Table 3.
Proportion of patients experiencing first and sustained improvement events in the WOMAC domains during study 2a.
| N | Pain |
Physical Function |
Stiffness |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First n (%) | Sustained n (%) | First to Sustained (%)b | First n (%) | Sustained n (%) | First to Sustained (%)b | First n (%) | Sustained n (%) | First to Sustained (%)b | ||
| 15% | ||||||||||
| PBO | 282 | 242 (85.8) | 222 (78.7) | 91.7 | 245 (86.9) | 220 (78.0) | 89.8 | 247 (87.6) | 220 (78.0) | 89.1 |
| TNZ 2.5 mg | 283 | 268 (94.7) | 258 (91.2) | 96.3 | 268 (94.7) | 253 (89.4) | 94.4 | 263 (92.9) | 250 (88.3) | 95.1 |
| TNZ 5 mg |
284 |
271 (95.4) |
252 (88.7) |
93.0 |
262 (92.3) |
252 (88.7) |
96.2 |
269 (94.7) |
250 (88.0) |
92.9 |
| 30% | ||||||||||
| PBO | 282 | 207 (73.4) | 186 (66.0) | 89.9 | 196 (69.5) | 170 (60.3) | 86.7 | 209 (74.1) | 178 (63.1) | 85.2 |
| TNZ 2.5 mg | 283 | 245 (86.6) | 220 (77.7) | 89.8 | 238 (84.1) | 214 (75.6) | 89.9 | 250 (88.3) | 219 (77.4) | 87.6 |
| TNZ 5 mg |
284 |
238 (83.8) |
215 (75.7) |
90.3 |
231 (81.3) |
217 (76.4) |
93.9 |
241 (84.9) |
224 (78.9) |
92.9 |
| 50% | ||||||||||
| PBO | 282 | 152 (53.9) | 119 (42.2) | 78.3 | 137 (48.6) | 107 (37.9) | 78.1 | 160 (56.7) | 125 (44.3) | 78.1 |
| TNZ 2.5 mg | 283 | 192 (67.8) | 154 (54.4) | 80.2 | 171 (60.4) | 142 (50.2) | 83.0 | 207 (73.1) | 160 (56.5) | 77.3 |
| TNZ 5 mg |
284 |
194 (68.3) |
171 (60.2) |
88.1 |
181 (63.7) |
153 (53.9) |
84.5 |
211 (74.3) |
172 (60.6) |
81.5 |
| 70% | ||||||||||
| PBO | 282 | 83 (29.4) | 63 (22.3) | 75.9 | 67 (23.8) | 48 (17.0) | 71.6 | 95 (33.7) | 65 (23.0) | 68.4 |
| TNZ 2.5 mg | 283 | 107 (37.8) | 76 (26.9) | 71.0 | 92 (32.5) | 67 (23.7) | 72.8 | 135 (47.7) | 91 (32.2) | 67.4 |
| TNZ 5 mg | 284 | 113 (39.8) | 80 (28.2) | 70.8 | 97 (34.2) | 66 (23.2) | 68.0 | 152 (53.5) | 110 (38.7) | 72.4 |
PBO = placebo, TNZ = tanezumab.
The 15%, 30%, 50%, and 70% thresholds were selected as representative, clinically meaningful thresholds of improvement.
First to sustained shows, among patients experiencing a first event, the proportion who experienced a sustained event (calculated as sustained n divided by first n).