Table 1.
Baseline demographics and characteristics
| Denosumab | |||||
|---|---|---|---|---|---|
| Placebo (N=88) | 60 mg Q6M (N=85) | 60 mg Q3M (N=82) | 60 mg Q2M (N=85) | Total (N=340) | |
| Gender: female | 76 (86.4%) | 65 (76.5%) | 59 (72.0%) | 66 (77.6%) | 266 (78.2%) |
| Age (years) | 57.0±10.57 | 54.4±10.57 | 52.0±11.65 | 54.6±10.51 | 54.5±10.92 |
| ≥65 | 26 (29.5%) | 11 (12.9%) | 10 (12.2%) | 16 (18.8%) | 63 (18.5%) |
| BMI (kg/m2) | 22.08±3.27 | 22.31±3.65 | 22.21±3.14 | 23.86±3.46 | 22.61±3.45 |
| Osteoporosis* | 23 (26.1%) | 12 (14.1%) | 10 (12.2%) | 12 (14.1%) | 57 (16.8%) |
| Duration of RA (years) | 2.31±1.34 | 2.16±1.31 | 2.26±1.27 | 2.25±1.40 | 2.25±1.33 |
| RF status positive | 60 (68.2%) | 59 (69.4%) | 56 (68.3%) | 57 (67.1%) | 232 (68.2%) |
| Anti-CCP positive | 66 (75.0%) | 70 (82.4%) | 64 (78.0%) | 65 (76.5%) | 265 (77.9%) |
| Modified total Sharp score (0–448) | 13.56±24.03 | 11.43±14.48 | 10.02±14.03 | 12.74±16.57 | 11.97±17.81 |
| Modified Sharp erosion score (0–280) | 6.61±10.35 | 6.39±7.77 | 5.95±6.75 | 7.41±8.68 | 6.60±8.50 |
| Modified Sharp JSN score (0–168) | 6.94±14.29 | 5.04±8.31 | 4.07±8.06 | 5.33±8.70 | 5.37±10.24 |
| Swollen joint count (0–66) | 10.50±5.93 | 8.89±4.16 | 10.51±4.63 | 10.19±4.71 | 10.02±4.94 |
| Tender joint count (0–68) | 9.90±9.67 | 8.00±7.37 | 8.15±7.34 | 8.33±7.77 | 8.61±8.12 |
| DAS28-CRP | 3.95±0.99 | 3.63±1.02 | 3.79±1.03 | 3.75±0.93 | 3.78±1.00 |
| Remission | 8 (9.1%) | 14 (16.5%) | 10 (12.2%) | 6 (7.1%) | 38 (11.2%) |
| Low | 11 (12.5%) | 14 (16.5%) | 13 (15.9%) | 21 (24.7%) | 59 (17.4%) |
| Moderate | 59 (67.0%) | 50 (58.8%) | 51 (62.2%) | 54 (63.5%) | 214 (62.9%) |
| High | 10 (11.4%) | 7 (8.2%) | 8 (9.8%) | 4 (4.7%) | 29 (8.5%) |
| CRP (mg/dL) | 0.75±1.24 | 0.52±0.92 | 0.61±1.17 | 0.60±1.08 | 0.62±1.11 |
| HAQ-DI (0–3) | 0.47±0.52 | 0.39±0.45 | 0.32±0.38 | 0.35±0.39 | 0.38±0.44 |
| MTX weekly dose (mg) | 7.61±1.76 | 7.98±2.01 | 8.40±2.19 | 8.25±2.00 | 8.05±2.01 |
| Glucocorticoid use | 37 (42.0%) | 36 (42.4%) | 37 (45.1%) | 37 (43.5%) | 147 (43.2%) |
| Amount of glucocorticoid (mg/day) | 3.78±2.31 | 3.90±2.27 | 3.68±1.70 | 4.03±2.04 | 3.85±2.08 |
| NSAIDs use | 64 (72.7%) | 61 (71.8%) | 60 (73.2%) | 68 (80.0%) | 253 (74.4%) |
| DMARDs use† | 22 (25.0%) | 18 (21.2%) | 15 (18.3%) | 22 (25.9%) | 77 (22.6%) |
| Lumbar spine BMD by machine type (g/cm2) | |||||
| Hologic‡ | 0.87±0.18 | 0.90±0.17 | 0.92±0.16 | 0.92±0.16 | 0.90±0.17 |
| Lunar‡ | 1.04±0.18 | 1.05±0.21 | 1.11±0.21 | 1.06±0.19 | 1.07±0.19 |
| Total hip BMD by machine type (g/cm2) | |||||
| Hologic‡ | 0.76±0.14 | 0.80±0.13 | 0.80±0.13 | 0.83±0.13 | 0.80±0.13 |
| Lunar‡ | 0.83±0.15 | 0.84±0.13 | 0.87±0.16 | 0.86±0.16 | 0.85±0.15 |
| CTX-I (ng/mL)§ | 0.38 (0.26, 0.53) | 0.36 (0.21, 0.51) | 0.36 (0.22, 0.56) | 0.37 (0.26, 0.65) | 0.37 (0.23, 0.56) |
| PINP (μg/L)§ | 46.60 (30.25, 62.20) | 42.90 (30.00, 58.30) | 42.95 (31.60, 57.40) | 46.40 (33.30, 64.50) | 44.35 (31.45, 60.30) |
| COMP (U/L)§ | 8.05 (6.60, 10.30) | 8.10 (6.60, 9.70) | 8.20 (6.70, 9.60) | 8.40 (7.10, 10.30) | 8.20 (6.60, 9.95) |
| CTX-II (ng/mmol Cre)§ | 361.50 (205.50, 649.50) | 304.50 (183.50, 497.00) | 325.00 (191.00, 501.00) | 320.00 (210.00, 661.00) | 324.00 (199.00, 537.00) |
N=number of patients who received ≥1 dose of investigational product and had a baseline and at least 1 postbaseline measurement of the radiograph score.
Values are mean±SD or n (%) unless otherwise indicated.
*Osteoporosis was diagnosed by the investigators at each site.
†Excluding methotrexate.
‡Hologic machines use: 65, 58, 61 and 57 patients; Lunar machines use: 23, 27, 21 and 28 patients. Placebo, Q6M, Q3M and Q2M, respectively.
§Values are median (quartile 1, quartile 3).
BMD, bone mineral density; BMI, bone mass index; CCP, cyclic citrullinated peptide; COMP, cartilage oligomeric matrix protein; Cre, creatinine; CRP, C-reactive protein; CTX-I, C-telopeptide of type I collagen; CTX-II, C-telopeptide of type II collagen; DAS, disease activity score; DMARDs, disease-modifying antirheumatic drugs; HAQ-DI, Health Assessment Questionnaire Disability Index; JSN, joint space narrowing; MTX, methotrexate; NSAIDs, non-steroidal anti-inflammatory drugs; PINP, N-propeptide of type I collagen; Q2M, every 2 months; Q3M, every 3 months; Q6M, every 6 months; RA, rheumatoid arthritis; RF, rheumatoid factor.