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      Fremanezumab in the treatment of migraines: evidence to date

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          Abstract

          Calcitonin gene-related peptide (CGRP) is a major player in migraine pathophysiology, and CGRP monoclonal antibodies including fremanezumab may be a safe effective preventive therapy. Phase IIb studies in episodic migraine (EM) and chronic migraine (CM) demonstrated efficacy at both the monthly 225 mg and quarterly 675 mg doses. The Phase III trials for EM and CM both showed a reduction in the primary endpoint of monthly migraine days (MMD). In the EM trial, the baseline MMD of 8.9 days was reduced to 5.3 at 12 weeks and to 4.0 days in the 6-month open-label extension (OLE) for monthly dosing. In the quarterly dosing, the baseline was 9.2 days reduced to 5.3 at 12 weeks and to 4.2 days in the OLE. In the CM data for monthly dosing, the baseline was 16.2 days decreased to 11.4 at 12 weeks then to 8.3 in the OLE. In the CM quarterly dosing, the baseline of 16.4 days was reduced to 11.9 at 12 weeks and 9.9 days in the OLE. Randomized controlled trials of fremanezumab in both episodic cluster and post-traumatic headache are underway, but the trial for chronic cluster headache was stopped for futility. The most common adverse events are injection site pain (24% vs 22% for placebo), induration (17% vs 13% for placebo), and erythema (16% vs 12% for placebo). Severe adverse events were reported in 3.9% of the fremanezumab vs 3.7% of the placebo. No changes in vitals or ECG were reported. The long-term effects are not known, but the American Headache Society recommends that CGRP monoclonal antibodies be considered in EM or CM depending on previous medication trials and headache disability/frequency. Further, post-market studies are required, but for EM and CM fremanezumab is a new option for migraine preventive treatment.

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          Most cited references 29

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          Perspectives on Immunoglobulins in Colostrum and Milk

          Immunoglobulins form an important component of the immunological activity found in milk and colostrum. They are central to the immunological link that occurs when the mother transfers passive immunity to the offspring. The mechanism of transfer varies among mammalian species. Cattle provide a readily available immune rich colostrum and milk in large quantities, making those secretions important potential sources of immune products that may benefit humans. Immune milk is a term used to describe a range of products of the bovine mammary gland that have been tested against several human diseases. The use of colostrum or milk as a source of immunoglobulins, whether intended for the neonate of the species producing the secretion or for a different species, can be viewed in the context of the types of immunoglobulins in the secretion, the mechanisms by which the immunoglobulins are secreted, and the mechanisms by which the neonate or adult consuming the milk then gains immunological benefit. The stability of immunoglobulins as they undergo processing in the milk, or undergo digestion in the intestine, is an additional consideration for evaluating the value of milk immunoglobulins. This review summarizes the fundamental knowledge of immunoglobulins found in colostrum, milk, and immune milk.
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            Fremanezumab for the Preventive Treatment of Chronic Migraine

            Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide (CGRP), is being investigated as a preventive treatment for migraine. We compared two fremanezumab dose regimens with placebo for the prevention of chronic migraine.
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              Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study.

              Calcitonin gene-related peptide (CGRP) is a validated target for the treatment of episodic migraine. Here we assess the safety, tolerability, and efficacy of TEV-48125, a monoclonal anti-CGRP antibody, in the preventive treatment of high-frequency episodic migraine.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                JPR
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                22 August 2019
                2019
                : 12
                : 2589-2595
                Affiliations
                [1 ]Department of Neurology, Mayo Clinic , Scottsdale, AZ, USA
                Author notes
                Correspondence: Juliana VanderPluymDepartment of Neurology, Mayo Clinic , 13400 E Shea Blvd, Scottsdale, AZ 85259, USAEmail vanderpluym.juliana@mayo.edu
                Article
                166427
                10.2147/JPR.S166427
                6709817
                © 2019 Robblee and VanderPluym.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

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                Tables: 1, References: 32, Pages: 7
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