Demographics and baseline characteristics
| Placebo (n=282) | Tanezumab 2.5 mg (n=283) | Tanezumab 5 mg (n=284) | ||
| Sex, n (%) | Male | 86 (30.5%) | 85 (30.0%) | 91 (32.0%) |
| Female | 196 (69.5%) | 198 (70.0%) | 193 (68.0%) | |
| Age, years | Mean (SD) | 64.2 (9.6) | 65.2 (8.4) | 65.2 (10.2) |
| Range | 26–87 | 41–88 | 32–89 | |
| Race, n (%) | White | 247 (87.6%) | 245 (86.6%) | 248 (87.3%) |
| Black or African-American | 0 | 0 | 0 | |
| Asian | 34 (12.1%) | 38 (13.4%) | 34 (12.0%) | |
| Other | 1 (0.4%) | 0 | 2 (0.7%) | |
| Body mass index, kg/m2 | Mean (SD) | 30.4 (4.8) | 29.9 (4.8) | 30.3 (4.6) |
| Range | 20–39 | 20–39 | 17–39 | |
| Time since index joint OA diagnosis, years | Mean | 7.4 | 6.0 | 6.7 |
| Range | 0–37.9 | 0–30.6 | 0–37.7 | |
| Index joint, n (%) | Hip | 47 (16.7%) | 49 (17.3%) | 48 (16.9%) |
| Knee | 235 (83.3%) | 234 (82.7%) | 236 (83.1%) | |
| Kellgren-Lawrence grade of index joint, n (%)* | 0 | 0 | 2 (0.7)† | 0 |
| 1 | 0 | 0 | 0 | |
| 2 | 59 (20.9%) | 49 (17.3%) | 58 (20.4%) | |
| 3 | 123 (43.6%) | 131 (46.3%) | 121 (42.6%) | |
| 4 | 100 (35.5%) | 101 (35.7%) | 105 (37.0%) | |
| WOMAC Pain subscale score | Mean (SD) | 6.59 (0.94) | 6.70 (0.94) | 6.60 (0.89) |
| Range | 4.4–9.4 | 2.8–10.0 | 4.6–9.6 | |
| WOMAC Physical Function subscale score | Mean (SD) | 6.67 (0.87) | 6.77 (0.87) | 6.76 (0.88) |
| Range | 5.1–9.4 | 4.9–9.8 | 4.6–9.4 | |
| PGA-OA score, n (%) | Very good | 0 | 0 | 1 (0.4%) |
| Good | 0 | 0 | 1 (0.4%) | |
| Fair | 145 (51.6%) | 132 (46.8%) | 136 (47.9%) | |
| Poor | 117 (41.6%) | 129 (45.7%) | 129 (45.4%) | |
| Very poor | 19 (6.8%) | 21 (7.4%) | 17 (6.0%) |
*Kellgren-Lawrence grade for classifying OA severity, ranging from 0 (no OA) to 4 (severe OA).
†In the tanezumab 2.5 mg group, two patients with OA grade 0 were included as a result of protocol deviations.
OA, osteoarthritis; PGA-OA, Patient’s Global Assessment of osteoarthritis; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.