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Living FRIendly Summaries of the Body of Evidence using Epistemonikos (FRISBEE)
Medwave 2018;18(7):e7363 doi: 10.5867/medwave.2018.07.7363
Secukinumab for plaque psoriasis
Gonzalo Ordenes-Cavieres, Romina Andino-Navarrete
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Key Words: Plaque psoriasis, biological treatments, secukinumab, Epistemonikos, GRADE.

Abstract

INTRODUCTION
Biological treatments have appeared as the main alternative for the management of patients with plaque psoriasis that do not respond to conventional treatment. So, evaluating its actual efficacy and safety is needed.

METHODS
We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach.

RESULTS AND CONCLUSIONS
We identified 21 systematic reviews including ten studies overall, of which all were randomized trials. We concluded secukinumab achieves clinical improvement in patients with plaque psoriasis, although it is probably associated with serious adverse effects.


 
Problem

Approximately 20% of patients with plaque psoriasis have moderate to severe disease [1], requiring conventional systemic treatment, such as methotrexate, cyclosporine or acitretin, or phototherapy. However, for a large number of patients, these treatments are not sufficient, due to a limited therapeutic effect or to the presence of adverse effects.
In the search for more effective and safe treatments, biological therapies have emerged in the last years as an alternative. Secukinumab is a human monoclonal antibody that selectively neutralizes interleukin-17A, which has a major role in the pathogenesis of psoriasis. We aimed to evaluate the efficacy and safety of secukinumab in patients with plaque psoriasis.

Methods

We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others, to identify systematic reviews and their included primary studies. We extracted data from the identified reviews and reanalyzed data from primary studies included in those reviews. With this information, we generated a structured summary denominated FRISBEE (Friendly Summary of Body of Evidence using Epistemonikos) using a pre-established format, which includes key messages, a summary of the body of evidence (presented as an evidence matrix in Epistemonikos), meta-analysis of the total of studies when it is possible, a summary of findings table following the GRADE approach and a table of other considerations for decision-making.

Key messages

  • Secukinumab leads to clinical improvement in moderate to severe plaque psoriasis.
  • Secukinumab probably is associated to an increase in serious adverse events.
About the body of evidence for this question

What is the evidence.
See evidence matrix in Epistemonikos later

We found 21 systematic reviews [2], [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19], [20], [21], [22] that included ten primary studies, reported in 23 references [23], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39], [40], [41], [42], [43], [44], [45], all corresponding to randomized controlled trials. However, four of these trials were excluded from our analysis: two because the intervention was not administered in usual doses [27], [39] and two because no comparison was made against placebo [32], [33], [34], [44], [45].

This table and the summary in general are based on the six randomized trials that answer the question of interest [23], [28], [31], [35], [37], [40].

What types of patients were included*

All trials included adult patients older than 18 years with plaque psoriasis on the trunk, upper and lower limbs, not including scalp, with moderate to severe disease determined by PASI ≥ 12, IGA 3-4, BSA ≥ 10%, without response to topical treatment, phototherapy or conventional systemic treatment.

All trials excluded immunosuppressed patients, with a history of neoplasia or suffering an infection.

Two trials [23], [37] excluded patients who had received biological treatment with anti-interleukin-17.

What types of interventions were included*

Four trials [23], [28], [31], [37] included subcutaneous secukinumab 150 mg or 300 mg weekly for four weeks and then in monthly doses. One trial [35] included an intervention group with subcutaneous secukinumab 150 mg at weeks 0,4 and 8. Another trial [40] included three intervention groups: subcutaneous secukinumab 150 mg in single dose; subcutaneous secukinumab 150 mg at weeks 0,4 and 8; and subcutaneous secukinumab 150 mg at weeks 0, 1, 2 and 4.

All trials compared against placebo.

What types of outcomes
were measured

The trials evaluated multiple outcomes, which were grouped in the systematic reviews as follows:

  • PASI (Psoriasis Area Severity Index): PASI 50, PASI 75, PASI 90, PASI 100
  • IGA (Investigator's Global Assessment); PGA (Physician Global Assessment)
  • DLQI (Dermatology Quality of Life Index)
  • Adverse events (headache, pruritus, nausea)
  • Cardiovascular disease
  • Infections (upper respiratory tract infection, Candida infection, Herpes viral infection, reactivation of latent tuberculosis)
  • Neutropenia
  • Neoplasms
  • Crohn's disease
  • Discontinuation
The average follow-up of the trials was 45 weeks, with a range between 28 and 52 weeks

* The information about primary studies is extracted from the systematic reviews identified, unless otherwise specified.

Summary of findings

The information about the effects of secukinumab is based on six randomized trials including 2531 patients [23], [28], [31], [35], [37], [40].
All trials reported PASI 75 and PGA/IGA (2531 patients) [23], [28], [31], [35], [37], [40]. Five trials reported PASI 90 and serious adverse events (2482 patients) [23], [28], [31], [37], [40]. Two trials reported DLQI (1708 patients) [28], [31].

