Table 1

Summary of efficacy data at week 104 among patients randomised to secukinumab at baseline

ImputedObserved
Efficacy end pointSecukinumab
intravenous 150 mg
(n=125)
Secukinumab
intravenous 75 mg
(n=124)
Secukinumab
intravenous 150 mg
Secukinumab
intravenous 75 mg
ASAS20 response73.7%68.0%69/87 (79.3%)62/86 (72.1%)
ASAS40 response55.7%48.5%56/87 (64.4%)46/86 (53.5%)
hsCRP, median change from baseline
(min, max) (mg/L)
N/AN/A–4.20 (–143.6, 50.0)
(n=88)
–2.7 (–97.5, 30.2)
(n=87)
ASAS5/6 response57.9%52.2%56/87 (64.4%)49/86 (57.0%)
BASDAI, mean change from baseline–2.93 (0.18)–2.75 (0.18)–3.41 (2.12)
(n=87)
–3.04 (1.81)
(n=86)
SF-36 PCS score, mean change from baseline6.88 (0.68)6.36 (0.69)8.06 (8.08)
(n=87)
7.41 (6.83)
(n=85)
ASQoL score, mean change from baseline–4.38 (0.45)–4.34 (0.45)–4.82 (4.83)
(n=86)
–4.58 (4.44)
(n=85)
ASAS partial remission25.6%19.3%28/87 (32.2%)20/86 (23.3%)
  • Binary variables are reported using multiple imputation (percentage of responders) to account for missing data and as observed data (n/m (%), where n=number of patients with response and m=number of patients with evaluable data). For continuous variables, mean change from baseline is reported as least-square mean change (SE) where mixed-effects model repeated measures analysis was performed and as observed data (SD). Patients received a 10 mg/kg loading dose of secukinumab at baseline and weeks 2 and 4, before receiving indicated dose of secukinumab subcutaneously every four weeks from week 8.

  • ASAS, Assessment of SpondyloArthritis international Society response criteria; ASQoL, Ankylosing Spondylitis Quality of Life; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; hsCRP, high-sensitivity C-reactive protein; N/A, not available; SF-36 PCS, Short Form-36 physical component summary.