title: Proposal for an anti-TNF-exit strategy based on trough serum level.
abstract: OBJECTIVE
  The aim of the study was to evaluate, if the strategy to stop anti-TNF treatment after determination of low trough serum levels and exclusion of inflammation is associated with lower relapse rates.
  
  
  METHODS
  Since 2013 we followed an exit strategy in patients treated with anti-TNF treatment for inflammatory bowel disease based on trough serum levels. The relapse rates were observed prospectively, data analysis was performed in a retrospective manner of the collected clinical data.
  
  
  RESULTS
  Forty patients were enrolled, who stopped anti-TNF therapy. 13 Patients followed the clinical algorithm, 27 patients were used as control group (13 patients with ulcerative colitis and 14 patients with Crohn's disease). 19 patients received Infliximab, 21 Adalimumab. The median follow-up time after discontinuation was 19 months (IQR 18). Relapses were observed in 22/40 patients (55%). Among the 13 patients with a targeted discontinuation of therapy based on the algorithm, three relapses were observed (23%), compared to 19/27 (70%) from the non-algorithm group (OR: 7.9; 95%-CI: 1.7-36.5). Relapse-free-survival after anti-TNF discontinuation was significantly higher in patients treated by the algorithm compared to the non-algorithm group (p = 0.032).
  
  
  CONCLUSIONS
  An exit strategy based on trough serum levels significantly reduces the relapse rate.
authors.affiliation: University of Kiel, Medical Practice for Internal Medicine, Neue Donnerschweer Str. 30, 26123 Oldenburg, Germany. Electronic address: helwig@internisten-ol.de.
authors.forename: Ulf
authors.initials: U
authors.lastname: Helwig
authors.affiliation: University of Kiel, Medical Practice for Internal Medicine, Neue Donnerschweer Str. 30, 26123 Oldenburg, Germany.
authors.forename: Frederik
authors.initials: F
authors.lastname: Lutter
authors.affiliation: Medical Practice for Internal Medicine, Neue Donnerschweer Str. 30, 26123 Oldenburg, Germany.
authors.forename: Nadine
authors.initials: N
authors.lastname: Koppka
authors.affiliation: Department of Internal Medicine I - Gastroenterology, Hepatology, Nutrition and Geriatric Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Arnold-Heller-Straße 3, 24105 Kiel, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000465:Algorithms; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014409:Tumor Necrosis Factor-alpha / Q000097:blood*
chemical_list: D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab
keywords: Exit strategy; Infliximab; TSL (trough serum level)