Safety and efficacy of efruxifermin in metabolic dysfunction-associated steatohepatitis: A systematic review

Table 5 Comparison of the hepatic efficacy (categorical) outcomes in the efruxifermin vs placebo arms

Outcome variables (categorical)	EFX dose (mg)	No. of study reports	No. of participants with outcome/participants analyzed (n/N)		Pooled effect size, RR (95%CI)	P value (EFX vs placebo)	I2 (%)	P value (EFX 28 vs 50)
			EFX arm	Placebo arm
Reduction in HFF ≥ 30%	28	2	48/54	11/62	4.73 (2.54 to 8.82)	< 0.00001	16	0.98
	50	2	48/52	11/62	4.79 (2.76 to 8.30)	< 0.00001	4
Reduction in HFF ≥ 50%	28	2	35/54	2/62	19.06 (4.82 to 75.40)	< 0.0001	0	1.0
	50	2	44/52	2/62	19.03 (5.68 to 63.78)	< 0.00001	0
HFF ≤ 5%	28	2	17/54	2/62	8.71 (2.06 to 36.75)	0.003	0	0.70
	50	3	41/68	3/72	12.45 (4.09 to 37.93)	< 0.00001	0
Decrease in NAS ≥ 2	50	2	17/25	2/7	1.96 (0.64 to 5.99)	0.24	0	NA
MASH resolution and improvement in fibrosis stage	28	2	15/51	2/43	4.59 (1.29 to 16.25)	0.02	0	0.72
	50	2	19/47	2/43	6.33 (1.83 to 21.90)	0.004	0
MASH resolution and no worsening of fibrosis stage	28	2	24/51	6 43	3.19 (1.47 to 6.93)	0.003	0	0.43
	50	3	36/59	6/48	4.89 (2.41 to 9.91)	< 0.0001	0
Fibrosis regression by ≥ 1 stage and no worsening in steatohepatitis	28	3	42/108	19/104	2.06 (1.28 to 3.30)	0.003	0	0.61
	50	4	55/122	19/109	2.44 (1.55 to 3.83)	0.0001	0
Fibrosis regression by ≥ 2 stage and no worsening in steatohepatitis	28	2	9/51	2/43	2.68 (0.70 to 10.18)	0.15	0	1.00
	50	2	9/47	2/43	2.68 (0.69 to 10.38)	0.15	0

EFX: Efruxifermin; HFF: Hepatic fat fraction; MASH: Nonalcoholic steatohepatitis; NA: Not available; NAS: Non-alcoholic fatty liver disease activity score; RR: Risk ratio.