Study II eva luated 611 subjects who received placebo or etanercept SC at doses of 25 mg or 50 mg twice a week for3 months. After 3 months of randomized, blinded treatment, subjects in all three arms began receiving open-labeletanercept at 25 mg twice weekly for 9 additional months.
Response to treatment in both studies was assessed after 3 months of therapy and was defined as the proportion ofsubjects who achieved a reduction in PASI score of at least 75% from baseline. The PASI is a composite score thattakes into consideration both the fraction of body surface area affected and the nature and severity of psoriaticchanges within the affected regions (induration, erythema and scaling).
Other eva luated outcomes included the proportion of subjects who achieved a score of “clear” or “minimal” by theStatic Physician Global Assessment (sPGA) and the proportion of subjects with a reduction of PASI of at least 50%from baseline. The sPGA is a 6-category scale ranging from “5=severe” to “0=none” indicating the physician’soverall assessment of the PsO severity focusing on induration, erythema and scaling. Treatment success of “clear”or “minimal” consisted of none or minimal elevation in plaque, up to faint red coloration in erythema and none orminimal fine scale over < 5% of the plaque.
Subjects in all treatment groups and in both studies had a median baseline PASI score ranging from 15 to 17, and the percentage of subjects with baseline sPGA classifications ranged from 54% to 66% for moderate, 17% to 26%for marked and 1% to 5% for severe. Across all treatment groups, the percentage of subjects who previouslyreceived systemic therapy for PsO ranged from 61% to 65% in Study I and 71% to 75% in Study II, and those whopreviously received phototherapy ranged from 44% to 50% in Study I and 72% to 73% in Study II.
More subjects randomized to etanercept than placebo achieved at least a 75% reduction from baseline PASI score(PASI 75) with a dose response relationship across doses of 25 mg once a week, 25 mg twice a week and 50 mgtwice a week (Tables 13 and 14).
The individual components of the PASI (induration, erythema and scaling)contributed comparably to the overall treatment-associated improvement in PASI.
Table 13. Study I Outcomes at 3 and 6 Months
Placebo/Etanercept
25 mg BIW 25 mg QW
Etanercept/Etanercept
25 mg BIW 50 mg BIW
(N=168) (N=169) (N=167) (N=168)
3 Months
PASI 75 n (%) 6 (4%) 23 (14%)a 53 (32%)b 79 (47%)b
Difference (95% CI) 10% (4, 16) 28% (21, 36) 43% (35, 52)
sPGA, “clear” or
“minimal” n (%) 8 (5%) 36 (21%)b 53 (32%)b 79 (47%)b
Difference (95% CI) 17% (10, 24) 27% (19, 35) 42% (34, 50)
PASI 50 n (%) 24 (14%) 62 (37%)b 90 (54%)b 119 (71%)b
Difference (95% CI) 22% (13, 31) 40% (30, 49) 57% (48, 65)
6 Months
PASI 75 n (%) 55 (33%) 36 (21%) 68 (41%) 90 (54%)
a p=0.001 compared with placebo.
b p < 0.0001 compared with placebo.
Table 14. Study II Outcomes at 3 Months
Etanercept
Placebo
(N=204)
25 mg BIW
(N=204)
50 mg BIW
(N=203)
PASI 75 n (%) 6 (3%) 66 (32%)a 94 (46%)a
Difference (95% CI)
sPGA, “clear” or
“minimal” n (%)
Difference (95% CI)
7 (3%)
29% (23, 36)
75 (37%)a
34% (26, 41)
43% (36, 51)
109 (54%)a
50% (43, 58)
PASI 50 n (%) 18 (9%) 124 (61%)a 147 (72%)a
Difference (95% CI) 52% (44, 60) 64% (56, 71)
a p < 0.0001 compared with placebo.
Amo |
