| Per-protocol population | Tocilizumab subcutaneous 162 mg/week (n=16) | Placebo (n=17) |
| Protocol definition* | ||
| Patients who relapsed, n (%) | 7 (43.8) | 11 (64.7) |
| Treatment duration, weeks, median | 21.00 | 12.86 |
| Time to relapse,† weeks, median (95% CI) | NE (13.3 to NE) | 12.1 (10.7 to 14.0) |
| HR (95.41 % CI); p value‡ | 0.34 (0.11 to 1.00); p=0.0345 | |
| Estimated relapse-free rate at week 24, % (95% CI)† | 51.7 (25.3 to 78.0) | 16.7 (0.0 to 37.5) |
*Two or more of five signs of relapse present: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, ischaemic symptoms.
†Kaplan-Meier estimate.
‡Stratified by age (<18, 18–<65, ≥65 years).
§Two or more of four signs of relapse present: systemic symptoms (objective or subjective), elevated inflammation markers, vascular signs and symptoms and ischaemic symptoms, imaging (enhanced CT or MRI).
¶One or more of four signs of relapse present: objective systemic symptoms, subjective systemic symptoms, vascular signs and symptoms, ischaemic symptoms.
ITT, intent-to-treat; NE, not evaluable.