Table 2

Secondary efficacy outcomes from baseline to week 28

Efficacy measuresIFX+NPX
N=105
PBO+NPX
N=51
p Value for treatment group difference
Baseline, meanWeek 28, meanChange from baseline, mean (SD)% ChangeBaseline, meanWeek 28, meanChange from baseline, mean (SD)% Change
PhGADA (100 mm VAS)66.615.6–51.3 (23.00)–76.563.330.6–33.0 (22.44)–51.7<0.001
PtGADA (100 mm VAS)73.518.8–54.5 (25.71)–74.472.334.4–38.1 (29.02)–52.4<0.001
Patient's total back pain (100 mm VAS)76.718.6–58.0 (25.61)–75.776.630.8–45.2 (29.27)–59.80.005
Patient's nocturnal pain (100 mm VAS)70.616.7–54.0 (26.03)–76.469.331.4–37.4 (30.66)–54.7<0.001
EQ-5D index score*0.380.750.37 (0.303)95.40.330.600.27 (0.313)81.60.003
EQ-5D global health status*46.876.830.0 (29.23)64.240.058.918.5 (23.11)47.0<0.001
SF-36 physical component*34.046.612.6 (10.31)42.532.440.38.6 (8.93)29.40.003
SF-36 mental component*40.049.09.0 (10.96)33.537.745.77.6 (11.10)27.10.16
BASMI3.12.0–1.1 (1.13)–34.63.12.5–0.6(0.72)–18.7<0.001
ESR (mm/h)23.07.1–16.0 (16.11)–54.728.319.0–9.4 (13.18)–13.0<0.001
CRP (mg/dL)2.020.91–1.24 (6.209)–55.11.651.15–0.55 (1.315)–30.50.59
66-joint swollen joint count, mean (SD)1.490.15–1.44 (4.131)–89.60.780.40–0.42 (0.917)–49.00.06
68-joint tender joint count, mean (SD)4.060.94–3.29 (6.385)–76.93.801.07–2.93 (5.101)–72.00.73
Patients who met criterion
at week 28, %
Patients who met criterion
at week 28, %
BASDAI≥50% improvement77.351.10.003
BASDAI<376.353.30.01
  • *An increase in scores indicates improvement on these measures. For all other measures, a decrease in score indicates improvement.

  • BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; EQ-5D, EuroQoL 5D Health Questionnaire; IFX, infliximab; NPX, naproxen; PBO, placebo; PhGADA, Physician Global Assessment of Disease Activity; PtGADA, Patient Global Assessment of Disease Activity; SF-36, Short Form 36 Health Survey; VAS, visual analogue scale.