Table 3.
Factors associated with lack of response to obeticholic acid at 12 months.
| Variable | Univariate |
Multivariate |
|
|---|---|---|---|
| RR (95% CI), p | aRR (95% CI), p | aRR∗ (95% CI), p | |
| Age, years | 1.01 (1.00–1.02), 0.088 | ||
| Age at PBC diagnosis, years | 1.01 (1.00–1.03), 0.020 | ||
| Age at OCA start, years | 1.01 (1.00–1.02), 0.089 | 1.01 (1–1.02), 0.068 | 1.01 (1.00–1.02), 0.253 |
| Male sex | 0.79 (0.41–1.52), 0.476 | ||
| ANA positivity | 1.16 (0.90–1.49), 0.243 | ||
| AMA positivity | 0.81 (0.61–1.09), 0.163 | ||
| Liver cirrhosis | 1.39 (1.10–1.76), 0.006 | 1.26 (0.98–1.62), 0.077 | 1.11 (0.86–1.43), 0.418 |
| PBC-AIH overlap | 0.93 (0.64–1.34), 0.696 | ||
| Triple therapy with UDCA, OCA, and fibrates | 1.26 (0.78–2.05), 0.345 | ||
| OCA started after fibrates | 1.48 (1.01–2.17), 0.042 | 1.81 (1.10–3.00), 0.021 | 2.04 (1.23–3.38), 0.006 |
| Duration of PBC, years | 0.99 (0.97–1.01), 0.374 | ||
| ALP/ULN at baseline | 1.12 (1.05–1.20), <0.001 | 1.16 (1.06–1.27), 0.001 | 1.14 (1.04–1.26), 0.005 |
| ALT/ULN at baseline | 1.05 (0.95–1.17), 0.339 | ||
| AST/ULN at baseline | 1.13 (1.02–1.24), 0.017 | 0.92 (0.78–1.09), 0.328 | 0.87 (0.73–1.04), 0.134 |
| GGT/ULN at baseline | 1.01 (1.00–1.03), 0.069 | 0.99 (0.97–1.02), 0.604 | 1.01 (0.98–1.03), 0.549 |
| Total bilirubin/ULN at baseline | 1.18 (1.06–1.32), 0.003 | 1.20 (1.03–1.40), 0.021 | 1.15 (1.00–1.34), 0.040 |
Response to OCA evaluated according to Poise criteria in the overall cohort (OC). Risk ratios with 95% confidence intervals were from Poisson regression models with robust error variance. Age at OCA start (which was collinear with age and age at PBC diagnosis), sex and all variables associated at univariate analysis with a p < 0.10 entered the multivariate model. A second multivariable model (∗) was fitted additionally correcting for OCA discontinuation. AIH, autoimmune hepatitis; ALP, alkaline phosphatase; ALT, alanine transferase; AMA, antimitochondrial antibodies; ANA, antinuclear antibodies; aRR, adjusted risk ratio; AST, aspartate transferase; GGT, gamma-glutamyl transferase; OCA, obeticholic acid; PBC, primary biliary cholangitis; RR, risk ratio; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.
Additionally corrected for OCA discontinuation.