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 1
Baseline demographic and clinical characteristics of biomarker substudy patients () and the overall intent-to-treat population () [10].
Biomarker substudy population ()
Overall intent-to-treat population ()*
Placebo
Apremilast
Placebo
Apremilast
20 mg BID
30 mg BID
20 mg BID
30 mg BID
Age, mean (SD), years
49.7 (12.4)
47.3 (11.2)
52.3 (11.2)
51.1 (12.1)
48.7 (11.0)
51.4 (11.7)
Female, (%)
20 (39.2)
25 (49.0)
23 (47.9)
80 (47.6)
83 (49.4)
92 (54.8)
White, (%)
49 (96.1)
46 (90.2)
47 (97.9)
153 (91.1)
150 (89.3)
152 (90.5)
Body mass index, mean (SD), kg/m2
30.7 (7.4)
33.0 (7.1)
32.8 (6.8)
31.1 (6.6)
30.9 (7.3)
30.6 (5.9)
Duration, mean (SD), years
PsA
6.5 (5.7)
4.9 (4.6)
10.1 (8.3)
7.3 (7.1)
7.2 (6.8)
8.1 (8.1)
Psoriasis
13.5 (11.7)
13.1 (11.9)
19.0 (13.5)
15.7 (13.0)
15.5 (11.9)
16.5 (12.3)
Swollen joint count (0–76), mean (SD)
13.0 (8.2)
12.7 (10.4)
13.9 (8.7)
12.8 (8.8)
12.5 (9.5)
12.8 (7.8)
Tender joint count (0–78), mean (SD)
27.9 (17.8)
22.4 (15.6)
27.4 (16.5)
23.3 (15.2)
22.2 (15.9)
23.1 (14.5)
HAQ-DI (0–3), mean (SD)
1.1 (0.59)
1.0 (0.55)
1.2 (0.61)
1.2 (0.6)
1.2 (0.6)
1.2 (0.6)
Physician’s global assessment of disease activity (0–100 mm VAS), mean (SD)
58.0 (20.4)
59.4 (18.9)
57.9 (17.4)
55.2 (20.3)
54.1 (21.8)
55.7 (19.2)
Prior use of biologics, (%)
24 (47.1)
24 (47.1)
25 (52.1)
41 (24.4)
37 (22.0)
41 (24.4)
Prior use of methotrexate, (%)
41 (80.4)
40 (78.4)
39 (81.3)
90 (53.6)
95 (56.5)
88 (52.4)
Prior biologic failure, (%)
11 (21.6)
10 (19.6)
10 (20.8)
19 (11.3)
14 (8.3)
14 (8.3)
reflects the number of patients randomized; actual number of patients available for each end point may vary. HAQ-DI: Health Assessment Questionnaire-Disability Index; PsA: psoriatic arthritis; VAS: visual analog scale.
