Double-blind period, week 48 | Open-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)20 | 12 (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.