Cargando…

Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study

INTRODUCTION: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term c...

Descripción completa

Detalles Bibliográficos
Autores principales: Kiltz, Uta, Sfikakis, Petros P., Gaffney, Karl, Sator, Paul-Gunther, von Kiedrowski, Ralph, Bounas, Andreas, Gullick, Nicola, Conrad, Curdin, Rigopoulos, Dimitris, Lespessailles, Eric, Romanelli, Marco, Ghislain, Pierre-Dominique, Brandt-Jürgens, Jan, Rashkov, Rasho, Aassi, Maher, Orsenigo, Roberto, Perella, Chiara, Pournara, Effie, Gathmann, Sven, Jagiello, Piotr, Veit, Justyna, Augustin, Matthias
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7467439/
https://www.ncbi.nlm.nih.gov/pubmed/32378070
http://dx.doi.org/10.1007/s12325-020-01352-8
_version_ 1783578013495984128
author Kiltz, Uta
Sfikakis, Petros P.
Gaffney, Karl
Sator, Paul-Gunther
von Kiedrowski, Ralph
Bounas, Andreas
Gullick, Nicola
Conrad, Curdin
Rigopoulos, Dimitris
Lespessailles, Eric
Romanelli, Marco
Ghislain, Pierre-Dominique
Brandt-Jürgens, Jan
Rashkov, Rasho
Aassi, Maher
Orsenigo, Roberto
Perella, Chiara
Pournara, Effie
Gathmann, Sven
Jagiello, Piotr
Veit, Justyna
Augustin, Matthias
author_facet Kiltz, Uta
Sfikakis, Petros P.
Gaffney, Karl
Sator, Paul-Gunther
von Kiedrowski, Ralph
Bounas, Andreas
Gullick, Nicola
Conrad, Curdin
Rigopoulos, Dimitris
Lespessailles, Eric
Romanelli, Marco
Ghislain, Pierre-Dominique
Brandt-Jürgens, Jan
Rashkov, Rasho
Aassi, Maher
Orsenigo, Roberto
Perella, Chiara
Pournara, Effie
Gathmann, Sven
Jagiello, Piotr
Veit, Justyna
Augustin, Matthias
author_sort Kiltz, Uta
collection PubMed
description INTRODUCTION: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications. METHODS: SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study. RESULTS: Overall 2800 patients were included in the safety set; patients with PsA (N = 541) were older than patients with PsO (N = 1799) and patients with AS (N = 460); patients with PsO had a higher mean body weight than patients with PsA and patients with AS; and patients with PsO and patients with AS were predominantly male. Time since diagnosis was longer in patients with PsO compared with patients with PsA and patients with AS, and about 40% of patients were either current or former smokers. The proportion of obese patients (body mass index ≥ 30 kg/m(2)) was similar across indications. Patients were treated with secukinumab for a mean duration of 1 year prior to enrolment (range 0.89–1.04). The percentages of patients with prior biologics exposure were 31.5% PsO, 59.7% PsA and 55% AS. The percentages of patients prescribed secukinumab monotherapy were 75% (n = 1349) in PsO, 48.2% (n = 261) in PsA and 48.9% (n = 225) in AS groups. CONCLUSION: Baseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-020-01352-8) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-7467439
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-74674392020-09-11 Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study Kiltz, Uta Sfikakis, Petros P. Gaffney, Karl Sator, Paul-Gunther von Kiedrowski, Ralph Bounas, Andreas Gullick, Nicola Conrad, Curdin Rigopoulos, Dimitris Lespessailles, Eric Romanelli, Marco Ghislain, Pierre-Dominique Brandt-Jürgens, Jan Rashkov, Rasho Aassi, Maher Orsenigo, Roberto Perella, Chiara Pournara, Effie Gathmann, Sven Jagiello, Piotr Veit, Justyna Augustin, Matthias Adv Ther Original Research INTRODUCTION: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications. METHODS: SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study. RESULTS: Overall 2800 patients were included in the safety set; patients with PsA (N = 541) were older than patients with PsO (N = 1799) and patients with AS (N = 460); patients with PsO had a higher mean body weight than patients with PsA and patients with AS; and patients with PsO and patients with AS were predominantly male. Time since diagnosis was longer in patients with PsO compared with patients with PsA and patients with AS, and about 40% of patients were either current or former smokers. The proportion of obese patients (body mass index ≥ 30 kg/m(2)) was similar across indications. Patients were treated with secukinumab for a mean duration of 1 year prior to enrolment (range 0.89–1.04). The percentages of patients with prior biologics exposure were 31.5% PsO, 59.7% PsA and 55% AS. The percentages of patients prescribed secukinumab monotherapy were 75% (n = 1349) in PsO, 48.2% (n = 261) in PsA and 48.9% (n = 225) in AS groups. CONCLUSION: Baseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-020-01352-8) contains supplementary material, which is available to authorized users. Springer Healthcare 2020-05-06 2020 /pmc/articles/PMC7467439/ /pubmed/32378070 http://dx.doi.org/10.1007/s12325-020-01352-8 Text en © The Author(s) 2020 https://creativecommons.org/licenses/by-nc/4.0/This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Kiltz, Uta
Sfikakis, Petros P.
Gaffney, Karl
Sator, Paul-Gunther
von Kiedrowski, Ralph
Bounas, Andreas
Gullick, Nicola
Conrad, Curdin
Rigopoulos, Dimitris
Lespessailles, Eric
Romanelli, Marco
Ghislain, Pierre-Dominique
Brandt-Jürgens, Jan
Rashkov, Rasho
Aassi, Maher
Orsenigo, Roberto
Perella, Chiara
Pournara, Effie
Gathmann, Sven
Jagiello, Piotr
Veit, Justyna
Augustin, Matthias
Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study
title Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study
title_full Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study
title_fullStr Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study
title_full_unstemmed Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study
title_short Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study
title_sort secukinumab use in patients with moderate to severe psoriasis, psoriatic arthritis and ankylosing spondylitis in real-world setting in europe: baseline data from serena study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7467439/
https://www.ncbi.nlm.nih.gov/pubmed/32378070
http://dx.doi.org/10.1007/s12325-020-01352-8
work_keys_str_mv AT kiltzuta secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT sfikakispetrosp secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT gaffneykarl secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT satorpaulgunther secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT vonkiedrowskiralph secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT bounasandreas secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT gullicknicola secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT conradcurdin secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT rigopoulosdimitris secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT lespessailleseric secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT romanellimarco secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT ghislainpierredominique secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT brandtjurgensjan secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT rashkovrasho secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT aassimaher secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT orsenigoroberto secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT perellachiara secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT pournaraeffie secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT gathmannsven secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT jagiellopiotr secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT veitjustyna secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy
AT augustinmatthias secukinumabuseinpatientswithmoderatetoseverepsoriasispsoriaticarthritisandankylosingspondylitisinrealworldsettingineuropebaselinedatafromserenastudy