Table 1

Baseline demographics and disease characteristics (safety population)

Patients randomly assigned in the double-blind periodPatients who transitioned to the open-label period*
Placebo QW SC
n=44
Tocilizumab 162 mg QW SC
n=43
Placebo- tocilizumab 162 mg QW SC
n=31
Continuous-tocilizumab 162 mg QW SC
n=30
Age, years48 (12.9)51 (11.7)47 (11.9)52 (11.8)
Female, n (%)35 (80)32 (74)26 (84)23 (77)
White, n (%)40 (91)38 (88)28 (90)26 (87)
Duration of SSc, months19.5 (17.0)17.6 (13.9)§20.0 (18.2)17.7 (13.5)
Total mRSS†25.6 (5.9)26.4 (7.2)24.6 (5.4)25.2 (6.9)
TJC287.4 (8.5)‡7.4 (8.9)8.3 (9.1)8.1 (10.0)
TJC28 ≥4, n (%)21 (49)‡20 (47)16 (52)12 (40)
Overall HAQ-DI Score1.4 (0.7)1.3 (0.6)§1.2 (0.7)1.2 (0.6)¶
Clinician Global VAS, mm60.9 (15.2)64.1 (15.1)57.9 (15.2)62.5 (15.7)
Patient Global VAS, mm61.9 (21.0)59.8 (18.3)60.2 (22.9)56.6 (18.3)
FACIT-Fatigue26.5 (11.6)‡25.6 (11.4)27.9 (12.1)**26.2 (10.5)
Pruritus 5-D Itch13.5 (5.1)‡13.1 (4.5)§13.2 (4.8)**13.0 (4.2)¶
CRP, mg/L10.3 (13.5)‡10.0 (13.5)7.7 (7.2)7.4 (12.7)
%pFVC82 (13)§80 (14)83 (14)**78 (13)
%pDLCO (Hb corr)74 (21)‡73 (19)§75 (23)**73 (17)
  • All values are mean (SD) unless stated otherwise.

  • *Original baseline data for patients who entered the OL period.

  • †Possible scores: mRSS, 0–51; HAQ-DI, 0–3; Clinician Global VAS, 0–100; ULN for CRP, 3 mg/L.

  • ‡n = 43.

  • §n = 42.

  • ¶n = 29.

  • **n = 30.

  • %pDLCO (Hb corr), per cent predicted diffusing capacity of the lung for carbon monoxide corrected for haemoglobin; %pFVC, per cent predicted forced vital capacity; CRP, C reactive protein; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire–Disability Index; mRSS, modified Rodnan Skin Score; QW, every week; SC, subcutaneously; SSc, systemic sclerosis; TJC28, tender joint count based on 28 joints; ULN, upper limit of normal; VAS, Visual Analogue Scale.