Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients

Daclizumab was approved by the FDA and the EMA in 2016 for the treatment of relapsing forms of multiple sclerosis (MS). Cases of severe inflammatory brain disease with fatal outcome led to the withdrawal of approval in Europe and the US on March 2, 2018. Approximately 8,000 patients worldwide receiv...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Paulus S. Rommer [verfasserIn] Klaus Berger [verfasserIn] David Ellenberger [verfasserIn] Firas Fneish [verfasserIn] Alexandra Simbrich [verfasserIn] Alexander Stahmann [verfasserIn] Uwe K. Zettl [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Schlagwörter:	multiple sclerosis multiple sclerosis—drug therapy daclizumab side effects registers

Übergeordnetes Werk:	In: Frontiers in Neurology - Frontiers Media S.A., 2010, 11(2020)
Übergeordnetes Werk:	volume:11 ; year:2020

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3389/fneur.2020.00996

Katalog-ID:	DOAJ05612452X

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allfieldsGer	10.3389/fneur.2020.00996 doi (DE-627)DOAJ05612452X (DE-599)DOAJe6c33d9b2b4b49d19dcdf78faaefe9d2 DE-627 ger DE-627 rakwb eng RC346-429 Paulus S. Rommer verfasserin aut Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Daclizumab was approved by the FDA and the EMA in 2016 for the treatment of relapsing forms of multiple sclerosis (MS). Cases of severe inflammatory brain disease with fatal outcome led to the withdrawal of approval in Europe and the US on March 2, 2018. Approximately 8,000 patients worldwide received daclizumab, but little is known about the further therapy management of these patients after the withdrawal of daclizumab. The aim of this study is to further analyze therapy management in MS patients after safety warnings and market withdrawal. Data from two registries in Germany, the German MS Registry (GMSR) and REGIMS, were used for this analysis. In total, 267 patients were included in this study. For almost 25% of patients (in the GMSR) daclizumab was the initial treatment. Most common pre-treatments were fingolimod, dimethyl fumarate, and natalizumab; various injectables summed up to 25.9%. The most common follow-up therapies were ocrelizumab and fingolimod. In most patients, follow-up therapies were administered shortly after discontinuation of daclizumab. The wash-out time for subsequent therapies varied between 1.2 and 4.0 months. Warnings and decisions by authorities led to a rapid decline and termination of therapies in both cohorts, indicating that such warnings have an immediate impact on the treatment landscape. Therapies that were started within a short time after the discontinuation of daclizumab were subsequently replaced by other therapies and may be considered as bridging therapies. multiple sclerosis multiple sclerosis—drug therapy daclizumab side effects registers Neurology. Diseases of the nervous system Paulus S. Rommer verfasserin aut Klaus Berger verfasserin aut David Ellenberger verfasserin aut Firas Fneish verfasserin aut Alexandra Simbrich verfasserin aut Alexander Stahmann verfasserin aut Uwe K. Zettl verfasserin aut In Frontiers in Neurology Frontiers Media S.A., 2010 11(2020) (DE-627)631498753 (DE-600)2564214-5 16642295 nnns volume:11 year:2020 https://doi.org/10.3389/fneur.2020.00996 kostenfrei https://doaj.org/article/e6c33d9b2b4b49d19dcdf78faaefe9d2 kostenfrei https://www.frontiersin.org/article/10.3389/fneur.2020.00996/full kostenfrei https://doaj.org/toc/1664-2295 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2020
allfieldsSound	10.3389/fneur.2020.00996 doi (DE-627)DOAJ05612452X (DE-599)DOAJe6c33d9b2b4b49d19dcdf78faaefe9d2 DE-627 ger DE-627 rakwb eng RC346-429 Paulus S. Rommer verfasserin aut Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Daclizumab was approved by the FDA and the EMA in 2016 for the treatment of relapsing forms of multiple sclerosis (MS). Cases of severe inflammatory brain disease with fatal outcome led to the withdrawal of approval in Europe and the US on March 2, 2018. Approximately 8,000 patients worldwide received daclizumab, but little is known about the further therapy management of these patients after the withdrawal of daclizumab. The aim of this study is to further analyze therapy management in MS patients after safety warnings and market withdrawal. Data from two registries in Germany, the German MS Registry (GMSR) and REGIMS, were used for this analysis. In total, 267 patients were included in this study. For almost 25% of patients (in the GMSR) daclizumab was the initial treatment. Most common pre-treatments were fingolimod, dimethyl fumarate, and natalizumab; various injectables summed up to 25.9%. The most common follow-up therapies were ocrelizumab and fingolimod. In most patients, follow-up therapies were administered shortly after discontinuation of daclizumab. The wash-out time for subsequent therapies varied between 1.2 and 4.0 months. Warnings and decisions by authorities led to a rapid decline and termination of therapies in both cohorts, indicating that such warnings have an immediate impact on the treatment landscape. Therapies that were started within a short time after the discontinuation of daclizumab were subsequently replaced by other therapies and may be considered as bridging therapies. multiple sclerosis multiple sclerosis—drug therapy daclizumab side effects registers Neurology. Diseases of the nervous system Paulus S. Rommer verfasserin aut Klaus Berger verfasserin aut David Ellenberger verfasserin aut Firas Fneish verfasserin aut Alexandra Simbrich verfasserin aut Alexander Stahmann verfasserin aut Uwe K. Zettl verfasserin aut In Frontiers in Neurology Frontiers Media S.A., 2010 11(2020) (DE-627)631498753 (DE-600)2564214-5 16642295 nnns volume:11 year:2020 https://doi.org/10.3389/fneur.2020.00996 kostenfrei https://doaj.org/article/e6c33d9b2b4b49d19dcdf78faaefe9d2 kostenfrei https://www.frontiersin.org/article/10.3389/fneur.2020.00996/full kostenfrei https://doaj.org/toc/1664-2295 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2020
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authorswithroles_txt_mv	Paulus S. Rommer @@aut@@ Klaus Berger @@aut@@ David Ellenberger @@aut@@ Firas Fneish @@aut@@ Alexandra Simbrich @@aut@@ Alexander Stahmann @@aut@@ Uwe K. Zettl @@aut@@
