Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials

Langley, Richard; Elewski, Boni E.; Lebwohl, Mark; Reich, Kristian; Griffiths, C.E.M.; Papp, Kim; Puig, Lluís; Nakagawa, Hidemi; Spelman, Lynda; Sigurgeirsson, Bárður; Rivas, Enrique; Tsai, Tsen‐Fang; Wasel, Norman; Tyring, Stephen K.; Salko, Thomas; Hampele, Isabelle; Notter, Marianne; Karpov, Alexei S.; Helou, Silvia; Papavassilis, Charis

doi:10.1056/nejmoa1314258

Cited by 1,712 publications

(1,873 citation statements)

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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%

“…The primary end‐point of PASI 75 at week 16 was achieved by 82.4% of patients receiving secukinumab. This response rate was highly comparable with the results of a previous pivotal phase III study (ERASURE),12 in which the PASI 75 response with secukinumab 300 mg in Japanese patients was 82.8% at week 16 26. More stringent treatment goals of PASI 90 and PASI 100 responses were achieved by 64.7% and 29.4% of patients, respectively, at week 16.…”

Section: Discussionsupporting

confidence: 86%

“…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: Discussionsupporting

confidence: 86%

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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“…Similarly, in the phase 3 ERASURE and FIXTURE studies of the IL‐17A antibody, secukinumab, 12.5–29.3% of patients had psoriasis that was poorly controlled with previous a biologic therapy (anti‐TNFα or ustekinumab), with up to 7.6% of patients experiencing no response to previous anti‐TNFα therapy 15. In these studies, PASI 75 response rates at week 12 ranged from 67.0% to 81.6%, supporting the efficacy of IL‐17 inhibition in patients with moderate‐to‐severe psoriasis, including those who failed on previous biologics 15. Taken together, data from ustekinumab and secukinumab studies indicate that switching to a biologic that acts independently from TNFα can result in significant and dramatic improvements in both biologic‐naïve patients and in those who failed to respond to one or more previous biologic agents.…”

Section: Published Literature Evaluating Switching Psoriasis Treatmentsmentioning

confidence: 99%

An evolution in switching therapy for psoriasis patients who fail to meet treatment goals

Kerdel

Zaiac

2015

Dermatologic Therapy

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Switching psoriasis treatment is a common, accepted practice that is used to improve disease management and improve patient outcomes (e.g., when patients are experiencing suboptimal efficacy and/or tolerability with a given therapy). Historically, switching treatment was often performed to limit patients’ cumulative exposure to conventional systemic agents (e.g., methotrexate, cyclosporine) with the goal of reducing end‐organ toxicity. However, the practice of switching treatments has evolved in recent years with the availability of highly effective and tolerable biologic agents. In current practice, near‐complete skin clearance with minimal side effects should be a realistic treatment goal for most patients with moderate‐to‐severe psoriasis, and consideration for switching therapies has shifted to become more focused on achieving maximum possible skin clearance, enhanced quality of life, and improved patient satisfaction. This review provides a discussion of recent guidance on switching psoriasis therapies, including initial considerations for when switching therapy may be advisable and challenges associated with switching therapy, along with an overview of published clinical studies evaluating outcomes associated with switching therapy. The goal of this review is to empower dermatologists to optimally manage their patients’ psoriasis by providing the tools needed to develop rational strategies for switching treatments based on the pharmacologic characteristics of available treatments and each patient's clinical needs and treatment preferences.

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“…In the pivotal phase 3 trials, secukinumab achieved significantly greater improvements on skin‐related quality of life as measured by the Dermatology Life Quality Index (DLQI), including aspects related to sexual difficulty and clothing worn, when compared to both placebo and etanercept 22, 26. The impact of secukinumab vs. ustekinumab on daily activities and personal relationships has not be investigated.…”

Section: Introductionmentioning

confidence: 99%

Secukinumab demonstrates greater sustained improvements in daily activities and personal relationships than ustekinumab in patients with moderate‐to‐severe plaque psoriasis: 52‐week results from the CLEAR study

Blauvelt

Reich

Mehlis

et al. 2017

Acad Dermatol Venereol

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BackgroundPsoriasis can greatly impact patients’ lives by influencing clothing worn as well as by impairing sexual functioning. Secukinumab, a human monoclonal antibody selectively neutralizing interleukin‐17A, has demonstrated good efficacy and safety in the treatment of moderate‐to‐severe psoriasis and psoriatic arthritis with a rapid onset of action and sustained response.ObjectiveThis analysis using the CLEAR study, a phase 3b double‐blind study comparing the efficacy and safety of secukinumab vs. ustekinumab in adults with moderate‐to‐severe plaque psoriasis, evaluated the treatment effects on patient's daily activities and personal relationships.MethodsImpact on daily activities (interference with home/shopping/garden, and influence on clothes worn) and impact on personal relationships (problems with partner/others, and sexual difficulties) as well as their corresponding subscales were selected from the Dermatology Life Quality Index scale and evaluated for patients treated with secukinumab vs. ustekinumab from the CLEAR study. Treatment differences in mean scores and proportions of responders (score = 0, indicating no impact) were evaluated through 52 weeks. Time to response was evaluated through Week 16.ResultsSignificant differences between secukinumab and ustekinumab were observed for daily activities and personal relationships at Week 16 and sustained through Week 52 (Week 52 response rates for daily activities: 82.9% vs. 73.5%, including interference with home/shopping/garden: 88.5% vs. 78.2%, and influence on clothes worn: 85.6% vs. 74.4%; personal relationships: 86.1% vs. 73.7%, including problems with partner/others: 86.6% vs. 74.8%, and sexual difficulties: 88.5% vs. 74.3%; all P < 0.01). The median time to response was 4 weeks for secukinumab vs. 8 weeks for ustekinumab for daily activities and personal relationships (both P < 0.05).ConclusionSecukinumab treatment helps patients with moderate‐to‐severe plaque psoriasis have a more normal life faster when compared to ustekinumab, by providing greater and sustained improvement in clothing choice and sexual functioning.

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Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials

Abstract: Secukinumab was effective for psoriasis in two randomized trials, validating interleukin-17A as a therapeutic target. (Funded by Novartis Pharmaceuticals; ERASURE and FIXTURE ClinicalTrials.gov numbers, NCT01365455 and NCT01358578, respectively.).

Cited by 1,712 publications

References 24 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

An evolution in switching therapy for psoriasis patients who fail to meet treatment goals

Secukinumab demonstrates greater sustained improvements in daily activities and personal relationships than ustekinumab in patients with moderate‐to‐severe plaque psoriasis: 52‐week results from the CLEAR study

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