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Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study.

作者信息

Ohtsuki Mamitaro, Morita Akimichi, Abe Masatoshi, Takahashi Hidetoshi, Seko Noriko, Karpov Alexander, Shima Tomohiro, Papavassilis Charis, Nakagawa Hidemi

机构信息

Jichi Medical University, Shimotsuke, Japan.

出版信息

J Dermatol. 2014 Dec;41(12):1039-46. doi: 10.1111/1346-8138.12668. Epub 2014 Oct 30.


DOI:10.1111/1346-8138.12668
PMID:25354738
Abstract

Secukinumab, a fully human anti-IL-17A monoclonal antibody, neutralizes IL-17A, a key cytokine in the pathogenesis of psoriasis. Efficacy and safety of secukinumab was evaluated in Japanese patients with moderate-to-severe plaque psoriasis as part of a large Phase 3 global study (ERASURE). In this 52-week, double-blind study (ClinicalTrials.gov Identifier: NCT01365455, JapicCTI-111529), 87 patients from Japan (11.8% of 738 patients randomized in the overall study population) were equally randomized to receive secukinumab 300 mg or 150 mg, or placebo once weekly at baseline and at Weeks 1, 2, 3 and 4, then every 4 weeks. Co-primary endpoints (Week 12) were ≥75% improvement in psoriasis area-and-severity index (PASI 75) from baseline and a score of 0 (clear) or 1 (almost clear) on a 5-point Investigator's Global Assessment scale (IGA mod 2011 0/1) versus placebo. PASI 75 and IGA mod 2011 0/1 responses at Week 12 were superior with secukinumab 300 mg (82.8% and 55.2%, respectively) or 150 mg (86.2% and 55.2%, respectively) versus placebo (6.9% and 3.4%, respectively; P < 0.0001 for all). Greater than 90% improvement in PASI (PASI 90) was also superior with secukinumab 300 mg (62.1%) or 150 mg (55.2%) versus placebo (0.0%) at Week 12 (P < 0.0001 for both). Clinical responses were sustained up to Week 52 in the majority of patients. During a 12-week induction period, adverse event incidences were 48.3% with secukinumab 300 mg, 55.2% with 150 mg, and 41.4% with placebo. Secukinumab showed robust and sustainable efficacy in symptom reduction for moderate-to-severe plaque psoriasis in the Japanese patients.

摘要

相似文献

[1]
Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study.

J Dermatol. 2014-12

[2]
Secukinumab in plaque psoriasis--results of two phase 3 trials.

N Engl J Med. 2014-7-9

[3]
Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial.

Lancet. 2019-8-8

[4]
Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study.

Br J Dermatol. 2013-1-18

[5]
Secukinumab Improves Physical Function in Subjects With Plaque Psoriasis and Psoriatic Arthritis: Results from Two Randomized, Phase 3 Trials.

J Drugs Dermatol. 2015-8

[6]
Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE).

J Eur Acad Dermatol Venereol. 2014-9-22

[7]
Secukinumab Self-Administration by Prefilled Syringe Maintains Reduction of Plaque Psoriasis Severity Over 52 Weeks: Results of the FEATURE Trial.

J Drugs Dermatol. 2016-10-1

[8]
Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE).

Br J Dermatol. 2014-12-11

[9]
Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial.

J Am Acad Dermatol. 2015-6-17

[10]
Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial.

J Eur Acad Dermatol Venereol. 2017-5

引用本文的文献

[1]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2025-8-6

[2]
Cardiovascular and Kidney Outcomes After Systemic Treatment for Plaque Psoriasis: A Systematic Review and Network Meta-analysis.

Dermatol Ther (Heidelb). 2025-7-5

[3]
Safety and effectiveness of secukinumab subcutaneous injection in Japanese patients with psoriasis vulgaris and psoriatic arthritis: A post-marketing surveillance.

J Dermatol. 2025-1

[4]
Response to Biologic Therapy in Skin of Colour Participants With Moderate-to-Severe Psoriasis and Atopic Dermatitis: A Systematic Review.

J Cutan Med Surg. 2024

[5]
Effects of secukinumab and ixekizumab on major adverse cardiovascular events in patients with psoriasis: a meta-analysis of randomized controlled trials.

Front Med (Lausanne). 2024-3-6

[6]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2023-7-12

[7]
Adverse events associated with anti-IL-17 agents for psoriasis and psoriatic arthritis: a systematic scoping review.

Front Immunol. 2023

[8]
Efficacy, Safety, and Pharmacoeconomic Analysis of Adalimumab and Secukinumab for Moderate-to-Severe Plaque Psoriasis: A Single-Center, Real-World Study.

Dermatol Ther (Heidelb). 2022-9

[9]
Dermatology: how to manage psoriasis and recognize differences in pathophysiology and presentation in patients with skin of colour.

Drugs Context. 2022-5-31

[10]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2022-5-23

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