Safety and efficacy of erenumab in patients with trigeminal neuralgia in Denmark: a double-blind, randomised, placebo-controlled, proof-of-concept study

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Standard

Safety and efficacy of erenumab in patients with trigeminal neuralgia in Denmark : a double-blind, randomised, placebo-controlled, proof-of-concept study. / Schott Andersen, Anne Sofie; Maarbjerg, Stine; Noory, Navid; Heinskou, Tone Bruvik; Forman, Julie Lyng; Cruccu, Giorgio; Ashina, Messoud; Bendtsen, Lars.

I: The Lancet Neurology, Bind 21, Nr. 11, 2022, s. 994-1003.

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Harvard

Schott Andersen, AS, Maarbjerg, S, Noory, N, Heinskou, TB, Forman, JL, Cruccu, G, Ashina, M & Bendtsen, L 2022, 'Safety and efficacy of erenumab in patients with trigeminal neuralgia in Denmark: a double-blind, randomised, placebo-controlled, proof-of-concept study', The Lancet Neurology, bind 21, nr. 11, s. 994-1003. https://doi.org/10.1016/S1474-4422(22)00294-0

APA

Schott Andersen, A. S., Maarbjerg, S., Noory, N., Heinskou, T. B., Forman, J. L., Cruccu, G., Ashina, M., & Bendtsen, L. (2022). Safety and efficacy of erenumab in patients with trigeminal neuralgia in Denmark: a double-blind, randomised, placebo-controlled, proof-of-concept study. The Lancet Neurology, 21(11), 994-1003. https://doi.org/10.1016/S1474-4422(22)00294-0

Vancouver

Schott Andersen AS, Maarbjerg S, Noory N, Heinskou TB, Forman JL, Cruccu G o.a. Safety and efficacy of erenumab in patients with trigeminal neuralgia in Denmark: a double-blind, randomised, placebo-controlled, proof-of-concept study. The Lancet Neurology. 2022;21(11):994-1003. https://doi.org/10.1016/S1474-4422(22)00294-0

Author

Schott Andersen, Anne Sofie ; Maarbjerg, Stine ; Noory, Navid ; Heinskou, Tone Bruvik ; Forman, Julie Lyng ; Cruccu, Giorgio ; Ashina, Messoud ; Bendtsen, Lars. / Safety and efficacy of erenumab in patients with trigeminal neuralgia in Denmark : a double-blind, randomised, placebo-controlled, proof-of-concept study. I: The Lancet Neurology. 2022 ; Bind 21, Nr. 11. s. 994-1003.

