Immunogenicity of biologic therapies for migraine: a review of current evidence

Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Cohen, Joshua M. [verfasserIn] Ning, Xiaoping [verfasserIn] Kessler, Yoel [verfasserIn] Rasamoelisolo, Michele [verfasserIn] Campos, Verena Ramirez [verfasserIn] Seminerio, Michael J. [verfasserIn] Krasenbaum, Lynda J. [verfasserIn] Shen, Honglue [verfasserIn] Stratton, Jennifer [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2021

Schlagwörter:	Migraine prevention Prophylaxis CGRP pathway–targeted monoclonal antibodies Immunogenicity Anti-drug antibodies

Übergeordnetes Werk:	Enthalten in: The journal of headache and pain - Milano : Springer Italia, 2000, 22(2021), 1 vom: 07. Jan.
Übergeordnetes Werk:	volume:22 ; year:2021 ; number:1 ; day:07 ; month:01

Links:	Volltext

DOI / URN:	10.1186/s10194-020-01211-5

Katalog-ID:	SPR042607337

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520			\|a Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications.
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allfields	10.1186/s10194-020-01211-5 doi (DE-627)SPR042607337 (DE-599)SPRs10194-020-01211-5-e (SPR)s10194-020-01211-5-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.90 bkl Cohen, Joshua M. verfasserin aut Immunogenicity of biologic therapies for migraine: a review of current evidence 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications. Migraine prevention (dpeaa)DE-He213 Prophylaxis (dpeaa)DE-He213 CGRP pathway–targeted monoclonal antibodies (dpeaa)DE-He213 Immunogenicity (dpeaa)DE-He213 Anti-drug antibodies (dpeaa)DE-He213 Ning, Xiaoping verfasserin aut Kessler, Yoel verfasserin aut Rasamoelisolo, Michele verfasserin aut Campos, Verena Ramirez verfasserin aut Seminerio, Michael J. verfasserin aut Krasenbaum, Lynda J. verfasserin aut Shen, Honglue verfasserin aut Stratton, Jennifer verfasserin aut Enthalten in The journal of headache and pain Milano : Springer Italia, 2000 22(2021), 1 vom: 07. Jan. (DE-627)320600963 (DE-600)2020168-0 1129-2377 nnns volume:22 year:2021 number:1 day:07 month:01 https://dx.doi.org/10.1186/s10194-020-01211-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_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_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 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 44.90 ASE AR 22 2021 1 07 01
spelling	10.1186/s10194-020-01211-5 doi (DE-627)SPR042607337 (DE-599)SPRs10194-020-01211-5-e (SPR)s10194-020-01211-5-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.90 bkl Cohen, Joshua M. verfasserin aut Immunogenicity of biologic therapies for migraine: a review of current evidence 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications. Migraine prevention (dpeaa)DE-He213 Prophylaxis (dpeaa)DE-He213 CGRP pathway–targeted monoclonal antibodies (dpeaa)DE-He213 Immunogenicity (dpeaa)DE-He213 Anti-drug antibodies (dpeaa)DE-He213 Ning, Xiaoping verfasserin aut Kessler, Yoel verfasserin aut Rasamoelisolo, Michele verfasserin aut Campos, Verena Ramirez verfasserin aut Seminerio, Michael J. verfasserin aut Krasenbaum, Lynda J. verfasserin aut Shen, Honglue verfasserin aut Stratton, Jennifer verfasserin aut Enthalten in The journal of headache and pain Milano : Springer Italia, 2000 22(2021), 1 vom: 07. Jan. (DE-627)320600963 (DE-600)2020168-0 1129-2377 nnns volume:22 year:2021 number:1 day:07 month:01 https://dx.doi.org/10.1186/s10194-020-01211-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_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_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 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 44.90 ASE AR 22 2021 1 07 01
allfields_unstemmed	10.1186/s10194-020-01211-5 doi (DE-627)SPR042607337 (DE-599)SPRs10194-020-01211-5-e (SPR)s10194-020-01211-5-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.90 bkl Cohen, Joshua M. verfasserin aut Immunogenicity of biologic therapies for migraine: a review of current evidence 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications. Migraine prevention (dpeaa)DE-He213 Prophylaxis (dpeaa)DE-He213 CGRP pathway–targeted monoclonal antibodies (dpeaa)DE-He213 Immunogenicity (dpeaa)DE-He213 Anti-drug antibodies (dpeaa)DE-He213 Ning, Xiaoping verfasserin aut Kessler, Yoel verfasserin aut Rasamoelisolo, Michele verfasserin aut Campos, Verena Ramirez verfasserin aut Seminerio, Michael J. verfasserin aut Krasenbaum, Lynda J. verfasserin aut Shen, Honglue verfasserin aut Stratton, Jennifer verfasserin aut Enthalten in The journal of headache and pain Milano : Springer Italia, 2000 22(2021), 1 vom: 07. Jan. (DE-627)320600963 (DE-600)2020168-0 1129-2377 nnns volume:22 year:2021 number:1 day:07 month:01 https://dx.doi.org/10.1186/s10194-020-01211-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_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_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 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 44.90 ASE AR 22 2021 1 07 01
