In both studies, a greater proportion of patients achieved ACR 20, ACR 50 and PASI 75 response in the STELARA® 45 mg and 90 mg groups compared to placebo at Week 24 (see TABLE 7). ACR 70 responses were also higher in the STELARA® 45 mg and 90 mg groups, although the difference was only numerical (p=NS) in STUDY 2. Responses were similar in patients regardless of prior TNFα exposure.
Table 7: ACR 20, ACR 50, ACR 70 and PASI 75 responses in PsA STUDY 1 and PsA STUDY 2 at Week 24
PsA STUDY 1 PsA STUDY 2
STELARA® STELARA®
Placebo 45 mg 90 mg Placebo 45 mg 90 mg
* Number of patients with ≥ 3% BSA psoriasis skin involvement at baseline
Number of patients randomized 206 205 204 104 103 105
ACR 20 response, N (%) 47 (23%) 87 (42%) 101 (50%) 21 (20%) 45 (44%) 46 (44%)
ACR 50 response, N (%) 18 (9%) 51 (25%) 57 (28%) 7 (7%) 18 (17%) 24 (23%)
ACR 70 response, N (%) 5 (2%) 25 (12%) 29 (14%) 3 (3%) 7 (7%) 9 (9%)
Number of patients with ≥ 3% BSA* 146 145 149 80 80 81
PASI 75 response, N (%) 16 (11%) 83 (57%) 93 (62%) 4 (5%) 41 (51%) 45 (56%)
The percent of patients achieving ACR 20 responses by visit is shown in Figure 1.
Figure 1: Percent of patients achieving ACR 20 response through Week 24
PsA STUDY 1
Figure 1
The results of the components of the ACR response criteria are shown in Table 8.
Table 8: Mean change from baseline in ACR components at Week 24
PsA STUDY 1
STELARA®
Placebo
(N=206) 45 mg
(N= 205) 90 mg
(N= 204)
* Number of swollen joints counted (0–66) † Number of tender joints counted (0–68) ‡ Visual analogue scale; 0= best, 10=worst. § Disability Index of the Health Assessment Questionnaire; 0 = best, 3 = worst, measures the patient's ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity. ¶ CRP: (Normal Range 0.0–1.0 mg/dL)
Number of swollen joints*
Baseline 15 12 13
Mean Change at Week 24 -3 -5 -6
Number of tender joints †
Baseline 25 22 23
Mean Change at Week 24 -4 -8 -9
Patient's assessment of pain‡
Baseline 6.1 6.2 6.6
Mean Change at Week 24 -0.5 -2.0 -2.6
Patient global assessment‡
Baseline 6.1 6.3 6.4
Mean Change at Week 24 -0.5 -2.0 -2.5
Physician global assessment‡
Baseline 5.8 5.7 6.1
Mean Change at Week 24 -1.4 -2.6 -3.1
Disability index (HAQ)§
Baseline 1.2 1.2 1.2
Mean Change at Week 24 -0.1 -0.3 -0.4
CRP (mg/dL)¶
Baseline 1.6 1.7 1.8
Mean Change at Week 24 0.01 -0.5 -0.8
An improvement in enthesitis and dactylitis scores was observed in each STELARA& |