The summary of findings is as follows: 

  • Secukinumab leads to an improvement in PASI 75 and PASI 90 score in patients with moderate to severe plaque psoriasis. The certainty of the evidence is high.
  • Secukinumab leads to an improvement in PGA/IGA score in patients with moderate to severe plaque psoriasis. The certainty of the evidence is high.
  • Secukinumab probably leads to an improvement in DLQI score in patients with moderate to severe plaque psoriasis. The certainty of the evidence is moderate.
  • Secukinumab probably leads to an increase in serious adverse events in patients with moderate to severe plaque psoriasis. The certainty of the evidence is moderate.

Follow the link to access the interactive version of this table (Interactive Summary of Findings – iSoF)

Other considerations for decision-making

To whom this evidence does and does not apply

  • The evidence presented in this summary apply to patients with a diagnosis of plaque psoriasis of the trunk, upper and lower limbs, with moderate to severe disease, non-responders to topical treatment, phototherapy, or conventional systemic treatment.
  • Although the trials did not evaluate children and adolescents, in the absence of direct evidence, it is reasonable to extrapolate these results to those who meet all other characteristics evaluated in the trials.
  • These results do not apply to the group of patients with psoriasis of the scalp or nails, who generally show a different response to treatment.
About the outcomes included in this summary
  • The outcomes analyzed in the summary of findings table are those considered critical for decision-making by the authors of this summary. They generally agree with those presented in the systematic reviews identified and in the main guidelines.
  • PASI 75, PASI 90 and PGA/IGA were selected, since they are clinical scores that correlate with severity or disease improvement.
  • Quality of life was measured using DLQI score (Dermatology Life Quality Index), a critical outcome that allows to know the direct impact of treatment with secukinumab in the life of patients with plaque psoriasis.
  • Serious adverse events were considered as they are key for decision-making. For serious adverse events, the definition of ICH (International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) was used, which includes deaths, life-threatening events, hospital admission or prolongation of hospitalization, and adverse events that require intervention to prevent harm or permanent deterioration.
Balance between benefits and risks, and certainty of the evidence
  • The use of secukinumab has benefits on most outcomes, with clinical improvement that translates into better quality of life for patients. However, it should be kept in mind that there are serious adverse events, mainly cardiac events, infections and neoplasms, which although infrequent, should be considered in clinical practice. It is important to note that all of the primary studies evaluating secukinumab in plaque psoriasis were funded by the pharmaceutical company that developed secukinumab (Novartis Pharmaceuticals).
Resource considerations
  • Biological treatments, and in particular secukinumab, have a cost considerably higher than conventional systemic treatments (e.g. methotrexate, cyclosporine, acitretin), however they have high effectiveness in the management of plaque psoriasis. A cost-effectiveness systematic review of biological treatments (infliximab, etanercept, adalimumab, apremilast, ustekinumab, secukinumab, and ixekizumab) in moderate to severe plaque psoriasis, places secukinumab in third place considering cost-effectiveness, followed closely by adalimumab in second place, both widely overtaken by infliximab [22]
  • A formal economic analysis directly evaluating this intervention might be needed in order to reach more accurate estimations. It is important to adjust for healthcare systems with different levels of resources, considering factors such as the costs associated with disease progression, quality-adjusted life years (QALY) and the possible impact on work disability.
What would patients and their doctors think about this intervention
  • Faced with the evidence presented in this article, most patients and clinicians should be inclined in favor of the use of this intervention, due to its high clinical effectiveness. However, significant variability might be expected, mainly due to the high cost, the increase on serious adverse effects, and the existence of multiple alternative biological treatments, such as infliximab, adalimumab, ixekizumab, among others.

Differences between this summary and other sources

  • The conclusions of this summary agree with those of the systematic reviews that were analyzed.
  • The main guidelines, such as the American Academy of Dermatology [1] and the European Academy of Dermatology and Venereology [46] do not mention secukinumab as an alternative for psoriasis, probably because it is a treatment that was not available at the time of their publication. However, the British Association of Dermatologists [47] in its last update (2017), suggests secukinumab as a first-line biological agent in adults with psoriasis, with or without psoriatic arthritis.
Could this evidence change in the future?
  • The likelihood that future research changes the conclusions of this summary is low, due to the high certainty of the existing evidence.
  • We identified ten ongoing systematic reviews in the International prospective register of systematic reviews (PROSPERO) of the National Institute for Health Research about secukinumab for plaque psoriasis compared against placebo [48], [49], [50], [51], [52], [ 53], [54], [55], [56], [57].
  • We identified two ongoing randomized trials in adult population [58], [59] and one in pediatric and adolescent population [60] in the International Clinical Trials Registry Platform of the World Health Organization.
How we conducted this summary

Using automated and collaborative means, we compiled all the relevant evidence for the question of interest and we present it as a matrix of evidence.

