Table 1

Patient disposition, demographics and baseline characteristics

Placebo (N=35)Tabalumab
30 mg (N=35)80 mg (N=30)
Patient disposition
 Completed the study29 (82.9)30 (85.7)24 (80.0)
 Discontinued study medication6 (17.1)5 (14.3)6 (20.0)
 Reason for discontinuation
  Adverse event01 (2.9)1 (3.3)
  Lost to follow-up000
  Consent withdrawal3 (8.6)4 (11.4)4 (13.3)
  Protocol violation1 (2.9)00
  Lack of efficacy2 (5.7)01 (3.3)
 Received rescue therapy20 (57.1)12 (34.3)11 (36.7)
Demographics and baseline characteristics
 Age (years)52.2±11.552.4±13.052.7±14.1
 Women32 (91.4)28 (80.0)26 (86.7)
 Caucasian21 (60.0)26 (74.3)20 (66.7)
 BMI (kg/m2)27.8±5.027.4±6.030.0±8.5
 Weight (kg)72.8±13.975.1±18.079.2±27.0
 Disease duration (years)10.9±8.310.4±6.79.8±7.6
 Swollen joint count (28)14.5±5.712.6±5.711.5±6.5*
 Tender joint count (28)18.3±7.117.2±6.816.1±9.0
 HAQ-DI1.8±0.51.7±0.61.6±0.7
 CRP (mg/dl)2.2±2.51.7±2.02.0±2.3
 ESR (mm/h)52.5±31.644.9±21.951.0±25.0
 DAS28-CRP6.2±0.96.0±0.95.8±1.3
 MTX dose (mg/week)17.1±4.815.6±4.616.8±4.6
 Currently using prednisone24 (68.6)24 (68.6)17 (56.7)
 Prednisone dose (mg/week)48.4±18.653.8±16.453.5±17.2
  • Values are mean±SD or number (%) of patients.

  • *p<0.05 vs placebo.

  • BMI, body mass index; CRP, C-reactive protein; DAS28, Disease Activity Score (based on 28 joints); ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire–Disability Index; MTX, methotrexate; N, total number of patients randomised.