Schoen Klinik Hamburg Eilbek, Hamburg, Germany.
authors.forename: Jurgen
authors.initials: J
authors.lastname: Wollenhaupt
authors.affiliation: Service et Pôle de Rhumatologie, Cliniques Universitaires Saint-Luc, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Durez
authors.affiliation: Hospital Clinico Universidad De Santiago, A Coruna, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Gomez-Reino
authors.affiliation: Clinica Reumatologica, Università Politecnica delle Marche, Ancona, Italy.
authors.forename: Walter
authors.initials: W
authors.lastname: Grassi
authors.affiliation: Institut de Rhumatologie de Montréal, Montréal, Quebec, Canada.
authors.forename: Boulos
authors.initials: B
authors.lastname: Haraoui
authors.affiliation: University of Alabama, Huntsville, Alabama, USA.
authors.forename: William
authors.initials: W
authors.lastname: Shergy
authors.affiliation: The Catholic University of Korea, Seoul, South Korea.
authors.forename: Sung-Hwan
authors.initials: SH
authors.lastname: Park
authors.affiliation: University of California, San Francisco/Synarc, San Francisco, California, USA.
authors.forename: Harry
authors.initials: H
authors.lastname: Genant
authors.affiliation: Spire Sciences, Inc., Boca Raton, Florida, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Peterfy
authors.affiliation: Becker Clinical Research Consulting LLC, New York, New York, USA.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Becker
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey, USA.
authors.forename: Bindu
authors.initials: B
authors.lastname: Murthy
mesh_terms: D000069594:Abatacept; D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000008:administration & dosage*; D060828:Induction Chemotherapy / Q000379:methods; D053208:Kaplan-Meier Estimate; D060046:Maintenance Chemotherapy / Q000379:methods; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012008:Recurrence; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D018796:Immunoconjugates; D000069594:Abatacept
keywords: DMARDs (biologic); Disease Activity; Early Rheumatoid Arthritis; Rheumatoid Arthritis; Treatment