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)

Figure 1

The PALACE 1 study design. Plasma samples for the biomarker assay were obtained at baseline and at Weeks 4, 16, and 24. All doses were titrated over the first week of treatment. Patients whose swollen and tender joint counts had not improved by ≥20% at Week 16 were considered nonresponders and were required to be rerandomized (1 : 1) to apremilast 20 mg BID or 30 mg BID if they were initially randomized to placebo, or continued on their initial apremilast dose. ^‡At Week 24, all remaining placebo patients were rerandomized to apremilast 20 mg BID or 30 mg BID.