Table 2

Measures of disease activity and health-related quality of life (secondary endpoints) at week 16 (NRI and MMRM analysis)

Anti-TNF-naiveAnti-TNF-IR
Secukinumab s.c.Secukinumab s.c.
150 mg (N=44)75 mg (N=45)Placebo (N=45)150 mg (N=28)75 mg (N=28)Placebo (N=29)
ASAS20, n (%) responders¶30 (68.2)†23 (51.1)14 (31.1)14 (50.0)‡7 (25.0)7 (24.1)
ASAS40, n (%) responders**19 (43.2)‡14 (31.1)8 (17.8)7 (25.0)§5 (17.9)‡0 (0.0)
ASAS 5/6, n (%) responders††22 (50.0)†18 (40.0)§6 (13.3)9 (32.1)§7 (25.0)§0 (0.0)
ASAS partial remission, n (%) responders‡‡8 (18.2)9 (20.0)3 (6.7)2 (7.1)2 (7.1)0 (0.0)
BASDAI,§§ LS mean change from baseline (SE)¶¶–2.6§ (0.3)
n=43
–2.3‡ (0.3)
n=45
–1.2 (0.3)
n=42
–1.6 (0.4)
n=24
–1.4 (0.4)
n=22
–0.6 (0.4)
n=22
hsCRP, geometric mean post-baseline/baseline ratio*** (SE)¶¶0.46* (1.1)
n=43
0.49* (1.1)
n=45
1.00 (1.1)
n=42
0.69‡ (1.2)
n=25
0.84 (1.2)
n=24
1.27 (1.2)
n=24
SF-36 PCS,††† LS mean change from baseline (SE)¶¶7.5§ (1.0)
n=43
6.0‡ (1.0)
n=45
3.0 (1.0)
n=43
4.5‡ (1.2)
n=24
3.6 (1.3)
n=21
0.3 (1.2)
n=23
ASQoL,‡‡‡ LS mean change from baseline (SE)¶¶–5.0§ (0.7)
n=43
–4.0‡ (0.7)
n=44
–1.9 (0.7)
n=43
–2.4 (0.8)
n=23
–2.5 (0.9)
n=22
–0.5 (0.8)
n=23
  • *p<0.0001; †p<0.001; §p<0.01; ‡p<0.05 vs placebo.

  • At week 16 missing response values were imputed as non-response (non-responder imputation). Continuous results are from MMRM.

  • ¶≥20% improvement in three of four core ASAS response criteria, with no worsening of ≥20% in the fourth.

  • **≥40% improvement in three of four core ASAS response criteria, with no worsening in the fourth.

  • ††≥20% improvement in five of the six ASAS response criteria.

  • ‡‡A score of ≤2 units (from 0 to 10) in each of the four core ASAS domains.

  • §§Scores range from 0 to 10, with 0 representing no problem and 10 the worst problem.

  • ¶¶n=number of subjects with measurements at both baseline and the post-baseline visit.

  • ***Exponentially transformed least square mean (LSM), the geometric mean ratio of post-baseline/baseline. A value <1 indicates a reduced CRP.

  • †††SF-36 PCS v2; scores range from 0 to 100 for individual domains (0 representing maximum disability and 100 no disability), with a normative score of 50 for the composite PCS.

  • ‡‡‡Scores range from 0 to 18, with 0 representing lowest severity and 18 highest severity.

  • ASAS, Assessment of SpondyloArthritis International Society criteria; ASQoL, Ankylosing Spondylitis Quality of Life questionnaire; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; hsCRP, high-sensitivity C-reactive protein; LS, least squares; MMRM, mixed-effect model repeated-measures; NRI, non-responder imputation; SF-36 PCS, Short Form-36 Physical Component Summary; TNF, tumour necrosis factor.