Original article
Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept

https://doi.org/10.1016/j.jaad.2016.11.043Get rights and content

Background

Psoriasis is a chronic condition with negative impact on patients' quality of life that most often requires lifelong effective and safe treatment.

Objective

This analysis focused on the effect of secukinumab treatment on patient-reported health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis.

Methods

The proportion of subjects achieving DLQI score 0/1 response at week 24, time to DLQI score 0/1 response, and sustained DLQI score 0/1 response up to week 52 were compared between secukinumab and etanercept.

Results

Of 1470 subjects, 1144 received secukinumab and 326 received etanercept. DLQI score 0/1 response rates were significantly higher for secukinumab than for etanercept at week 24. The median time to DLQI score 0/1 response was significantly shorter for secukinumab versus etanercept (12 vs 24 weeks; P < .01). The majority of secukinumab-treated subjects achieved DLQI score 0/1 response at week 24 and sustained it through week 52 along with a 90% to 100% reduction in the Psoriasis Area and Severity Index total score response.

Limitations

Placebo comparisons are limited during the maintenance period because of rerandomization at week 12.

Conclusion

Secukinumab treatment provided faster and greater sustained improvements in quality of life than etanercept over 52 weeks, consistent with greater clinical response.

Section snippets

Clinical trials

Patient enrollment criteria and study design for the 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter phase III trials (ERASURE and FIXTURE) have been described in detail.15 The trials were conducted between June 2011 and July 2013 and were designed to assess the efficacy and safety of subcutaneous secukinumab in subjects with moderate to severe chronic plaque psoriasis. There were 4 periods: screening (1-4 weeks), induction (12 weeks), maintenance (40 weeks), and

Results

Of the 2042 patients randomized to both studies, 1470 (72%) received active treatment (secukinumab 300 mg, 572; secukinumab 150 mg, 572; etanercept, 326; and placebo, 572). The baseline demographic and clinical characteristics were similar across treatment groups (Table I). The subjects were predominantly male, and the mean age of subjects ranged from 42.9 to 44.8 years (secukinumab 300 mg, 44.5 years; secukinumab 150 mg, 44.8 years; etanercept, 42.9 years; and placebo, 44.8 years). Mean PASI

Discussion

This study assessed the speed and sustainability of secukinumab's treatment benefit on patient-reported health-related QOL as assessed by the DLQI score 0/1 response. Psoriasis therapies, especially therapies with newer modes of action such as secukinumab, should be evaluated for both short-term (eg, primary end points usually planned for 12-16 weeks) and long-term (≥52 weeks) efficacy given patients must remain on therapeutics indefinitely for the management of this chronic incurable

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    • Supported by Novartis Pharmaceuticals.

    Disclosure: Dr Strober has served as part of the speakers' bureau for AbbVie; as a consultant for AbbVie, Amgen, Celgene, Dermira, Janssen, LEO Pharma, Lilly, Maruho, Medac, Merck, Novartis, Pfizer, Stiefel/GlaxoSmithKline, and UCB; as an investigator for AbbVie, Amgen, Novartis, Lilly, Janssen, and Merck; and as a scientific director for Corrona Psoriasis Registry; and receives grant support through the University of Connecticut from AbbVie and Janssen. Dr Gottlieb has consulted or served on advisory boards for Amgen Inc, Astellas, Akros, Centocor (Janssen) Inc, Celgene Corp, Bristol Myers Squibb Co, Beiersdorf Inc, Abbott Labs (Abbvie), TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor Ltd, Incyte, Pfizer, Canfite, Lilly, Coronado, Vertex, Karyopharm, CSL Behring Biotherapies for Life, Glaxo Smith Kline, Xenoport, Catabasis, Meiji Seika Pharma Co Ltd, Takeda, Mitsubishi Tanabe Pharma Development America Inc, Genentech, and Baxalta; and participated in research/educational grants for Centocor (Janssen), Amgen, Abbott (Abbvie), Novartis, Celgene, Pfizer, Lilly, Coronado, Levia, Merck, Xenoport, Dermira, and Baxalta. Ms Sherif, Dr McLeod, and Ms Mordin are full-time employees of RTI Health Solutions. Drs Fox and Papavassilis and Ms Gilloteau are full-time employees of Novartis. Dr Mollon and Mr Gnanasakthy were full-time employees of Novartis. Dr Lebwohl is an employee of the Mount Sinai Medical Center, which receives research funds from AbGenomics, AbbVie, Amgen, Anacor, Aqua, Canfite Biopharma, Celgene, Clinuvel, Coronado Biosciences, Ferndale, Lilly, Janssen Biotech, LEO Pharma, Merz, Novartis, Pfizer, Sandoz, Sun Pharmaceuticals, and Valeant.

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    © 2016 by the American Academy of Dermatology, Inc.