title: Efficacy and safety of adalimumab for the treatment of peripheral arthritis in spondyloarthritis patients without ankylosing spondylitis or psoriatic arthritis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of adalimumab in patients with peripheral spondyloarthritis (SpA) not fulfilling the criteria for ankylosing spondylitis (AS) or psoriatic arthritis (PsA).
  
  
  METHODS
  40 patients with active peripheral SpA fulfilling the European Spondyloarthropathy Study Group or Amor criteria but not the criteria for AS or PsA were included in a randomised, double-blind, placebo-controlled clinical trial. Patients were treated 1 : 1 with adalimumab or placebo for 12 weeks, followed by an open label extension up to week 24. Safety and efficacy measurements were performed every 6 weeks, with the patient's global assessment of disease activity at week 12 as the primary endpoint.
  
  
  RESULTS
  At week 12, the patient's and physician's global assessment of disease activity, swollen joint count, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS) and erythrocyte sedimentation rate improved significantly in the adalimumab group compared with the baseline values and compared with placebo. A similar improvement was seen upon adalimumab treatment from weeks 12 to 24 in the patients originally randomised to placebo, whereas the clinical response was maintained or even augmented at week 24 in the patients who received adalimumab from the start. ASDAS inactive disease and BASDAI50 responses were met in 42% of the adalimumab group versus 0%-5% in the placebo group at week 12 (p=0.001 and p=0.008, respectively), and were further increased at week 24. The number of adverse events was not different between the adalimumab and placebo groups.
  
  
  CONCLUSIONS
  Adalimumab appears to be effective and well tolerated in SpA patients with peripheral arthritis, also in those patients not fulfilling the AS or PsA criteria.
authors.affiliation: Division of Clinical Immunology and Rheumatology, Academic Medical Center/ University of Amsterdam, , Amsterdam, The Netherlands.
authors.forename: Jacqueline E
authors.initials: JE
authors.lastname: Paramarta
authors.forename: Leen
authors.initials: L
authors.lastname: De Rycke
authors.forename: Tanja F
authors.initials: TF
authors.lastname: Heijda
authors.forename: Carmen A
authors.initials: CA
authors.lastname: Ambarus
authors.forename: Koen
authors.initials: K
authors.lastname: Vos
authors.forename: Huib J
authors.initials: HJ
authors.lastname: Dinant
authors.forename: Paul P
authors.initials: PP
authors.lastname: Tak
authors.forename: Dominique L
authors.initials: DL
authors.lastname: Baeten
mesh_terms: D000068879:Adalimumab; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D025241:Spondylarthritis / Q000188:drug therapy*; D013167:Spondylitis, Ankylosing; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab
keywords: Anti-TNF; Arthritis; Spondyloarthritis; Treatment