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Table 2 Absolute changes from baseline (week 0) to weeks 4 and 8 by treatment group (intent-to-treat population, last observation carried forward)

From: Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study

Parameter Week 4 Week 8
Etanercept 50 mg Placebo Pvalue Etanercept 50 mg Placebo Pvalue
(n  = 39) (n  = 44) (n  = 41) (n  = 45)
ASAS-NSAID score 50.3 (6.7) 61.0 (6.5) 0.256 32.4 (6.1) 59.7 (5.9) 0.002
 Change from baseline –46.3 (6.7) –35.6 (6.5) –63.9 (6.1) –36.6 (5.9)
 (95% confidence interval) (–59.8, –32.9) (–48.5, –22.7) (–76.0, –51.8) (–48.3, –24.9)
BASDAI (0 to 100) 4.5 (0.3) 5.4 (0.3) 0.015 4.0 (0.3) 4.8 (0.3) 0.051
 Change from baseline –1.5 (0.3) –0.6 (0.3) –2.0 (0.3) –1.1 (0.3)
 (95% confidence interval) (–2.0, –0.9) (–1.1, –0.0) (–2.7, –1.4) (–1.7, –0.5)
ASDAS-CRP 2.4 (0.1) 3.1 (0.1) <0.0001 2.1 (0.1) 2.8 (0.1) 0.001
 Change from baseline –0.9 (0.1) –0.2 (0.1) –1.2 (0.1) –0.5 (0.1)
 (95% confidence interval) (–1.2, –0.7) (–0.4, 0.1) (–1.5, –0.9) (–0.8, –0.2)
PGA of disease activity (0 to 10) 4.2 (0.3) 5.6 (0.3) 0.002 3.6 (0.4) 4.7 (0.3) 0.023
 Change from baseline –2.0 (0.3) –0.7 (0.3) –2.7 (0.3) –1.6 (0.3)
 (95% confidence interval) (–2.6, –1.5) (–1.3, –0.1) (–3.4, –2.0) (–2.2, –0.9)
Total back pain (0 to 100 mm) 5.0 (0.4) 6.0 (0.3) 0.047 4.3 (0.4) 5.6 (0.4) 0.021
 Change from baseline –1.6 (0.4) –0.6 (0.3) –2.2 (0.4) –1.0 (0.4)
 (95% confidence interval) (–2.3, –0.9) (–1.3, 0.1) (–3.0, –1.5) (–1.7, –0.2)
BASFI (0 to 100) 4.0 (0.3) 4.9 (0.2) 0.024 3.5 (0.3) 4.4 (0.3) 0.030
 Change from baseline –1.1 (0.3) –0.3 (0.2) –1.7 (0.3) –0.8 (0.3)
 (95% confidence interval) (–1.6, –0.6) (–0.8, 0.2) (–2.3, –1.1) (–1.3, –0.2)
BASMI (0 to 10) 2.3 (0.2) 2.7 (0.2) 0.160 2.2 (0.2) 2.5 (0.2) 0.300
 Change from baseline –0.3 (0.2) 0.1 (0.2) –0.4 (0.2) –0.1 (0.2)
 (95% confidence interval) (–0.7, 0.1) (–0.3, 0.4) (–0.8, 0.0) (–0.5, 0.3)
  1. Data are adjusted mean (standard error). Analysis of covariance model on change from baseline, with baseline value as a covariate and treatment as a factor. For ASAS-NSAID scores, only patients with nonmissing change from baseline values were included for postbaseline visits. ASAS-NSAID, Assessment of SpondyloArthritis International Society nonsteroidal anti-inflammatory drug use; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score based on C-reactive protein; PGA, Physician Global Assessment; BASFI, Bath Ankylosing Spondylitis Function Index; BASMI, Bath Ankylosing Spondylitis Metrology Index.
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