Placebo (n=282) | Tanezumab 2.5 mg (n=283) | Tanezumab 5 mg (n=284) | ||
Treatment response: ≥50% reduction from baseline in WOMAC Pain at week 24* | Number of patients with treatment response | 95 (33.8%) | 128 (45.4%) | 136 (47.9%) |
Odds ratio vs placebo | 1.72 | 1.87 | ||
P value† | 0.0022 | 0.0004 | ||
WOMAC Pain: change from baseline to week 2‡ | LS mean (SE) | –1.35 (0.14) | –2.02 (0.14) | –1.69 (0.14) |
LS mean difference vs placebo (SE) | –0.67 (0.14) | –0.34 (0.14) | ||
P value† | <0.0001 | 0.0149 | ||
Average pain score: change from baseline to week 1‡ | LS mean (SE) | –0.57 (0.11) | –1.06 (0.11) | –0.93 (0.11) |
LS mean difference vs placebo (SE) | –0.49 (0.11) | –0.36 (0.11) | ||
P value† | <0.0001 | 0.0009 |
*Mixed baseline/last observation carried forward.
†Nominal, unadjusted p value. In line with the predefined gatekeeping strategy, hypothesis testing of the three key secondary end points could not be performed: no key secondary end points can be declared as statistically significantly better than placebo treatment.
‡Multiple imputation.
LS, least squares; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.