pondylitis
The safety and efficacy of ENBREL® were assessed in a randomized, double-blind, placebo-controlled study in 277 patients with active ankylosing spondylitis. Patients were between 18 and 70 years of age and had ankylosing spondylitis as defined by the modified New York Criteria for Ankylosing Spondylitis.5 Patients were to have evidence of active disease based on values of ≥ 30 on a 0 – 100 unit Visual Analog Scale (VAS) for the average of morning stiffness duration and intensity, and 2 of the following 3 other parameters: a) patient global assessment, b) average of nocturnal and total back pain, and c) the average score on the Bath Ankylosing Spondylitis Functional Index (BASFI). Patients with complete ankylosis of the spine were excluded from study participation. Patients taking hydroxychloroquine, sulfasalazine, methotrexate, or prednisone (≤ 10 mg/day) could continue these drugs at stable doses for the duration of the study. Doses of 25 mg ENBREL® 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.6 Compared to placebo, treatment with ENBREL® resulted in improvements in the ASAS and other measures of disease activity (Figure 2 and Table 7).
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 receiving ENBREL®, compared to 27%, 13%, and 7%, respectively, of patients receiving placebo (p ≤ 0.0001, ENBREL® vs. placebo). Similar responses were seen at week 24. Responses were similar between those patients receiving concomitant therapies at baseline and those who were not. The results of this study were similar to those seen in a single-center, randomized, placebo-controlled study of 40 patients and a multi-center, randomized, placebo-controlled study of 84 patients with ankylosing spondylitis.
Table 7: Components of Ankylosing Spondylitis Disease Activity *
p < 0.0015 for all comparisons between ENBREL ® and placebo at 6 months. P-values for continuous endpoints were based on percent change from baseline.
†
Measured on a Visual Analog Scale (VAS) with 0 = “none” and 100 = “severe.”
‡
Average of total nocturnal and back pain scores, measured on a VAS with 0 = “no pain” and 100 = “most severe pain.”
§
Bath Ankylosing Spondylitis Functional Index (BASFI), average of 10 questions.
¶
Inflammation represented by the average of the last 2 questions on the 6-question Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
#
C-reactive protein (CRP) normal range: 0 – 1.0 mg/dL.
Placebo
N = 139 ENBREL®*
N = 138
Mean values at time points Baseline 6 Months Baseline 6 Months
ASAS response criteria
Patient global assessment † 63 56 63 36
Back pain‡ 62 56 60 34
BASFI§ 56 55 52 36
Inflammation¶ 64 57 61 33
Acute phase reactants
CRP (mg/dL)# 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
Plaque Psoriasis
The safety and efficacy of ENBREL® were assessed in two randomized, double-blind |
