Table 2.
Change from baseline to week 8 and week 16 in the average daily LBPI NRS, RMDQ and PGA of LBP scores (mITT analysis set)
| Placebo (n=140) |
Fasinumab | |||
| 6 mg SC Q4W (n=139) |
9 mg SC Q4W (n=139) |
9 mg IV Q8W (n=140) |
||
| LBPI NRS | ||||
| Baseline average daily LBPI NRS score, mean (SD); n | 6.5 (1.3); 139 | 6.5 (1.3); 137 | 6.7 (1.3); 139 | 6.4 (1.2); 140 |
| Week 8 | ||||
| Average daily LBPI NRS score, mean (SD); n | 5.3 (2.1); 96 | 4.7 (2.0); 99 | 4.3 (2.4); 105 | 4.1 (2.3); 103 |
| Change from baseline to week 8, mean (SD); n | –1.3 (1.8); 95 | –1.9 (1.9); 98 | –2.4 (2.2); 105 | –2.3 (2.2); 103 |
| LS mean (SE) | –1.2 (0.2) | –1.8 (0.2) | –2.3 (0.2) | –2.2 (0.2) |
| 95% CI | –1.6 to –0.8 | –2.2 to –1.4 | –2.7 to –1.9 | –2.6 to –1.8 |
| Difference versus placebo, LS mean (SE) | –0.5 (0.3) | –1.1 (0.3) | –1.0 (0.3) | |
| 95% CI | –1.06 to –0.03 | –1.57 to –0.55 | –1.48 to –0.47 | |
| P value versus placebo | 0.04 | <0.01 | <0.01 | |
| Week 16 | ||||
| Average daily LBPI NRS score, mean (SD); n | 4.7 (2.0); 50 | 4.3 (1.9); 48 | 4.2 (2.3); 55 | 3.9 (2.4); 56 |
| Change from baseline to week 16, mean (SD); n | –1.9 (2.1); 49 | –2.1 (1.9); 48 | –2.6 (2.0); 55 | –2.5 (2.2); 56 |
| LS mean (SE) | –1.7 (0.2) | –2.0 (0.2) | –2.5 (0.2) | –2.4 (0.2) |
| 95% CI | –2.19 to –1.29 | –2.46 to –1.56 | –2.90 to –2.03 | –2.83 to –1.97 |
| Difference versus placebo, LS mean (SE) | –0.3 (0.3) | –0.7 (0.3) | –0.7 (0.3) | |
| 95% CI | –0.88 to 0.34 | –1.32 to –0.12 | –1.26 to –0.07 | |
| P value versus placebo | 0.39 | 0.02 | 0.03 | |
| RMDQ | ||||
| Baseline RMDQ total score, mean (SD); n | 10.9 (5.3); 132 | 10.8 (5.2); 135 | 10.7 (5.7); 136 | 11.7 (5.3): 136 |
| Week 8 | ||||
| RMDQ total score, mean (SD); n | 7.9 (5.6); 100 | 5.7 (5.2); 101 | 5.9 (5.6); 105 | 5.6 (5.4); 104 |
| Change from baseline to week 8, mean (SD); n | –3.2 (4.9); 92 | –5.4 (5.3); 97 | –4.7 (4.9); 102 | –6.2 (5.4); 101 |
| LS mean (SE) | –3.1 (0.5) | –5.3 (0.5) | –5.0 (0.5) | –5.9 (0.5) |
| 95% CI | –3.99 to –2.17 | –6.18 to –4.40 | –5.86 to –4.10 | –6.77 to –5.01 |
| Difference versus placebo, LS mean (SE) | –2.2 (0.6) | –1.9 (0.6) | –2.8 (0.6) | |
| 95% CI | –3.42 to –1.01 | –3.10 to –0.70 | –4.01 to –1.61 | |
| P value versus placebo | <0.01 | <0.01 | <0.01 | |
| Week 16 | ||||
| RMDQ total score, mean (SD); n | 6.6 (5.6); 50 | 5.1 (4.9); 48 | 4.8 (4.6); 55 | 5.0 (5.2); 57 |
| Change from baseline to week 16, mean (SD); n | –3.8 (4.5); 46 | –6.0 (5.7); 46 | –6.2 (4.7); 55 | –6.6 (5.6); 55 |
