title: Efficacy of thiopurines and adalimumab in preventing Crohn's disease recurrence in high-risk patients - a POCER study analysis.
abstract: BACKGROUND
  Crohn's disease recurs in the majority of patients after intestinal resection.
  
  
  OBJECTIVE
  To compare the relative efficacy of thiopurines and anti-TNF therapy in patients at high risk of disease recurrence.
  
  
  METHODS
  As part of a larger study comparing post-operative management strategies, patients at high risk of recurrence (smoker, perforating disease, ≥2nd operation) were treated after resection of all macroscopic disease with 3 months metronidazole together with either azathioprine 2 mg/kg/day or mercaptopurine 1.5 mg/kg/day. Thiopurine-intolerant patients received adalimumab induction then 40 mg fortnightly. Patients underwent colonoscopy at 6 months with endoscopic recurrence assessed blind to treatment.
  
  
  RESULTS
  A total of 101 patients [50% male; median (IQR) age 36 (25-46) years] were included. There were no differences in disease history between thiopurine- and adalimumab-treated patients. Fifteen patients withdrew prior to 6 months, five due to symptom recurrence (of whom four were colonoscoped). Endoscopic recurrence (Rutgeerts score i2-i4) occurred in 33 of 73 (45%) thiopurine vs. 6 of 28 (21%) adalimumab-treated patients [intention-to-treat (ITT); P = 0.028] or 24 of 62 (39%) vs. 3 of 24 (13%) respectively [per-protocol analysis (PPA); P = 0.020]. Complete mucosal endoscopic normality (Rutgeerts i0) occurred in 17/73 (23%) vs. 15/28 (54%) (ITT; P = 0.003) and in 27% vs. 63% (PPA; P = 0.002). The most advanced disease (Rutgeerts i3 and i4) occurred in 8% vs. 4% (thiopurine vs. adalimumab).
  
  
  CONCLUSIONS
  In Crohn's disease patients at high risk of post-operative recurrence adalimumab is superior to thiopurines in preventing early disease recurrence.
authors: St Vincent's Hospital and University of Melbourne, Melbourne, Vic.
authors: P
authors: P
authors: De Cruz
authors: St Vincent's Hospital and University of Melbourne, Melbourne, Vic.
authors: M A
authors: MA
authors: Kamm
authors: St Vincent's Hospital and University of Melbourne, Melbourne, Vic.
authors: A L
authors: AL
authors: Hamilton
authors: St Vincent's Hospital, Melbourne.
authors: K J
authors: KJ
authors: Ritchie
authors: St Vincent's Hospital and University of Melbourne, Melbourne, Vic.
authors: E O
authors: EO
authors: Krejany
authors: Melbourne EpiCentre, Royal Melbourne Hospital, Melbourne.
authors: A
authors: A
authors: Gorelik
authors: Melbourne EpiCentre, Royal Melbourne Hospital, Melbourne.
authors: D
authors: D
authors: Liew
authors: St Vincent's Hospital and University of Melbourne, Melbourne, Vic.
authors: L
authors: L
authors: Prideaux
authors: University of Western Australia, Fremantle.
authors: I C
authors: IC
authors: Lawrance
authors: Royal Adelaide Hospital, Adelaide.
authors: J M
authors: JM
authors: Andrews
authors: Flinders Medical Centre and Flinders University, Bedford Park, SA, Australia.
authors: P A
authors: PA
authors: Bampton
authors: Alfred Health and Monash University, Melbourne, Vic., Australia.
authors: S
authors: S
authors: Jakobovits
authors: University of Queensland, St Lucia.
authors: T H
authors: TH
authors: Florin
authors: Alfred Health and Monash University, Melbourne, Vic., Australia.
authors: P R
authors: PR
authors: Gibson
authors: Cabrini Hospital, Melbourne.
authors: H
authors: H
authors: Debinski
authors: Christchurch Hospital, Christchurch, New Zealand.
authors: R B
authors: RB
authors: Gearry
authors: Colorectal Medicine and Genetics, Royal Melbourne Hospital, Melbourne.
authors: F A
authors: FA
authors: Macrae
authors: Gastroenterology and Liver Services, Concord Hospital, Sydney.
authors: R W
authors: RW
authors: Leong
authors: Western Hospital, Melbourne.
authors: I
authors: I
authors: Kronborg
authors: Queensland Institute of Medical Research and University of Queensland School of Medicine, Herston Campus, Brisbane.
authors: G
authors: G
authors: Radford-Smith
authors: Royal Prince Alfred Hospital, Sydney.
authors: W
authors: W
authors: Selby
authors: St Vincent's Hospital, Melbourne.
authors: M J
authors: MJ
authors: Johnston
authors: St Vincent's Hospital, Melbourne.
authors: R
authors: R
authors: Woods
authors: St Vincent's Hospital, Melbourne.
authors: P R
authors: PR
authors: Elliott
authors: St Vincent's Hospital and University of Melbourne, Melbourne, Vic.
authors: S J
authors: SJ
authors: Bell
authors: St Vincent's Hospital, Melbourne.
authors: S J
authors: SJ
authors: Brown
authors: St Vincent's Hospital, Melbourne.
authors: W R
authors: WR
authors: Connell
authors: St Vincent's Hospital, Melbourne.
authors: P V
authors: PV
authors: Desmond
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001379:Azathioprine / Q000008:administration & dosage* / Q000009:adverse effects; D003113:Colonoscopy / Q000379:methods; D003424:Crohn Disease / Q000175:diagnosis / Q000517:prevention & control* / Q000601:surgery*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage* / Q000009:adverse effects; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011184:Postoperative Period; D012008:Recurrence; D012307:Risk Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000276:immunology
chemical_list: D014409:Tumor Necrosis Factor-alpha; D008795:Metronidazole; D015122:Mercaptopurine; D000068879:Adalimumab; D001379:Azathioprine