Calcitonin Gene‐Related Peptide Antagonists in the Treatment of Episodic Migraine

2019 ◽  
Vol 105 (5) ◽  
pp. 1121-1129 ◽  
Author(s):  
Hsiangkuo Yuan ◽  
Courtney S. White ◽  
Stephen D. Silberstein
Keyword(s):  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Related Peptide ◽  
Calcitonin Gene

Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial

2014 ◽  
Vol 13 (11) ◽  
pp. 1100-1107 ◽  
Author(s):  
David W Dodick ◽  
Peter J Goadsby ◽  
Stephen D Silberstein ◽  
Richard B Lipton ◽  
Jes Olesen ◽  
...  
Keyword(s):  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Phase 2 ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
Related Peptide ◽  
Phase 2 Trial ◽  
Calcitonin Gene

The efficacy and safety of calcitonin gene-related peptide monoclonal antibody for episodic migraine: a meta-analysis

2018 ◽  
Vol 39 (12) ◽  
pp. 2097-2106 ◽  
Author(s):  
Yuhan Zhu ◽  
Yanyan Liu ◽  
Jing Zhao ◽  
Qingqing Han ◽  
Lei Liu ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Meta Analysis ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Efficacy And Safety ◽  
Related Peptide ◽  
Calcitonin Gene

Safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine – a meta-analysis of randomized controlled trials

Cephalalgia ◽  
2019 ◽  
Vol 39 (9) ◽  
pp. 1164-1179 ◽  
Author(s):  
Da Xu ◽  
Deng Chen ◽  
Li-na Zhu ◽  
Ge Tan ◽  
Hai-jiao Wang ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Injection Site ◽  
Meta Analysis ◽  
Peptide Binding ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Serious Adverse Events ◽  
Related Peptide ◽  
Calcitonin Gene

Aim To systematically evaluate the safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies from the results of randomized controlled trials. Methods Online databases were searched on calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine. Overall withdrawal, withdrawal due to adverse events, adverse events, serious adverse events and specific adverse events were extracted from the included studies. A meta-analysis was performed with Revman 5.3.0 software. Results Ten studies that investigated four drugs (galcanezumab, erenumab, fremanezumab and eptinezumab) with 5817 participants were included in this study. Serious adverse events, overall withdrawals, withdrawal due to adverse events and any adverse events were not significantly associated with monoclonal antibody treatment. Injection site pain and erythema were significantly higher in the calcitonin-gene-related peptide binding monoclonal antibodies treatment group than in the placebo group. The rates of serious adverse events were significantly higher in the galcanezumab 120 mg group. Injection site erythema was associated with galcanezumab 120 mg and 240 mg. Injection site pain and nasopharyngitis were associated with galcanezumab 150 mg and 5 mg, respectively. Overall adverse events were significantly higher with erenumab 70 mg and 140 mg. Treatment-related adverse events were significantly higher with fremanezumab 225 mg/month and 675 mg/quarter. Conclusions This study provides data on the safety and tolerability profiles of calcitonin-gene-related peptide binding monoclonal antibodies and confirms their potential use as preventive treatments for episodic migraine. In addition to the acceptable withdrawal rates, serious adverse events were rare, and the severity of most adverse events was mild to moderate. Injection site reaction may be the major adverse event associated with galcanezumab.

Diagnostic value of migraine biomarker — calcitonin-gene-related peptide

2021 ◽  
Author(s):  
O. Y. Dubenko ◽  
A. G. Chernenko
Keyword(s):  
Serum Level ◽  
Daily Activity ◽  
Episodic Migraine ◽  
Cervicogenic Headache ◽  
Calcitonin Gene Related Peptide ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Related Peptide ◽  
Calcitonin Gene ◽  
And Performance

Objective — to study the diagnostic significance of the serum level of calcitonin‑gene‑related peptide as a tool for the differential diagnosis of migraine with comorbid neck pain and tension of the pericranial muscles and cervicogenic headache. Methods and subjects. The study included 112 patients (84 women, 28 men) aged from 18 to 58 years. In 77 patients episodic migraine was diagnosed (with a typical aura in 17 and without aura in 60 patients), in 35 patients suffered from cervicalgia with muscle‑tonic syndromes and cervicogenic headache. Among patients with migraine, 42 had concomitant cervicalgia with muscle‑tonic dysfunction. The examined patients were distributed into 3 clinical groups: I — combination of episodic migraine with cervicalgia, II — episodic migraine, III — cervicalgia without migraine. In all patients, pain intensity was assessed using a visual analogue scale, the effect of migraine on daily activity and performance using the MIDAS and HIT‑6 scales, and the Neck Disability Index. The control group for comparing the serum level of CGRP consisted of 30 clinically healthy persons. The serum level of CGRP was determined by enzyme‑linked immunosorbent assay using the sandwich ELISA principle. Results. In the group of patients with a combination of episodic migraine with cervicalgia and cervicogenic headache, compared with the group with isolated migraine, the number of days with headache over the last 3 months was higher (р < 0.001), the influence of headache on daily activity and performance according to the MIDAS scales and HIT‑6 was more significant (both р < 0.001) and the number of combined analgesics used was higher (р < 0.001). Plasma level of CGRP was statistically significantly higher in patients with episodic migraine compared with the group with cervicalgia without migraine (р < 0.05), where it did not differ from the control. The CGRP level was statistically significantly higher in women with migraine compared to men (р < 0.001), but did not differ in patients with migraine with and without aura (р > 0.05). Conclusions. The serum level of calcitonin‑gene‑related peptide is a reliable diagnostic and differential diagnostic laboratory biomarker of episodic migraine. The presence of concomitant cervicalgia in patients with episodic migraine significantly affects the level of CGRP in the blood plasma and the course of the disease (an increase in the number of days with headache, the amount of analgesic use, decreased performance and daily activity).  

