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Table 2 Summary of results of the primary and secondary efficacy endpoints through week 104

From: Efficacy and Safety of Secukinumab 150 mg with and Without Loading Regimen in Ankylosing Spondylitis: 104-week Results from MEASURE 4 Study

Endpoints Week Secukinumab Placebo (N = 117)
150 mg (N = 116) P value (adjusted) 150 mg no load (N = 117) P value (adjusted)
ASAS20, % 4 49.1 0.356 53.8 0.356 39.3
16 59.5 0.057 61.5 0.054 47.0
52 71.7 N/A 72.0 N/A N/A
104 74.0 N/A 77.5 N/A N/A
ASAS40, % 4 29.3 0.356 26.5 0.356 17.9
16 38.8 0.188 35.9 0.356 28.2
52 51.3 N/A 54.1 N/A N/A
104 51.9 N/A 58.9 N/A N/A
hsCRP (post-baseline/baseline ratio), LS mean ± SE 16 0.59 ± 1.08 0.188 0.62 ± 1.08 0.356 1.12 ± 1.08
52 0.56 ± 1.09 N/A 0.61 ± 1.09 N/A N/A
104a − 0.61 ± 0.08 N/A − 0.56 ± 0.08 N/A N/A
ASAS 5/6, % 16 37.1 0.356 42.7 0.356 29.1
52 50.5 N/A 55.9 N/A N/A
104 54.3 N/A 60.0 N/A N/A
BASDAI, LS mean change from baseline ± SE 16 − 2.39 ± 0.20 0.356 − 2.58 ± 0.21 0.356 − 1.86 ± 0.20
52 − 3.14 ± 0.21 N/A − 3.29 ± 0.21 N/A N/A
104 − 3.27 ± 0.23 N/A − 3.41 ± 0.23 N/A N/A
SF-36 PCS, LS mean change from baseline ± SE 16 5.90 ± 0.70 0.356 7.02 ± 0.70 0.356 4.50 ± 0.69
52 7.80 ± 0.79 N/A 8.24 ± 0.78 N/A N/A
104 7.70 ± 0.81 N/A 8.74 ± 0.82 N/A N/A
ASQoL, LS mean change from baseline ± SE 16 − 3.79 ± 0.43 0.356 − 4.46 ± 0.43 0.356 − 2.84 ± 0.43
52 − 4.63 ± 0.47 N/A − 4.82 ± 0.47 N/A N/A
104 − 4.99 ± 0.50 N/A − 5.32 ± 0.50 N/A N/A
  1. P values versus placebo. For binary variables, non-responder imputation analyses presented at week 16, multiple imputation analyses at weeks 52 and 104, and mixed-effect model repeated measures data for continuous variables at weeks 16, 52, and 104
  2. ASAS Assessment of Spondyloarthritis International Society, ASQoL ankylosing spondylitis quality of life, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, hsCRP high-sensitivity C-reactive protein, LS least squares, N/A not applicable, N number of patients randomized, SE standard error, SF-36 PCS short form-36 physical component summary
  3. aNegative LS mean value at a particular time point indicates reduction of CRP