Table 1
Control (n)Experimental (n)Difference
Per protocol efficacy analysis5558
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 analysis6060
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 events40%30%ns
 Infections25%17%ns
 Severe adverse events7%3%ns