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

scholarly journals Efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibodies for the preventive treatment of episodic migraine – An updated systematic review and meta-analysis

2019 ◽  
Author(s):  
Hong Deng ◽  
Gai-gai Li ◽  
Hao Nie ◽  
Yang-yang Feng ◽  
Guang-yu Guo ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Meta Analysis ◽  
Peptide Binding ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Efficacy And Safety ◽  
High Quality ◽  
Related Peptide ◽  
Calcitonin Gene

Abstract Background: Migraine is one of the most common neurological disorders that leads to disabilities. However, the conventional drug therapy for migraine is unsatisfactory. Therefore, this meta-analysis aimed to evaluate the efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibody (CGRP mAb) for the preventive treatment of episodic migraine, and provide high-quality clinical evidence for migraine therapy. Methods: A systematic electronic database search was conducted to identify the potentially relevant studies. Two independent authors performed data extraction and quality appraisal. Mean difference (MD) and risk ratio (RR) were pooled for continuous and dichotomous data, respectively. The significance levels, weighted effect sizes and homogeneity of variance were calculated. Results: Eleven high-quality randomized control trials that collectively included 4402 patients were included in this meta-analysis. Compared to placebo group, CGRP mAb therapy resulted in a reduction of monthly migraine days [weighted mean difference (WMD) = −1.44, 95% CI = (−1.68,−1.19)] and acute migraine-specific medication days [WMD = −1.28, 95% CI = (−1.66,−0.90)], with an improvement in 50% responder rate [RR = 1.51, 95% CI =(1.37,1.66)]. In addition, the adverse events (AEs) and treatment withdrawal rates due to AEs were not significantly different between CGRP mAb and placebo groups. Similar efficacy and safety results were obtained for erenumab, fremanezumab, and galcanezumab in subgroup analysis. Conclusions: The current body of evidence reveals that CGRP mAb is an effective and safe preventive treatment for episodic migraine. Keywords: calcitonin gene-related peptide monoclonal antibody, episodic migraine, efficacy, safety, meta-analysis

scholarly journals Efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibodies for the preventive treatment of episodic migraine – An updated systematic review and meta-analysis

2019 ◽  
Author(s):  
Hong Deng ◽  
Gai-gai Li ◽  
Hao Nie ◽  
Yang-yang Feng ◽  
Guang-yu Guo ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Peptide Binding ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Mean Difference ◽  
Efficacy And Safety ◽  
High Quality ◽  
Related Peptide ◽  
Calcitonin Gene

Abstract Background Migraine is one of the most common neurological disorders that leads to disabilities. However, the conventional drug therapy for migraine is unsatisfactory. Therefore, this meta-analysis aimed to evaluate the efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibody (CGRP mAb) for the preventive treatment of episodic migraine, and provide high-quality clinical evidence for migraine therapy.Methods A systematic electronic database search was conducted to identify the potentially relevant studies. Two independent authors performed data extraction and quality appraisal. Mean difference (MD) and risk ratio (RR) were pooled for continuous and dichotomous data, respectively. The significance levels, weighted effect sizes and homogeneity of variance were calculated.Results Eleven high-quality randomized control trials that collectively included 4402 patients were included in this meta-analysis. Compared to placebo group, CGRP mAb therapy resulted in a reduction of monthly migraine days [weighted mean difference (WMD) = −1.44, 95% CI = (−1.68,−1.19)] and acute migraine-specific medication days [WMD = −1.28, 95% CI = (−1.66,−0.90)], with an improvement in 50% responder rate [RR = 1.51, 95% CI =(1.37,1.66)]. In addition, the adverse events (AEs) and treatment withdrawal rates due to AEs were not significantly different between CGRP mAb and placebo groups. Similar efficacy and safety results were obtained for erenumab, fremanezumab, and galcanezumab in subgroup analysis.Conclusions The current body of evidence reveals that CGRP mAb is an effective and safe preventive treatment for episodic migraine.

Galcanezumab for the prevention of migraine

2020 ◽  
Author(s):  
Lindsay M Frerichs ◽  
Deborah I Friedman
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Efficacy ◽  
Preventive Treatment ◽  
Calcitonin Gene Related Peptide ◽  
Efficacy And Safety ◽  
Related Peptide ◽  
Calcitonin Gene

Migraine is a common and disabling disorder affecting approximately 1.02 billion people worldwide. Calcitonin gene-related peptide (CGRP) has been identified as playing an important role in the pathophysiology of migraine and several migraine-specific therapies targeting the CGRP ligand or its receptor have been approved since 2018 for the acute and preventive treatment of migraine. This review focuses on the pharmacology, clinical efficacy and safety/tolerability of galcanezumab, an anti-CGRP monoclonal antibody approved for the prevention of migraine.

