Eptinezumab for the preventive treatment of migraine

2020 ◽  
Author(s):  
María Dolores Villar-Martínez ◽  
David Moreno-Ajona ◽  
Peter J Goadsby
Keyword(s):  
Preventive Treatment ◽  
Calcitonin Gene Related Peptide ◽  
Phase Iii ◽  
Two Phase ◽  
Related Peptide ◽  
Phase Iii Clinical Trials ◽  
Fda Approval ◽  
Calcitonin Gene ◽  
The Us ◽  
Us Fda

Our knowledge of the pathophysiology of migraine and the molecules implicated in the disorder have evolved over time. Among these, calcitonin gene-related peptide has shown a crucial role that led to the development of therapies specifically targeting the molecule. Four monoclonal antibodies targeting the calcitonin gene-related peptide pathway are currently available after the US FDA approval of eptinezumab for the indication of migraine prevention. This is the only one of the class to be administered intravenously. The pharmacology of eptinezumab and the four studies that led to the approval, two Phase II and two Phase III clinical trials, are reviewed in this paper. Eptinezumab has demonstrated efficacy, tolerability and safety in patients with episodic and chronic migraine. Studies including migraineurs who have failed previous preventives, and comparison with other options administered quarterly, as well as real-world experience data will all be welcome.

Fremanezumab autoinjector pen for the prevention of migraine

2021 ◽  
Author(s):  
Mark W Weatherall
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Calcitonin Gene Related Peptide ◽  
Phase Iii ◽  
Tolerability Profile ◽  
Related Peptide ◽  
Phase Iii Clinical Trials ◽  
Humanized Monoclonal Antibody ◽  
Calcitonin Gene ◽  
Favorable Tolerability Profile

Ajovy (fremanezumab, Teva Pharmaceuticals, Israel) is a fully humanized monoclonal antibody that selectively binds both isoforms of the calcitonin gene-related peptide. Calcitonin gene-related peptide is a 37-amino acid neuropeptide involved in central and peripheral pathophysiological events in migraine. It is indicated for prophylaxis of migraine in adults who have at least four migraine days per month, and can be administered as a subcutaneous injection using an autoinjector device, with two dosing options: 225 mg once a month or 675 mg quarterly. In this article, I present data from Phase III clinical trials of fremanezumab in episodic and chronic migraine, in which fremanezumab demonstrated efficacy and had a favorable tolerability profile, with no serious treatment-related adverse events.

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.

scholarly journals Role of Calcitonin Gene Related Peptide (CGRP) in Migraine

2017 ◽  
Vol 33 (1) ◽  
pp. 39-43
Author(s):  
Md Ashraf Ali ◽  
Habibur Rahaman
Keyword(s):  
Family Relationships ◽  
Preventive Treatment ◽  
Primary Headache ◽  
Calcitonin Gene Related Peptide ◽  
Childhood And Adolescence ◽  
Protein Extravasation ◽  
Related Peptide ◽  
Plasma Protein Extravasation ◽  
Calcitonin Gene ◽  
Potent Vasodilator

Migraine is the second most primary headache. The prevalence of Migraine is 12% in the general population, including 18% in women and 6% in men. Migraine can start in childhood and adolescence and continue throughout lifespan. It is most prevalent among people in their 30s and 40s. Migraine is a debilitating hemicranial headache that is pulsating, aggravated by movement, nausea, vomiting and having sensitivity to light and sound, with or without aura. It can affect all aspects of life as work and school, parenting and family relationships and personal and leisure time. There are some theory regarding pathogenesis of migraine which includes cortical spreading depression, cortical spreading oligemia, activation of trigeminocervical complex leading to neuroinflammation & release of vasodialating neuropeptides which include calcitonin gene related peptide (CGRP), substance P, vasoactive intestinal polypeptide (VIP), nitric oxide (NO), and pituitary adenylate cyclase activating peptide (PACAP) & genetic factor. CGRP is a potent vasodilator and causes perivascular plasma protein extravasation and nociceptive pain. Newer medications target CGRP both for acute and preventive treatment of migraine. Bangladesh Journal of Neuroscience 2017; Vol.  33 (1): 39-43

scholarly journals Calcitonin Gene-Related Peptide Monoclonal Antibodies Versus Botulinum Neurotoxin a in the Preventive Treatment of Chronic Migraine: An Adjusted Indirect Treatment Comparison Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Yao-Yao Chen ◽  
Xiao-Qian Ye ◽  
Tai-Chun Tang ◽  
Tian-Wei She ◽  
Min Chen ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Chronic Migraine ◽  
Botulinum Neurotoxin ◽  
Meta Analysis ◽  
Preventive Treatment ◽  
Calcitonin Gene Related Peptide ◽  
Controlled Trials ◽  
Botulinum Neurotoxin A ◽  
Related Peptide ◽  
Calcitonin Gene

