, methotrexate, orprednisone (≤ 10 mg/day) could continue these drugs at stable doses for the duration of the study. Doses of 25 mgetanercept or placebo were administered SC twice a week for 6 months.
The primary measure of efficacy was a 20% improvement in the Assessment in Ankylosing Spondylitis (ASAS)response criteria. Compared to placebo, treatment with etanercept resulted in improvements in the ASAS and othermeasures of disease activity (Figure 2 and Table 12).
Figure 2. ASAS 20 Responses in Ankylosing Spondylitis
At 12 weeks, the ASAS 20/50/70 responses were achieved by 60%, 45%, and 29%, respectively, of patients receivingetanercept, compared to 27%, 13%, and 7%, respectively, of patients receiving placebo (p ≤ 0.0001,etanercept vs placebo). Similar responses were seen at Week 24. Responses were similar between those patientsreceiving concomitant therapies at baseline and those who were not. The results of this study were similar to thoseseen in a single-center, randomized, placebo-controlled study of 40 patients and a multicenter, randomized,placebo-controlled study of 84 patients with AS.
Table 12. Components of Ankylosing Spondylitis Disease Activity
Placebo Etanercepta
N=139 N=138
Median values at time points Baseline 6 Months Baseline 6 Months
ASAS response criteria
Patient global assessmentb 63 56 63 36
Back painc 62 56 60 34
BASFId 56 55 52 36
Inflammatione 64 57 61 33
Acute phase reactants
CRP (mg/dL)f 2.0 1.9 1.9 0.6
Spinal mobility (cm):
Modified Schober’s test 3.0 2.9 3.1 3.3
Chest expansion 3.2 3.0 3.3 3.9
Occiput-to-wall measurement 5.3 6.0 5.6 4.5 a p < 0.0015 for all comparisons between etanercept and placebo at 6 months. P values for continuous endpoints
were based on percent change from baseline.
b Measured on a Visual Analog Scale (VAS) with 0=“none” and 100=“severe.” c Average of total nocturnal and back pain scores, measured on a VAS with 0=“no pain” and 100=“most severepain.”
d Bath Ankylosing Spondylitis Functional Index (BASFI), average of 10 questions.
e Inflammation represented by the average of the last 2 questions on the 6-question Bath Ankylosing SpondylitisDisease Activity Index (BASDAI). f C-reactive protein (CRP) normal range: 0-1.0 mg/dL.
14.5 Adult Plaque Psoriasis
The safety and efficacy of etanercept were assessed in two randomized, double-blind, placebo-controlled studies inadults with chronic stable PsO involving ≥ 10% of the body surface area, a minimum Psoriasis Area and SeverityIndex (PASI) score of 10 and who had received or were candidates for systemic antipsoriatic therapy or
phototherapy. Patients with guttate, erythrodermic, or pustular psoriasis and patients with severe infections within 4weeks of screening were excluded from study. No concomitant major antipsoriatic therapies were allowed duringthe study.
Study I eva luated 672 subjects who received placebo or etanercept SC at doses of 25 mg once a week, 25 mg twicea week, or 50 mg twice a week for 3 months. After 3 months, subjects continued on blinded treatments for anadditional 3 months during which time subjects originally randomized to placebo began treatment with blindedetanercept at 25 mg twice weekly (designated as placebo/etanercept in Table 13); subjects originally randomized toetanercept continued on the originally randomized dose (designated as etanercept/etanercept groups in Table 13).
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