Efficacy and safety of semaglutide in non-alcoholic fatty liver disease

Table 2 Grading of recommendations assessment, development, and evaluation summary of findings table

Outcomes	Anticipated absolute effects1 (95%CI)		Relative effect (95%CI)	Number of participants (studies)	Certainty of the evidence (GRADE)
	Risk with placebo	Risk with semaglutide
Resolution of NASH with no worsening of liver fibrosis assessed with: Liver biopsy	183 per 1000	416 per 1000 (276 to 571)	OR 3.18 (1.70 to 5.95)	301 (2 RCTs)	+++O: Moderate2
Improvement in liver fibrosis stage without worsening of NASH assessed with: Liver biopsy	317 per 1000	248 per 1000 (65 to 613)	OR 0.71 (0.15 to 3.41)	301 (2 RCTs)	++OO: Low2,3,4
Liver stiffness assessed with: MRI-PDFF or Fibroscan	-	SMD 0.48 lower (0.86 lower to 0.11 lower)	-	350 (3 RCTs)	++++: High
Liver steatosis assessed with: MRE	The mean liver steatosis ranged from -0.57% to -2.57%	MD 4.96 % lower (9.92 lower to 0.01 higher)	-	138 (2 RCTs)	+++O: Moderate3
ALT	The mean ALT ranged from 1.90 U/L to -11.22 U/L	MD 14.06 U/L lower (22.06 lower to 6.07 lower)	-	458 (3 RCTs)	++++: High
AST	The mean AST ranged from 1.50 U/K to -5.76 U/K	MD 11.44 U/K lower (17.23 lower to 5.65 lower)	-	458 (3 RCTs)	++++: High
Serious adverse events	109 per 1000	147 per 1000 (84 to 244)	OR 1.40 (0.75 to 2.62)	456 (3 RCTs)	+++O: Moderate2,4

¹The risk in the intervention group [and its 95% confidence interval (95%CI)] is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95%CI).

²Few events.

³Possibly substantial heterogeneity.

⁴Wide confidence interval including no effect and does not exclude appreciable benefit or harm.

GRADE Working Group grades of evidence. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. CI: Confidence interval; MD: Mean difference; OR: Odds ratio; SMD: Standardised mean difference; MRI-PDFF: MRI proton density fat fraction; MRE: Magnetic resonance elastography.