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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2020
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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 |
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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 |
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