Baseline patient demographics and characteristics
| Pooled analysis | DRIVE study | DESIRABLE study | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Denosumab | Denosumab | Denosumab | |||||||
| Placebo (N=306) | Q6M (N=302) | Q3M (N=301) | Placebo (N=88) | Q6M (N=85) | Q3M (N=82) | Placebo (N=218) | Q6M (N=217) | Q3M (N=219) | |
| Female, n (%) | 243 (79.4) | 233 (77.2) | 213 (70.8) | 76 (86.4) | 65 (76.5) | 59 (72.0) | 167 (76.6) | 168 (77.4) | 154 (70.3) |
| Age (years) | 56.2±11.4 | 57.0±11.9 | 56.5±12.2 | 57.0±10.6 | 54.4±10.6 | 52.0±11.7 | 55.8±11.7 | 58.1±12.3 | 58.2±12.0 |
| RA disease duration (years) | 2.1±1.3 | 2.2±1.3 | 2.2±1.3 | 2.3±1.3 | 2.2±1.3 | 2.3±1.3 | 2.1±1.3 | 2.2±1.3 | 2.2±1.3 |
| CRP (mg/dL) | 0.47±0.84 | 0.61±1.16 | 0.53±1.07 | 0.75±1.24 | 0.52±0.92 | 0.61±1.17 | 0.36±057 | 0.65±1.25 | 0.50±1.03 |
| ESR (mm/hour) | 21.7±18.6 | 24.0±21.3 | 22.6±18.8 | 27.8±23.6 | 22.0±18.0 | 24.0±19.9 | 19.2±15.6 | 24.8±22.4 | 22.1±18.4 |
| RF status, n (%) | 197 (64.4) | 199 (65.9) | 184 (61.1) | 60 (68.2) | 59 (69.4) | 56 (68.3) | 137 (62.8) | 140 (64.5) | 128 (58.4) |
| Anti-CCP antibodies, n (%) | 211 (69.0) | 228 (75.5) | 213 (70.8) | 66 (75.0) | 70 (82.4) | 64 (78.0) | 145 (66.5) | 158 (72.8) | 149 (68.0) |
| Tender joint count (0–68) | 7.6±7.6 | 7.6±8.0 | 7.6±7.8 | 9.9±9.7 | 8.0±7.4 | 8.2±7.3 | 6.6±6.4 | 7.5±8.2 | 7.3±8.0 |
| Swollen joint count (0–66) | 9.7±4.9 | 9.3±4.7 | 9.4±4.4 | 10.5±5.9 | 8.9±4.2 | 10.5±4.6 | 9.4±4.4 | 9.5±4.9 | 9.0±4.3 |
| Glucocorticoid use, n (%) | 106 (34.6) | 109 (36.1) | 106 (35.2) | 37 (42.0) | 36 (42.4) | 37 (45.1) | 69 (31.7) | 73 (33.6) | 68 (31.1) |
| MTX use, n (%) | 278 (90.8) | 261 (86.4) | 271 (90.0) | 88 (100.0) | 85 (100.0) | 82 (100.0) | 190 (87.2) | 176 (81.1) | 189 (86.3) |
| Modified total Sharp score (0–448) | 13.26±22.18 | 14.66±20.41 | 13.77±17.89 | 13.56±24.03 | 11.43±14.48 | 10.02±14.03 | 13.14±21.44 | 15.92±22.21 | 15.17±18.97 |
| Modified Sharp erosion score (0–280) | 6.57±10.50 | 7.21±9.51 | 6.83±8.77 | 6.61±10.35 | 6.39±7.77 | 5.95±6.75 | 6.55±10.58 | 7.53±10.11 | 7.16±9.41 |
| Modified Sharp JSNS (0–168) | 6.69±12.64 | 7.45±12.59 | 6.94±10.31 | 6.94±14.29 | 5.04±8.31 | 4.07±8.06 | 6.59±11.94 | 8.39±13.82 | 8.01±10.86 |
Values are shown as mean±SD unless otherwise indicated.
N=number of patients who received at least one dose of investigational product and had a baseline value and at least one post-baseline measurement with radiographs.
CCP, cyclic citrullinated peptide; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; JSNS, joint space narrowing score; MTX, methotrexate; Q3M, denosumab 60 mg every 3 months; Q6M, denosumab 60 mg every 6 months; RA, rheumatoid arthritis; RF, rheumatoid factor.