Secukinumab Sustains Good Efficacy and Favourable Safety in Moderate to Severe Psoriasis up to 3 Years of Treatment: Results from A Double-Blind Extension Study

Summary

Background

Secukinumab has demonstrated significant efficacy with a good safety profile through 1 year in plaque psoriasis. Given the chronic nature of this disease, long-term follow-up is needed to fully evaluate psoriasis therapies.

Objectives

Determine long-term (3-year) efficacy/safety of secukinumab in moderate-to-severe psoriasis.

Methods

Subjects completing 52 weeks of secukinumab treatment in the SCULPTURE core study entered an extension in which they continued the same double-blind regimens. Dosing regimens included a fixed-interval schedule (FI; every 4 weeks) and retreatment as needed (RAN), in which subjects were withdrawn from secukinumab and received placebo until start of relapse, at which time secukinumab every 4 weeks was re-initiated.

Results

168 subjects receiving secukinumab 300 mg FI and 172 receiving secukinumab 300 mg RAN entered the extension. Secukinumab 300 mg FI sustained high efficacy: at end of Year 3, the proportion of Psoriasis Area and Severity Index (PASI) 90 responders was 63.8% and PASI 100 responders was 42.6%. Mean absolute PASI remained low (2–4) from Week 52–Week 152 with 300 mg FI, with approximately two-thirds of subjects reporting no impact of skin disease on their lives (Dermatology Life Quality Index of 0/1). Improvements in overall and subscale scores on all quality of life instruments were well sustained. As in the core study, FI dosing was consistently more efficacious than RAN. No new safety signals were identified to Year 3.

Conclusions

Secukinumab 300 mg FI sustained high responses and improved quality of life with no new safety concerns through 3 years. (NCT01640951)

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