Año 2023
Revista International immunopharmacology
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OBJECTIVE: This systematic review aims to show the efficiency of Erenumab in the preventive therapy of episodic and chronic migraine, which is still under research. BACKGROUND: Migraine is a chronic neurovascular disorder that causes disability and a social burden. There are various medications used for migraine prevention regimens, most of which have unwanted side effects and aren't often quite effective. Erenumab is a monoclonal antibody that targets calcitonin gene-related peptide receptors and was recently approved by the Food and Drug Administration for migraine prevention. METHODS: For this systematic review, we searched through Scopus and PubMed databases using "Erenumab" or "AMG 334" and "migraine" as keywords, and all the studies from 2016 to March 18, 2022, were included. Original English articles assessing any outcomes referring to the efficacy of Erenumab in migraine headache treatment were included in this study. RESULTS: We found 53 out of 605 papers eligible to be investigated. Erenumab in both dosages of 70 mg and 140 mg could decrease the mean of monthly migraine days and monthly acute migraine-specific medication days. Erenumab also has a higher rate of ≥ 50 %, ≥ 75 %, and 100 % reduction in monthly migraine days from the baseline in different regions. The efficacy of Erenumab was initiated in the first week of administration and sustained throughout and after treatment. Erenumab was also potent in the treatment of migraine with allodynia, aura, prior preventive therapy failure, medication overuse headache, and menstrual migraine. Erenumab also had favorable outcomes in combination therapy with other preventive drugs like Onabotulinumtoxin-A. CONCLUSION: Erenumab had remarkable efficacy in the short and long-term treatment of episodic and chronic migraine, notably the patients with difficult-to-treat migraine headaches.

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Año 2021
Autores Deligianni CI , Mitsikostas DD , Ashina M - Más
Revista Expert opinion on drug safety
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Introduction: Erenumab, a monoclonal antibody targeting the receptor of calcitonin gene related peptide (CGRP), is the first disease-specific and mechanism-based treatment approved for the prevention of migraine. Although the safety and tolerability data from randomized trials are clear, the physiological effects of CGRP rise reasonable concerns. We aimed to evaluate the current evidence for safety and tolerability related to erenumab use in migraine.Areas covered: This review outlines the severe adverse events (AEs), common AEs, AEs leading to treatment discontinuation and AEs of special interest, reported in all phase 2, phase 3, open label and observational studies with erenumab in migraine. Individual safety reports were also included in the systematic review of evidence.Expert opinion: No safety and tolerability flags were detected in this review. The most common AE are local skin reactions and constipation. No severe AEs, or frequent AEs leading to treatment discontinuation were detected. Treatment is well tolerated. The only AE of interest that may play a role in decision making and treatment monitoring is constipation. These findings are in line with previous safety reports, further highlighting the substantial tolerability and safety profile of the modern anti-CGRP monoclonal antibodies for the prevention of migraine.

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Año 2021
Autores Rashmi Halker Singh, MD - Más
Registro de estudios clinicaltrials.gov
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This research is being conducting to learn if the study drug erenumab is successful in treating hemicrania continua. The study is also evaluating the safety and tolerability of erenumab in individuals being treated for hemicrania continua.

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Año 2021
Autores [No se listan los autores]
Registro de estudios clinicaltrials.gov
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Erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (CGRP) receptor, is an effective and safe migraine-specific preventive drug. The use of migraine-specific preventive drugs paves the way for a novel method to study migraine pathogenesis. Migraine is a complex disorder with several genetic and epigenetic influence, including that of microRNA. Several microRNAs, including those of inflammation and of endothelial function, have high expression levels in subjects with migraine; however, the findings of the available studies are insufficient to provide epigenetic biomarkers for migraine. Besides, little evidence is available on the role of migraine preventive treatments in the expression of microRNA. The study aims at evaluating the expression profiles of microRNAs before and after erenumab treatment prescribed according to clinical indication. The study will include women with episodic or chronic migraine treated with erenumab 140 mg monthly according to the Summary of Product Characteristics and local reimbursement criteria. The study will compare the expression profile of microRNAs in women with episodic and chronic migraine; besides, it will investigate differences in migraine-associated microRNA expression according to age, migraine characteristics, pain intensity, response to erenumab, migraine-related impact and disability.

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Año 2021
Autores David Jang, MD - Más
Registro de estudios clinicaltrials.gov
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Eligible participants are randomized to receive either Erenumab or placebo by subcutaneous injection once monthly for 6 months. Study duration is eight months which includes a 30 day screening/lead-in period and 6 monthly treatment visits followed by a follow-up visit one month following the last dose of study drug administration. Participants will be expected to score on a scale of 1 to 10 their symptoms of facial pain/pressure, nasal congestion, and rhinorrhea as well well as any rescue medicines taken for pain each day via a mobile app.

