title: Low serum trough levels are associated with post-surgical recurrence in Crohn's disease patients undergoing prophylaxis with adalimumab.
abstract: BACKGROUND
  Whether therapeutic drug monitoring of biologic therapy can predict the efficacy of adalimumab to prevent postoperative Crohn's disease recurrence is unknown.
  
  
  OBJECTIVE
  To investigate whether adalimumab trough levels and anti-adalimumab antibodies correlate with endoscopic and clinical outcomes in a series of patients treated with prophylactic adalimumab monotherapy after resective surgery.
  
  
  METHODS
  Post hoc analysis of a randomized, mesalamine-controlled trial. Adalimumab trough levels and antibodies were analysed every 8 weeks for 2 years using an homogeneous mobility shift assay.
  
  
  RESULTS
  At two years, 1/6 patient had clinical recurrence and 1/6 patient had endoscopic and clinical recurrence. At baseline (9.5 vs. 14.4 mcg/mL) and during follow-up [7.5 (4.4-9.8) vs. 13.9 (8.9-23.6)mcg/mL, p<0.01], median adalimumab trough levels in patients with clinical or endoscopic recurrence were lower than in those who maintained remission. Persistent antibodies-against-adalimumab were detected in the patient with both endoscopic and clinical recurrence.
  
  
  CONCLUSIONS
  Measurement of adalimumab trough levels and anti-adalimumab antibodies after surgery could be useful to further reduce postoperative recurrence.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: Giorgia
authors.initials: G
authors.lastname: Bodini
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Savarino
authors.affiliation: Inserm U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Université de Lorraine, Vandoeuvre-lès-Nancy, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Peyrin-Biroulet
authors.affiliation: Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: de Cassan
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Dulbecco
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: Isabella
authors.initials: I
authors.lastname: Baldissarro
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Fazio
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Giambruno
authors.affiliation: Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. Electronic address: edoardo.savarino@unipd.it.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Savarino
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000097:blood; D003424:Crohn Disease / Q000175:diagnosis / Q000601:surgery*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D016099:Endoscopy, Gastrointestinal / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage; D008875:Middle Aged; D011183:Postoperative Complications / Q000097:blood* / Q000175:diagnosis; D011446:Prospective Studies; D012008:Recurrence; D012016:Reference Values; D018570:Risk Assessment; D055502:Secondary Prevention / Q000379:methods*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D019804:Mesalamine; D000068879:Adalimumab
keywords: Adalimumab; Anti-tumour necrosis factor alpha antibodies; Crohn's disease; Post-surgical recurrence