scholarly journals Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab

2017 ◽  
Vol Volume 10 ◽  
pp. 2751-2760 ◽  
Author(s):  
Maria Giamberardino ◽  
Giannapia Affaitati ◽  
Raffaele Costantini ◽  
Francesco Cipollone ◽  
Paolo Martelletti
Keyword(s):  
Safety Profile ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Current Evidence ◽  
Peptide Receptor ◽  
Related Peptide ◽  
Calcitonin Gene ◽  
Novel Target

Hypersensitivity to calcitonin gene-related peptide in chronic migraine

Cephalalgia ◽  
2020 ◽  
pp. 033310242098166
Author(s):  
Afrim Iljazi ◽  
Håkan Ashina ◽  
Zixuan Alice Zhuang ◽  
Cristina Lopez Lopez ◽  
Josefin Snellman ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Pain Threshold ◽  
Pressure Pain Threshold ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Trigeminal System ◽  
Pressure Pain ◽  
Related Peptide ◽  
Calcitonin Gene ◽  
Historic Cohort

Objective To investigate if calcitonin gene-related peptide infusion induces migraine-like attacks in chronic migraine patients. Methods Fifty-eight patients with chronic migraine, either with or without headache on the experimental day, were assessed for the incidence of migraine-like attacks after an intravenous infusion with calcitonin gene-related peptide 1.5 µg/min over 20 min. The primary endpoint was the incidence of migraine-like attacks after calcitonin gene-related peptide. Exploratory endpoints were the association between the incidence of migraine-like attacks and presence of headache on the experimental day, and headache frequency in the past month. Migraine-like attack data was compared to a historic cohort of 91 episodic migraine patients without headache on the experimental day. Total tenderness score, pressure-pain threshold and supra-threshold pressure pain at baseline were investigated in relation to incidence of migraine-like attacks and presence of headache on the experimental day. Results In total, 83% of the 58 chronic migraine patients developed migraine-like attacks after calcitonin gene-related peptide infusion. Migraine-like attacks were found in 92% of chronic migraine patients with headache on the experimental day compared to 65% of chronic migraine patients without headache on the experimental day ( p = 0.035). No differences were observed in total tenderness score and pressure-pain threshold between chronic migraine patients with and without headache on the experimental day. The incidence of migraine-like attacks following calcitonin gene-related peptide in chronic migraine patients without headache (65%) was equal to the historic cohort of 91 episodic migraine patients without headache (67%) on the experimental day. Conclusions Chronic migraine patients are hypersensitive to calcitonin gene-related peptide. The potency of calcitonin gene-related peptide as a migraine inductor is increased in chronic migraine patients with ongoing headache. We suggest that calcitonin gene-related peptide, besides being a migraine trigger also acts as a modulator of nociceptive transmission in the trigeminal system.

scholarly journals Assessment of immunogenicity from galcanezumab phase 3 trials in patients with episodic or chronic migraine

Cephalalgia ◽  
2020 ◽  
Vol 40 (9) ◽  
pp. 978-989 ◽  
Author(s):  
James M Martinez ◽  
Nada Hindiyeh ◽  
Greg Anglin ◽  
Kavita Kalidas ◽  
Michael E Hodsdon ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Antibody Titer ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Phase 3 ◽  
Related Peptide ◽  
Antidrug Antibody ◽  
Calcitonin Gene ◽  
Antidrug Antibodies

Background This analysis characterizes the immunogenicity profile of galcanezumab, a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and inhibits its activity, in phase 3 migraine trials. Methods Immunogenicity data were analyzed from baseline and double-blind, placebo-controlled phases of the 3-month chronic migraine study REGAIN, the 6-month episodic migraine studies EVOLVE-1 and EVOLVE-2, and from baseline and open-label phases of the 12-month chronic and episodic migraine Study CGAJ. The incidence of baseline antidrug antibodies, treatment-emergent antidrug antibodies, neutralizing antidrug antibodies, and the effect of antidrug antibody titer on pharmacokinetics and pharmacodynamics were assessed. The relationship between antidrug antibody status and efficacy was explored using average change in monthly migraine headache days. Safety analyses assessed the potential relationship between treatment-emergent antidrug antibodies and hypersensitivity events or adverse events related to injection sites. Findings Across studies, 5.9–11.2% of patients had baseline antidrug antibodies. The incidence of treatment-emergent antidrug antibodies was 2.6–12.4% in the galcanezumab group and 0.5–1.7% in the placebo group. The majority of treatment-emergent antidrug antibodies were detected approximately 3–6 months after first study drug dose. Overall, the observed antidrug antibody titer did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or galcanezumab efficacy. There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies. Interpretation These data showed that immunogenicity did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or the efficacy and hypersensitivity profile of galcanezumab in patients with migraine.

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