Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial
WOS: 000438864700007 PubMed ID: 29772578 Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluat...
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Online Access: | https://hdl.handle.net/11454/31162 https://doi.org/10.1159/000488349 |
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ftunivege:oai:acikerisim.ege.edu.tr:11454/31162 2023-05-15T18:13:54+02:00 Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial Yorgancioglu, Arzu Erkekol, Ferda Oner Mungan, Dilsad Erdinc, Munevver Gemicioglu, Bilun Ozseker, Zeynep Ferhan Degirmenci, Papatya Bayrak Nayci, Sibel Cilli, Aykut Erdenen, Fusun Kirmaz, Cengiz Ediger, Dane Yalcin, Arzu Didem Buyukozturk, Suna Ozturk, Sami Gulec, Mustafa Isik, Sacide Rana Kalyoncu, Ali Fuat Goksel, Ozlem Aydin, Omur Havlucu, Yavuz Ar, Idilhan Baloglu Erdogdu, Ahmet Ege Üniversitesi 2018 https://hdl.handle.net/11454/31162 https://doi.org/10.1159/000488349 eng eng Karger 10.1159/000488349 Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı International Archives of Allergy and Immunology 1018-2438 1423-0097 https://doi.org/10.1159/000488349 https://hdl.handle.net/11454/31162 176 03.Apr info:eu-repo/semantics/closedAccess Anti-IgE Omalizumab Effectiveness Real-life trial Long-term treatment article 2018 ftunivege https://doi.org/10.1159/000488349 2022-05-02T06:39:20Z WOS: 000438864700007 PubMed ID: 29772578 Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. Methods: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. Results: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. Conclusion: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good. (C) 2018 S. Karger AG, Basel Novartis Pharmaceuticals Ltd.; NovartisNovartis The study was sponsored by Novartis Pharmaceuticals Ltd. The sponsor was involved in the design of the study and conducted the analysis according to a detailed analysis agreed by the investigators. The interpretation of the results is that of the author of this paper. Arzu Yorgancioglu, Ferda Oner Erkekol, Dilsad Mungan, Munevver Erdinc, Bilun Gemicioglu, Zeynep Ferhan Ozseker, Papatya Bayrak, Sibel Atis Nayci, Aykut Cilli, Cengiz Kirmaz, Dane Ediger, Arzu Didem Yalcin, Suna Buyukozturk, Sami Ozturk, Rana Isik, Fuat Kalyoncu, and Yavuz Havlucu received grant/research support for consultations, speaking at conferences and for support to attend international conferences from Novartis. Fusun Erdenen, Mustafa Gulec, Ozlem Goksel, Omur Aydin do not have conflict of interest. Idilhan Baloglu Ar, Ahmet Erdogdu work for the Medical Department of Novartis Pharmaceuticals, Istanbul, Turkey. Article in Journal/Newspaper sami Ege University Institutional Repository Dane ENVELOPE(-146.667,-146.667,-76.850,-76.850) International Archives of Allergy and Immunology 176 3-4 225 233 |
institution |
Open Polar |
collection |
Ege University Institutional Repository |
op_collection_id |
ftunivege |
language |
English |
topic |
Anti-IgE Omalizumab Effectiveness Real-life trial Long-term treatment |
spellingShingle |
Anti-IgE Omalizumab Effectiveness Real-life trial Long-term treatment Yorgancioglu, Arzu Erkekol, Ferda Oner Mungan, Dilsad Erdinc, Munevver Gemicioglu, Bilun Ozseker, Zeynep Ferhan Degirmenci, Papatya Bayrak Nayci, Sibel Cilli, Aykut Erdenen, Fusun Kirmaz, Cengiz Ediger, Dane Yalcin, Arzu Didem Buyukozturk, Suna Ozturk, Sami Gulec, Mustafa Isik, Sacide Rana Kalyoncu, Ali Fuat Goksel, Ozlem Aydin, Omur Havlucu, Yavuz Ar, Idilhan Baloglu Erdogdu, Ahmet Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial |
