Table 3.
Patients with Psoriatic Arthritis: Mean Change in ACR Components with Apremilast, at Week 16 of the PALACE-1 Study
| ACR component | Placebo (N = 168) | Apremilast 30 mg twice daily (N = 168) |
|---|---|---|
| Number of tender jointsa | ||
| Sample size, N | 166 | 164 |
| Baselinea | 23 | 23 |
| Mean change at week 16b | −2 | −7 |
| Number of swollen jointsc | ||
| Sample size, N | 166 | 164 |
| Baselinec | 13 | 13 |
| Mean change at week 16b | −2 | −5 |
| Patient's assessment of pain (VAS)d | ||
| Sample size, N | 165 | 159 |
| Baselined | 61 | 58 |
| Mean change at week 16b | −6 | −14 |
| Patient's global assessment of disease activity (VAS)d | ||
| Sample size, N | 165 | 159 |
| Baselined | 59 | 56 |
| Mean change at week 16b | −3 | −10 |
| Physician's global assessment of disease activityd | ||
| Sample size, N | 158 | 159 |
| Baselined | 55 | 56 |
| Mean change at week 16b | −8 | −19 |
| HAQ-DI scoree | ||
| Sample size, N | 165 | 159 |
| Baselinee | 1.2 | 1.2 |
| Mean change at week 16b | −0.09 | −0.2 |
| C-reactive proteinf | ||
| Sample size, N | 166 | 167 |
| Baselinef | 1.1 | 0.8 |
| Mean change at week 16a | 0.1 | −0.1 |
a
Scale, 0–78.
b
Mean changes from baseline are least square means from analyses of covariance.
c
Scale, 0–76.
d
0 = best; 100 = worst.
e
0 = best; 3 = worst; the HAQ-DI measures the subject's ability to perform daily activities.
f
Reference range, 0–0.5 mg/dL.
ACR indicates American College of Rheumatology; HAQ-DI, health assessment questionnaire disability index; VAS, visual analog scale.
Sources: Otezla (apremilast) tablets prescribing information; September 2014; Kavanaugh A, et al. Ann Rheum Dis. 2014;73:1020–1026.