Bibtex

@article{6c18260c1dda41af9f33aba7003cc989,
title = "Safety and efficacy of erenumab in patients with trigeminal neuralgia in Denmark: a double-blind, randomised, placebo-controlled, proof-of-concept study",
abstract = "Background: Trigeminal neuralgia is a severe facial pain disorder that is difficult to treat. Erenumab, a monoclonal antibody against the calcitonin gene-related peptide (CGRP) receptor, has proven efficacy in migraine. Erenumab modulates sensory processing in peripheral trigeminal pain pathways in mice and was reported to be effective for patients with trigeminal neuralgia in open-label studies. We aimed to evaluate the efficacy of erenumab in patients with trigeminal neuralgia. Methods: We did a randomised, double-blind, placebo-controlled trial in adults (aged 18–85 years) with idiopathic or classic trigeminal neuralgia as defined by the 3rd edition of the International Classification of Headache Disorders. The trial was based at the Danish Headache Center, Copenhagen University Hospital. Eligible participants had no clinically significant cerebrovascular or cardiovascular disease, had self-reported pain intensity of at least 4 on the 11-point Numeric Rating Scale (0=no pain, 10=worst pain imaginable), and had at least three daily pain paroxysms. After a 1-week pre-screening period, patients entered a 4-week baseline period. Participants who met pain inclusion criteria at the end of the baseline period were randomly assigned (1:1) to receive subcutaneous injections of either erenumab 140 mg or placebo and entered the 4-week follow-up period. Randomisation was done in blocks of 10 using a computer-generated schedule by a third-party company. Participants and assessors were masked to treatment allocation, and erenumab and placebo were packed in identical prefilled syringes. The primary outcome was the number of responders, defined as patients who had a reduction of at least 30% in mean average daily pain intensity during the follow-up period compared with during the baseline period, analysed in the intention-to-treat population. This trial is registered with the European Union Drug Regulating Authorities Clinical Trials Database, EudraCT number 2019–000848–95. Findings: We assessed 860 patients for suitability and excluded 741 between Oct 28, 2019, and Sept 13, 2021. 119 participants entered a 1-week pre-screening period and 26 were excluded, 93 participants entered a 4-week baseline period with 13 excluded before randomisation, and 80 participants were randomly assigned to erenumab 140 mg (n=40) or placebo (n=40). There was no difference between groups in the number of responders at 4 weeks in the intention-to-treat population (14 [35%] of 40 with erenumab vs 18 [45%] of 40 with placebo; estimated effect size –10% [95% CI –31 to 11]; p=0·36). 20 (50%) of 40 participants reported adverse events in each group. The most common adverse events were constipation (28%) and headache (10%) in the erenumab group, and headache (13%), constipation (10%), and abdominal pain (10%) in the placebo group. Interpretation: Erenumab did not reduce pain intensity compared with placebo in patients with trigeminal neuralgia and CGRP probably does not have an important role in paroxysmal pain. Well tolerated, effective treatments in trigeminal neuralgia are still needed. Funding: Novartis.",
author = "{Schott Andersen}, {Anne Sofie} and Stine Maarbjerg and Navid Noory and Heinskou, {Tone Bruvik} and Forman, {Julie Lyng} and Giorgio Cruccu and Messoud Ashina and Lars Bendtsen",
note = "Publisher Copyright: {\textcopyright} 2022 Elsevier Ltd",
year = "2022",
doi = "10.1016/S1474-4422(22)00294-0",
language = "English",
volume = "21",
pages = "994--1003",
journal = "The Lancet Neurology",
issn = "1474-4422",
publisher = "TheLancet Publishing Group",
number = "11",

}

RIS

TY - JOUR

T1 - Safety and efficacy of erenumab in patients with trigeminal neuralgia in Denmark

T2 - a double-blind, randomised, placebo-controlled, proof-of-concept study

AU - Schott Andersen, Anne Sofie

AU - Maarbjerg, Stine

AU - Noory, Navid

AU - Heinskou, Tone Bruvik

AU - Forman, Julie Lyng

AU - Cruccu, Giorgio

AU - Ashina, Messoud

AU - Bendtsen, Lars

N1 - Publisher Copyright: © 2022 Elsevier Ltd

PY - 2022

Y1 - 2022

N2 - Background: Trigeminal neuralgia is a severe facial pain disorder that is difficult to treat. Erenumab, a monoclonal antibody against the calcitonin gene-related peptide (CGRP) receptor, has proven efficacy in migraine. Erenumab modulates sensory processing in peripheral trigeminal pain pathways in mice and was reported to be effective for patients with trigeminal neuralgia in open-label studies. We aimed to evaluate the efficacy of erenumab in patients with trigeminal neuralgia. Methods: We did a randomised, double-blind, placebo-controlled trial in adults (aged 18–85 years) with idiopathic or classic trigeminal neuralgia as defined by the 3rd edition of the International Classification of Headache Disorders. The trial was based at the Danish Headache Center, Copenhagen University Hospital. Eligible participants had no clinically significant cerebrovascular or cardiovascular disease, had self-reported pain intensity of at least 4 on the 11-point Numeric Rating Scale (0=no pain, 10=worst pain imaginable), and had at least three daily pain paroxysms. After a 1-week pre-screening period, patients entered a 4-week baseline period. Participants who met pain inclusion criteria at the end of the baseline period were randomly assigned (1:1) to receive subcutaneous injections of either erenumab 140 mg or placebo and entered the 4-week follow-up period. Randomisation was done in blocks of 10 using a computer-generated schedule by a third-party company. Participants and assessors were masked to treatment allocation, and erenumab and placebo were packed in identical prefilled syringes. The primary outcome was the number of responders, defined as patients who had a reduction of at least 30% in mean average daily pain intensity during the follow-up period compared with during the baseline period, analysed in the intention-to-treat population. This trial is registered with the European Union Drug Regulating Authorities Clinical Trials Database, EudraCT number 2019–000848–95. Findings: We assessed 860 patients for suitability and excluded 741 between Oct 28, 2019, and Sept 13, 2021. 119 participants entered a 1-week pre-screening period and 26 were excluded, 93 participants entered a 4-week baseline period with 13 excluded before randomisation, and 80 participants were randomly assigned to erenumab 140 mg (n=40) or placebo (n=40). There was no difference between groups in the number of responders at 4 weeks in the intention-to-treat population (14 [35%] of 40 with erenumab vs 18 [45%] of 40 with placebo; estimated effect size –10% [95% CI –31 to 11]; p=0·36). 20 (50%) of 40 participants reported adverse events in each group. The most common adverse events were constipation (28%) and headache (10%) in the erenumab group, and headache (13%), constipation (10%), and abdominal pain (10%) in the placebo group. Interpretation: Erenumab did not reduce pain intensity compared with placebo in patients with trigeminal neuralgia and CGRP probably does not have an important role in paroxysmal pain. Well tolerated, effective treatments in trigeminal neuralgia are still needed. Funding: Novartis.

