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Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions

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Ashina, Messoud ; Kudrow, David ; Reuter, Uwe ; Dolezil, David ; Silberstein, Stephen ; Tepper, Stewart J ; Xue, Fei ; Picard, Hernan ; Zhang, Feng ; Wang, Andrea ; Zhou, Yanchen ; Hong, Frank ; Klatt, Jan ; Mikol, Daniel D. / Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine : A pooled analysis of four placebo-controlled trials with long-term extensions. I: Cephalalgia : an international journal of headache. 2019 ; Bind 39, Nr. 14. s. 1798-1808.

Bibtex

@article{92c8f671727e496ba8248e95fd014190,
title = "Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions",
abstract = "BACKGROUND: Efficacy and safety of erenumab have been evaluated in a comprehensive clinical development program resulting in approval for migraine prevention in over 40 countries to date.METHODS: This integrated safety analysis included four double-blind randomized trials and their extensions (up to three-plus years). Safety endpoints included exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies.RESULTS: In all, 2375 of the patients randomized across the four studies received at least one dose of erenumab (70 mg or 140 mg), with cumulative exposure of 2641.2 patient-years. Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years). During the long-term extensions, adverse events reported were similar to those observed during the double-blind treatment phase, and rates of injection site reactions, constipation, and muscle spasm were reported at lower rates than in the double-blind treatment phase. There were two deaths reported, both confounded by pre-existing conditions.CONCLUSIONS: This pooled safety analysis revealed a favorable and stable adverse event profile over time for erenumab with more than three years of exposure.TRIAL REGISTRATION: ClinicalTrials.gov NCT01952574, NCT02483585, NCT02456740, NCT02066415, and NCT02174861.",
author = "Messoud Ashina and David Kudrow and Uwe Reuter and David Dolezil and Stephen Silberstein and Tepper, {Stewart J} and Fei Xue and Hernan Picard and Feng Zhang and Andrea Wang and Yanchen Zhou and Frank Hong and Jan Klatt and Mikol, {Daniel D}",
year = "2019",
doi = "10.1177/0333102419888222",
language = "English",
volume = "39",
pages = "1798--1808",
journal = "Cephalalgia",
issn = "0333-1024",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "14",

}

RIS

TY - JOUR

T1 - Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine

T2 - A pooled analysis of four placebo-controlled trials with long-term extensions

AU - Ashina, Messoud

AU - Kudrow, David

AU - Reuter, Uwe

AU - Dolezil, David

AU - Silberstein, Stephen

AU - Tepper, Stewart J

AU - Xue, Fei

AU - Picard, Hernan

AU - Zhang, Feng

AU - Wang, Andrea

AU - Zhou, Yanchen

AU - Hong, Frank

AU - Klatt, Jan

AU - Mikol, Daniel D

PY - 2019

Y1 - 2019

N2 - BACKGROUND: Efficacy and safety of erenumab have been evaluated in a comprehensive clinical development program resulting in approval for migraine prevention in over 40 countries to date.METHODS: This integrated safety analysis included four double-blind randomized trials and their extensions (up to three-plus years). Safety endpoints included exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies.RESULTS: In all, 2375 of the patients randomized across the four studies received at least one dose of erenumab (70 mg or 140 mg), with cumulative exposure of 2641.2 patient-years. Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years). During the long-term extensions, adverse events reported were similar to those observed during the double-blind treatment phase, and rates of injection site reactions, constipation, and muscle spasm were reported at lower rates than in the double-blind treatment phase. There were two deaths reported, both confounded by pre-existing conditions.CONCLUSIONS: This pooled safety analysis revealed a favorable and stable adverse event profile over time for erenumab with more than three years of exposure.TRIAL REGISTRATION: ClinicalTrials.gov NCT01952574, NCT02483585, NCT02456740, NCT02066415, and NCT02174861.

AB - BACKGROUND: Efficacy and safety of erenumab have been evaluated in a comprehensive clinical development program resulting in approval for migraine prevention in over 40 countries to date.METHODS: This integrated safety analysis included four double-blind randomized trials and their extensions (up to three-plus years). Safety endpoints included exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies.RESULTS: In all, 2375 of the patients randomized across the four studies received at least one dose of erenumab (70 mg or 140 mg), with cumulative exposure of 2641.2 patient-years. Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years). During the long-term extensions, adverse events reported were similar to those observed during the double-blind treatment phase, and rates of injection site reactions, constipation, and muscle spasm were reported at lower rates than in the double-blind treatment phase. There were two deaths reported, both confounded by pre-existing conditions.CONCLUSIONS: This pooled safety analysis revealed a favorable and stable adverse event profile over time for erenumab with more than three years of exposure.TRIAL REGISTRATION: ClinicalTrials.gov NCT01952574, NCT02483585, NCT02456740, NCT02066415, and NCT02174861.

U2 - 10.1177/0333102419888222

DO - 10.1177/0333102419888222

M3 - Journal article

VL - 39

SP - 1798

EP - 1808

JO - Cephalalgia

JF - Cephalalgia

SN - 0333-1024

IS - 14

ER -

ID: 58930498