Secukinumab in psoriasis: randomized, controlled phase 3 trial results assessing the potential to improve treatment response in partial responders (STATURE)

Thaçi, Diamant; Humeniuk, John M.; Frambach, Yvonne; Bissonnette, Robert; Goodman, Joseph; Shevade, S; Gong, Yankun; Papavassilis, Charis

doi:10.1111/bjd.13814

Cited by 71 publications

(52 citation statements)

References 41 publications

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“…In agreement with the concept, the present direct switch study showed no new or unexpected safety signals during the 16‐week treatment, with a safety profile consistent with that reported in the pivotal secukinumab phase III trials 12, 14, 16, 17. It is noteworthy that the incidence of AE during the 4‐week induction period was lower (29.4%) than that of the 16‐week entire study period (70.6%), suggesting a smooth switch to secukinumab without major safety concerns.…”

Section: Discussionsupporting

confidence: 90%

“…Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL‐17A, has been shown to have a significant efficacy in the treatment of moderate‐to‐severe psoriasis11, 12, 13, 14 and psoriatic arthritis,15, 16, 17 showing a rapid onset of action and sustained responses with a favorable safety profile. Secukinumab has been approved for the treatment of multiple indications, such as moderate‐to‐severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis in USA and Europe 15, 17, 18.…”

Section: Introductionmentioning

confidence: 99%

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Secukinumab improves psoriasis symptoms in patients with inadequate response to cyclosporine A: A prospective study to evaluate direct switch

Ohtsuki

Morita

Igarashi

et al. 2017

The Journal of Dermatology

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There are limited data on the safety and efficacy of switching to secukinumab from cyclosporine A (CyA) in patients with psoriasis. The purpose of the present study was to assess the efficacy and safety of secukinumab for 16 weeks after direct switching from CyA in patients with moderate‐to‐severe psoriasis. In this multicenter, open‐label, phase IV study, 34 patients with moderate‐to‐severe psoriasis and inadequate response to CyA received secukinumab 300 mg s.c. at baseline and weeks 1, 2, 3, 4, 8 and 12. The primary end‐point was ≥75% improvement from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 16. The efficacy of secukinumab treatment was evaluated up to week 16, and adverse events (AE) were monitored during the study. The primary end‐point of the PASI 75 response at week 16 was achieved by 82.4% (n = 28) of patients receiving secukinumab. Early improvements were observed with secukinumab, with PASI 50 response of 41.2% at week 2 and PASI 75 response of 44.1% at week 4. AE were observed in 70.6% (n = 24) of patients, and there were no serious AE or deaths reported in the entire study period. Secukinumab showed a favorable safety profile consistent with previous data with no new or unexpected safety signals. The results of the present study show that secukinumab is effective in patients with psoriasis enabling a smooth and safe direct switch from CyA to biological therapy.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Secukinumab improves psoriasis symptoms in patients with inadequate response to cyclosporine A: A prospective study to evaluate direct switch

Ohtsuki

Morita

Igarashi

et al. 2017

The Journal of Dermatology

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“…In a pooled safety analysis of 10 studies (4 Phase II and 6 Phase III; Table 1) [8][9][10][11][12]14,[21][22][23], secukinumab demonstrated a favorable safety profile in patients with moderate-to-severe plaque psoriasis over a total follow-up period of 52 weeks [15]. Exclusion criteria were similar across all 10 studies.…”

Section: General Overview Of Safetymentioning

confidence: 99%

“…Its therapeutic efficacy was first demonstrated in a proof-of-concept study in patients with chronic plaque-type psoriasis [7]. Subsequently, secukinumab has been studied in patients with moderate-to-severe plaque psoriasis in a number of Phase II and Phase III clinical trials [8][9][10][11][12][13][14]. In 2015, secukinumab was approved for the treatment of adult patients with moderate-tosevere plaque psoriasis in the United States (US) who are candidates for systemic therapy or phototherapy and also in the European Union as a first-line systemic agent.…”

Section: Introductionmentioning

confidence: 99%

Safety of secukinumab in the treatment of psoriasis

Blauvelt

2016

Expert Opinion on Drug Safety

109

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Introduction: Secukinumab is a human monoclonal antibody that selectively targets and neutralizes interleukin (IL)-17A, a cytokine that is normally involved in mucocutaneous defense against extracellular organisms and is abnormally expressed in psoriasis. In 2015, secukinumab was the first IL-17A inhibitor approved for the treatment of moderate-to-severe psoriasis. Areas covered: This review evaluates the safety profile of secukinumab for the treatment of moderateto-severe psoriasis and its role in the clinical landscape. A literature search was performed for articles published through February 2016; additional data from a pooled safety analysis of 10 Phase II and III secukinumab studies were reviewed. Expert opinion: Collectively, these studies show that secukinumab demonstrates a highly favorable safety profile, especially compared with commonly used psoriasis treatments such as methotrexate and TNF-α blockers. More specifically, secukinumab carries no increased risks for end-organ toxicities, serious infection, multiple sclerosis, reactivation of latent tuberculosis or hepatitis B, leukemia/lymphoma, and nonmelanoma skin cancer. Mucocutaneous candidiasis is a common side effect and occurs at a rate of 3.55/100 subject-years with secukinumab 300 mg, yet these infections usually do not interfere with maintenance of secukinumab therapy. The combination of proven efficacy and safety make secukinumab an excellent new treatment choice for individuals with moderate-to-severe psoriasis.ARTICLE HISTORY

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“…Partial responders to secukinumab treatment may achieve an improved response with continued treatment [30]. Partial responders (PASI 50 but not PASI 75 response) at 12 weeks in the SCULPTURE study (n = 43) were enrolled in the STATURE trial, where they were randomized to treatment with subcutaneous secukinumab 300 mg (weeks 0 and 4) or intravenous secukinumab 10 mg/kg (weeks 0, 2 and 4).…”

Section: Longer-term Treatmentmentioning

confidence: 99%

Secukinumab: A Review in Moderate to Severe Plaque Psoriasis

Garnock-Jones

2015

Am J Clin Dermatol

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Secukinumab (Cosentyx™) is a fully human monoclonal immunoglobulin G1κ antibody targeting human interleukin-17A, an important cytokine in the pathogenesis of psoriasis. Secukinumab, as well as being first in its drug class, is the first biologic treatment to be approved in the EU for the first-line systemic treatment of moderate to severe plaque psoriasis. This article reviews the pharmacologic properties of secukinumab and its clinical efficacy and tolerability in adult patients with moderate to severe plaque psoriasis. In clinical trials, subcutaneous secukinumab was more effective than placebo, etanercept and ustekinumab at improving both psoriasis symptoms (with high skin clearance) and health-related quality of life. Moreover, secukinumab was more effective than placebo in the difficult-to-treat palmoplantar and nail psoriasis populations. Secukinumab was generally well tolerated, with low immunogenicity. Longer-term, efficacy was sustained and secukinumab remained well tolerated. Subcutaneous secukinumab is an effective and generally well tolerated first-line treatment for moderate to severe plaque psoriasis, and is a useful addition to the treatment options for this disease.

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Secukinumab in psoriasis: randomized, controlled phase 3 trial results assessing the potential to improve treatment response in partial responders (STATURE)

Cited by 71 publications

References 41 publications

Secukinumab improves psoriasis symptoms in patients with inadequate response to cyclosporine A: A prospective study to evaluate direct switch

Secukinumab improves psoriasis symptoms in patients with inadequate response to cyclosporine A: A prospective study to evaluate direct switch

Safety of secukinumab in the treatment of psoriasis

Secukinumab: A Review in Moderate to Severe Plaque Psoriasis

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