AB - Background: Trigeminal neuralgia is a severe facial pain disorder that is difficult to treat. Erenumab, a monoclonal antibody against the calcitonin gene-related peptide (CGRP) receptor, has proven efficacy in migraine. Erenumab modulates sensory processing in peripheral trigeminal pain pathways in mice and was reported to be effective for patients with trigeminal neuralgia in open-label studies. We aimed to evaluate the efficacy of erenumab in patients with trigeminal neuralgia. Methods: We did a randomised, double-blind, placebo-controlled trial in adults (aged 18–85 years) with idiopathic or classic trigeminal neuralgia as defined by the 3rd edition of the International Classification of Headache Disorders. The trial was based at the Danish Headache Center, Copenhagen University Hospital. Eligible participants had no clinically significant cerebrovascular or cardiovascular disease, had self-reported pain intensity of at least 4 on the 11-point Numeric Rating Scale (0=no pain, 10=worst pain imaginable), and had at least three daily pain paroxysms. After a 1-week pre-screening period, patients entered a 4-week baseline period. Participants who met pain inclusion criteria at the end of the baseline period were randomly assigned (1:1) to receive subcutaneous injections of either erenumab 140 mg or placebo and entered the 4-week follow-up period. Randomisation was done in blocks of 10 using a computer-generated schedule by a third-party company. Participants and assessors were masked to treatment allocation, and erenumab and placebo were packed in identical prefilled syringes. The primary outcome was the number of responders, defined as patients who had a reduction of at least 30% in mean average daily pain intensity during the follow-up period compared with during the baseline period, analysed in the intention-to-treat population. This trial is registered with the European Union Drug Regulating Authorities Clinical Trials Database, EudraCT number 2019–000848–95. Findings: We assessed 860 patients for suitability and excluded 741 between Oct 28, 2019, and Sept 13, 2021. 119 participants entered a 1-week pre-screening period and 26 were excluded, 93 participants entered a 4-week baseline period with 13 excluded before randomisation, and 80 participants were randomly assigned to erenumab 140 mg (n=40) or placebo (n=40). There was no difference between groups in the number of responders at 4 weeks in the intention-to-treat population (14 [35%] of 40 with erenumab vs 18 [45%] of 40 with placebo; estimated effect size –10% [95% CI –31 to 11]; p=0·36). 20 (50%) of 40 participants reported adverse events in each group. The most common adverse events were constipation (28%) and headache (10%) in the erenumab group, and headache (13%), constipation (10%), and abdominal pain (10%) in the placebo group. Interpretation: Erenumab did not reduce pain intensity compared with placebo in patients with trigeminal neuralgia and CGRP probably does not have an important role in paroxysmal pain. Well tolerated, effective treatments in trigeminal neuralgia are still needed. Funding: Novartis.

U2 - 10.1016/S1474-4422(22)00294-0

DO - 10.1016/S1474-4422(22)00294-0

M3 - Journal article

C2 - 36113495

AN - SCOPUS:85140232629

VL - 21

SP - 994

EP - 1003

JO - The Lancet Neurology

JF - The Lancet Neurology

SN - 1474-4422

IS - 11

ER -

ID: 331361893