Cargando…

The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity

Immune thrombocytopenia (ITP) treatment has evolved recently. However, none of the treatments have only benefits without drawbacks. This study aimed to compare the clinical outcomes and adverse drug patterns of Eltrombopag, Romiplostim, Prednisolone + Azathioprine, High Dose-dexamethasone (HD-DXM) (...

Descripción completa

Detalles Bibliográficos
Autores principales: Hamed, Eman Mostafa, Ibrahim, Ahmed R. N., Meabed, Mohamed Hussein, Khalaf, Ahmed M., El Demerdash, Doaa Mohamed, Elgendy, Marwa O., Saeed, Haitham, Salem, Heba F., Rabea, Hoda
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10303883/
https://www.ncbi.nlm.nih.gov/pubmed/37375815
http://dx.doi.org/10.3390/ph16060868
_version_ 1785065380355506176
author Hamed, Eman Mostafa
Ibrahim, Ahmed R. N.
Meabed, Mohamed Hussein
Khalaf, Ahmed M.
El Demerdash, Doaa Mohamed
Elgendy, Marwa O.
Saeed, Haitham
Salem, Heba F.
Rabea, Hoda
author_facet Hamed, Eman Mostafa
Ibrahim, Ahmed R. N.
Meabed, Mohamed Hussein
Khalaf, Ahmed M.
El Demerdash, Doaa Mohamed
Elgendy, Marwa O.
Saeed, Haitham
Salem, Heba F.
Rabea, Hoda
author_sort Hamed, Eman Mostafa
collection PubMed
description Immune thrombocytopenia (ITP) treatment has evolved recently. However, none of the treatments have only benefits without drawbacks. This study aimed to compare the clinical outcomes and adverse drug patterns of Eltrombopag, Romiplostim, Prednisolone + Azathioprine, High Dose-dexamethasone (HD-DXM) (control group), and Rituximab in primary ITP Egyptian patients. All patients were initiated with corticosteroids, HD-DXM, as a first-line treatment for the first month immediately following diagnosis. Four hundred sixty-seven ITP patients were randomly assigned to five groups. The outcome measures were judged at baseline, at the end of treatment (6 months), and after an additional 6-month free treatment period. The follow-up period for which relapse is noted was 6 months after the end of treatment. Eltrombopag and Romiplostim resulted in a significantly higher incidence of sustained response than Rituximab, HD-DXM, and Prednisolone + Azathioprine (55.2% and 50.6% vs. 29.2%, 29.1%, and 18%, respectively; p-value < 0.001). More patients on immunomodulators (Prednisolone+ Azathioprine, HD-DXM, and Rituximab) relapsed than those on Romiplostim and Eltrombopag (81.9%, 70.8%, and 70.7% vs. 49.3%, and 44.7%, respectively; p-value < 0.01). We also describe 23 reports of pulmonary hypertension with Prednisolone+ Azathioprine and 13 reports with HD-DXM. The thrombotic events occurred in 16.6% and 13% of patients who received Eltrombopag and Romiplostim treatment, respectively. Most patients had at least one or two risk factors (92.8% of cases). Corticosteroids are effective first-line therapy in primary ITP patients. However, relapse is frequent. Eltrombopag and Romiplostim are safer and more effective than Prednisolone, HD-DXM, and Rituximab. They might be reasonable beneficial options after a one-month HD-DXM regimen.
format Online
Article
Text
id pubmed-10303883
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-103038832023-06-29 The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity Hamed, Eman Mostafa Ibrahim, Ahmed R. N. Meabed, Mohamed Hussein Khalaf, Ahmed M. El Demerdash, Doaa Mohamed Elgendy, Marwa O. Saeed, Haitham Salem, Heba F. Rabea, Hoda Pharmaceuticals (Basel) Article Immune thrombocytopenia (ITP) treatment has evolved recently. However, none of the treatments have only benefits without drawbacks. This study aimed to compare the clinical outcomes and adverse drug patterns of Eltrombopag, Romiplostim, Prednisolone + Azathioprine, High Dose-dexamethasone (HD-DXM) (control group), and Rituximab in primary ITP Egyptian patients. All patients were initiated with corticosteroids, HD-DXM, as a first-line treatment for the first month immediately following diagnosis. Four hundred sixty-seven ITP patients were randomly assigned to five groups. The outcome measures were judged at baseline, at the end of treatment (6 months), and after an additional 6-month free treatment period. The follow-up period for which relapse is noted was 6 months after the end of treatment. Eltrombopag and Romiplostim resulted in a significantly higher incidence of sustained response than Rituximab, HD-DXM, and Prednisolone + Azathioprine (55.2% and 50.6% vs. 29.2%, 29.1%, and 18%, respectively; p-value < 0.001). More patients on immunomodulators (Prednisolone+ Azathioprine, HD-DXM, and Rituximab) relapsed than those on Romiplostim and Eltrombopag (81.9%, 70.8%, and 70.7% vs. 49.3%, and 44.7%, respectively; p-value < 0.01). We also describe 23 reports of pulmonary hypertension with Prednisolone+ Azathioprine and 13 reports with HD-DXM. The thrombotic events occurred in 16.6% and 13% of patients who received Eltrombopag and Romiplostim treatment, respectively. Most patients had at least one or two risk factors (92.8% of cases). Corticosteroids are effective first-line therapy in primary ITP patients. However, relapse is frequent. Eltrombopag and Romiplostim are safer and more effective than Prednisolone, HD-DXM, and Rituximab. They might be reasonable beneficial options after a one-month HD-DXM regimen. MDPI 2023-06-12 /pmc/articles/PMC10303883/ /pubmed/37375815 http://dx.doi.org/10.3390/ph16060868 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/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 (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Hamed, Eman Mostafa
Ibrahim, Ahmed R. N.
Meabed, Mohamed Hussein
Khalaf, Ahmed M.
El Demerdash, Doaa Mohamed
Elgendy, Marwa O.
Saeed, Haitham
Salem, Heba F.
Rabea, Hoda
The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity
title The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity
title_full The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity
title_fullStr The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity
title_full_unstemmed The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity
title_short The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity
title_sort outcomes and adverse drug patterns of immunomodulators and thrombopoietin receptor agonists in primary immune thrombocytopenia egyptian patients with hemorrhage comorbidity
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10303883/
https://www.ncbi.nlm.nih.gov/pubmed/37375815
http://dx.doi.org/10.3390/ph16060868
work_keys_str_mv AT hamedemanmostafa theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT ibrahimahmedrn theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT meabedmohamedhussein theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT khalafahmedm theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT eldemerdashdoaamohamed theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT elgendymarwao theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT saeedhaitham theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT salemhebaf theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT rabeahoda theoutcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT hamedemanmostafa outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT ibrahimahmedrn outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT meabedmohamedhussein outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT khalafahmedm outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT eldemerdashdoaamohamed outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT elgendymarwao outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT saeedhaitham outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT salemhebaf outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity
AT rabeahoda outcomesandadversedrugpatternsofimmunomodulatorsandthrombopoietinreceptoragonistsinprimaryimmunethrombocytopeniaegyptianpatientswithhemorrhagecomorbidity