| LS mean (SE) | –3.8 (0.5) | –6.0 (0.5) | –5.8 (0.5) | –6.3 (0.5) |
| 95% CI | –4.88 to –2.76 | –7.09 to –4.97 | –6.78 to –4.76 | –7.30 to –5.28 |
| Difference versus placebo, LS mean (SE) | –2.2 (0.7) | –2.0 (0.7) | –2.5 (0.7) | |
| 95% CI | –3.65 to –0.77 | –3.36 to –0.54 | –3.88 to –1.06 | |
| P value versus placebo | <0.01 | <0.01 | <0.01 | |
| PGA of LBP | ||||
| Baseline PGA, mean (SD); n | 3.5 (0.7); 140 | 3.5 (0.7); 139 | 3.4 (0.8); 139 | 3.4 (0.7); 140 |
| Week 8 | ||||
| PGA, mean (SD); n | 3.0 (0.8); 100 | 2.7 (0.8); 101 | 2.6 (0.9); 105 | 2.5 (1.0); 104 |
| Change from baseline to week 8, mean (SD); n | –0.5 (0.8); 100 | –0.8 (0.9); 101 | –0.8 (0.9); 105 | –0.9 (1.0); 104 |
| LS mean (SE) | –0.5 (0.1) | –0.8 (0.1) | –0.8 (0.1) | –0.9 (0.1) |
| 95% CI | (–0.65 to –0.33) | (–0.94 to –0.62) | (–0.95 to –0.64) | (–1.05 to –0.74) |
| Difference versus placebo, LS mean (SE) | –0.3 (0.1) | –0.3 (0.1) | –0.4 (0.1) | |
| 95% CI | –0.51 to –0.08 | –0.52 to –0.09 | –0.62 to –0.19 | |
| P value versus placebo | 0.01 | 0.01 | <0.01 | |
| Week 16 | ||||
| PGA, mean (SD); n | 2.8 (0.8); 50 | 2.5 (0.9); 48 | 2.5 (0.9); 55 | 2.3 (1.0); 57 |
| Change from baseline to week 16, mean (SD); n | –0.7 (0.8); 50 | –0.9 (1.1); 48 | –0.8 (1.0); 55 | –1.0 (0.9); 57 |
| LS mean (SE) | –0.7 (0.1) | –0.9 (0.1) | –0.8 (0.1) | –1.0 (0.1) |
| 95% CI | –0.88 to –0.49 | –1.08 to –0.69 | –1.03 to –0.65 | –1.20 to –0.83 |
| Difference versus placebo, LS Mean (SE) | –0.2 (0.1) | –0.1 (0.1) | –0.3 (0.1) | |
| 95% CI | –0.46 to 0.07 | –0.41 to 0.11 | –0.59 to –0.07 | |
| P value versus placebo | 0.15 | 0.26 | 0.01 | |
Analyses are based on MMRM model with baseline randomisation strata, baseline score, treatment, visit and treatment-by-visit interaction. P values are nominal. Average daily LBPI NRS score was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including the nominal visit. The daily LBPI NRS score for the week 16 nominal visit day was missing for all patients because the daily LBPI NRS score was entered each day starting at 18:00 and clinic visits typically occurred during the day with diaries returned at the end of the visit. Therefore, the average LBPI NRS score at week 16 was based on 6 days.
IV, intravenous; LS, least squares; mITT, modified intent-to-treat; MMRM, mixed effect model repeated measures; LBP NRS, Lower Back Pain Numeric Rating Scale; PGA, Patient Global Assessment; Q4W, every 4 weeks; Q8W, every 8 weeks; RMDQ, Roland-Morris Disability Questionnaire; SC, subcutaneous.