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author	Paulus S. Rommer
spellingShingle	Paulus S. Rommer misc RC346-429 misc multiple sclerosis misc multiple sclerosis—drug therapy misc daclizumab misc side effects misc registers misc Neurology. Diseases of the nervous system Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients
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topic_title	RC346-429 Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients multiple sclerosis multiple sclerosis—drug therapy daclizumab side effects registers
topic	misc RC346-429 misc multiple sclerosis misc multiple sclerosis—drug therapy misc daclizumab misc side effects misc registers misc Neurology. Diseases of the nervous system
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title	Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients
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title_sort	management of ms patients treated with daclizumab – a case series of 267 patients
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title_auth	Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients
abstract	Daclizumab was approved by the FDA and the EMA in 2016 for the treatment of relapsing forms of multiple sclerosis (MS). Cases of severe inflammatory brain disease with fatal outcome led to the withdrawal of approval in Europe and the US on March 2, 2018. Approximately 8,000 patients worldwide received daclizumab, but little is known about the further therapy management of these patients after the withdrawal of daclizumab. The aim of this study is to further analyze therapy management in MS patients after safety warnings and market withdrawal. Data from two registries in Germany, the German MS Registry (GMSR) and REGIMS, were used for this analysis. In total, 267 patients were included in this study. For almost 25% of patients (in the GMSR) daclizumab was the initial treatment. Most common pre-treatments were fingolimod, dimethyl fumarate, and natalizumab; various injectables summed up to 25.9%. The most common follow-up therapies were ocrelizumab and fingolimod. In most patients, follow-up therapies were administered shortly after discontinuation of daclizumab. The wash-out time for subsequent therapies varied between 1.2 and 4.0 months. Warnings and decisions by authorities led to a rapid decline and termination of therapies in both cohorts, indicating that such warnings have an immediate impact on the treatment landscape. Therapies that were started within a short time after the discontinuation of daclizumab were subsequently replaced by other therapies and may be considered as bridging therapies.
abstractGer	Daclizumab was approved by the FDA and the EMA in 2016 for the treatment of relapsing forms of multiple sclerosis (MS). Cases of severe inflammatory brain disease with fatal outcome led to the withdrawal of approval in Europe and the US on March 2, 2018. Approximately 8,000 patients worldwide received daclizumab, but little is known about the further therapy management of these patients after the withdrawal of daclizumab. The aim of this study is to further analyze therapy management in MS patients after safety warnings and market withdrawal. Data from two registries in Germany, the German MS Registry (GMSR) and REGIMS, were used for this analysis. In total, 267 patients were included in this study. For almost 25% of patients (in the GMSR) daclizumab was the initial treatment. Most common pre-treatments were fingolimod, dimethyl fumarate, and natalizumab; various injectables summed up to 25.9%. The most common follow-up therapies were ocrelizumab and fingolimod. In most patients, follow-up therapies were administered shortly after discontinuation of daclizumab. The wash-out time for subsequent therapies varied between 1.2 and 4.0 months. Warnings and decisions by authorities led to a rapid decline and termination of therapies in both cohorts, indicating that such warnings have an immediate impact on the treatment landscape. Therapies that were started within a short time after the discontinuation of daclizumab were subsequently replaced by other therapies and may be considered as bridging therapies.
abstract_unstemmed	Daclizumab was approved by the FDA and the EMA in 2016 for the treatment of relapsing forms of multiple sclerosis (MS). Cases of severe inflammatory brain disease with fatal outcome led to the withdrawal of approval in Europe and the US on March 2, 2018. Approximately 8,000 patients worldwide received daclizumab, but little is known about the further therapy management of these patients after the withdrawal of daclizumab. The aim of this study is to further analyze therapy management in MS patients after safety warnings and market withdrawal. Data from two registries in Germany, the German MS Registry (GMSR) and REGIMS, were used for this analysis. In total, 267 patients were included in this study. For almost 25% of patients (in the GMSR) daclizumab was the initial treatment. Most common pre-treatments were fingolimod, dimethyl fumarate, and natalizumab; various injectables summed up to 25.9%. The most common follow-up therapies were ocrelizumab and fingolimod. In most patients, follow-up therapies were administered shortly after discontinuation of daclizumab. The wash-out time for subsequent therapies varied between 1.2 and 4.0 months. Warnings and decisions by authorities led to a rapid decline and termination of therapies in both cohorts, indicating that such warnings have an immediate impact on the treatment landscape. Therapies that were started within a short time after the discontinuation of daclizumab were subsequently replaced by other therapies and may be considered as bridging therapies.
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title_short	Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients
url	https://doi.org/10.3389/fneur.2020.00996 https://doaj.org/article/e6c33d9b2b4b49d19dcdf78faaefe9d2 https://www.frontiersin.org/article/10.3389/fneur.2020.00996/full https://doaj.org/toc/1664-2295
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Management of MS Patients Treated With Daclizumab – a Case Series of 267 Patients

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