allfieldsGer	10.1186/s10194-020-01211-5 doi (DE-627)SPR042607337 (DE-599)SPRs10194-020-01211-5-e (SPR)s10194-020-01211-5-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.90 bkl Cohen, Joshua M. verfasserin aut Immunogenicity of biologic therapies for migraine: a review of current evidence 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications. Migraine prevention (dpeaa)DE-He213 Prophylaxis (dpeaa)DE-He213 CGRP pathway–targeted monoclonal antibodies (dpeaa)DE-He213 Immunogenicity (dpeaa)DE-He213 Anti-drug antibodies (dpeaa)DE-He213 Ning, Xiaoping verfasserin aut Kessler, Yoel verfasserin aut Rasamoelisolo, Michele verfasserin aut Campos, Verena Ramirez verfasserin aut Seminerio, Michael J. verfasserin aut Krasenbaum, Lynda J. verfasserin aut Shen, Honglue verfasserin aut Stratton, Jennifer verfasserin aut Enthalten in The journal of headache and pain Milano : Springer Italia, 2000 22(2021), 1 vom: 07. Jan. (DE-627)320600963 (DE-600)2020168-0 1129-2377 nnns volume:22 year:2021 number:1 day:07 month:01 https://dx.doi.org/10.1186/s10194-020-01211-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_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_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 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 44.90 ASE AR 22 2021 1 07 01
allfieldsSound	10.1186/s10194-020-01211-5 doi (DE-627)SPR042607337 (DE-599)SPRs10194-020-01211-5-e (SPR)s10194-020-01211-5-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.90 bkl Cohen, Joshua M. verfasserin aut Immunogenicity of biologic therapies for migraine: a review of current evidence 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications. Migraine prevention (dpeaa)DE-He213 Prophylaxis (dpeaa)DE-He213 CGRP pathway–targeted monoclonal antibodies (dpeaa)DE-He213 Immunogenicity (dpeaa)DE-He213 Anti-drug antibodies (dpeaa)DE-He213 Ning, Xiaoping verfasserin aut Kessler, Yoel verfasserin aut Rasamoelisolo, Michele verfasserin aut Campos, Verena Ramirez verfasserin aut Seminerio, Michael J. verfasserin aut Krasenbaum, Lynda J. verfasserin aut Shen, Honglue verfasserin aut Stratton, Jennifer verfasserin aut Enthalten in The journal of headache and pain Milano : Springer Italia, 2000 22(2021), 1 vom: 07. Jan. (DE-627)320600963 (DE-600)2020168-0 1129-2377 nnns volume:22 year:2021 number:1 day:07 month:01 https://dx.doi.org/10.1186/s10194-020-01211-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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_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_267 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_2153 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 44.90 ASE AR 22 2021 1 07 01
language	English
source	Enthalten in The journal of headache and pain 22(2021), 1 vom: 07. Jan. volume:22 year:2021 number:1 day:07 month:01
sourceStr	Enthalten in The journal of headache and pain 22(2021), 1 vom: 07. Jan. volume:22 year:2021 number:1 day:07 month:01
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Migraine prevention Prophylaxis CGRP pathway–targeted monoclonal antibodies Immunogenicity Anti-drug antibodies
dewey-raw	610
isfreeaccess_bool	true
container_title	The journal of headache and pain
authorswithroles_txt_mv	Cohen, Joshua M. @@aut@@ Ning, Xiaoping @@aut@@ Kessler, Yoel @@aut@@ Rasamoelisolo, Michele @@aut@@ Campos, Verena Ramirez @@aut@@ Seminerio, Michael J. @@aut@@ Krasenbaum, Lynda J. @@aut@@ Shen, Honglue @@aut@@ Stratton, Jennifer @@aut@@
publishDateDaySort_date	2021-01-07T00:00:00Z
hierarchy_top_id	320600963
dewey-sort	3610
id	SPR042607337
language_de	englisch
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author	Cohen, Joshua M.
spellingShingle	Cohen, Joshua M. ddc 610 bkl 44.90 misc Migraine prevention misc Prophylaxis misc CGRP pathway–targeted monoclonal antibodies misc Immunogenicity misc Anti-drug antibodies Immunogenicity of biologic therapies for migraine: a review of current evidence
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topic_title	610 ASE 44.90 bkl Immunogenicity of biologic therapies for migraine: a review of current evidence Migraine prevention (dpeaa)DE-He213 Prophylaxis (dpeaa)DE-He213 CGRP pathway–targeted monoclonal antibodies (dpeaa)DE-He213 Immunogenicity (dpeaa)DE-He213 Anti-drug antibodies (dpeaa)DE-He213
topic	ddc 610 bkl 44.90 misc Migraine prevention misc Prophylaxis misc CGRP pathway–targeted monoclonal antibodies misc Immunogenicity misc Anti-drug antibodies
topic_unstemmed	ddc 610 bkl 44.90 misc Migraine prevention misc Prophylaxis misc CGRP pathway–targeted monoclonal antibodies misc Immunogenicity misc Anti-drug antibodies
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title	Immunogenicity of biologic therapies for migraine: a review of current evidence
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title_full	Immunogenicity of biologic therapies for migraine: a review of current evidence
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author_browse	Cohen, Joshua M. Ning, Xiaoping Kessler, Yoel Rasamoelisolo, Michele Campos, Verena Ramirez Seminerio, Michael J. Krasenbaum, Lynda J. Shen, Honglue Stratton, Jennifer
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title_sort	immunogenicity of biologic therapies for migraine: a review of current evidence
title_auth	Immunogenicity of biologic therapies for migraine: a review of current evidence
abstract	Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications.
abstractGer	Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications.
abstract_unstemmed	Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications. Findings The incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare. Conclusions As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications.
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title_short	Immunogenicity of biologic therapies for migraine: a review of current evidence
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author2	Ning, Xiaoping Kessler, Yoel Rasamoelisolo, Michele Campos, Verena Ramirez Seminerio, Michael J. Krasenbaum, Lynda J. Shen, Honglue Stratton, Jennifer
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