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. 2019 Jan 3;25(7):1169–1186. doi: 10.1093/ibd/izy383

TABLE 1.

Study Characteristics and Considerations for Analysis

Author Year Country Type of Study Abstract or Full Text Definition of Severity Eligibility for Rescue Therapy Sample Size Subgroups IFX Dose IFX Dose Number (ITT) IFX Dose Strategy (ITT) CFS (N) Considerations for the Meta-analysis
Month 1 Month 3 Month 12
Al Khoury 2017 Canada Retrospective Abstract Mayo severity score 6–12 with Mayo endoscopic score ≥2 IV steroid-refractory (Oxford criteria) 72 69 67 64
37 5 mg/kg 3 Standard 36 35 33
35 10 mg/kg 3 Standard 30 30 29
5 10 mg/kg 3 Accelerated 3 2 2
An 2017 Australia Retrospective Abstract TLW criteria IV steroid-refractory 44 5 mg/kg 38 35 34
16 3 Standard 15 13 13
28 3 Accelerated 23 22 21
Aratari 2008 Italy Retrospective Full text TLW criteria and Powell Tuck IV steroid-refractory 11 5 mg/kg 3 Standard 11 11 10
Beswick 2016 Australia Prospective observational Abstract TLW criteria IV steroid-refractory 24 5 mg/kg 22 22 19
3 5 mg/kg 1 Single dose 3 3 3
9 5 mg/kg ≥2 Standard 9 9 9
12 5 mg/kg ≥2 Accelerated 10 10 7
Bressler 2008 Canada Retrospective Full text Hospitalized UC IV steroid-refractory 21 5 mg/kg 1 Single dose 16 13 NS
Croft 2013 Australia Prospective observational Full text TLW criteria IV steroid-refractory 38 5 mg/kg 1 Single dose 31 28 24
Dean 2011 New Zealand Retrospective Full text Hospitalized UC IV steroid-refractory 19 5 mg/kg 1–5 Single or multiple dose NS 15 12
Duijvis 2016 Netherlands Retrospective Full text Hospitalized UC IV or oral steroid-refractory 22 5 mg/kg 3 Standard 21 16 12 Mixture of moderate–severe and severe patients
Fernandes 2016 Portugal Retrospective Full text TLW criteria IV steroid-refractory (Oxford criteria) 25 5 mg/kg 3 Standard 20 20 19
Florhomen 2011 Norway RCT Full text TLW criteria IV steroid-refractory 13 5 mg/kg 3 Standard 13 13 NS
Gibson 2015 Ireland Retrospective Full text Hospitalized UC IV steroid-refractory 50 36 32 29
35 5 mg/kg 3 Standard 22 20 18
15 5 mg/kg 3 Accelerated 14 12 11
Gibson 2018 Ireland Retrospective Abstract Hospitalized UC IV steroid-refractory 145
87 5 mg/kg 3 Standard 71 66 60
58 5 mg/kg 3 Accelerated 53 49 44
Govani 2016 USA Retrospective Abstract Hospitalized UC IV steroid-refractory 55 44 42 33 Mixture of 5 mg/kg and 10 mg/kg given to patients in both accelerated and high-dose cohorts, unable to include into the meta-analysis
17 10 mg/kg starting dose 3 NA 10 9 9
38 5 mg/kg starting dose 3 NA 34 33 24
Jarnerot/ Gustavsson 2005/ 2010 Sweden RCT/retrospective Full text Seo index IV steroid-refractory (failure to improve according to Seo index) 24 4-5 mg/kg 1 Single dose 17 17 14 Jarnerot and Gustavsson cohorts merged; mixture of moderate–severe and severe patients
Halpin 2013 UK Retrospective Full text TLW criteria IV steroid-refractory 44 5 mg/kg 3 Standard 34 34 31 IV steroid-refractory
Ho 2009 UK/Scotland Prospective observational Full text TLW criteria IV steroid-refractory (Oxford criteria or Ho index) 21 5 mg/kg 1 Single dose 10 NS NS
Hulkower 2016 USA Prospective observational Abstract Hospitalized UC/Mayo score >9 IV steroid-refractory 4 10 mg/kg 2–3 Accelerated 4 4 NS
Kaser 2001 Austria Prospective observational Full text Hospitalized UC IV steroid-refractory 6 5 mg/kg 1 Single dose 6 6 NS
Kim 2015 South Korea Retrospective Full text Hospitalized UC IV steroid-refractory 33 5 mg/kg 3 Standard 33 33 32