Purpose: Calcitonin gene-related peptide monoclonal antibodies (CGRPmAbs) are new agents approved by the US Food and Drug Administration for preventive treatment of chronic migraine. Comparison between CGRPmAbs and previously approved Botulinum neurotoxin A (BoNT-A) will inform optimal preventive treatment of chronic migraine, but head-to-head trials are lacking. We therefore aimed to perform adjusted indirect comparison between CGRPmAbs and BoNT-A through a meta-analysis.Methods: OVID MEDLINE, EMBASE and the Cochrane central register of controlled trials, clinical registries, and government websites were searched from inception to September 2019. Randomized controlled trials comparing CGRPmAbs or BoNT-A with placebo in the preventive treatment of chronic migraine were included. The primary outcomes were headache days and migraine days measured at week 12. Data were synthesized by using a frequentist approach; and the treatments were ranked by P-score.Results: We included 10 trials (n = 4,678) after screening 1049 candidates. Six trials were with low risk of bias. Fremanezumab had an effect similar to BoNT-A in the reduction of headache days at week 12 (standard mean difference [SMD] 0.08, 95%CI -0.55 to -0.7). Galcanezumab reduced more migraine days than BoNT-A at week 12 (SMD, -0.94, 95%CI −1.24 to −0.63); fremanezumab showed similar findings (SMD, −0.55, 95%CI −0.85 to −0.24). Galcanezumab and fremanezumab had better effect in mitigating headache impact at week 12. CGRPmAbs and BoNT-A had similar adverse event rate.Conclusion: CGRPmAbs and BoNT-A had similar effect in the preventive treatment of chronic migraine. BoNT-A might be preferentially selected owing to its cost-effectiveness profiles. Further studies with direct comparison of the two treatments are warranted.

scholarly journals Calcitonin Gene–Related Peptide Monoclonal Antibody Use for the Preventive Treatment of Refractory Headache Disorders in Adolescents

2021 ◽  
Vol 114 ◽  
pp. 62-67
Author(s):  
Kaitlin A. Greene ◽  
Carlyn P. Gentile ◽  
Christina L. Szperka ◽  
Marcy Yonker ◽  
Amy A. Gelfand ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Preventive Treatment ◽  
Calcitonin Gene Related Peptide ◽  
Headache Disorders ◽  
Related Peptide ◽  
Refractory Headache ◽  
Calcitonin Gene

CGRP ligand and receptor monoclonal antibodies for migraine prevention: Evidence review and clinical implications

Cephalalgia ◽  
2019 ◽  
Vol 39 (3) ◽  
pp. 445-458 ◽  
Author(s):  
David W Dodick
Keyword(s):  
Monoclonal Antibodies ◽  
Preventive Treatment ◽  
Calcitonin Gene Related Peptide ◽  
Long Term Outcomes ◽  
Open Label ◽  
Peptide Receptor ◽  
Related Peptide ◽  
Calcitonin Gene ◽  
Open Label Extension

Background: Monoclonal antibodies that target calcitonin gene-related peptide or the canonical calcitonin gene-related peptide receptor have emerged as effective and well tolerated for the preventive treatment of migraine. These large molecules appear ideally suited for migraine prevention. They have an extended biological half-life, are administered either monthly or quarterly either by subcutaneous injection or intravenous infusion, require minimal or no dose-titration and have the potential for a rapid onset of effect compared to conventional oral preventive drugs. There is high selectivity and they target an important mediator in the pathogenesis of migraine. Investigation: Phase II and pivotal phase III studies have all yielded positive results with a favorable adverse event profile. No serious treatment-related adverse outcomes have thus far been reported in controlled or long-term open-label extension studies. This tolerability profile promises to improve adherence and, possibly, long-term outcomes. Conclusions: Calcitonin gene-related peptide monoclonal antibodies are effective and well tolerated for the preventive treatment of migraine. They have distinct advantages over currently available oral preventive drugs. While treatment-related serious adverse events have not been observed in open-label extension studies, long-term outcomes and safety will require broad exposure in heterogeneous patient populations in clinical practice. In addition, their safety in women, especially during pregnancy, will require longitudinal surveillance. Given the overlapping mechanism(s), the effectiveness of existing (triptans) and emerging (calcitonin gene-related peptide receptor antagonists) acute therapies in those using a calcitonin gene-related peptide mAb will require further study.

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.

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

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