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. Author manuscript; available in PMC: 2020 Apr 2.
Published in final edited form as: Gastroenterology. 2020 Jan 13;158(5):1465–1496.e17. doi: 10.1053/j.gastro.2020.01.007

Table 13.

GRADE Evidence Profile comparing infliximab and cyclosporine vs. placebo for decreasing short-term risk of colectomy, in patients hospitalized with corticosteroid-refractory acute severe ulcerative colitis


Infliximab compared to Placebo for Hospitalized Patients with Acute Severe Ulcerative Colitis, refractory to intravenous corticosteroids
Outcomes Study event rates (95% CI) Relative effect (95% CI) Absolute effect* No of participants (studies) Quality of the evidence (GRADE)
Risk with Placebo Risk with Infliximab
Short-term colectomy 14/21 (66.7%) 7/24 (29.2%) RR 0.44 (0.22 to 0.87) 373 fewer per 1,000 (from 520 fewer to 87 fewer) 45 (1 RCTs) ⨁⨁⨁◯1 MODERATE

Cyclosporine compared to Placebo for Hospitalized Patients with Acute Severe Ulcerative Colitis, refractory to intravenous corticosteroids
Outcomes Study event rates (95% CI) Relative effect (95% CI) Absolute effect* No of participants (studies) Quality of the evidence (GRADE)
Risk with Placebo Risk with Cyclosporine
Short-term colectomy 4/9 (44.4%) 3/11 (27.3%) RR 0.61 (0.18 to 2.01) 173 fewer per 1,000 (from 364 fewer to 471 more) 20 (1 RCTs) ⨁⨁◯◯1 LOW
GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
1

Rated down for imprecision due to low number of events

2

Rated down for very serious imprecision (very wide confidence intervals)