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