title: Autoantibody profile during short-term infliximab treatment for Crohn's disease: a prospective cohort study.
abstract: BACKGROUND
  The potential clinical implications of autoimmunity during treatment with infliximab are unclear.
  
  
  OBJECTIVE
  To determine the frequency and correlation of autoantibody formation in patients with Crohn's disease treated with infliximab in a routine clinical setting.
  
  
  METHODS
  Sixty-three patients with refractory/inflammatory (31) and/or fistulising Crohn's disease (32), received an infliximab infusion at a dose 5 mg/kg in weeks 0, 2 and 6, and were evaluated for the development of antinuclear, anti-double-stranded DNA, anti-Sm, anti-RNP, anti-SSA, anti-SSB and antihistone antibodies. The correlates with pharmacological treatments, the response to infliximab and adverse events were evaluated.
  
  
  RESULTS
  Antinuclear antibodies were found in five of the 63 patients (8%) at baseline and in 26 (42%) after 10 weeks (P < 0.001). Of the 26 antinuclear antibody-positive patients who were further subtyped, nine of 63 (17%) had anti-double-stranded DNA (P = 0.003), and 1.5% were extractable nuclear antigen (ENA) and antihistone-positive. Five patients were initially positive for anticardiolipin antibodies and two more patients became positive during infliximab treatment. New autoantibody formation was more frequent in the patients with inflammatory/refractory disease than in those with fistulising disease (17 vs. 7; P = 0.02). One patient developed drug-induced lupus without major organ damage.
  
  
  CONCLUSIONS
  Autoantibody formation occurs in 42% of patients (8% of these patients were positive before infliximab treatment) with Crohn's disease receiving induction treatment with infliximab, but the clinical significance of this remains to be determined.
authors.affiliation: Rheumatology Unit, L. Sacco University Hospital, Milan, Italy. reumatologia@hsacco.it
authors.forename: F
authors.initials: F
authors.lastname: Atzeni
authors.forename: S
authors.initials: S
authors.lastname: Ardizzone
authors.forename: P
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.forename: E
authors.initials: E
authors.lastname: Colombo
authors.forename: G
authors.initials: G
authors.lastname: Maconi
authors.forename: S
authors.initials: S
authors.lastname: De Portu
authors.forename: M
authors.initials: M
authors.lastname: Carrabba
authors.forename: G
authors.initials: G
authors.lastname: Bianchi Porro
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D001323:Autoantibodies / Q000032:analysis*; D015331:Cohort Studies; D003424:Crohn Disease / Q000188:drug therapy* / Q000276:immunology; D004351:Drug Resistance; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000911:Antibodies, Monoclonal; D001323:Autoantibodies; D005765:Gastrointestinal Agents; D000069285:Infliximab