Baseline demographics and characteristics
| Denosumab | ||||
| Placebo (n=218) | 60 mg Q6M (n=217) | 60 mg Q3M (n=219) | Total (n=654) | |
| Female, n (%) | 167 (76.6) | 168 (77.4) | 154 (70.3) | 489 (74.8) |
| Age (years) | 55.8 (11.70) | 58.1 (12.30) | 58.2 (12.04) | 57.4 (12.04) |
| ≥65 years, n (%) | 55 (25.2) | 77 (35.5) | 69 (31.5) | 201 (30.7) |
| BMI (kg/m2) | 22.65 (3.49) | 22.38 (3.68) | 22.64 (3.62) | 22.56 (3.59) |
| Osteoporosis, n (%) | 44 (20.2) | 42 (19.4) | 46 (21.0) | 132 (20.2) |
| Duration of RA (years) | 2.07 (1.30) | 2.20 (1.33) | 2.20 (1.30) | 2.16 (1.31) |
| RF status positive, n (%) | 137 (62.8) | 140 (64.5) | 128 (58.4) | 405 (61.9) |
| ACPA positive, n (%) | 145 (66.5) | 158 (72.8) | 149 (68.0) | 452 (69.1) |
| Modified total Sharp score (0–448) | 13.14 (21.44) | 15.92 (22.21) | 15.17 (18.97) | 14.75 (20.91) |
| Modified Sharp erosion score (0–280) | 6.55 (10.58) | 7.53 (10.11) | 7.16 (9.41) | 7.08 (10.04) |
| Modified Sharp JSN score (0–168) | 6.59 (11.94) | 8.39 (13.82) | 8.01 (10.86) | 7.66 (12.27) |
| Swollen joint count (0–66) | 9.35 (4.43) | 9.46 (4.88) | 8.96 (4.30) | 9.25 (4.54) |
| Tender joint count (0–68) | 6.62 (6.39) | 7.48 (8.20) | 7.32 (8.00) | 7.14 (7.57) |
| DAS28-CRP | 3.43 (1.02) | 3.62 (1.09) | 3.52 (1.04) | 3.52 (1.05) |
| DAS28 >3.2, n (%) | 119 (54.6) | 141 (65.0) | 138 (63.0) | 398 (60.9) |
| CRP (mg/dL) | 0.36 (0.57) | 0.65 (1.25) | 0.50 (1.03) | 0.51 (1.00) |
| HAQ-DI (0–3) | 0.31 (0.39) | 0.40 (0.51) | 0.38 (0.45) | 0.36 (0.45) |
| MTX use, n (%) | 190 (87.2) | 176 (81.1) | 189 (86.3) | 555 (84.9) |
| MTX weekly dose (mg) | 9.80 (3.33) | 9.33 (3.05) | 9.80 (2.97) | 9.65 (3.13) |
| Other major DMARDs | ||||
| Salazosulfapyridine, n (%) | 44 (20.2) | 59 (27.2) | 49 (22.4) | 152 (23.2) |
| Bucillamine, n (%) | 35 (16.1) | 28 (12.9) | 23 (10.5) | 86 (13.1) |
| Iguratimod, n (%) | 14 (6.4) | 12 (5.5) | 11 (5.0) | 37 (5.7) |
| Tacrolimus, n (%) | 2 (0.9) | 10 (4.6) | 5 (2.3) | 17 (2.6) |
| Gold sodium thiosulfate, n (%) | 3 (1.4) | 4 (1.8) | 7 (3.2) | 14 (2.1) |
| Glucocorticoid use, n (%) | 69 (31.7) | 73 (33.6) | 68 (31.1) | 210 (32.1) |
| Glucocorticoid dose (mg/day) | 3.73±1.89 | 3.96±2.16 | 4.10±2.27 | 3.93±2.11 |
| NSAID use, n (%) | 145 (66.5) | 152 (70.0) | 151 (68.9) | 448 (68.5) |
| Hormone replacement therapy for osteoporosis treatment | 0 (0.0) | 2 (0.9) | 1 (0.5) | 3 (0.5) |
| Lumbar spine (L1–L4) BMD by machine type (g/cm2) | ||||
| Hologic* | 0.89 (0.16) | 0.89 (0.16) | 0.90 (0.16) | 0.89 (0.16) |
| Lunar* | 1.11 (0.19) | 1.01 (0.19) | 1.02 (0.15) | 1.05 (0.18) |
| CTX-I (ng/mL)† | 0.46 (0.29, 0.59) | 0.45 (0.28, 0.56) | 0.48 (0.26, 0.64) | 0.47 (0.28, 0.59) |
| COMP (U/L)† | 9.43 (7.00, 11.40) | 9.61 (7.80, 11.00) | 9.58 (7.70, 11.50) | 9.54 (7.45, 11.30) |
| CTX-II (ng/mmol Cre)† | 397.09 (184.00, 480.00) | 442.90 (189.00, 563.00) | 389.27 (184.00, 457.00) | 409.73 (184.00, 492.00) |
n=number of patients who received ≥1 dose of study drug and had a baseline and at least 1 postbaseline measurement of the radiograph score.
Values are mean (SD) unless otherwise indicated.
*Hologic machine use: 142, 151 and 145 patients; Lunar machine use: 76, 66 and 74 patients; placebo, Q6M and Q3M, respectively.
†Values are medians (quartile 1, quartile 3).
ACPA, anticyclic citrullinated peptide antibody; BMD, bone mineral density; BMI, body mass index; COMP, cartilage oligomeric matrix protein; CRP, C reactive protein; CTX-I, C-telopeptide of type I collagen; CTX-II, C-telopeptide of type II collagen; Cre, creatinine; DAS, disease activity score; DMARDs, disease-modifying antirheumatic drugs; HAQ-DI, Health Assessment Questionnaire-Disability Index; JSN, joint space narrowing; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; Q3M, every 3 months; Q6M, every 6 months; RA, rheumatoid arthritis; RF, rheumatoid factor.