Tacrolimus and mycophenolate mofetil as second-line treatment in autoimmune hepatitis: Is the evidence of sufficient quality to develop recommendations?

Table 2 Summary of findings and quality assessment of evidence per our outcomes of interest using the Grading of Recommendations Assessment, Development and Evaluation approach

Outcomes	Certainty assessment							Patient (n)	Certainty	Importance
	Studies (n)	Study design	Risk of bias	Inconsis-tency	Indirect-ness	Imprecision	Other considerations	Per event/in total (%)
Tacrolimus
Biochemical remission	9	Observational	Serious1	Serious2	Not serious	Not serious	None	112/157 (71.3)	+OOO Very low	Critical
Adverse events	7	Observational	Serious1	Serious2	Not serious	Not serious	None	28/143 (19.6)	+OOO Very low	Important
Mortality	9	Observational	Serious1	Not serious	Not serious	Not serious	None	14/157 (8.9)	+OOO Very low	Critical
MMF
Biochemical remission	16	Observational	Serious1	Serious2	Not serious	Not serious	Dose response gradient	256/427 (59.9)	+OOO Very low	Critical
Adverse events	13	Observational	Serious1	Serious2	Not serious	Not serious	None	97/416 (23.3)	+OOO Very low	Important
Mortality	16	Observational	Serious1	Not serious	Not serious	Not serious	Publication bias strongly suspected	22/427 (5.2)	+OOO Very low	Critical

¹Failure to develop and apply appropriate eligibility criteria.

²Statistically significant heterogeneity. MMF: Mycophenolate mofetil.