Table 1.
Author (year) | ClinicalTrials.gov identifier | Region | Time to primary endpoint (weeks) | Study duration (weeks) | Medication | Number of cases | Age (years)a | Males ratios (%) | Disease duration (years)a | HLA-B27 positive rate (%) | Baseline BASDAIa |
---|---|---|---|---|---|---|---|---|---|---|---|
Baeten (2013) [32] | NCT00809159 | 8 centers in Europe | 6 | 28 | SEC 2× 10 mg/kg | 24 | 41.1 (10.1) | 58 | 10.1 (12.2) | 70 | 7.1 (1.40) |
placebo | 6 | 45.0 (10.0) | 83 | 10.2 (12.0) | 83 | 7.2 (1.76) | |||||
Deodhar (2016) [33] | NCT01358175 | 106 centers | 16 | 52 | SEC 150 mg | 125 | 40.1 (11.6) | 67 | 6.5 (6.9) | 69 | 6.4 (1.6) |
SEC 75 mg | 124 | 42.3 (13.2) | 71 | 7.9 (9.7) | 80 | 6.1 (1.4) | |||||
placebo | 122 | 43.1 (12.4) | 70 | 8.3 (8.9) | 74 | 6.5 (1.5) | |||||
Deodhar (2019) [34] | NCT02696798 | 106 centers in 15 countries | 16 | 52 | IXE 80 mg Q2W | 98 | 44.2 (10.8) | 76.5 | 11.7 (8.8) | NA | 7.5 (1.3) |
IXE 80 mg Q4W | 114 | 47.4 (13.4) | 79.8 | 10.1 (7.8) | NA | 7.5 (1.3) | |||||
placebo | 104 | 46.6 (12.7) | 83.7 | 13.0 (10.5) | NA | 7.3 (1.3) | |||||
Erdes (2019) [35] | NA | NA | 16 | NA | NTK 40 mg | 22 | NA | NA | NA | NA | NA |
NTK 80 mg | 22 | NA | NA | NA | NA | NA | |||||
NTK 120 mg | 22 | NA | NA | NA | NA | NA | |||||
placebo | 23 | NA | NA | NA | NA | NA | |||||
Huang (2019) [36] | NCT02896127 | China, Czech Republic, South Korea and the UK | 16 | 52 | SEC 150 mg | 305 | NA | NA | NA | NA | NA |
placebo | 153 | NA | NA | NA | NA | NA | |||||
Kivitz (2018) [37] | NCT02159053 | 85 centers in 19 countries | 16 | 104 | SEC 150 mg with load | 116 | 44.5 (11.6) | 69.8 | 8.4 (10.8) | 86.2 | 7.0 (1.2) |
SEC 150 mg without load | 117 | 41.2 (11.1) | 70.9 | 6.5 (7.6) | 84.6 | 6.95 (1.3) | |||||
placebo | 117 | 43.4 (12.5) | 65 | 7.1 (9.2) | 79.5 | 7.1 (1.2) | |||||
Pavelka (2017) [38] | NCT02008916 | 54 centers across the America and Europe | 16 | 52 | SEC 300 mg | 76 | 42.1 (11.8) | 65.8 | 5.3 (7.3) | 73.7 | 7.0 (1.4) |
SEC 150 mg | 74 | 42.9 (11.1) | 62.2 | 6.0 (7.2) | 70.3 | 7.0 (1.4) | |||||
placebo | 76 | 42.7 (11.4) | 52.6 | 5.2 (6.4) | 69.7 | 6.9 (1.3) | |||||
Sieper (2016) [39] | NCT01649375 | 106 centers | 16 | 52 | SEC 150 mg | 72 | 41.9 (12.5) | 64 | 7.0 (8.2) | 79 | 6.6 (1.5) |
SEC 75 mg | 73 | 44.4 (13.1) | 70 | 5.3 (7.4) | 73 | 6.6 (1.3) | |||||
placebo | 74 | 43.6 (13.2) | 76 | 6.4 (8.9) | 78 | 6.8 (1.3) | |||||
van der Heijde (2018) (1) [40] | NCT02696785 | 84 centers in 12 countries | 16 | 52 | IXE 80 mg Q2W | 83 | 41.3 (11.2) | 77 | 8.2 (9.0) | 90 | 6.7 (1.6) |
IXE 80 mg Q4W | 81 | 41.0 (12.1) | 84 | 8.3 (9.6) | 93 | 6.8 (1.3) | |||||
placebo | 87 | 42.7 (12.0) | 83 | 6.8 (7.6) | 89 | 6.8 (1.2) | |||||
van der Heijde (2018) (2) [41] | NCT02963506 | NA | 12 | 48 | BIM 16 mg | 243 | 42.2 (11.8) | 84.5 | NA | NA | NA |
BIM 64 mg | NA | NA | NA | ||||||||
BIM 160 mg | NA | NA | NA | ||||||||
BIM 320 mg | NA | NA | NA | ||||||||
placebo | 60 | NA | NA | NA |
SEC, secukinumab; IXE, ixekizumab; NTK, netakimab; BIM, bimekizumab; BASDAI, Bath AS Disease Activity Index; Q2W, every 2 weeks; Q4W, every 4 weeks
aData were shown by mean and SD