title: Decrease of disease activity under ineffective therapy in DMARD-naive patients with early rheumatoid arthritis: role of antibody profiles and carriage of the HLA shared epitope in predicting decrease of disease activity.
abstract: OBJECTIVE
  To evaluate whether the baseline presence of rheumatoid arthritis (RA)-associated biomarkers could define subgroups of patients that are more prone to show a spontaneous decrease of RA disease activity. In a previous placebo-controlled phase II trial that failed to show any superiority of the experimental compound versus placebo, a remarkable decrease of such disease activity was observed despite the lack of effective treatment.
  
  
  METHODS
  A subgroup of 83 disease modifying antirheumatic drug-naive RA patients with disease duration < 3 years was analyzed. Rheumatoid factor (RF), anti-citrullinated protein/peptide antibodies (ACPA), and HLA shared epitope (SE) were determined at baseline.
  
  
  RESULTS
  RF-positive patients tended to have higher levels of disease activity at baseline compared to RF-negative patients [Disease Activity Score (DAS) 6.12 vs 5.65, p = 0.02 at screening], but the decrease in disease activity was similar in both subgroups (DAS -1.23 vs -1.07). In contrast, ACPA-positive patients showed similar baseline disease activity scores compared to ACPA-negative patients, but tended to show a smaller decrease of disease activity than patients without ACPA (Delta DAS -1.53 vs -0.79, p = 0.013). Presence of the HLA-SE seemed not to have any effect on the baseline DAS or on the spontaneous decrease of DAS.
  
  
  CONCLUSIONS
  The predictive value of baseline RA-associated biomarkers for spontaneous decrease of disease activity under placebo or ineffective treatment is limited. Yet the data analyzed here might be useful for the design of future placebo-controlled trials in RA.
authors.affiliation: Ghent University, Gent, Belgium. Bert.VanderCruyssen@Ugent.be
authors.forename: Bert
authors.initials: B
authors.lastname: Vander Cruyssen
authors.forename: André M M
authors.initials: AM
authors.lastname: Miltenburg
authors.forename: Filip
authors.initials: F
authors.lastname: Van den Bosch
authors.forename: Jos G A
authors.initials: JG
authors.lastname: Houbiers
authors.forename: Ruth
authors.initials: R
authors.lastname: Wittoek
authors.forename: Annemieke M H
authors.initials: AM
authors.lastname: Boots
authors.forename: Filip
authors.initials: F
authors.lastname: De Keyser
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology; D015415:Biomarkers / Q000378:metabolism*; D002986:Clinical Trials as Topic; D018450:Disease Progression; D000939:Epitopes; D006680:HLA Antigens; D006801:Humans; D010919:Placebos; D011237:Predictive Value of Tests
chemical_list: D018501:Antirheumatic Agents; D015415:Biomarkers; D000939:Epitopes; D006680:HLA Antigens; D010919:Placebos