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

Table 2 Comparison of the general safety outcomes in the efruxifermin vs placebo arms

Outcome variables	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
Any TEAE	28	3	110/116	113/125	1.03 (0.96-1.10)	0.39	9	0.56
	50	4	141/145	121/135	1.05 (1.00-1.11)	0.04	0
Drug-related TEAE	28	3	79/116	58/125	1.45 (1.16-1.82)	0.001	0	0.38
	50	4	110/145	61/135	1.67 (1.36-2.05)	< 0.00001	0
Severe TEAE	28	2	1/59	1/64	1.11 (0.07-16.47)	0.94	NA	0.70
	50	3	2/82	1/74	2.21 (0.22-22.47)	0.50	NA
TEAE leading to treatment discontinuation	28	3	10/116	3/125	3.15 (0.96-10.35)	0.06	0	0.97
	50	5	16/166	3/145	3.05 (1.06-8.81)	0.04	0
Serious AE	28	3	16/116	11/125	1.51 (0.77-2.97)	0.23	0	0.89
	50	5	19/166	12/145	1.35 (0.30-6.11)	0.70	40
Abdominal pain	28	2	10/76	8/82	1.35 (0.56-3.21)	0.50	0	0.84
	50	2	8/82	8 /82	1.13 (0.27-4.69)	0.87	37
Nausea	28	3	36/116	29/125	1.38 (0.66-2.91)	0.39	53	0.55
	50	5	68/166	32/145	1.78 (1.25-2.54)	0.001	0
Vomiting	28	3	28/116	12/125	2.17 (1.16-4.08)	0.02	0	0.57
	50	4	27/145	12/135	1.80 (0.95-3.39)	0.07	0
Diarrhea	28	2	29/76	22/82	1.42 (0.90-2.24)	0.13	0	0.45
	50	4	59/123	26/102	1.90 (1.04-3.49)	0.04	36
Frequent bowel movements	28	2	12/59	1/64	8.98 (1.71-47.13)	0.009	0	0.26
	50	2	2/62	1/64	1.43 (0.09-22.30)	0.80	37
Increased appetite	28	3	21/116	7/125	3.16 (1.39-7.20)	0.0006	0	0.30
	50	4	45/146	7/135	5.66 (2.71-11.82)	< 0.00001	0
Fatigue	28	2	12/76	12/82	1.04 (0.51-2.14)	0.90	0	0.73
	50	2	11/82	12/82	0.87 (0.42-1.83)	0.72	0
Headache	28	2	14/97	13/104	1.15 (0.57-2.33)	0.69	0	0.68
	50	3	22/126	14/114	1.41 (0.75-2.65)	0.29	0
Injection site erythema	28	3	23/116	14/125	1.66 (0.88-3.14)	0.12	4	0.89
	50	4	30/145	14/135	1.77 (0.95-3.32)	0.07	5
Injection site reaction	28	3	16/116	14/125	1.17 (0.60-2.28)	0.65	0	0.51
	50	4	26/145	14/135	1.71 (0.67-4.39)	0.26	21

AE: Adverse events; EFX: Efruxifermin; NA: Not available; RR: Risk ratio; TEAE: Treatment-emergent adverse event.