. 2022 Aug 23;42(11):2453–2465. doi: 10.1111/liv.15386

TABLE 2.

Factors associated with lack of response to Obeticholic acid at 12 months

Variable	Univariate			Multivariate
Variable	RR	95%CI	p	aRR	95%CI	p
Age at OCA start, years	1.00	0.98–1.02	.905
Age at PBC diagnosis, years	1.00	0.99–1.02	.647
Duration of PBC, years	0.99	0.97–1.02	.634
Female sex	0.57	0.47–0.70	<.001	0.63	0.42–0.93	.020
Diabetes Mellitus	0.93	0.50–1.73	.831
BMI, Kg/m²	0.95	0.90–1.01	.081	0.95	0.9–1.00	.070
ANA positivity	1.35	0.92–1.98	.125
AMA positivity	0.75	0.51–1.10	.144
PBC‐AIH overlap	0.99	0.59–1.66	.961
Concomitant Fibrate therapy	1.38	0.92–2.07	.123
Oesophageal varices	1.38	0.93–2.06	.110
History of ascites ^a	1.71	1.42–2.07	<.001	0.91	0.48–1.73	.780
Platelets <150 000/mm³	1.10	0.75–1.62	.635
INR ^b	1.18	0.98–1.42	.081	1.37	1.00–1.87	.048
Albumin, g/dl	1.01	1.01–1.02	<.001	1.01	1.00–1.02	.100
Creatinine, mg/dl	1.12	0.75–1.68	.578
Child‐Pugh score	1.57	1.12–2.20	.008	1.79 ^d	1.28–2.50	<.001
MELD	1.12	1.04–1.21	.003	1.17 ^d	1.04–1.30	.004
OCA dose ^c	1.06	0.78–1.44	.720
ALP/ULN at baseline	1.25	1.13–1.38	<.001	1.07	0.93–1.24	.340
ALT/ULN at baseline	1.23	1.04–1.45	.015	1.32	0.89–1.96	.170
AST/ULN at baseline	1.42	1.11–1.83	.006	0.77	0.42–1.40	.390
GGT/ULN at baseline	1.01	1.00–1.02	.006	1.02	1.00–1.04	.080
Total bilirubin at baseline	2.08	1.49–2.90	<.001	1.83	1.11–3.01	.020

Note: Lack of response to Obeticholic acid were evaluated according to Poise criteria in the treatment completer cohort (TTC). Risk ratios with 95% confidence intervals were from Poisson regression models with robust error variance. All variables associated at univariate analysis with a p < .10 entered the multivariate model.

Abbreviations: AIH, autoimmune hepatitis; ALP, alkaline phosphatase; ALT, alanine transferase; AMA, antimitochondrial antibodies; ANA, antinuclear antibodies; aRR, adjusted risk ratio; AST, aspartate transferase; BMI, body mass index; GGT, gamma‐glutamyl transferase; INR, international normalized ratio; MELD, model for end‐stage liver disease; OCA, obeticholic acid; PBC, primary biliary cholangitis; RR, risk ratio; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.

^{^a}

currently controlled by diuretic therapy.

^{^b}

Risk estimates reported for 1 standard deviation increase to provide a more clinically useful result.

^{^c}

OCA dose categorized as <5 mg daily, 5 mg daily and >5 mg daily.

^{^d}

Since included in their computation, Child‐Pugh score and MELD were included in multivariate models after exclusion of ascites, albumin, INR and total bilirubin (for Child‐Pugh score) and INR and total bilirubin for MELD.