Research Article

Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East

Table 1

Demographics and baseline disease characteristics.

Tocilizumab

Patient characteristics
 Sex, (%)
  Female78 (82.1)
  Male17 (17.9)
 Race, (%)
  White 69 (72.6)
  Black3 (3.2)
  Other23 (24.2)
 Smokers, (%)4 (4.2)
 Age, years, mean (SD)44.9 (13.7)
 BMI, kg/m2, mean (SD)28.1 (5.4)
Disease characteristics
 DAS28, mean (median [range])6.1 (5.8 [3.4, 8.8])
 Tender joint count, mean13.28
 Swollen joint count, mean8.6
 HAQ-DI, mean (SD)1.6 (0.6)
 CRP, mg/L, mean (SD) 26.9 (34.4)
 ESR, mm/h, mean (SD)45.3 (29.2)
Concomitant medication used by >10%, (%)
 Immunosuppressants86 (90.5)
  Methotrexate 83 (87.4)
  Prednisolone47 (49.5)
  Methylprednisolone6 (6.3)
  Prednisone7 (7.4)
  aTNF agent (etanercept or adalimumab)5 (5.3)
 Antianemia preparations65 (68.4)
 Anti-inflammatory and antirheumatic products50 (52.6)
 Vasoprotectives46 (48.4)
 Antiprotozoals37 (38.9)
 Mineral supplements35 (36.8)
 Vitamins30 (31.6)
 Antidiarrheals, intestinal anti-inflammatory/anti-infective agents29 (30.5)
 Drugs for acid-related disorders27 (28.4)
 Lipid-modifying agents21 (22.1)
 Drugs for treatment of bone diseases14 (14.7)
 Agents acting on the renin-angiotensin system12 (12.6)
 Drugs used in diabetes11 (11.6)

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; SD, standard deviation.