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PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis
INTRODUCTION: Randomised clinical studies in psoriatic arthritis (PsA) do not always reflect patients in routine clinical practice. Large-scale data from routine practice are needed to better understand drug persistence, effectiveness and long-term safety of therapeutic agents. METHODS: PsABIOnd is...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10011238/ https://www.ncbi.nlm.nih.gov/pubmed/36585602 http://dx.doi.org/10.1007/s40744-022-00518-w |
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author | Siebert, Stefan Behrens, Frank Lubrano, Ennio Martin, Nicolas Sharaf, Mohamed Contré, Christine Theander, Elke Queiro, Rubén Zimmermann, Miriam Gossec, Laure |
author_facet | Siebert, Stefan Behrens, Frank Lubrano, Ennio Martin, Nicolas Sharaf, Mohamed Contré, Christine Theander, Elke Queiro, Rubén Zimmermann, Miriam Gossec, Laure |
author_sort | Siebert, Stefan |
collection | PubMed |
description | INTRODUCTION: Randomised clinical studies in psoriatic arthritis (PsA) do not always reflect patients in routine clinical practice. Large-scale data from routine practice are needed to better understand drug persistence, effectiveness and long-term safety of therapeutic agents. METHODS: PsABIOnd is an international, prospective, observational study designed to collect long-term routine care data in patients with PsA who receive guselkumab (an interleukin-23 [IL-23] inhibitor) or an interleukin-17 (IL-17) inhibitor. Adult patients (≥ 18 years) with a confirmed diagnosis of PsA who are starting guselkumab or any approved IL-17 inhibitor as a first, second, third or fourth line of PsA treatment and who provide written informed consent will be eligible to participate. Participants will be followed for a maximum of 36 months (+3 months) from the start of treatment. Study visits will occur in line with the standard of care, approximately every 6 months, plus an additional visit at 3 months after the start of treatment. eDaily by PsABIOnd - aneHealth substudy, will document the impact of these treatments on wellbeing and symptoms in a subgroup of participants over a 24-week (+4 weeks) observation period on treatment. PLANNED OUTCOMES: The primary objective of PsABIOnd is to evaluate treatment persistence with guselkumab and IL-17 inhibitors. Data sources will include validated electronic patient-reported outcomes (ePROs) and physician-completed assessments. Safety data will be collected through reporting adverse events. The eDaily by PsABIOnd substudy will use wearable and digital technologies for continuous activity and sleep monitoring, and frequent patient eDiary and ePRO collection to provide a more detailed and comprehensive picture of PsA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05049798. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-022-00518-w. |
format | Online Article Text |
id | pubmed-10011238 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-100112382023-03-15 PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis Siebert, Stefan Behrens, Frank Lubrano, Ennio Martin, Nicolas Sharaf, Mohamed Contré, Christine Theander, Elke Queiro, Rubén Zimmermann, Miriam Gossec, Laure Rheumatol Ther Study Protocol INTRODUCTION: Randomised clinical studies in psoriatic arthritis (PsA) do not always reflect patients in routine clinical practice. Large-scale data from routine practice are needed to better understand drug persistence, effectiveness and long-term safety of therapeutic agents. METHODS: PsABIOnd is an international, prospective, observational study designed to collect long-term routine care data in patients with PsA who receive guselkumab (an interleukin-23 [IL-23] inhibitor) or an interleukin-17 (IL-17) inhibitor. Adult patients (≥ 18 years) with a confirmed diagnosis of PsA who are starting guselkumab or any approved IL-17 inhibitor as a first, second, third or fourth line of PsA treatment and who provide written informed consent will be eligible to participate. Participants will be followed for a maximum of 36 months (+3 months) from the start of treatment. Study visits will occur in line with the standard of care, approximately every 6 months, plus an additional visit at 3 months after the start of treatment. eDaily by PsABIOnd - aneHealth substudy, will document the impact of these treatments on wellbeing and symptoms in a subgroup of participants over a 24-week (+4 weeks) observation period on treatment. PLANNED OUTCOMES: The primary objective of PsABIOnd is to evaluate treatment persistence with guselkumab and IL-17 inhibitors. Data sources will include validated electronic patient-reported outcomes (ePROs) and physician-completed assessments. Safety data will be collected through reporting adverse events. The eDaily by PsABIOnd substudy will use wearable and digital technologies for continuous activity and sleep monitoring, and frequent patient eDiary and ePRO collection to provide a more detailed and comprehensive picture of PsA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05049798. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-022-00518-w. Springer Healthcare 2022-12-30 /pmc/articles/PMC10011238/ /pubmed/36585602 http://dx.doi.org/10.1007/s40744-022-00518-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis 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 | Study Protocol Siebert, Stefan Behrens, Frank Lubrano, Ennio Martin, Nicolas Sharaf, Mohamed Contré, Christine Theander, Elke Queiro, Rubén Zimmermann, Miriam Gossec, Laure PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis |
title | PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis |
title_full | PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis |
title_fullStr | PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis |
title_full_unstemmed | PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis |
title_short | PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis |
title_sort | psabiond study and edaily substudy design: long-term effectiveness and safety of guselkumab and il-17 inhibitors in routine clinical practice in patients with psoriatic arthritis |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10011238/ https://www.ncbi.nlm.nih.gov/pubmed/36585602 http://dx.doi.org/10.1007/s40744-022-00518-w |
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