Table 4.
WOMAC™ LK 3.1 Function subscale score response
| Lumiracoxib 100 mg od (n = 811) |
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 | -8.7b ± 10.71 | -8.9b ± 11.19 | -8.7b ± 10.61 | -4.1 ± 9.41 |
| Mean change from baseline at week 13 ± SDa | -11.2b ± 12.65 | -11.2b ± 12.71 | -10.5b ± 12.41 | -7.2 ± 12.62 |
| Response by MCIIc | ||||
| Responders at week 2, n (%) | 425 (52.7) | 413 (51.7) | 422 (52.1) | 264 (32.9) |
| Odds ratio versus placebod (95% CI) | 2.27b (1.86–2.78) | 2.18b (1.78–2.67) | 2.22b (1.81–2.72) | NA |
| Odds ratio versus celecoxibd (95% CI) | 1.02e (0.84–1.24) | 0.98e (0.81–1.20) | NA | NA |
| Responders at week 13, n (%) | 506 (62.7) | 495 (62.0) | 490 (60.5) | 378 (47.1) |
| Odds ratio versus placebod (95% CI) | 1.89b (1.55–2.31) | 1.83b (1.50–2.23) | 1.72b (1.41–2.10) | NA |
| Odds ratio versus celecoxibd (95% CI) | 1.10e (0.90–1.34) | 1.06e (0.87–1.30) | NA | NA |
| Patients considering their current state as satisfactory by PASSf | ||||
| Satisfied patients at week 2, n (%) | 262 (32.3) | 271 (33.7) | 259 (31.9) | 154 (19.1) |
| Odds ratio versus placebod (95% CI) | 2.02b (1.61–2.54) | 2.15b (1.71–2.71) | 1.98b (1.57–2.49) | NA |
| Odds ratio versus celecoxibd (95% CI) | 1.02e (0.83–1.26) | 1.09e (0.88–1.34) | NA | NA |
| Satisfied patients at week 13, n (%) | 337 (41.6) | 333 (41.4) | 315 (38.7) | 238 (29.5) |
| Odds ratio versus placebod | 1.70b (1.38–2.09) | 1.69b (1.37–2.07) | 1.51b (1.23–1.86) | NA |
| Odds ratio versus celecoxibd | 1.12e (0.92–1.37) | 1.12e (0.92–1.36) | 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 WOMAC™ LK 3.1 Function was decreased by greater than or equal to 6.19 (converted from VAS). 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 WOMAC™ LK 3.1 Function was less than or equal to 21.08 (converted from VAS). CI, confidence interval; MCII, Minimal Clinically Important Improvement; NA, not applicable; od, once daily; PASS, Patient Acceptable Symptom State; SD, standard deviation; VAS, visual-analogue scale; WOMAC™ LK 3.1, Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1.