Migraine induction with calcitonin gene-related peptide in patients from erenumab trials

Casper Emil Christensen; Samaira Younis; Marie Deen; Sabrina Khan; Hashmat Ghanizada; Messoud Ashina

doi:10.1186/s10194-018-0927-2

Migraine induction with calcitonin gene-related peptide in patients from erenumab trials

Casper Emil Christensen, Samaira Younis, Marie Deen, Sabrina Khan, Hashmat Ghanizada, Messoud Ashina

Department of Clinical Medicine

19 Citations (Scopus)

25 Downloads (Pure)

Abstract

BACKGROUND: Migraine prevention with erenumab and migraine induction by calcitonin gene-related peptide (CGRP) both carry notable individual variance. We wanted to explore a possible association between individual efficacy of anti-CGRP treatment and susceptibility to migraine induction by CGRP.

METHODS: Thirteen migraine patients, previously enrolled in erenumab anti-CGRP receptor monoclonal antibody trials, received CGRP in a double-blind, placebo-controlled, randomized cross-over design to investigate their susceptibility to migraine induction. A standardized questionnaire was used to assess the efficacy of previous antibody treatment. The patients were stratified into groups of high responders and poor responders. Primary outcomes were incidence of migraine-like attacks and area under the curve of headache intensity after infusion of CGRP and placebo. All interviews and experiments were performed in laboratories at the Danish Headache Center, Copenhagen, Denmark.

RESULTS: Ten high responders and three poor responders were included. CGRP induced migraine-like attacks in ten (77%) patients, whereof two were poor responders, compared to none after placebo (p = 0.002). The area under the curve for headache intensity was greater after CGRP, compared to placebo, at 0-90 min (p = 0.009), and 2-12 h (p = 0.014). The median peak headache intensity score was 5 (5-9) after CGRP, compared to 2 (0-4) after placebo (p = 0.004).

CONCLUSIONS: Patients with an excellent effect of erenumab are highly susceptible to CGRP provocation. If an association is evident, CGRP provocation could prove a biomarker for predicting antibody treatment efficacy.

TRIAL REGISTRATION: Retrospectively registered at clinicaltrials.gov with identifier: NCT03481400 .

Original language	English
Article number	105
Journal	The Journal of Headache and Pain
Volume	19
Number of pages	9
ISSN	1129-2369
DOIs	https://doi.org/10.1186/s10194-018-0927-2
Publication status	Published - 8 Nov 2018

Keywords

Adult
Antibodies, Monoclonal/pharmacology
Calcitonin Gene-Related Peptide/antagonists & inhibitors
Cross-Over Studies
Denmark/epidemiology
Double-Blind Method
Female
Humans
Male
Middle Aged
Migraine Disorders/chemically induced
Retrospective Studies
Young Adult

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Cite this

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title = "Migraine induction with calcitonin gene-related peptide in patients from erenumab trials",

abstract = "BACKGROUND: Migraine prevention with erenumab and migraine induction by calcitonin gene-related peptide (CGRP) both carry notable individual variance. We wanted to explore a possible association between individual efficacy of anti-CGRP treatment and susceptibility to migraine induction by CGRP.METHODS: Thirteen migraine patients, previously enrolled in erenumab anti-CGRP receptor monoclonal antibody trials, received CGRP in a double-blind, placebo-controlled, randomized cross-over design to investigate their susceptibility to migraine induction. A standardized questionnaire was used to assess the efficacy of previous antibody treatment. The patients were stratified into groups of high responders and poor responders. Primary outcomes were incidence of migraine-like attacks and area under the curve of headache intensity after infusion of CGRP and placebo. All interviews and experiments were performed in laboratories at the Danish Headache Center, Copenhagen, Denmark.RESULTS: Ten high responders and three poor responders were included. CGRP induced migraine-like attacks in ten (77%) patients, whereof two were poor responders, compared to none after placebo (p = 0.002). The area under the curve for headache intensity was greater after CGRP, compared to placebo, at 0-90 min (p = 0.009), and 2-12 h (p = 0.014). The median peak headache intensity score was 5 (5-9) after CGRP, compared to 2 (0-4) after placebo (p = 0.004).CONCLUSIONS: Patients with an excellent effect of erenumab are highly susceptible to CGRP provocation. If an association is evident, CGRP provocation could prove a biomarker for predicting antibody treatment efficacy.TRIAL REGISTRATION: Retrospectively registered at clinicaltrials.gov with identifier: NCT03481400 .",

keywords = "Adult, Antibodies, Monoclonal/pharmacology, Calcitonin Gene-Related Peptide/antagonists & inhibitors, Cross-Over Studies, Denmark/epidemiology, Double-Blind Method, Female, Humans, Male, Middle Aged, Migraine Disorders/chemically induced, Retrospective Studies, Young Adult",

author = "Christensen, {Casper Emil} and Samaira Younis and Marie Deen and Sabrina Khan and Hashmat Ghanizada and Messoud Ashina",

year = "2018",

month = nov,

day = "8",

doi = "10.1186/s10194-018-0927-2",

language = "English",

volume = "19",

journal = "The Journal of Headache and Pain",

issn = "1129-2369",

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TY - JOUR

T1 - Migraine induction with calcitonin gene-related peptide in patients from erenumab trials

