Table 1: Efficacy
of acthar gel for treatment of psoriatic arthritis
[DRAFT_1_5MAY2015_v2].
|
Outcome |
Week
0 |
Week
12 |
Week
24 |
|
Physician Global Assessment |
3.44 ± 0.70 |
0.25 ± 0.16, P < 0.0001 |
0.43 ± 0.30, P = 0.001 |
|
Patient global assessment |
7.56 ± 0.44 |
1.0 ± 0.46, P < 0.0001 |
0.86 ± 0.34, P < 0.0001 |
|
CDAI |
42.50 ± 2.15 |
5.13 ± 3.17, P < 0.0001 |
4.29 ± 1.44, P < 0.0001 |
|
Tender Joint Count |
18.44 ± 1.08 |
2.63 ± 1.81, P < 0.0001 |
1.86 ± 0.67, P < 0.0001 |
|
Swollen Joint Count |
12.67 ± 1.19 |
1.25 ± 0.84, P < 0.0001 |
1.14 ± 0.50, P < 0.0001 |
|
VAS Pain Measurement |
8.00 ± 0.33 |
1.13 ± 0.67, P < 0.0001 |
0.71 ± 0.34, P < 0.0001 |
|
Cortisol (Pre-injection), mcg/dL |
10.36 ± 1.85 |
9.06 ± 1.13, NS |
12.50 ± 2.00, NS |
|
Cortisol (Post-injectiona),
mcg/dL |
26.13 ± 2.30 |
32.35 ± 2.75, NS |
34.19 ± 2.30, NS |
|
CRP, mg/dL |
0.81 ± 0.57 |
1.22 ± 0.56, NS |
0.51 ± 0.15, NS |
|
ESR, mm/hr |
21.89 ± 9.04 |
13.13 ± 2.83, NS |
10.51 ± 2.67, NS |
aP-value < 0.0001 as calculated by the simple
Wilcoxon sign test for comparison of pre- and post-injection cortisol levels at
Week 0, Week 12, and Week 24. Data obtained at Week 12 and Week 24 was compared
to those from Week 0 for all outcome measures other than CRP and ESR which were
compared to samples from screening.
CDAI:
Clinical Disease Activity Index; CRP: C-reactive protein; ESR: Erythrocyte Sedimentation Rate; NS: Not Significant; VAS:
Visual Analog Scale.