Table 13.

GRADE Evidence Profile comparing budesonide versus systemic corticosteroids versus placebo, for inducing and maintaining remission for moderate to severe luminal Crohn’s disease

BUDESONIDE COMPARED TO PLACEBO FOR MODERATE TO SEVERE LUMINAL CROHN’S DISEASE INVOLVING DISTAL ILEUM AND/OR CECUM AND ASCENDING COLON
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 budesonide
Induction of clinical remission (CRITICAL)	104/133 (78.2%)	131/246 (53.3%)	RR 0.74 (0.60 to 0.91)	203 fewer per 1,000 (from 313 fewer to 70 fewer)	379 (3 RCT)	⨁⨁◯◯1,2 LOW
Maintenance of clinical remission (CRITICAL)	78/145 (53.8%)	62/145 (42.8%)	RR 0.79 (0.62 to 1.00)	113 fewer per 1,000 (from 204 fewer to 0 fewer)	290 (4 RCT)	⨁⨁◯◯1,2 LOW
1 Rated down for indirectness (trials focused on patients with mild to moderately active disease, with CDAI between 180–400)
2 Rated down for imprecision since optimal information size not met (<200 events)
SYSTEMIC CORTICOSTEROIDS COMPARED TO PLACEBO FOR MODERATE TO SEVERE LUMINAL CROHN’S DISEASE
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 prednisone
Induction of clinical remission (CRITICAL)	91/135 (67.4%)	53/132 (40.2%)	RR 0.57 (0.45 to 0.72)	290 fewer per 1,000 (from 371 fewer to 182 fewer)	267 (2 RCTs)	⨁⨁◯◯1,2 LOW
Maintenance of clinical remission (CRITICAL)	94/131 (71.8%)	95/138 (68.8%)	RR 1.01 (0.81 to 1.29)	7 more per 1,000 (from 136 fewer to 208 more)	269 (3 RCTs)	⨁⨁◯◯3,4 LOW
1 Rated down for risk of bias (sequence generation and allocation concealment not adequately reported)
2 Rated down for imprecision since optimal information size not met (<200 events)
3 Rated down for risk of bias (unclear randomization scheme)
4 Rated down for imprecision (wide 95% CI that could not exclude significant benefit or harm)
BUDESONIDE COMPARED WITH SYSTEMIC CORTICOSTEROIDS FOR MODERATE TO SEVERE LUMINAL CROHN’S DISEASE
Outcomes	Study event rates (95% CI)		Relative effect (95% CI)	Absolute effect*	No of participants (studies)	Quality of the evidence (GRADE)
	Risk with systemic corticosteroids	Risk with budesonide
Induction of clinical remission (CRITICAL)	179/295 (60.7%)	186/356 (52.2%)	RR 1.20 (1.01 to 1.44)	79 more per 1,000 (from 4 more to 173 more)	651 (5 RCT)	⨁⨁⨁◯1 MODERATE
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 risk of bias (sequence generation and allocation concealment not adequately reported)