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. 2018 Mar 17;77(6):890–897. doi: 10.1136/annrheumdis-2017-212687

Table 2.

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

Secukinumab 300 mg with LD
(n=222)
Secukinumab 150 mg with LD
(n=220)
Secukinumab
150 mg without LD (n=222)
Placebo
(n=332)
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* 41.9 35.4
 Dactylitis resolution (%)¶ 65.9* 57.5* 56.3 32.3

*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.