title: Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period.
abstract: OBJECTIVE
  To evaluate clinical remission with subcutaneous abatacept plus methotrexate (MTX) and abatacept monotherapy at 12 months in patients with early rheumatoid arthritis (RA), and maintenance of remission following the rapid withdrawal of all RA treatment.
  
  
  METHODS
  In the Assessing Very Early Rheumatoid arthritis Treatment phase 3b trial, patients with early active RA were randomised to double-blind, weekly, subcutaneous abatacept 125 mg plus MTX, abatacept 125 mg monotherapy, or MTX for 12 months. Patients with low disease activity (Disease Activity Score (DAS)28 (C reactive protein (CRP)) <3.2) at month 12 entered a 12-month period of withdrawal of all RA therapy. The coprimary endpoints were the proportion of patients with DAS28 (CRP) <2.6 at month 12 and both months 12 and 18, for abatacept plus MTX versus MTX.
  
  
  RESULTS
  Patients had <2 years of RA symptoms, DAS28 (CRP) ≥3.2, anticitrullinated peptide-2 antibody positivity and 95.2% were rheumatoid factor positive. For abatacept plus MTX versus MTX, DAS28 (CRP) <2.6 was achieved in 60.9% versus 45.2% (p=0.010) at 12 months, and following treatment withdrawal, in 14.8% versus 7.8% (p=0.045) at both 12 and 18 months. DAS28 (CRP) <2.6 was achieved for abatacept monotherapy in 42.5% (month 12) and 12.4% (both months 12 and 18). Both abatacept arms had a safety profile comparable with MTX alone.
  
  
  CONCLUSIONS
  Abatacept plus MTX demonstrated robust efficacy compared with MTX alone in early RA, with a good safety profile. The achievement of sustained remission following withdrawal of all RA therapy suggests an effect of abatacept's mechanism on autoimmune processes.
  
  
  BACKGROUND
  NCT01142726.
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.affiliation: Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany.
authors.forename: Gerd R
authors.initials: GR
authors.lastname: Burmester
authors.affiliation: Department of Rheumatology, Hospital for Special Surgery, New York, New York, USA.
authors.forename: Vivian P
authors.initials: VP
authors.lastname: Bykerk
authors.affiliation: Department of Rheumatology, Lapeyronie Hospital, Montpellier I University, Montpellier, France.
authors.forename: Bernard G
authors.initials: BG
authors.lastname: Combe
authors.affiliation: Department of Medicine, University of California Los Angeles, Los Angeles, California, USA.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
authors.affiliation: Bristol-Myers Squibb, Braine-L'Alleud, Belgium.
authors.forename: Emilie
authors.initials: E
authors.lastname: Barré
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey, USA.
authors.forename: Chetan S
authors.initials: CS
authors.lastname: Karyekar
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey, USA.
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Wong
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Tom W J
authors.initials: TW
authors.lastname: Huizinga
mesh_terms: D000069594:Abatacept; D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology; D002097:C-Reactive Protein / Q000276:immunology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D061345:Early Medical Intervention / Q000379:methods; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D018796:Immunoconjugates; D000069594:Abatacept; D002097:C-Reactive Protein; D008727:Methotrexate
keywords: DMARDs (biological); Disease Activity; Methotrexate; Rheumatoid Arthritis