Follow the link to access the interactive version: Secukinumab for plaque psoriasis.

Notes

The upper portion of the matrix of evidence will display a warning of “new evidence” if new systematic reviews are published after the publication of this summary. Even though the project considers the periodical update of these summaries, users are invited to comment in Medwave or to contact the authors through email if they find new evidence and the summary should be updated earlier.

After creating an account in Epistemonikos, users will be able to save the matrixes and to receive automated notifications any time new evidence potentially relevant for the question appears.

This article is part of the Epistemonikos Evidence Synthesis project. It is elaborated with a pre-established methodology, following rigorous methodological standards and internal peer review process. Each of these articles corresponds to a summary, denominated FRISBEE (Friendly Summary of Body of Evidence using Epistemonikos), whose main objective is to synthesize the body of evidence for a specific question, with a friendly format to clinical professionals. Its main resources are based on the evidence matrix of Epistemonikos and analysis of results using GRADE methodology. Further details of the methods for developing this FRISBEE are described here (http://dx.doi.org/10.5867/medwave.2014.06.5997)

Epistemonikos foundation is a non-for-profit organization aiming to bring information closer to health decision-makers with technology. Its main development is Epistemonikos database (www.epistemonikos.org).

Potential conflicts of interest

The authors do not have relevant interests to declare.

Licencia Creative Commons Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

 

INTRODUCCIÓN
Los tratamientos biológicos han aparecido como principal alternativa para el manejo de los pacientes con psoriasis en placa que no responden a tratamiento convencional, resultando necesario evaluar su real efectividad y seguridad.

MÉTODOS
Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE.

RESULTADOS Y CONCLUSIONES
Identificamos 21 revisiones sistemáticas que en conjunto incluyeron diez estudios primarios, todos correspondientes a ensayos aleatorizados. Concluimos que secukinumab logra mejoría clínica en pacientes con psoriasis en placa, aunque probablemente se asocia a efectos adversos graves.

Authors: Gonzalo Ordenes-Cavieres[1,2], Romina Andino-Navarrete[2,3]

Affiliation:
[1] Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
[2] Proyecto Epistemonikos, Santiago, Chile
[3] Departamento de Dermatología, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile

E-mail: rominaandino@gmail.com

Author address:
[1] Centro Evidencia UC
Pontificia Universidad Católica de Chile
Diagonal Paraguay 476
Santiago
Chile

Citation: Ordenes-Cavieres G, Andino-Navarrete R. Secukinumab for plaque psoriasis. Medwave 2018;18(7):e7363 doi: 10.5867/medwave.2018.07.7363

Submission date: 6/11/2018

Acceptance date: 27/11/2018

Publication date: 30/11/2018

Origin: This article is a product of the Evidence Synthesis Project of Epistemonikos Fundation, in collaboration with Medwave for its publication.

Type of review: Non-blinded peer review by members of the methodological team of Epistemonikos Evidence Synthesis Project.

PubMed record

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Rich P, Sigurgeirsson B, Thaci D, Ortonne JP, Paul C, Schopf RE, Morita A, Roseau K, Harfst E, Guettner A, Machacek M, Papavassilis C. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. Br J Dermatol. 2013 Feb;168(2):402-11. | CrossRef | PubMed |

Paul C, Reich K, Gottlieb AB, Mrowietz U, Philipp S, Nakayama J, Harfst E, Guettner A, Papavassilis C; CAIN457A2211 study group. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5. | CrossRef | PubMed |

Augustin M, Abeysinghe S, Mallya U, Qureshi A, Roskell N, McBride D, Papavassillis C, Gelfand J. Secukinumab treatment of plaque psoriasis shows early improvement in DLQI response - results of a phase II regimen-finding trial. J Eur Acad Dermatol Venereol. 2016 Apr;30(4):645-9. | CrossRef | PubMed | PMC |

Novartis Pharmaceuticals. AIN457 regimen finding extension study in patients with moderate to severe psoriasis. clinicaltrials.gov. 2010. | Link |

Thaçi D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. 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 Sep;73(3):400-9. | CrossRef | PubMed |

Blauvelt A, Reich K, Tsai TF, Tyring S, Vanaclocha F, Kingo K, Ziv M, Pinter A, Vender R, Hugot S, You R, Milutinovic M, Thaçi D. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017 Jan;76(1):60-69.e9. | CrossRef | PubMed |

