Subject demographics and baseline characteristics
| Placebo+NSAID* (n=539) | Tanezumab 5 mg (n=541) | Tanezumab 10 mg (n=542) | Tanezumab 5 mg+NSAID* (n=536) | Tanezumab 10 mg+NSAID* (n=542) | |
|---|---|---|---|---|---|
| Baseline demographics | |||||
| Gender, n (%) | |||||
| Female | 388 (72.0) | 392 (72.5) | 392 (72.3) | 363 (67.7) | 369 (68.1) |
| Age, years | |||||
| Mean (SD) | 61.3 (9.3) | 61.9 (9.7) | 62.0 (10.0) | 61.7 (10.2) | 61.3 (10.0) |
| Range | 28–89 | 28–86 | 20–92 | 29–93 | 28–86 |
| ≥65 years, n (%) | 183 (34.0) | 211 (39.0) | 225 (41.5) | 211 (39.4) | 213 (39.3) |
| ≥75 years, n (%) | 38 (7.1) | 40 (7.4) | 51 (9.4) | 40 (7.5) | 40 (7.4) |
| BMI, kg/m2 | |||||
| Mean (SD) | 30.5 (4.8) | 30.7 (4.9) | 30.2 (4.9) | 30.0 (4.8) | 30.4 (5.0) |
| Race, n (%) | |||||
| White | 381 (70.7) | 353 (65.2) | 375 (69.2) | 369 (68.8) | 356 (65.7) |
| Black | 62 (11.5) | 60 (11.1) | 69 (12.7) | 59 (11.0) | 65 (12.0) |
| Asian | 53 (9.8) | 71 (13.1) | 56 (10.3) | 67 (12.5) | 70 (12.9) |
| Other | 43 (8.0) | 57 (10.5) | 42 (7.7) | 41 (7.6) | 51 (9.4) |
| Disease characteristics | |||||
| Duration since OA diagnosis, mean (range) | 7.5 (0–49.7) | 7.3 (0–43.8) | 7.1 (0–49.7) | 7.0 (0–46.8) | 7.4 (0–42.8) |
| Index joint, n (%) | |||||
| Knee | 446 (82.7) | 449 (83.0) | 449 (82.8) | 446 (83.2) | 452 (83.4) |
| Hip | 93 (17.3) | 92 (17.0) | 93 (17.2) | 90 (16.8) | 90 (16.6) |
| Subjects with >1 joint with OA, n (%) | 235 (43.6) | 234 (43.3) | 250 (46.1) | 247 (46.1) | 245 (45.2) |
| Subjects with prior TJR, n (%) | 18 (3.3) | 26 (4.8) | 22 (4.1) | 15 (2.8) | 20 (3.7) |
| NSAID, n (%) | |||||
| Naproxen | 283 (52.5) | 285 (52.7) | 288 (53.1) | 280 (52.2) | 288 (53.1) |
| Celecoxib | 256 (47.5) | 256 (47.3) | 254 (46.9) | 256 (47.8) | 254 (46.9) |
| Kellgren–Lawrence grade, n (%) | |||||
| 2 | 197 (36.5) | 181 (33.5) | 187 (34.5) | 183 (34.2) | 161 (29.7) |
| 3 | 217 (40.3) | 191 (35.3) | 203 (37.5) | 212 (39.6) | 218 (40.2) |
| 4 | 125 (23.2) | 169 (31.2) | 152 (28.0) | 139 (26.0) | 163 (30.1) |
*Naproxen 500 mg twice daily or celecoxib 100 mg twice daily.
BMI, body mass index; NSAID, non-steroidal anti-inflammatory drug; OA, osteoarthritis; TJR, total joint replacement.