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Br J Dermatol. 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.

Author information

1
Innovaderm Research Inc, Montréal, QC, Canada.
2
Department of Dermatology, University of Münster, Münster, Germany.
3
Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany.
4
XLR8 Medical Research, Windsor, ON, Canada.
5
Novartis Pharmaceuticals, East Hanover, NJ, U.S.A.
6
Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China.
7
Novartis Pharma AG, Basel, Switzerland.
8
Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.

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included a fixed-interval schedule (FI; every 4 weeks) and retreatment as needed (RAN), in which patients were withdrawn from secukinumab and received placebo until the start of relapse, at which time secukinumab every 4 weeks was reinitiated.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

PMID:
28580579
DOI:
10.1111/bjd.15706
[Indexed for MEDLINE]

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