Time to relapse of Takayasu arteritis according to various definitions
ITT population | Tocilizumab subcutaneous 162 mg/week (n=18) | Placebo (n=18) |
Protocol definition* | ||
Patients who relapsed, n (%) | 8 (44.4) | 11 (61.1) |
Treatment duration, weeks, median | 19.00 | 12.86 |
Time to relapse,† weeks, median (95% CI) | NE (12.1 to NE) | 12.1 (10.7 to 16.0) |
HR (95.41% CI); p value‡ | 0.41 (0.15 to 1.10); p=0.0596 | |
Estimated relapse-free rate at week 24, % (95% CI)† | 50.6 (25.4 to 75.8) | 22.9 (0.4 to 45.4) |
Kerr’s definition§ | ||
Patients who relapsed, n (%) | 8 (44.4) | 11 (61.1) |
Time to relapse,† weeks, median (95% CI) | NE (12.1 to NE) | 12.1 (10.7 to 16.0) |
HR (95.41% CI); p value‡ | 0.41 (0.15 to 1.10); p=0.0596 | |
Estimated relapse-free rate at week 24, % (95% CI)† | 50.6 (25.4 to 75.8) | 22.9 (0.4 to 45.4) |
Clinical definition¶ | ||
Patients who relapsed, n (%) | 11 (61.1) | 11 (61.1) |
Time to relapse,† weeks, median (95% CI) | 16.0 (8.1 to NE) | 12.0 (8.3 to 16.0) |
HR (95.41% CI); p value‡ | 0.70 (0.29 to 1.70); p=0.4224 | |
Estimated relapse-free rate at week 24, % (95% CI) | 30.0 (5.3 to 54.7) | 24.6 (1.2 to 48.1) |