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Randomized Controlled Trial
. 2017 Oct;177(4):1033-1042.
doi: 10.1111/bjd.15706. Epub 2017 Sep 4.

Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study

R Bissonnette  1 , T Luger  2 , D Thaçi  3 , D Toth  4 , I Messina  5 , R You  6 , A Guana  5 , T Fox  7 , C Papavassilis  7 , I Gilloteau  7 , U Mrowietz  8
Affiliations
Randomized Controlled Trial

Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study

R Bissonnette et al. Br J Dermatol. 2017 Oct.

Abstract

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 evaluate psoriasis therapies fully.

Objectives: To determine the long-term (3-year) efficacy and safety of secukinumab in moderate-to-severe psoriasis.

Methods: Patients 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regimens included a fixed-interval schedule (FI; every 4 weeks) and retreatment as needed (RAN), in which patients were withdrawn from secukinumab and received placebo until the start of relapse, at which time secukinumab every 4 weeks was reinitiated. The study was registered with number NCT01640951.

Results: In total 168 patients receiving secukinumab 300 mg FI and 172 receiving secukinumab 300 mg RAN entered the extension. Secukinumab 300 mg FI sustained high efficacy: at the end of year 3, the proportion of responders achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90) was 63·8%, and of PASI 100 responders it was 42·6%. The mean absolute PASI remained low (2-4) from week 52 to week 152 with 300 mg FI, with approximately two-thirds of patients reporting no impact of skin disease on their lives (Dermatology Life Quality Index of 0 or 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.

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