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.