Table 1.
Demography and baseline characteristics (full analysis set)
| Placebo (n=141) |
Fasinumab | Total (N=563) |
||||
| 6 mg SC Q4W (n=141) |
9 mg SC Q4W (n=140) |
9 mg IV Q8W (n=141) |
Combined (n=422) |
|||
| Age (years), mean (SD) | 58.1 (12.5) | 58.2 (11.3) | 56.6 (11.0) | 55.4 (10.5) | 56.7 (11.0) | 57.1 (11.4) |
| Age category, n (%) | ||||||
| <65 years | 93 (66.0) | 95 (67.4) | 109 (77.9) | 117 (83.0) | 321 (76.1) | 414 (73.5) |
| ≥65 years | 48 (34.0) | 46 (32.6) | 31 (22.1) | 24 (17.0) | 101 (23.9) | 149 (26.5) |
| Sex, n (%) | ||||||
| Male | 58 (41.1) | 56 (39.7) | 56 (40.0) | 60 (42.6) | 172 (40.8) | 230 (40.9) |
| Female | 83 (58.9) | 85 (60.3) | 84 (60.0) | 81 (57.4) | 250 (59.2) | 333 (59.1) |
| Race, n (%) | ||||||
| White | 127 (90.1) | 119 (84.4) | 118 (84.3) | 116 (82.3) | 353 (83.6) | 480 (85.3) |
| Black or African American | 13 (9.2) | 19 (13.5) | 19 (13.6) | 21 (14.9) | 59 (14.0) | 72 (12.8) |
| Asian | 1 (0.7) | 2 (1.4) | 2 (1.4) | 1 (0.7) | 5 (1.2) | 6 (1.1) |
| American Indian or Alaska Native | 0 | 1 (0.7) | 0 | 1 (0.7) | 2 (0.5) | 2 (0.4) |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 | 1 (0.7) | 1 (0.2) | 1 (0.2) |
| Other | 0 | 0 | 1 (0.7) | 1 (0.7) | 2 (0.5) | 2 (0.4) |
| Body mass index (kg/m2), mean (SD); n | 29.7 (4.8); 141 | 29.0 (5.1); 139 | 29.6 (4.7); 140 | 30.1 (4.4); 141 | 29.6 (4.7); 420 | 29.6 (4.8); 561 |
| Average daily LBPI NRS score, mean (SD); n | 6.5 (1.3); 140 | 6.5 (1.3); 139 | 6.7 (1.3); 140 | 6.5 (1.2); 141 | 6.5 (1.3); 420 | 6.5 (1.3); 560 |
| Duration of chronic LBP (years), mean (SD); n | 11.8 (10.2); 126 | 13.6 (12.1); 131 | 13.7 (13.0); 135 | 12.7 (10.7); 134 | 13.3 (12.0); 400 | 13.0 (11.6); 526 |
| Maximum K-L score at any knee or hip joint at screening, n (%) | ||||||
| 0 | 25 (17.7) | 16 (11.3) | 35 (25.0) | 25 (17.7) | 76 (18.0) | 101 (17.9) |
| 1 | 51 (36.2) | 49 (34.8) | 35 (25.0) | 43 (30.5) | 127 (30.1) | 178 (31.6) |
| 2 | 40 (28.4) | 52 (36.9) | 42 (30.0) | 50 (35.5) | 144 (34.1) | 184 (32.7) |
| 3 | 21 (14.9) | 21 (14.9) | 23 (16.4) | 18 (12.8) | 62 (14.7) | 83 (14.7) |
| 4 | 4 (2.8) | 3 (2.1) | 5 (3.6) | 5 (3.5) | 13 (3.1) | 17 (3.0) |
| pOA, n (%) | ||||||
| Yes | 82 (58.2) | 94 (66.7) | 68 (48.6) | 78 (55.3) | 240 (56.9) | 322 (57.2) |
| No | 59 (41.8) | 47 (33.3) | 72 (51.4) | 63 (44.7) | 182 (43.1) | 241 (42.8) |
Baseline average daily LBPI NRS score was defined as the average of the non-missing daily LBPI NRS scores for 5 days prior to randomisation (from day –4 to day 1). pOA defined by medical history and/or K-L score ≥2 in hip or ≥3 in knee.
IV, intravenous; K-L, Kellgren-Lawrence; LBP, lower back pain; LBPI NRS, Lower Back Pain Intensity Numeric Rating Scale; pOA, peripheral osteoarthritis; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.