Table 2: Least Squares Mean Changes (LSM) from Randomization Visit to Final Visit in WOMAC Pain, Stiffness, Physical Function, and Total Scores for the Double-Blind Treatment Period

BMI <30 kg/m2 BMI ≥30 kg/m2
Continuous Use Celecoxib 200 mg qd n=209 Intermittent Use Celecoxib 200 mg qd n=205 p Value Continuous Use Celecoxib 200 mg qd n=222 Intermittent Use Celecoxib 200 mg qd n=222 p Value
ITT Population
Total WOMAC score, LSM (SE) 1.33 (1.03) 4.85 (1.03) 0.016 1.84 (0.98) 5.12 (0.99) 0.019
 95% CI (-0.69 to 3.35) (2.83 to 6.87) (-0.08 to 3.77) (3.18 to 7.06)
WOMAC pain subscale, LSM (SE) 0.32 (0.23) 1.05 (0.23) 0.024 0.40 (0.21) 1.31 (0.21) 0.002
 95% CI (-0.13 to 0.77) (0.60 to 1.50) (-0.01 to 0.81) (0.90 to 1.73)
WOMAC stiffness subscale, LSM (SE) 0.10 (0.10) 0.42 (0.10) 0.019 0.13 (0.10) 0.38 (0.10) 0.075
 95% CI (-0.10 to 0.29) (0.23 to 0.62) (-0.06 to 0.32) (0.19 to 0.57)
WOMAC physical function subscale, LSM (SE) 0.89 (0.74) 3.40 (0.74) 0.017 1.36 (0.71) 3.45 (0.71) 0.038
 95% CI (-0.57 to 2.34) (1.95 to 4.86) (-0.04 to 2.75) (2.05 to 4.85)
FmITT
Total WOMAC score, LSM (SE) -0.15 (1.18) 2.40 (1.28) 0.145 -0.13 (1.15) 3.89 (1.17) 0.015
 95% CI (-2.47 to 2.17) (-0.12 to 4.91) (-2.38 to 2.13) (1.59 to 6.18)
WOMAC pain subscale, LSM (SE) 0.07 (0.26) 0.48 (0.29) 0.292 -0.00 (0.24) 1.12 (0.25) 0.001
 95% CI (-0.45 to 0.58) (-0.09 to 1.04) (-0.48 to 0.48) (0.63 to 1.61)
WOMAC stiffness subscale, LSM (SE) 0.01 (0.11) 0.24 (0.12) 0.164 -0.00 (0.11) 0.23 (0.12) 0.162
 95% CI (-0.20 to 0.23) (0.00 to 0.47) (-0.22 to 0.23) (0.01 to 0.46)
WOMAC physical function subscale, LSM (SE) -0.25 (0.85) 1.71 (0.92) 0.117 -0.09 (0.83) 2.55 (0.84) 0.026
 95% CI (-1.92 to 1.41) (-0.10 to 3.52) (-1.71 to 1.54) (0.90 to 4.21)

BMI, body mass index; CI, confidence interval; ITT, intent-to-treat; FmITT: flare-modified ITT; qd, daily; SE, standard error; WOMAC, Western Ontario and McMaster Universities Arthritis Index.