Table 2

Comparison of secukinumab versus placebo at week 16 for prespecified hierarchical endpoints

Secukinumab 300 mg with LD
Secukinumab 150 mg with LD
150 mg without LD (n=222)
Primary endpoint
 ACR20 response (%)62.6***55.5***59.5***27.4
Prespecified secondary endpoints
 vdH-mTSS structural progression (mean change from BL)†0.08**0.17*−0.09*0.50
 PASI 75 response (%)‡70.0*60.0*58.1*12.3
 PASI 90 response (%)‡53.6*36.8*31.6*9.3
 ACR50 response (%)39.6*35.9*32.0*8.1
 HAQ-DI score (LS mean change from BL)−0.55*−0.44*−0.45*−0.21
 DAS28-CRP score (LS mean change from BL)−1.49*−1.29*−1.29*−0.63
 Enthesitis resolution (%)§55.7*54.6*41.935.4
 Dactylitis resolution (%)¶65.9*57.5*56.332.3
  • *P<0.05; **p<0.01; ***p<0.0001 unadjusted p values versus  placebo are shown for endpoints that were significant in the hierarchical testing.

  • †Week 24 data.

  • ‡Data from patients with baseline psoriasis affecting ≥3 BSA.

  • §Data from patients with enthesitis at baseline.

  • ¶Data from patients with dactylitis at baseline.

  • ACR20, American College of Rheumatology 20; BL, baseline; BSA, body surface area; DAS28-CRP, 28-joint Disease Activity Score using C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; LD, loading dose; LS, least squares; PASI, Psoriasis Area and Severity Index; vdH-mTSS, van der Heijde-modified total Sharp score.