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: female76 (86.4%)65 (76.5%)59 (72.0%)66 (77.6%)266 (78.2%)
Age (years)57.0±10.5754.4±10.5752.0±11.6554.6±10.5154.5±10.92
 ≥6526 (29.5%)11 (12.9%)10 (12.2%)16 (18.8%)63 (18.5%)
BMI (kg/m2)22.08±3.2722.31±3.6522.21±3.1423.86±3.4622.61±3.45
Osteoporosis*23 (26.1%)12 (14.1%)10 (12.2%)12 (14.1%)57 (16.8%)
Duration of RA (years)2.31±1.342.16±1.312.26±1.272.25±1.402.25±1.33
RF status positive60 (68.2%)59 (69.4%)56 (68.3%)57 (67.1%)232 (68.2%)
Anti-CCP positive66 (75.0%)70 (82.4%)64 (78.0%)65 (76.5%)265 (77.9%)
Modified total Sharp score (0–448)13.56±24.0311.43±14.4810.02±14.0312.74±16.5711.97±17.81
Modified Sharp erosion score (0–280)6.61±10.356.39±7.775.95±6.757.41±8.686.60±8.50
Modified Sharp JSN score (0–168)6.94±14.295.04±8.314.07±8.065.33±8.705.37±10.24
Swollen joint count (0–66)10.50±5.938.89±4.1610.51±4.6310.19±4.7110.02±4.94
Tender joint count (0–68)9.90±9.678.00±7.378.15±7.348.33±7.778.61±8.12
DAS28-CRP3.95±0.993.63±1.023.79±1.033.75±0.933.78±1.00
 Remission8 (9.1%)14 (16.5%)10 (12.2%)6 (7.1%)38 (11.2%)
 Low11 (12.5%)14 (16.5%)13 (15.9%)21 (24.7%)59 (17.4%)
 Moderate59 (67.0%)50 (58.8%)51 (62.2%)54 (63.5%)214 (62.9%)
 High10 (11.4%)7 (8.2%)8 (9.8%)4 (4.7%)29 (8.5%)
CRP (mg/dL)0.75±1.240.52±0.920.61±1.170.60±1.080.62±1.11
HAQ-DI (0–3)0.47±0.520.39±0.450.32±0.380.35±0.390.38±0.44
MTX weekly dose (mg)7.61±1.767.98±2.018.40±2.198.25±2.008.05±2.01
Glucocorticoid use37 (42.0%)36 (42.4%)37 (45.1%)37 (43.5%)147 (43.2%)
Amount of glucocorticoid (mg/day)3.78±2.313.90±2.273.68±1.704.03±2.043.85±2.08
NSAIDs use64 (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±0.180.90±0.170.92±0.160.92±0.160.90±0.17
 Lunar‡1.04±0.181.05±0.211.11±0.211.06±0.191.07±0.19
Total hip BMD by machine type (g/cm2)
 Hologic‡0.76±0.140.80±0.130.80±0.130.83±0.130.80±0.13
 Lunar‡0.83±0.150.84±0.130.87±0.160.86±0.160.85±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.