TABLE 1.
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.