Efficacy endpoints | Secukinumab 150 mg* (n=128) | ||||
Week 52 | Week 104 | Week 156 | Week 208 | Week 260 | |
ASAS20, n/M (%) | 97/122 (79.5) | 91/117 (77.8) | 96/126 (76.2) | 92/116 (79.3) | 88/112 (78.6) |
ASAS40, n/M (%) | 81/122 (66.4) | 70/117 (59.8) | 76/126 (60.3) | 69/116 (59.5) | 73/112 (65.2) |
ASAS partial remission, n/M (%) | 34/122 (27.9) | 32/117 (27.4) | 31/126 (24.6) | 32/116 (27.6) | 39/112 (34.8) |
BASDAI50, n/M (%) | 68/122 (55.7) | 59/117 (50.4) | 69/126 (54.8) | 69/117 (59.0) | 71/112 (63.4) |
ASDAS-CRP inactive disease, n/M (%) | 31/122 (25.4) | 32/117 (27.4) | 30/124 (24.2) | 29/115 (25.2) | 30/110 (27.3) |
ASDAS-CRP less than 2.1, n/M (%) | 77/122 (63.1) | 73/117 (62.4) | 78/124 (62.9) | 69/115 (60.0) | 75/110 (68.2) |
ASAS5/6, n/M (%) | 81/122 (66.4) | 71/117 (60.7) | 81/125 (64.8) | 75/117 (64.1) | 73/112 (65.2) |
BASDAI | |||||
M | 122 | 117 | 126 | 117 | 112 |
Mean±SD | 2.9±1.95 | 3.0±1.90 | 2.9±1.90 | 2.8±1.79 | 2.6±1.76 |
Mean change from baseline±SD | −3.2±2.12 | −3.2±2.10 | −3.2±2.32 | −3.3±2.17 | −3.5±2.08 |
BASFI | |||||
M | 122 | 117 | 126 | 117 | 112 |
Mean±SD | 2.9±2.10 | 2.9±2.02 | 2.8±2.00 | 2.6±1.86 | 2.4±1.77 |
Mean change from baseline±SD | −2.7±2.10 | −2.7±2.20 | −2.7±2.26 | −2.9±2.30 | −3.1±2.26 |
BASMI | |||||
M | 117 | 113 | 120 | 113 | 108 |
Mean±SD | 3.3±1.50 | 3.3±1.54 | 3.2±1.48 | 3.3±1.53 | 3.2±1.49 |
Mean change from baseline±SD | −0.6±0.96 | −0.7±1.04 | −0.7±1.04 | −0.6±1.18 | −0.7±1.12 |
SF-36 PCS | |||||
M | 127 | 115 | 125 | 117 | 112 |
Mean±SD | 45.1±6.92 | 44.4±7.81 | 44.8±7.61 | 45.7±6.60 | 46.3±6.99 |
Mean change from baseline±SD | 7.7±6.99 | 7.3±8.11 | 7.5±8.62 | 8.3±7.64 | 9.0±8.06 |
FACIT-Fatigue | |||||
M | 127 | 115 | 126 | 117 | 111 |
Mean±SD | 37.1±9.58 | 36.6±9.47 | 36.4±9.66 | 36.9±8.85 | 36.9±9.35 |
Mean change from baseline±SD | 10.4±10.62 | 9.8±10.09 | 9.9±11.22 | 10.2±11.06 | 10.2±11.38 |
*Total number of patients includes placebo switchers. Data shown are as observed through 5 years.
ASAS, Assessment of SpondyloArthritis international Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index;M, number of evaluable patients; N, total number of randomised patients; n, number of responders; SF-36 PCS, Short Form Survey-36 Physical Component Summary.