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. 2019 Aug 6;2019(8):CD010233. doi: 10.1002/14651858.CD010233.pub3

1. Key definitions and outcomes.

Comparison Study ID Time from surgery till recruitment Site of surgery % / exclusions Clinical relapse definition Endoscopic / surgical/ radiologic/ histological relapse definition/
AZA & 6‐MP versus Placebo
AZA versus Placebo (12 months)
both arms 750 mg/day metronidazole
(3 months)
D'Haens 2008 2 weeks Perforating disease 48
*Macroscopic evidence for CD proximally or distally to the site of resection or the presence of frank pancolitis or an ileorectal anastomosis, patients with a stoma; operation for fibrostenosis only
CDAI > 250 Rutgeerts i ≥ 2
6‐MP 50 mg/day versus Placebo
(24 months)
Hanauer 2004 Before postoperative hospital discharge N/A
* Active perianal disease or any active disease in other segments of the intestine
Clinical recurrence grading > 2 (Hanauer) Rutgeerts i ≥ 2
Radiographic relapse: Radiographic recurrence grading > 2
6‐MP 1 mg/kg/day versus Placebo
(3 years)
Mowat 2016 ≤ 3 months Ileal 39; Colonic 2; Ileocolonic 59
* Need for further surgery, stricturoplasty alone, formation of a stoma
CDAI > 150 and a 100‐point increase from baseline Rutgeerts i ≥ 2
HRQOL: IBDQ scores
AZA & 6‐MP vs 5‐ASA
AZA 2 mg/kg versus Mesalamine 3 mg/kg (24 months) Ardizzone 2004 Maximum 2 weeks Small bowel only 25.3; Colon 5.6; Small bowel and colon 9.8; upper gastrointestinal tract 16.2
*Surgical procedures other than conservative surgery or for perianal disease only
CDAI > 200
Surgical relapse: need for another surgical procedure
n/a
6‐MP 50 mg/day versus Mesalamine 3 g/day
(24 months)
Hanauer 2004 Before postoperative hospital discharge N/A
* Active perianal disease or any active disease in other segments of the intestine
clinical recurrence grading > 2 Rutgeerts i ≥ 2
Radiographic relapse: radiographic recurrence grading > 2
AZA 2 mg/kg/day versus Mesalamine 4 g/day
(12 months)
Reinisch 2010 6‐24 months N/A
* Short bowel syndrome, an ileocolonic stoma
CDAI > 200 Rutgeerts i ≥ 2
HRQOL: IBDQ
AZA 2 mg/kg/day versus Mesalazine 3 g/day
(24 months)
Savarino 2013 2‐4 weeks Ileum 49, Ileocolonic 51.
* Fibrostenotic stricture, macroscopically active disease not resected at the time of surgery, and presence of a stoma
1. ≥ 2 on the clinical recurrence grading scale by Hanauer
2. CDAI > 200
Rutgeerts i≥2
Radiologic relapse: ≥ 2 radiographic recurrence grading scale
HRQl: IBDQ>170
AZA & 6‐MP vs anti‐TNF‐α
AZA 2.5 mg versus Infliximab 5 mg/kg
(12 months)
Armuzzi 2013 2‐4 weeks Not reported
*Active perianal disease, presence of stoma
HBI ≥ 8 Rutgeerts' score ≥ i2
AZA 2 mg/kg/day versus Adalimumab
(24 months)
Savarino 2013 2‐4 weeks Ileum 49, Ileocolonic 51.
* Fibrostenotic stricture, macroscopically active disease not resected at the time of surgery, and presence of a stoma
1. ≥ 2 on the clinical recurrence grading scale by Hanauer
2. CDAI > 200
Rutgeerts i ≥ 2
Radiologic relapse: ≥ 2 radiographic recurrence grading scale
HRQl: IBDQ > 170
AZA 2.5 mg/kg/day versus Adalimumab
(52 weeks)
both arms 750mg/day metronidazole
(3 months)
Lopez‐Sanroman 2017 2 weeks Ileal 58, ileocolonic 41
* Postsurgical stoma, resection for short indolent stenosis, inaccessible anastomosis to endoscopy
CDAI > 200 Rutgeerts i ≥ 2
6‐MP 1.5 mg/kg/day versus Adalimumab
(12 months)
Scapa 2015 < 45 days 6‐MP 1.5 mg/kg/day vs Placebo (12 months) Scapa 2015 < 45 days

AZA: azathioprine; 6‐MP: 6‐mecarptopurine; mg: milligram; CD: Crohn's disease; CDAI: Crohn's disease activity index; NA: not applicable; kg: kilogram; g: gram; HRQOL: health related quality of life; IBDQ: inflammatory bowel disease questionnaire; TNF: tumour necrosis factor; HBI: Harvey Bradshaw index; 5‐ASA: 5‐aminosalicylic acid