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.

scholarly journals PEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine

2021 ◽  
Author(s):  
Messoud Ashina ◽  
Faisal Mohammad Amin ◽  
Pinar Kokturk ◽  
Joshua M Cohen ◽  
Martijn Konings ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Real World ◽  
Real Life ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Real World Data ◽  
Related Peptide ◽  
Humanized Monoclonal Antibody ◽  
Calcitonin Gene ◽  
Acute Headache

Fremanezumab is a humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide and is approved in Europe for migraine prevention in adults with ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month, prospective, observational study of fremanezumab in chronic or episodic migraine. End points include proportion of patients with ≥50% reduction in monthly migraine days during 6 months of treatment (primary); changes in monthly migraine days, disability scores and acute headache medication use; adherence and persistence; and effectiveness in patients switching from another calcitonin gene-related peptide pathway-targeting monoclonal antibody. PEARL is being conducted in approximately 100 centers in 11 European countries (estimated n = 1100). PEARL will generate important real-world data on effectiveness of fremanezumab and treatment patterns in patients with chronic migraine or episodic migraine.

scholarly journals Eptinezumab: A calcitonin gene-related peptide monoclonal antibody infusion for migraine prevention

2021 ◽  
Vol 9 ◽  
pp. 205031212110501
Author(s):  
Kelsey Woods Morgan ◽  
Kayla Rena Joyner
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Cochrane Library ◽  
Number Needed To Treat ◽  
Onset Of Action ◽  
Federal Drug Administration ◽  
Related Peptide ◽  
Calcitonin Gene

This article seeks to analyze the clinical trials concerning the newly approved eptinezumab to assess its efficacy, safety, and application to current clinical practice. The Institute of Health US National Library of Medicine Clinical Trials, PubMed, and Cochrane Library databases were searched for relevant abstracts, journal articles, and other published sources. Search terms included eptinezumab, Vyepti®, and ALD403. Relevant English-language articles were evaluated and included in the narrative. Two randomized controlled trials compared quarterly infusions of eptinezumab 100 mg, eptinezumab 300 mg, and placebo in chronic and episodic migraine sufferers. In episodic migraine, eptinezumab resulted in a reduction of approximately 4 monthly migraine days, which was significant compared to placebo. In chronic migraine, eptinezumab reduced monthly migraine days by approximately 8 days, also significant compared to placebo. More patients who received eptinezumab experienced at least 75% reduction in monthly migraine days compared to placebo, resulting in a number needed to treat as low as 6, depending on the study population and the dose. The preventive impact was noticed day one post-infusion. The most common treatment-emergent adverse events were nausea and fatigue, and there was a low incidence of hypersensitivity or study withdrawal. Eptinezumab is the fourth Calcitonin Gene-related Peptide monoclonal antibody to receive Federal Drug Administration approval. Its delivery as a quarterly infusion sets it apart from the other agents in this class. As an infusion, eptinezumab has a quick onset of action that may prove especially beneficial to those with severe or refractory episodic or chronic migraines, despite the perceived increased direct and indirect cost of an infusion.

scholarly journals Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Xing Wang ◽  
Yuqi Chen ◽  
Jinlei Song ◽  
Chao You
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Calcitonin Gene Related Peptide ◽  
Adult Patients ◽  
Related Peptide ◽  
Calcitonin Gene

Background: The optimal monoclonal antibody against calcitonin gene-related peptide (CGRP) for adult patients with migraine has yet to be determined. Therefore, we aimed to compare the effectiveness of different monoclonal antibodies against CGRP or its receptor for adult patients with migraine through a network meta-analysis of randomized controlled trials.Methods: We systematically searched the MEDILNE, Embase, ClinicalTrials.gov, and Cochrane Library databases for relevant publications from inception until October 30, 2020. Only randomized clinical trials of adults with migraine that assessed any calcitonin gene-related peptide monoclonal antibody and reported clinical outcomes were included. The primary outcomes were changes in monthly migraine days and treatment-emergent adverse eventsResults: We initially retrieved 2,070 publications, and ultimately, 18 randomized clinical trials totaling 8,926 patients were included. In terms of efficacy, eptinezumab (MD −1.43, 95% CrI −2.59 to −0.36), erenumab (MD −1.61, 95% CrI −2.40 to −0.84), fremanezumab (MD −2.19, 95% CrI −3.15 to −1.25), and galcanezumab (MD −2.10, 95% CrI −2.76 to −1.45) significantly reduced MMDs compared with placebo. In terms of safety, only galcanezumab increased the incidences of TEAEs (RR 1.11, 95% CrI 1.01–1.22) and serious adverse events (RR 2.95, 95% CrI 1.41–6.87) compared with placebo.Conclusion: Most drugs performed similarly and were superior to placebo in most of our analyses. Further head-to-head research on different types of CGRP monoclonal antibodies is necessary to validate the present findings.

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