Table 3.
Patient's global assessment of disease activity
| Lumiracoxib 100 mg od (n = 811) |
Lumiracoxib 100 mg od with initial dose (n = 805) |
Celecoxib 200 mg od (n = 813) |
Placebo (n = 806) |
|
| Mean change from baseline at week 2 ± SDa | -18.4b ± 23.62 | -19.0b ± 23.83 | -17.1b ± 23.72 | -9.5 ± 20.81 |
| Mean change from baseline at week 13 ± SDa | -24.2b ± 25.83 | -23.2b ± 25.57 | -21.3b ± 26.78 | -16.3b ± 25.19 |
| Response by MCIIc at week 13 | ||||
| Responders at week 2, n (%) | 359 (44.3) | 369 (45.8) | 352 (43.3) | 242 (30.1) |
| Odds ratio versus placebod (95% CI) | 1.85b (1.51–2.27) | 1.97b (1.60–2.42) | 1.78b (1.45–2.18) | NA |
| Odds ratio versus celecoxibd (95% CI) | 1.04e (0.85–1.27) | 1.11e (0.91–1.35) | NA | NA |
| Responders at week 13, n (%) | 465 (57.3) | 456 (56.6) | 432 (53.1) | 357 (44.3) |
| Odds ratio versus placebod (95% CI) | 1.69b (1.39–2.05) | 1.64b (1.35–2.00) | 1.42b (1.17–1.73) | NA |
| Odds ratio versus celecoxibd (95% CI) | 1.19e (0.97–1.44) | 1.15e (0.95–1.40) | NA | NA |
| Satisfaction with treatment by PASSf | ||||
| Satisfied patients at week 2, n (%) | 240 (29.6) | 255 (31.7) | 234 (28.8) | 140 (17.4) |
| Odds ratio versus placebod (95% CI) | 2.00b (1.58–2.53) | 2.21b (1.74–2.79) | 1.92b (1.52–2.44) | NA |
| Odds ratio versus celecoxibd (95% CI) | 1.04e (0.84–1.29) | 1.15e (0.93–1.42) | NA | NA |
| Satisfied patients at week 13, n (%) | 347 (42.8) | 353 (43.9) | 321(39.5) | 255 (31.6) |
| Odds ratio versus placebod (95% CI) | 1.62b (1.32–1.98) | 1.69b (1.38–2.07) | 1.41b (1.15–1.73) | NA |
| Odds ratio versus celecoxibd (95% CI) | 1.15e (0.94–1.40) | 1.20e (0.98–1.46) | NA | NA |
ap values for comparison with placebo in analysis of covariance adjusting for study and baseline. bp < 0.001 versus placebo. cA patient was considered a responder by MCII if his/her change from baseline for patient's global assessment was decreased by greater than or equal to 18.3 mm. dMultiple logistic regression model with treatment as main effect. Pairwise comparisons were tested using two-sided significance unadjusted for multiple comparisons. ep value non-significant. fA patient was considered as achieving a satisfactory state according to PASS if his/her value for patient's global assessment was less than or equal to 32.0 mm. CI, confidence interval; MCII, Minimal Clinically Important Improvement; NA, not applicable; od, once daily; PASS, Patient Acceptable Symptom State; SD, standard deviation.