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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Gespeichert in:

Autor*in:	Theodoros G. Soldatos [verfasserIn] Antonia Dimitrakopoulou-Strauss [verfasserIn] Lionel Larribere [verfasserIn] Jessica C. Hassel [verfasserIn] Christos Sachpekidis [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Schlagwörter:	side effects ipilimumab nivolumab melanoma real world data data mining pharmacoepidemiology proportional reporting ratio

Übergeordnetes Werk:	In: Diagnostics - MDPI AG, 2012, 8(2018), 4, p 76
Übergeordnetes Werk:	volume:8 ; year:2018 ; number:4, p 76

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3390/diagnostics8040076

Katalog-ID:	DOAJ085166669

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language	English
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topic_facet	side effects ipilimumab nivolumab melanoma real world data data mining pharmacoepidemiology proportional reporting ratio Medicine (General)
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container_title	Diagnostics
authorswithroles_txt_mv	Theodoros G. Soldatos @@aut@@ Antonia Dimitrakopoulou-Strauss @@aut@@ Lionel Larribere @@aut@@ Jessica C. Hassel @@aut@@ Christos Sachpekidis @@aut@@
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callnumber-first	R - Medicine
author	Theodoros G. Soldatos
spellingShingle	Theodoros G. Soldatos misc R5-920 misc side effects misc ipilimumab misc nivolumab misc melanoma misc real world data misc data mining misc pharmacoepidemiology misc proportional reporting ratio misc Medicine (General) Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
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topic_title	R5-920 Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data side effects ipilimumab nivolumab melanoma real world data data mining pharmacoepidemiology proportional reporting ratio
topic	misc R5-920 misc side effects misc ipilimumab misc nivolumab misc melanoma misc real world data misc data mining misc pharmacoepidemiology misc proportional reporting ratio misc Medicine (General)
topic_unstemmed	misc R5-920 misc side effects misc ipilimumab misc nivolumab misc melanoma misc real world data misc data mining misc pharmacoepidemiology misc proportional reporting ratio misc Medicine (General)
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title	Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
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title_sort	retrospective side effect profiling of the metastatic melanoma combination therapy ipilimumab-nivolumab using adverse event data
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title_auth	Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
abstract	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.
abstractGer	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.
abstract_unstemmed	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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title_short	Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data
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Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data

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