Table 2

Change from baseline to week 48 (double-blind period) or week 96 (including open-label period) in exploratory end points (intent-to-treat population; observed data)

Double-blind period, week 48Open-label period, week 96
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
Change from baseline in mRSS, n (% (95% CI))*
 ≥ 20%13 (29.5 [16.8 to 45.2])18 (41.9 [27.0 to 57.9])18 (40.9 [26.3 to 56.8])22 (51.2 [35.5 to 66.7])
 ≥ 40%3 (6.8 [1.4 to 18.7])10 (23.3 [11.8 to 38.6])13 (29.5 [16.8 to 45.2])15 (34.9 [21.0 to 50.9])
 ≥ 60%0 (0.0 [0.0 to 8.0])5 (11.6 [3.9 to 25.1])7 (15.9 [6.6 to 30.1])6 (14.0 [5.3 to 27.9])
 ≥4.7 units (MCID)2012 (27.3 [15.0, 42.8])
n=33
18 (41.9 [27.0, 57.9])
n=32
19 (43.2 [28.3, 59.0])
n=24
22 (51.2 [35.5, 66.7])
n=27
TJC28, mean (95% CI) change from baseline–0.97 (–2.85 to 0.91)–2.28 (–4.16 to –0.40)–4.88 (–7.99 to –1.76)–3.39 (–6.14 to –0.65)
 [min, max][–16, 12]
n=33
[–14, 9]
n=32
[–23, 2]
n=24
[–25, 7]
n=28
HAQ-DI, mean (95% CI) change from baseline†0.17 (0.05 to 0.30)–0.01 (–0.25 to 0.23)–0.29 (–0.46 to –0.13)–0.13 (–0.33 to 0.08)
 [min, max][–0.63, 0.88]
n=34
[–1.13, 1.75]
n=31
[–1.25, 0.50]
n=24
[–1.25, 1.38]
n=27
Clinician Global VAS, mean (95% CI) change from baseline†–7.69 (–15.06 to –0.32)–18.57 (–26.89 to –10.25)–20.61 (–29.52 to –11.7)–21.30 (–31.05 to –11.54)
 [min, max][–45, 39]
n=32
[–60, 14]
n=30
[–57, 21]
n=23
[–73, 14]
n=27
Patient Global VAS, mean (95% CI) change from baseline†–4.03 (–12.42 to 4.36)–9.13 (–18.68 to 0.43)–23.75 (–38.95 to –8.55)–11.11 (–18.75 to –3.46)
 [min, max] [–64, 57]
n=34
[–59, 36]
n=32
[–90, 38]
n=24
[–44, 33]
n=28
FACIT-Fatigue score, mean (95% CI) change from baseline†1.37 (–1.37 to 4.11)3.69 (0.34 to 7.04)11.26 (5.72 to 16.81)4.15 (1.51 to 6.79)
 [min, max][–18.0, 15.0]
n=32
[–15.0, 22.0]
n=32
[–15.0, 29.0]
n=23
[–10.0, 19.0]
n=27
Pruritus 5-D Itch Score, mean (95% CI) change from baseline†–1.87 (–3.26 to –0.48)–2.03 (–3.91 to –0.16)–4.43 (–6.32 to –2.55)–3.23 (–5.38 to –1.09)
 [min, max][–10, 5]
n=30
[–15, 7]
n=30
[–14, 1]
n=23
[–14, 9}
n=26
%pFVC, mean (95% CI) change from baseline–0.06 (–0.10 to –0.03)–0.02 (–0.04 to 0.00)–0.03 (–0.07 to 0.01)–0.01 (–0.03 to 0.02)
 [min, max][–0.33, 0.13]
n=32
[–0.15, 0.04]
n=30
[–0.25, 0.20]
n=25
[–0.15, 0.15]
n=28
% pDLCO (Hb corr), mean (95% CI) change from baseline–0.03 (–0.07 to 0.01)–0.03 (–0.06 to 0.00)–0.03 (–0.10 to 0.05)–0.03 (–0.08 to 0.01)
 [min, max][–0.23, 0.28]
n=31
[–0.26, 0.12]
n=27
[–0.71, 0.25]
n=24
[–0.25, 0.21]
n=25
  • n denotes number of patients with valid assessments at the time point. Escape data were not censored.

  • *Percentages were calculated based on n=43 (tocilizumab) and n=44 (placebo), the intent-to-treat population; thus, patients with missing change in mRSS Scores were considered non-responders.

  • †Negative change from baseline indicated improvement for all efficacy measures except FACIT-Fatigue, FVC and DLCO, for which positive change from baseline indicated improvement.

  • %pDLCO (Hb corr), per cent predicted diffusing capacity of lung for carbon monoxide corrected for haemoglobin; %pFVC, per cent predicted forced vital capacity; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire–Disability Index; max, maximum; MCID, minimal clinically important difference; min, minimum; mRSS, modified Rodnan Skin Score; QW, every week; SC, subcutaneously; TJC28, tender joint count based on 28 joints; VAS, Visual Analogue Scale.