topic_facet |
Anti-IgE Omalizumab Effectiveness Real-life trial Long-term treatment |
description |
WOS: 000438864700007 PubMed ID: 29772578 Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. Methods: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. Results: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. Conclusion: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good. (C) 2018 S. Karger AG, Basel Novartis Pharmaceuticals Ltd.; NovartisNovartis The study was sponsored by Novartis Pharmaceuticals Ltd. The sponsor was involved in the design of the study and conducted the analysis according to a detailed analysis agreed by the investigators. The interpretation of the results is that of the author of this paper. Arzu Yorgancioglu, Ferda Oner Erkekol, Dilsad Mungan, Munevver Erdinc, Bilun Gemicioglu, Zeynep Ferhan Ozseker, Papatya Bayrak, Sibel Atis Nayci, Aykut Cilli, Cengiz Kirmaz, Dane Ediger, Arzu Didem Yalcin, Suna Buyukozturk, Sami Ozturk, Rana Isik, Fuat Kalyoncu, and Yavuz Havlucu received grant/research support for consultations, speaking at conferences and for support to attend international conferences from Novartis. Fusun Erdenen, Mustafa Gulec, Ozlem Goksel, Omur Aydin do not have conflict of interest. Idilhan Baloglu Ar, Ahmet Erdogdu work for the Medical Department of Novartis Pharmaceuticals, Istanbul, Turkey. |
author2 |
Ege Üniversitesi |
format |
Article in Journal/Newspaper |
author |
Yorgancioglu, Arzu Erkekol, Ferda Oner Mungan, Dilsad Erdinc, Munevver Gemicioglu, Bilun Ozseker, Zeynep Ferhan Degirmenci, Papatya Bayrak Nayci, Sibel Cilli, Aykut Erdenen, Fusun Kirmaz, Cengiz Ediger, Dane Yalcin, Arzu Didem Buyukozturk, Suna Ozturk, Sami Gulec, Mustafa Isik, Sacide Rana Kalyoncu, Ali Fuat Goksel, Ozlem Aydin, Omur Havlucu, Yavuz Ar, Idilhan Baloglu Erdogdu, Ahmet |
author_facet |
Yorgancioglu, Arzu Erkekol, Ferda Oner Mungan, Dilsad Erdinc, Munevver Gemicioglu, Bilun Ozseker, Zeynep Ferhan Degirmenci, Papatya Bayrak Nayci, Sibel Cilli, Aykut Erdenen, Fusun Kirmaz, Cengiz Ediger, Dane Yalcin, Arzu Didem Buyukozturk, Suna Ozturk, Sami Gulec, Mustafa Isik, Sacide Rana Kalyoncu, Ali Fuat Goksel, Ozlem Aydin, Omur Havlucu, Yavuz Ar, Idilhan Baloglu Erdogdu, Ahmet |
author_sort |
Yorgancioglu, Arzu |
title |
Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial |
title_short |
Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial |
title_full |
Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial |
title_fullStr |
Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial |
title_full_unstemmed |
Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial |
title_sort |
long-term omalizumab treatment: a multicenter, real-life, 5-year trial |
publisher |
Karger |
publishDate |
2018 |
url |
https://hdl.handle.net/11454/31162 https://doi.org/10.1159/000488349 |
long_lat |
ENVELOPE(-146.667,-146.667,-76.850,-76.850) |
geographic |
Dane |
geographic_facet |
Dane |
genre |
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op_relation |
10.1159/000488349 Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı International Archives of Allergy and Immunology 1018-2438 1423-0097 https://doi.org/10.1159/000488349 https://hdl.handle.net/11454/31162 176 03.Apr |
op_rights |
info:eu-repo/semantics/closedAccess |
op_doi |
https://doi.org/10.1159/000488349 |
container_title |
International Archives of Allergy and Immunology |
container_volume |
176 |
container_issue |
3-4 |
container_start_page |
225 |
op_container_end_page |
233 |
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1766186572530581504 |