title: Association between serum adalimumab concentrations and endoscopic disease activity in patients with Crohn's disease.
abstract: OBJECTIVE
  The serum trough level of adalimumab (ADA) associated with mucosal healing (MH) remains unclear. Our objective was to determine the association between ADA trough levels and the endoscopic activity in Crohn's disease.
  
  
  METHODS
  This was a cross-sectional study including 42 patients with Crohn's disease. Endoscopic activity was assessed using the modified Rutgeerts scoring system. The primary outcome was mucosal healing, and the secondary outcomes were serum levels of C-reactive protein and albumin.
  
  
  RESULTS
  Endoscopic disease activity negatively correlated with serum ADA trough levels (Spearman's rank correlation coefficient (ρ) = -0.42, P < 0.01). MH was achieved in 14 of 42 patients (33.3%). Serum ADA trough levels were significantly higher in the MH group than in the no-MH group (ADA mean trough level, 11.7 vs 7.5 µg/mL). The proportion of patients with ADA as the first biologic was significantly higher in the MH group than in the no-MH group (85.7% vs 53.5%, P = 0.04). The ADA trough levels that were best associated with normal C-reactive protein and albumin levels were 5.57 µg/mL (odds ratio [OR] 16.0, specificity 0.80) and 6.95 µg/mL (OR 9.2, specificity 0.81), respectively. The ADA trough level that was best associated with MH was 7.9 µg/mL (OR 13.5, specificity 0.86). The endoscopic disease activity was significantly higher in the patients with ADA as the second biologic as compared with those with ADA as the first biologic (P < 0.05).
  
  
  CONCLUSIONS
  Mucosal healing requires higher ADA trough levels, compared with those required to normalization of routine clinical markers.
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Morita
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Imaeda
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nishida
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Inatomi
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Bamba
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Masaya
authors.initials: M
authors.lastname: Sasaki
authors.affiliation: Department of Comprehensive Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Tsujikawa
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Mitsushige
authors.initials: M
authors.lastname: Sugimoto
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Andoh
mesh_terms: D000068879:Adalimumab / Q000097:blood* / Q000627:therapeutic use; D000328:Adult; D002097:C-Reactive Protein / Q000032:analysis; D003113:Colonoscopy; D003424:Crohn Disease / Q000097:blood* / Q000188:drug therapy; D003430:Cross-Sectional Studies; D005260:Female; D005765:Gastrointestinal Agents / Q000097:blood* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012709:Serum Albumin / Q000032:analysis; D012720:Severity of Illness Index; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D014945:Wound Healing / Q000187:drug effects; D055815:Young Adult
chemical_list: D005765:Gastrointestinal Agents; D012709:Serum Albumin; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D000068879:Adalimumab
keywords: anti-adalimumab antibodies; mucosal healing; receiver operation curve