Nast A, Gisondi P, Ormerod AD, Saiag P, Smith C, Spuls PI, Arenberger P, Bachelez H, Barker J, Dauden E, de Jong EM, Feist E, Jacobs A, Jobling R, Kemény L, Maccarone M, Mrowietz U, Papp KA, Paul C, Reich K, Rosumeck S, Talme T, Thio HB, van de Kerkhof P, Werner RN, Yawalkar N. European S3-Guidelines on the systemic treatment of psoriasis vulgaris--Update 2015--Short version--EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2277-94. | CrossRef | PubMed |

Smith CH, Jabbar-Lopez ZK, Yiu ZZ, Bale T, Burden AD, Coates LC, Cruickshank M, Hadoke T, MacMahon E, Murphy R, Nelson-Piercy C, Owen CM, Parslew R, Peleva E, Pottinger E, Samarasekera EJ, Stoddart J, Strudwicke C, Venning VA, Warren RB, Exton LS, Mohd Mustapa MF. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. | CrossRef | PubMed |

Corinna Dressler, Miriam Zidane, Alexander Nast. A systematic review and "time-effectiveness" analysis of psoriasis treatments and different treatment sequences. PROSPERO 2017 CRD42017074218. | Link |

Christine Ballegaard, Tanja Schjødt Jørgensen, Marie Skougaard, Vibeke Strand, Philip J. Mease, Lars E. Kristensen, Lene Dreyer, Alice Gottlieb, Maarten de Wit, Robin Christensen, Simon Tarp. Assessing the importance of trial characteristics as contextual factors when evaluating targeted therapies in patients with psoriatic disease: protocol for an exploratory systematic review and meta-research project. PROSPERO 2016 CRD42016050049. | CrossRef | Link |

Daniel Ollendorf, Reiner Banken, Foluso Agboola, Katherine Fazioli, Celia Segel. Comparative clinical effectiveness of treatment options for moderate-to-severe plaque psoriasis. PROSPERO 2018 CRD42018088801. | Link |

Simon Tarp, Lars Erik Bryld, Lars Iversen, Lone Skov, Sigurd Broesby-Olsen, Birgitte Brock, Camilla Mikkelsen, Lis Andersen, Robin Christensen. Comparative effectiveness associated with the use of biologics and small-molecules for psoriasis: protocol for a systematic review and meta-analysis. PROSPERO 2015 CRD42015029122. | Link |

Catherine Smith, Zarif Jabbar-Lopez, Zenas Yiu, Ellie Samarasekera, M. Firouz Mohd Mustapa, Leslie Exton. In people with psoriasis (all types), what are the clinical effectiveness/efficacy, safety and tolerability of systemic biologics (adalimumab, etanercept, infliximab, secukinumab or ustekinumab) compared with each other, with methotrexate or with placebo?. PROSPERO 2015 CRD42015017538. | Link |

Juan Ruano, Francisco Gómez-García, Beatriz Isla-Tejera, Jesús Gay-Mimbrera, Macarena Aquilar-Luqe, Marcelino González-Padilla, Juan Luis Sanz-Cabanillas, Antonio Vélez García-Nieto. Pharmacogenetics of agents blocking TNF-a, IL-12/23, and IL17/IL17RA for the treatment of moderate-severe psoriasis: a systematic review and meta-analysis. PROSPERO 2016 CRD42016038769. | Link |

Francisco Jose Gomez Garcia, Juan Ruano, Beatriz Isla-Tejera, Marcelino Gonzalez Padilla, Juan Luis Sanz Cabanillas, Antonio Velez Garcia Nieto, Macarena Aguilar Luque, Jesus Gay Mimbrera, Pedro Carmona. Short-, medium- and long-term efficacy and safety of biological drugs for moderate to severe plaque psoriasis: systematic review and network meta-analysis. PROSPERO 2017 CRD42017057642. | Link |

Yayoi Tada, Rei Watanabe, Hisashi Noma. Short-term and long-term effectiveness of biologic agents targeting TNF-a, IL-23, and IL-17 for the treatment of plaque psoriasis: a systematic review and network meta-analysis. PROSPERO 2017 CRD42017063906. | Link |

Sarah Dewilde, Alison Griffiths, Leticia Barcena, Julie Winstone. Systematic review and network meta-analysis of biological agents for the treatment of moderate to severe and very severe psoriasis. PROSPERO 2016 CRD42016052312. | Link |

Rhea Jakubzyk, Dr. Alexander Nast, Corinna Dressler. Systematic review of the efficacy, effectiveness and safety of topical and systemic treatments for psoriasis in patients with hepatitis, diabetes mellitus, renal failure, HIV infection, pregnancy or cancer. PROSPERO 2018 CRD42018087908. | Link |

James G. Krueger, MD, PhD. Safety and Efficacy of Secukinumab in Mild Psoriasis. clinicaltrials.gov. 2017. | Link |

Novartis Pharmaceuticals. Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients ObePso-S. clinicaltrials.gov. 2017. | Link |

Novartis Pharmaceuticals. Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis. clinicaltrials.gov. 2015. | Link |