Table 2.

Multiple logistic regression analysis of histologic improvement on the 52-week relative changes in liver chemistries, controlling for treatment group, baseline liver chemistries, age, sex, and BMI z-score

	Odds Ratio	95% CI	P	AUROC
Outcome: Histologic improvement (yes vs. no)				0.74
Relative change in ALT (U/L), per 10% decrease from baseline to 52 weeks	1.24	1.10 – 1.39	<0.001
Treatment group (Cyst vs. Plbo)	1.08	0.48 – 2.43	0.85
Baseline ALT (U/L)	1.00	1.00 – 1.01	0.39
Baseline age (years)	0.98	0.84 – 1.14	0.78
Sex (male vs. female)	0.90	0.38 – 2.12	0.80
Baseline BMI z-score	1.14	0.46 – 2.83	0.78
Outcome: Histologic improvement (yes vs. no)				0.69
Relative change in AST (U/L), per 10% decrease from baseline to 52 weeks	1.16	1.04 – 1.29	0.006
Treatment group (Cyst vs. Plbo)	1.16	0.53 – 2.57	0.71
Baseline AST (U/L)	1.00	1.00 – 1.01	0.47
Baseline age (years)	0.95	0.82 – 1.10	0.52
Sex (male vs. female)	0.95	0.41 – 2.17	0.90
Baseline BMI z-score	0.93	0.39 – 2.24	0.87
Outcome: Histologic improvement (yes vs. no)				0.81
Relative change in GGT (U/L), per 10% decrease from baseline to 52 weeks	1.51	1.28 – 1.79	<0.001
Treatment group (Cyst vs. Plbo)	1.40	0.61 – 3.23	0.43
Baseline GGT (U/L)	0.99	0.98 – 1.01	0.26
Baseline age (years)	0.98	0.84 – 1.15	0.83
Sex (male vs. female)	0.92	0.37 – 2.32	0.87
Baseline BMI z-score	1.04	0.41 – 2.63	0.93

Three separate multiple logistic regression models were fit for the outcome of histologic improvement. Covariates included relative change in liver chemistry values (separate models fit for ALT, AST, and GGT), the baseline liver chemistry value, baseline age, sex, and baseline BMI z-score.

The liver chemistry effects were similar in Cysteamine Bitartrate DR and placebo groups. Interaction p-values 0.23, 0.37, 0.09 for ALT, AST, and GGT models, respective