Table 4.
Modified Patient Reported Treatment Impact (mPRTI) scores at week 16 and week 56
| Placebo (N = 406) | Tanezumab 5 mg (N = 407) | Tanezumab 10 mg (N = 407) | Tramadol (N = 605) | ||
|---|---|---|---|---|---|
| Week 16 | |||||
| Current or most recent treatment you were receiving for low back pain before enrolling? | Injectable prescription medicines | 20 (6.2%) | 21 (6.3%) | 22 (6.5%) | 39 (8.7%) |
| Prescription medicines taken by mouth | 213 (66.1%) | 211 (63.4%) | 229 (67.4%) | 287 (63.8%) | |
| Surgery | 2 (< 1.0%) | 2 (< 1.0%) | 1 (< 1.0%) | 1 (< 1.0%) | |
| Prescription medicines and surgery | 7 (2.2%) | 9 (2.7%) | 10 (2.9%) | 14 (3.1%) | |
| No treatment | 80 (24.8%) | 90 (27.0%) | 78 (22.9%) | 109 (24.2%) | |
| Overall, do you prefer the drug that you received in this study to previous treatment? | Yes, I definitely prefer the drug that I am receiving now | 150 (46.6%) | 172 (51.7%) | 191 (56.2%) | 232 (51.6%) |
| I have a slight preference for the drug that I am receiving now | 57 (17.7%) | 62 (18.6%) | 50 (14.7%) | 89 (19.8%) | |
| I have no preference either way | 62 (19.3%) | 66 (19.8%) | 55 (16.2%) | 82 (18.2%) | |
| I have a slight preference for my previous treatment | 24 (7.5%) | 14 (4.2%) | 23 (6.8%) | 17 (3.8%) | |
| No, I definitely prefer my previous treatment | 29 (9.0%) | 19 (5.7%) | 21 (6.2%) | 30 (6.7%) | |
| p value vs placebo | – | 0.0333 | 0.0244 | 0.0265 | |
| p value vs tramadol | – | 0.9512 | 0.8052 | – | |
| Willing to use the same drug that you have received in this study for your low back pain? | Yes, I would definitely want to use the same drug again | 167 (51.9%) | 191 (57.4%) | 210 (61.8%) | 251 (55.8%) |
| I might want to use the same drug again | 61 (18.9%) | 80 (24.0%) | 58 (17.1%) | 98 (21.8%) | |
| I am not sure | 51 (15.8%) | 36 (10.8%) | 38 (11.2%) | 64 (14.2%) | |
| I might not want to use the same drug again | 11 (3.4%) | 10 (3.0%) | 13 (3.8%) | 13 (2.9%) | |
| No, I definitely would not want to use the same drug again | 32 (9.9%) | 16 (4.8%) | 21 (6.2%) | 24 (5.3%) | |
| p value vs placebo | – | 0.0045 | 0.0099 | 0.0206 | |
| p value vs tramadol | – | 0.4266 | 0.5733 | – | |
| Week 56 | |||||
| Current or most recent treatment you were receiving for low back pain before enrolling? | Injectable prescription medicines | – | 6 (4.3%) | 13 (8.2%) | 9 (4.4%) |
| Prescription medicines taken by mouth | – | 91 (64.5%) | 102 (64.2%) | 147 (71.4%) | |
| Surgery | – | 2 (1.4%) | 0 | 3 (1.5%) | |
| Prescription medicines and surgery | – | 7 (5.0%) | 4 (2.5%) | 3 (1.5%) | |
| No treatment | – | 35 (24.8%) | 40 (25.2%) | 44 (21.4%) | |
| Overall, do you prefer the drug that you received in this study to previous treatment? | Yes, I definitely prefer the drug that I am receiving now | – | 90 (63.8%) | 104 (65.4%) | 129 (62.6%) |
| I have a slight preference for the drug that I am receiving now | – | 30 (21.3%) | 36 (22.6%) | 42 (20.4%) | |
| I have no preference either way | – | 15 (10.6%) | 12 (7.5%) | 22 (10.7%) | |
| I have a slight preference for my previous treatment | – | 2 (1.4%) | 4 (2.5%) | 7 (3.4%) | |
| No, I definitely prefer my previous treatment | – | 4 (2.8%) | 3 (1.9%) | 6 (2.9%) | |
| p value vs tramadol | – | 0.6107 | 0.2846 | – | |
| Willing to use the same drug that you have received in this study for your low back pain? | Yes, I would definitely want to use the same drug again | – | 99 (70.2%) | 114 (71.7%) | 133 (64.6%) |
| I might want to use the same drug again | – | 23 (16.3%) | 31 (19.5%) | 41 (19.9%) | |
| I am not sure | – | 15 (10.6%) | 10 (6.3%) | 26 (12.6%) | |
| I might not want to use the same drug again | – | 0 | 2 (1.3%) | 4 (1.9%) | |
| No, I definitely would not want to use the same drug again | – | 4 (2.8%) | 2 (1.3%) | 2 (< 1.0%) | |
| p value vs tramadol | – | 0.5358 | 0.1082 | – | |
Week 16 n was 322, 333, 340, and 450 for placebo, tanezumab 5 mg, tanezumab 10 mg, and tramadol, respectively
Week 56 n week 56 was 141, 159, and 206 for tanezumab 5 mg, tanezumab 10 mg, and tramadol, respectively