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Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data

Recent studies suggest that combining nivolumab with ipilimumab is a more effective treatment for melanoma patients, compared to using ipilimumab or nivolumab alone. However, treatment with these immunotherapeutic agents is frequently associated with increased risk of toxicity, and (auto-) immune-re...

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Autores principales: Soldatos, Theodoros G., Dimitrakopoulou-Strauss, Antonia, Larribere, Lionel, Hassel, Jessica C., Sachpekidis, Christos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6316083/
https://www.ncbi.nlm.nih.gov/pubmed/30384507
http://dx.doi.org/10.3390/diagnostics8040076
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author Soldatos, Theodoros G.
Dimitrakopoulou-Strauss, Antonia
Larribere, Lionel
Hassel, Jessica C.
Sachpekidis, Christos
author_facet Soldatos, Theodoros G.
Dimitrakopoulou-Strauss, Antonia
Larribere, Lionel
Hassel, Jessica C.
Sachpekidis, Christos
author_sort Soldatos, Theodoros G.
collection PubMed
description Recent studies suggest that combining nivolumab with ipilimumab is a more effective treatment for melanoma patients, compared to using ipilimumab or nivolumab alone. However, treatment with these immunotherapeutic agents is frequently associated with increased risk of toxicity, and (auto-) immune-related adverse events. The precise pathophysiologic mechanisms of these events are not yet clear, and evidence from clinical trials and translational studies remains limited. Our retrospective analysis of ~7700 metastatic melanoma patients treated with ipilimumab and/or nivolumab from the FDA Adverse Event Reporting System (FAERS) demonstrates that the identified immune-related reactions are specific to ipilimumab and/or nivolumab, and that when the two agents are administered together, their safety profile combines reactions from each drug alone. While more prospective studies are needed to characterize the safety of ipilimumab and nivolumab, the present work constitutes perhaps the first effort to examine the safety of these drugs and their combination based on computational evidence from real world post marketing data.
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spelling pubmed-63160832019-01-11 Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data Soldatos, Theodoros G. Dimitrakopoulou-Strauss, Antonia Larribere, Lionel Hassel, Jessica C. Sachpekidis, Christos Diagnostics (Basel) Article Recent studies suggest that combining nivolumab with ipilimumab is a more effective treatment for melanoma patients, compared to using ipilimumab or nivolumab alone. However, treatment with these immunotherapeutic agents is frequently associated with increased risk of toxicity, and (auto-) immune-related adverse events. The precise pathophysiologic mechanisms of these events are not yet clear, and evidence from clinical trials and translational studies remains limited. Our retrospective analysis of ~7700 metastatic melanoma patients treated with ipilimumab and/or nivolumab from the FDA Adverse Event Reporting System (FAERS) demonstrates that the identified immune-related reactions are specific to ipilimumab and/or nivolumab, and that when the two agents are administered together, their safety profile combines reactions from each drug alone. While more prospective studies are needed to characterize the safety of ipilimumab and nivolumab, the present work constitutes perhaps the first effort to examine the safety of these drugs and their combination based on computational evidence from real world post marketing data. MDPI 2018-10-31 /pmc/articles/PMC6316083/ /pubmed/30384507 http://dx.doi.org/10.3390/diagnostics8040076 Text en © 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Soldatos, Theodoros G.
Dimitrakopoulou-Strauss, Antonia
Larribere, Lionel
Hassel, Jessica C.
Sachpekidis, Christos
Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
title Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
title_full Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
title_fullStr Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
title_full_unstemmed Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
title_short Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
title_sort retrospective side effect profiling of the metastatic melanoma combination therapy ipilimumab-nivolumab using adverse event data
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6316083/
https://www.ncbi.nlm.nih.gov/pubmed/30384507
http://dx.doi.org/10.3390/diagnostics8040076
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