Kohn 2007 Italy Retrospective Full text TLW criteria IV steroid-refractory 83 5 mg/kg NS 71 NS 2-mo analysed as 3-mo outcomes; mixture of moderate–severe and severe patients
26 1 Single dose NS 17 NS
57 ≥2 Weeks 0, 2, 4, or 0, 2, 6 NS 54 NS
Laharie 2012/ 2017 France RCT Full text Lichtiger score >10 IV steroid-refractory 55 5 mg/kg 3 Standard NS 45 38 Laharie 2012/2017 cohorts merged; 2 patients excluded as received CyA; 12-mo outcome derived % estimate
Lees 2007 UK Retrospective Full text TLW criteria IV steroid-refractory 39 5 mg/kg 1–3 Single or multiple dose 26 26 24
Llao 2016 Spain Retrospective Full text Montreal classification/TLW IV steroid-refractory 14 5 mg/kg 3 Standard 14 14 11
Lowenberg 2014 Netherlands Retrospective Full text TLW criteria IV steroid-refractory (Oxford criteria) 16 5 mg/kg 3 Standard 15 12 10
Mocciaro 2012 Italy Retrospective Full text TLW criteria IV steroid-refractory 30 5 mg/kg 3 Standard 25 25 25
Monterubbianesi 2014 Italy Retrospective Full text TLW criteria (modified by Chapman) IV steroid-refractory 113 5 mg/kg 3 Standard 96 91 83
Mortensen 2011 Denmark Retrospective Full text Hospitalized UC/SCCAI IV or oral steroid-refractory 56 5 mg/kg 1–9 Single or standard 46 39 NS
Nalagatla 2018 USA Retrospective Full text Hospitalized UC IV steroid-refractory 213
132 5 mg/kg >2 Standard 121 113 96
81 5–10 mg/kg >2 Accelerated/intensified 74 65 58
Ordas 2017 Spain Retrospective Full text Hospitalized UC IV steroid-refractory 131 5 mg/kg 1 or 3 Single or standard NS 112 100
Regueiro 2006 USA Retrospective Full text Partial Mayo score ≥9 IV steroid-refractory 11 5 mg/kg 3 Standard 7 4 2
Ribaldone 2017 Italy Retrospective Full text TLW criteria IV steroid-refractory 20 5 mg/kg 3 Standard 19 19 15
Sands 2001 USA RCT Full text TLW criteria/Lichtiger score IV steroid-refractory 11 7 4 NS
3 5 mg/kg 1 Single dose 3 1 NS
3 10 mg/kg 1 Single dose 2 1 NS
2 20 mg/kg 1 Single dose 2 2 NS
Seah 2017 Australia Retrospective Full text TLW criteria IV steroid-refractory 41 5 mg/kg 3 37 36 30
30 Standard 28 28 24
10 Accelerated 9 8 6
Shah 2018 USA Retrospective Full text Hospitalized UC IV or oral steroid-refractory 126 3 106 97 89
89 5 mg/kg Standard 78 72 65
23 5 mg/kg Accelerated 16 14 14
8 10 mg/kg Standard 6 5 4
6 10 mg/kg Accelerated 6 6 6
Shepherd 2014 Australia Retrospective Abstract TLW criteria IV steroid-refractory 15 5 mg/kg 1–3 12 10 6
11 1 Single dose 8 6 4
4 ≥2 Multiple dose 4 4 2
Sjoberg 2013 Sweden Retrospective Full text TLW criteria IV steroid-refractory (fulminant colitis index–Lindgren 1998 or Seo index) 211 5 mg/kg 153 149 133
124 1 Single dose NS 76 NS
87 2–3 Standard NS 73 NS
Sly 2017 USA Retrospective Abstract Hospitalized UC IV steroid-refractory 41
18 5 mg/kg 3 Standard 16 16 13
23 5–10 mg/kg 3 Accelerated 16 14 11
Sood 2014 India Retrospective Full text Lichtiger score IV steroid-refractory 28 5 mg/kg 3 Standard 25 19
Van Langenberg 2015 Australia Retrospective Abstract TLW criteria IV steroid-refractory 88 5 mg/kg 80 76 67
41 1 Single dose 33 31 28
47 ≥2 Standard 47 45 39
Williams 2016 UK RCT Full text TLW criteria or clinical judgment IV steroid-refractory 135 5 mg/kg 3 Standard 106 96 88 Moderate-severity TLW in 27%
Yamamoto-Furusho 2008 Mexico Prospective observational Full text TLW criteria IV steroid-refractory 10 5 mg/kg 1 Single dose NS 2 2

Abbreviations: NS, not stated; TLW, Truelove and Witt’s.