2. Summary of interventions and outcomes.
| Study ID | Group 1 | Group 2 | Group 3 | Relapse |
Quailty of Life |
Adverse Events/ Serious adverse/ Withdrawal due to adverse events |
|
| Ardizzone 2004 | Azathioprine (2mg/kg/day) |
Mesalamine (3g/day) |
Clinical: 32/71 vs 35/71 Surgical: 26/71 vs 21/71 |
n/a |
AE:18/71 vs 27/71 SAE:6/71 vs 15/71 Withdrwal due to AE: 6/71 vs 15/71 |
||
| Armuzzi 2013 | Azathioprine (2.5 mg/kg/day) Infliximab (5 mg/kg/day) |
Infliximab (5 mg/kg/day) |
Clinical: 2/11 vs 1/11 Endoscopic: 5/11 vs 1/11; Histologic: 9/11 vs 2/11 |
n/a | Withdrawal due to AE: 0/11 vs 1/11 | ||
| D'Haens 2008 | Metronidazole (750 mg/day) first 3 mo + Azathioprine (100‐150 mg/day) |
Metronidazole (750mg/day) first 3 months + Placebo |
Clinical: 11/40 vs 19/41 Endoscopic: 22/40 vs 32/41 |
n/a |
AE: 3/40 vs 4/41 Withdrawal due to AE: 3/40 vs 4/41 |
||
| Hanauer 2004 | 6‐Mercaptopurine (50 mg/day) | Mesalamine (3 g/day) | Placebo | Clinical: 32/47 vs 33/44 vs 35/40 | n/a |
AE: 9/47 vs 6/44 vs 4/40 SAE: 2/47 vs 0/44 vs 2/40 Withdrawal due to AE: 9/47 vs 6/44 vs 4/40 |
|
| Lopez‐Sanroman 2017 | Azathioprine (2.5 mg/kg/d) + Metronidazole (750 mg/day) first 3 mo | Adalimumab + Metronidazole (750 mg/day) first 3 mo |
Clinical: 14/39 vs 7/45 Endoscopic: 23/39 vs 19/45 Radiologic: 26/39 vs 22/45 |
n.s. changes between groups |
AE: 20/45 vs 18/39 SAE: 9/45 vs 4/39 Withdrawal due to AE: 1/39 vs 9/45 |
||
| Mowat 2016 | Mercaptopurine (1 mg/kg/day) | Placebo |
Clinical: 66/128 vs 70/112 Endoscopic: 90/128 vs 83/112 |
n.s differences |
SAE: 3/128 vs 2/112 Withdrawal due to AE: 39/128 vs 41/112 |
||
| Reinisch 2010 | Azathioprine (2.0‐2.5 mg/kg/d) + Placebo mesalazine | Mesalazine (4g/d) + Placebo azathioprine |
Not included | Mean IBDQ change |
AE: 34/37 vs 32/41 SAE: 0/37 vs 10/41 Withdrawal due to AE: 1/37 vs 10/41 |
||
| Savarino 2013 | Adalimumab (160‐80 mg 0‐2 weeks and 40 mg/week thereafter) | Azathioprine (2 mg/kg/day) | Mesalamine (3 g/day) |
Clinical by Hanauer score: 2/16 vs 12/17 vs 9/18 Clinical by CDAI: 1/16 vs 12/17 vs 9/18 Endoscopic: 1/16 vs 11/17 vs 15/18 Radiologic: 1/16 vs 13/17 vs 15/18 |
HRQOL (IBDQ >170): 14/16 vs 2/17 vs 3/18 |
AE:11/16 vs 14/17 vs 14/18 Withdrawal due to AE:0/16 vs 1/17 vs 1/18 |
|
| Scapa 2015 | 6‐mercaptopurine (1.5 mg/kg/day) | Adalimumab (160‐80‐40 mg/2 week intervals) | Endoscopic: 4/8 vs 1/11 | n/a | n/a |
mg: milligram; kg: kilogram; g: gram; CDAI: Crohn's disease activity index; NA: not applicable; AE: adverse events; SAE: serious adverse events; HRQOL: health related quality of life; IBDQ: inflammatory bowel disease questionnaire; ns: not significant