Table 1.
Patient demographics and clinical characteristics.
| Study 111 | PBO |
TNZ |
TNZ |
|---|---|---|---|
| (N = 232) |
2.5 mg |
2.5/5 mga |
|
| (N = 231) | (N = 233) | ||
| Gender, n (%) | |||
| Male | 75 (32.3) | 86 (37.2) | 82 (35.2) |
| Female | 157 (67.7) | 145 (62.8) | 151 (64.8) |
| Race | |||
| White | 156 (67.2) | 178 (77.1) | 170 (73.0) |
| Black or African American | 60 (25.9) | 43 (18.6) | 50 (21.5) |
| Asian | 13 (5.6) | 5 (2.2) | 8 (3.4) |
| Other | 3 (1.3) | 5 (2.2) | 5 (2.1) |
| Mean (SD) age, years | 60.4 (9.8) | 60.9 (10.0) | 61.2 (9.0) |
| Index joint, n (%) | |||
| Knee | 199 (85.8) | 197 (85.3) | 198 (85.0) |
| Hip | 33 (14.2) | 34 (14.7) | 35 (15.0) |
| Mean (SD) WOMAC Pain score at baseline | 7.30 (1.15) | 7.08 (1.16) | 7.33 (1.26) |
| Mean (SD) WOMAC Physical Function score at baseline | 7.38 (1.12) | 7.18 (1.11) | 7.39 (1.18) |
| Mean (SD) WOMAC Stiffness score at baseline | 7.49 (1.38) | 7.27 (1.40) | 7.58 (1.40) |
| Completed the treatment period, n (%) |
192 (82.8) |
208 (90.0) |
209 (89.7) |
| Study 213 |
PBO |
TNZ |
TNZ |
| (N = 282) |
2.5 mg |
5 mg |
|
| (N = 283) |
(N = 284) |
||
| Gender, n (%) | |||
| Male | 86 (30.5) | 85 (30.0) | 91 (32.0) |
| Female | 196 (69.5) | 198 (70.0) | 193 (68.0) |
| Race | |||
| 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) |
| Mean (SD) age, years | 64.2 (9.6) | 65.2 (8.4) | 65.2 (10.2) |
| Index joint, n (%) | |||
| Knee | 235 (83.3) | 234 (82.7) | 236 (83.1) |
| Hip | 47 (16.7) | 49 (17.3) | 48 (16.9) |
| Mean (SD) WOMAC Pain score at baseline | 6.59 (0.94) | 6.70 (0.94) | 6.60 (0.89) |
| Mean (SD) WOMAC Physical Function score at baseline | 6.67 (0.87) | 6.77 (0.87) | 6.76 (0.88) |
| Mean (SD) WOMAC Stiffness score at baseline | 6.46 (1.43) | 6.44 (1.59) | 6.44 (1.53) |
| Completed the treatment period, n (%) |
238 (84.4) |
257 (90.8) |
255 (89.8) |
| Study 314 |
NSAIDsb |
TNZ |
TNZ |
| (N = 996) |
2.5 mg |
5 mg |
|
| (N = 1002) |
(N = 998) |
||
| Gender, n (%) | |||
| Male | 334 (33.5) | 365 (36.4) | 344 (34.5) |
| Female | 662 (66.5) | 637 (63.6) | 654 (65.5) |
| Race | |||
| White | 680 (68.3) | 705 (70.4) | 712 (71.3) |
| Black or African American | 186 (18.7) | 166 (16.6) | 162 (16.2) |
| Asian | 99 (9.9) | 110 (11.0) | 95 (9.5) |
| Other | 31 (3.1) | 21 (2.1) | 29 (2.9) |
| Mean (SD) age, years | 60.3 (9.5) | 60.3 (9.2) | 61.2 (9.6) |
| Index joint, n (%) | |||
| Knee | 852 (85.5) | 851 (84.9) | 850 (85.2) |
| Hip | 144 (14.5) | 151 (15.1) | 148 (14.8) |
| Mean (SD) WOMAC Pain score at baseline | 6.96 (1.08) | 7.01 (1.12) | 7.02 (1.12) |
| Mean (SD) WOMAC Physical Function score at baseline | 6.99 (1.09) | 7.09 (1.07) | 7.08 (1.11) |
| Mean (SD) WOMAC Stiffness score at baseline | 7.09 (1.42) | 7.15 (1.42) | 7.20 (1.40) |
| Completed the treatment period, n (%)c | 446 (44.8) | 447 (44.6) | 419 (42.0) |
Abbreviations: BID = twice daily, NSAID = nonsteroidal anti-inflammatory drug, PBO = placebo, SD = standard deviation, TNZ = tanezumab, WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index.
Patients received a 2.5 mg dose at baseline and a 5 mg dose at Week 8.
NSAID regimen included naproxen 500 mg BID, celecoxib 100 mg BID, or diclofenac extended release 75 mg BID.
In Study 3, patients had to meet the following criteria in order to continue receiving SC study medication at and beyond Week 16: a ≥30% reduction in WOMAC Pain subscale relative to baseline in the index joint at Week 16 and a ≥15% reduction in WOMAC Pain subscale relative to baseline in the index joint at Week 2, 4, or 8.