The Pharmacodynamic Impact of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, on Circulating Levels of Inflammatory Biomarkers in Patients with Psoriatic Arthritis: Substudy Results from a Phase III, Randomized, Placebo-Controlled Trial (PALACE 1)

Table 2

Association between ACR20 response and biomarker change at Week 16.

	Univariate analysis 1^*						Multivariate analysis
	Placebo		Apremilast 20 mg BID		Apremilast 30 mg BID		Interaction
	OR; (two-sided 95% CI)	value^‡	OR; (two-sided 95% CI)	value^‡	OR; (two-sided 95% CI)	P value^‡	P value
TNF-α (pg/mL)	0.995; (0.986, 1.003)	NS	1.006; (1.001, 1.011)	0.0205	0.978; (0.960, 0.996)	0.0166	0.0024
IL-8 (pg/mL)	1.000; (0.990, 1.010)	NS	0.997; (0.985, 1.008)	NS	0.994; (0.984, 1.004)	NS	NS
IL-6 (pg/mL)	0.998; (0.992, 1.004)	NS	1.002; (0.991, 1.013)	NS	0.989; (0.977, 1.002)	NS	NS
Ferritin (ng/mL)	0.996; (0.974, 1.019)	NS	1.001; (0.984, 1.018)	NS	0.992; (0.969, 1.016)	NS	NS
vWF factor (μg/mL)	1.012; (0.985, 1.040)	NS	0.996; (0.938, 0.996)	0.0253	1.007; (0.992, 1.022)	NS	0.0387

NS: not significant.
ORs, CIs, and values were calculated from a logistic regression model with percent change from baseline biomarker value at Week 16 (LOCF) as a covariate.
At Week 16 (LOCF) for the biomarkers with a significantly () different percent change from baseline in the between-treatment comparisons (apremilast 20 mg BID versus placebo or apremilast 30 mg BID versus placebo), the ACR20 (nonresponder imputation) and ACR20 (LOCF) datasets were identical.
^‡P values were calculated from a logistic regression model with treatment as a factor, percent change from baseline biomarker value at Week 16 (LOCF) as a covariate, and interaction of treatment and percent change from baseline value at Week 16 (LOCF).