ng PASI 75 achievers in both studies, the median time to PASI 50 and PASI 75 was approximately 1 monthand approximately 2 months, respectively, after the start of therapy with either 25 or 50 mg twice a week.
In Study I, subjects who achieved PASI 75 at month 6 were entered into a study drug withdrawal and retreatmentperiod. Following withdrawal of study drug, these subjects had a median duration of PASI 75 of between 1 and2 months.
In Study I, among subjects who were PASI 75 responders at 3 months, retreatment with their original blindedetanercept dose after discontinuation of up to 5 months resulted in a similar proportion of responders as in the initial double-blind portion of the study.
In Study II, most subjects initially randomized to 50 mg twice a week continued in the study after month 3 and hadtheir etanercept dose decreased to 25 mg twice a week. Of the 91 subjects who were PASI 75 responders at month3, 70 (77%) maintained their PASI 75 response at month 6.
14.6 Pediatric Plaque Psoriasis
A 48-week, randomized, double-blind, placebo-controlled study enrolled 211 pediatric subjects 4 to 17 years ofage, with moderate to severe plaque psoriasis (PsO) (as defined by a sPGA score ≥ 3 [moderate, marked, or severe],involving ≥ 10% of the body surface area, and a PASI score ≥ 12) who were candidates for phototherapy or
systemic therapy, or were inadequately controlled on topical therapy. Subjects in all treatment groups had a medianbaseline PASI score of 16.4, and the percentage of subjects with baseline sPGA classifications was 65% formoderate, 31% for marked, and 3% for severe. Across all treatment groups, the percentage of subjects who
previously received systemic or phototherapy for PsO was 57%.
Subjects received etanercept 0.8 mg/kg (up to a maximum of 50 mg per dose) or placebo once weekly for the first12 weeks. After 12 weeks, subjects entered a 24-week open-label treatment period, in which all subjects receivedetanercept at the same dose. This was followed by a 12-week withdrawal-retreatment period.
Response to treatment was assessed after 12 weeks of therapy and was defined as the proportion of subjects whoachieved a reduction in PASI score of at least 75% from baseline. The PASI is a composite score that takes intoconsideration both the fraction of body surface area affected and the nature and severity of psoriatic changes withinthe affected regions (induration, erythema and scaling).
Other eva luated outcomes included the proportion of subjects who achieved a score of “clear” or “almost clear” bythe sPGA and the proportion of subjects with a reduction in PASI score of at least 90% from baseline.
The sPGA isa 6-category scale ranging from “5 = severe” to “0 = none” indicating the physician’s overall assessment of the PsOseverity focusing on induration, erythema and scaling. Treatment success of “clear” or “almost clear” consisted ofnone or minimal elevation in plaque, up to faint red coloration in erythema and none or minimal fine scale over <5% of the plaque.
Efficacy results are summarized in Table 15.
Table 15. Pediatric Plaque Psoriasis Outcomes at 12 Weeks
Placebo
(N = 105)
Etanercept 0.8 mg/kg
Once Weekly
(N = 106)
PASI 75, n (%) 12 (11%) 60 (57%)
PASI 90, n (%) 7 (7%) 29 (27%)
sPGA “clear” or “almost clear” n (%) 14 (13%) 55 (52%)
Maintenance of Response
To eva luate maintenance of response, sub |