AU - Christensen, Casper Emil

AU - Younis, Samaira

AU - Deen, Marie

AU - Khan, Sabrina

AU - Ghanizada, Hashmat

AU - Ashina, Messoud

PY - 2018/11/8

Y1 - 2018/11/8

N2 - BACKGROUND: Migraine prevention with erenumab and migraine induction by calcitonin gene-related peptide (CGRP) both carry notable individual variance. We wanted to explore a possible association between individual efficacy of anti-CGRP treatment and susceptibility to migraine induction by CGRP.METHODS: Thirteen migraine patients, previously enrolled in erenumab anti-CGRP receptor monoclonal antibody trials, received CGRP in a double-blind, placebo-controlled, randomized cross-over design to investigate their susceptibility to migraine induction. A standardized questionnaire was used to assess the efficacy of previous antibody treatment. The patients were stratified into groups of high responders and poor responders. Primary outcomes were incidence of migraine-like attacks and area under the curve of headache intensity after infusion of CGRP and placebo. All interviews and experiments were performed in laboratories at the Danish Headache Center, Copenhagen, Denmark.RESULTS: Ten high responders and three poor responders were included. CGRP induced migraine-like attacks in ten (77%) patients, whereof two were poor responders, compared to none after placebo (p = 0.002). The area under the curve for headache intensity was greater after CGRP, compared to placebo, at 0-90 min (p = 0.009), and 2-12 h (p = 0.014). The median peak headache intensity score was 5 (5-9) after CGRP, compared to 2 (0-4) after placebo (p = 0.004).CONCLUSIONS: Patients with an excellent effect of erenumab are highly susceptible to CGRP provocation. If an association is evident, CGRP provocation could prove a biomarker for predicting antibody treatment efficacy.TRIAL REGISTRATION: Retrospectively registered at clinicaltrials.gov with identifier: NCT03481400 .

AB - BACKGROUND: Migraine prevention with erenumab and migraine induction by calcitonin gene-related peptide (CGRP) both carry notable individual variance. We wanted to explore a possible association between individual efficacy of anti-CGRP treatment and susceptibility to migraine induction by CGRP.METHODS: Thirteen migraine patients, previously enrolled in erenumab anti-CGRP receptor monoclonal antibody trials, received CGRP in a double-blind, placebo-controlled, randomized cross-over design to investigate their susceptibility to migraine induction. A standardized questionnaire was used to assess the efficacy of previous antibody treatment. The patients were stratified into groups of high responders and poor responders. Primary outcomes were incidence of migraine-like attacks and area under the curve of headache intensity after infusion of CGRP and placebo. All interviews and experiments were performed in laboratories at the Danish Headache Center, Copenhagen, Denmark.RESULTS: Ten high responders and three poor responders were included. CGRP induced migraine-like attacks in ten (77%) patients, whereof two were poor responders, compared to none after placebo (p = 0.002). The area under the curve for headache intensity was greater after CGRP, compared to placebo, at 0-90 min (p = 0.009), and 2-12 h (p = 0.014). The median peak headache intensity score was 5 (5-9) after CGRP, compared to 2 (0-4) after placebo (p = 0.004).CONCLUSIONS: Patients with an excellent effect of erenumab are highly susceptible to CGRP provocation. If an association is evident, CGRP provocation could prove a biomarker for predicting antibody treatment efficacy.TRIAL REGISTRATION: Retrospectively registered at clinicaltrials.gov with identifier: NCT03481400 .

KW - Adult

KW - Antibodies, Monoclonal/pharmacology

KW - Calcitonin Gene-Related Peptide/antagonists & inhibitors

KW - Cross-Over Studies

KW - Denmark/epidemiology

KW - Double-Blind Method

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Migraine Disorders/chemically induced

KW - Retrospective Studies

KW - Young Adult

U2 - 10.1186/s10194-018-0927-2

DO - 10.1186/s10194-018-0927-2

M3 - Journal article

C2 - 30409109

SN - 1129-2369

VL - 19

JO - The Journal of Headache and Pain

JF - The Journal of Headache and Pain

M1 - 105

ER -

Migraine induction with calcitonin gene-related peptide in patients from erenumab trials

Abstract

Keywords

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