Per protocol efficacy analysis | 55 | 58 | |
ATG 12 months (% [95%CI]) | 83.8% | 81.3% | −2.5% |
| [64.8% to 102.7%] | [62.8% to 99.8%] | [−16.6% to 11.7%] |
ITG 12 months (% [95%CI]) | 83.7% | 78.2% | −5.5% |
| [64.7% to 102.7%] | [59.7% to 96.8%] | [−20.6% to 9.7%] |
Intention to treat efficacy analysis | 60 | 60 | |
ATG 12 months (% [95%CI]) | 84.8% | 80.1% | −4.7% |
| [66.2% to 103.3%] | [61.7% to 98.5%] | −4.7% |
ITG 12 months (% [95%CI]) | 84.7% | 77.3% | −7.33% |
| [66.1% to 103.2%] | [59.0% to 95.7%] | [−22.2% to 7.5%] |
Other variables of efficacy |
BASDAI (median (P25, P75)) | 1 (0.6, 1.7) | 1 (0.2, 1.4) | ns |
VAS nocturnal axial pain (mean (SD)) | 0.84 (1.01) | 1.02 (1.15) | ns |
Physician GA (median (P25, P75)) | 1 (0.0, 2.0) | 1 (0.0, 1.0) | ns |
Patient GA (median (P25, P75)) | 1 (0.0, 2.0) | 1 (0.0, 1.0) | ns |
ASDAS-CRP (median (P25, P75)) | 1.1 (0.8, 3.5) | 1.0 (0.7, 1.9) | ns |
Withdrawal for inefficacy (physician crit.) | 3 (5%) | 9 (14%) | ns |
Safety |
Adverse events | 40% | 30% | ns |
Infections | 25% | 17% | ns |
Severe adverse events | 7% | 3% | ns |