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Año 2017
Revista The New England journal of medicine
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BACKGROUND: We tested erenumab, a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, for the prevention of episodic migraine. METHODS: We randomly assigned patients to receive a subcutaneous injection of either erenumab, at a dose of 70 mg or 140 mg, or placebo monthly for 6 months. The primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month. Secondary end points were a 50% or greater reduction in mean migraine days per month, change in the number of days of use of acute migraine-specific medication, and change in scores on the physical-impairment and everyday-activities domains of the Migraine Physical Function Impact Diary (scale transformed to 0 to 100, with higher scores representing greater migraine burden on functioning). RESULTS: A total of 955 patients underwent randomization: 317 were assigned to the 70-mg erenumab group, 319 to the 140-mg erenumab group, and 319 to the placebo group. The mean number of migraine days per month at baseline was 8.3 in the overall population; by months 4 through 6, the number of days was reduced by 3.2 in the 70-mg erenumab group and by 3.7 in the 140-mg erenumab group, as compared with 1.8 days in the placebo group (P<0.001 for each dose vs. placebo). A 50% or greater reduction in the mean number of migraine days per month was achieved for 43.3% of patients in the 70-mg erenumab group and 50.0% of patients in the 140-mg erenumab group, as compared with 26.6% in the placebo group (P<0.001 for each dose vs. placebo), and the number of days of use of acute migraine-specific medication was reduced by 1.1 days in the 70-mg erenumab group and by 1.6 days in the 140-mg erenumab group, as compared with 0.2 days in the placebo group (P<0.001 for each dose vs. placebo). Physical-impairment scores improved by 4.2 and 4.8 points in the 70-mg and 140-mg erenumab groups, respectively, as compared with 2.4 points in the placebo group (P<0.001 for each dose vs. placebo), and everyday-activities scores improved by 5.5 and 5.9 points in the 70-mg and 140-mg erenumab groups, respectively, as compared with 3.3 points in the placebo group (P<0.001 for each dose vs. placebo). The rates of adverse events were similar between erenumab and placebo. CONCLUSIONS: Erenumab administered subcutaneously at a monthly dose of 70 mg or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities, and the use of acute migraine-specific medication over a period of 6 months. The long-term safety and durability of the effect of erenumab require further study. (Funded by Amgen and Novartis; STRIVE ClinicalTrials.gov number, NCT02456740 .).

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Año 2020
Autores Merle Diamond, MD - Más
Registro de estudios clinicaltrials.gov
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This is a single group, multicenter, open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for migraine with or without aura and have 4 to 20 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 54 participants will be enrolled to study intervention. All participants in this single-group study will complete a 4-week run-in period. After the run-in period, eligible participants will be enrolled to study intervention and enter a 12-week treatment period.

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Año 2021
Autores Uwe Reuter, MD - Más
Registro de estudios clinicaltrials.gov
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The purpose of this study is to determine the efficacy of erenumab in a loading dose of 280mg followed by 140mg after 4 weeks compared to placebo as a prophylactic treatment in patients with chronic cluster headache. This study has a 10-week 2-arm, randomized, double-blind, parallel- group, placebo-controlled design. Data from this study will provide important information if the blockade of the CGRP receptor with erenumab is an efficacious principle for the treatment of chronic cluster headache

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Año 2022
Revista Headache
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BACKGROUND: Therapeutic monoclonal antibodies against the calcitonin gene-related peptide (CGRP) receptor or its ligand have changed the landscape of treatment options for migraine. Erenumab is the first and only fully human monoclonal antibody designed to target and block the CGRP receptor. It is approved by the Food and Drug Administration for preventive treatment of migraine in adults. The recommended dose of erenumab is 70 mg monthly, with guidance that some patients may benefit from the 140 mg monthly dose. There is a need for information to guide clinical practice on the comparative efficacy and safety of these two dosing options. OBJECTIVE: To evaluate therapeutic and tolerability differences between erenumab 70 and 140 mg based on evidence from published literature. METHODS: This narrative review evaluates therapeutic and tolerability differences between erenumab 70 and 140 mg based on a literature search using PubMed interface, Embase and Ovid MEDLINE(R) databases. The key search terms included migraine, AMG 334, AMG334, erenumab, erenumab-aooe, and Aimovig. The search was limited to English language articles or conference abstracts published up to May 2021. RESULTS: From the literature search, we retrieved 23 relevant articles/conference abstracts (19 articles [5 randomized, double-blind studies] and 4 conference abstracts) for inclusion in this narrative review. Although the recommended starting dosage of erenumab is 70 mg, this narrative review of the literature indicates that some patients may benefit from a dosage of 140 mg erenumab once monthly-especially those with difficult-to-treat disease and prior treatment failures. The evidence indicates that erenumab at 140 mg has a numerically better efficacy than 70 mg across a broad spectrum of migraine outcomes, including preventing progression to chronic migraine. CONCLUSION: Cumulative data from the literature support a therapeutic gain with an increase from erenumab 70 to 140 mg and a rationale for initiating 140 mg in selected patients.

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Año 2018
Autores LIN Yan , CHEN Deng , XU Da , LIU Ling - Más
Revista Chinese Journal of Contemporary Neurology & Neurosurgery
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Objective To systematically evaluate the clinical efficacy and safety of erenumab in the preventive treatment of migraine in adults. Methods Taking Erenumab or AMG334 AND Migraine as search terms, retrieve in databases such as PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data and VIP, and search engines such as Google Scholar, in order to collect randomized controlled trials (RCTs) of erenumab in the preventive treatment of adult migraine from January 1, 2001 to August 1, 2018. Jadad Scale was used to evaluate the quality of literatures. Results A total of 68 English articles were enrolled after preliminary searching, and 4 high-quality RCTs (Jadad score ≥ 4) with a total of 2682 cases (1626 cases in erenumab group and 1056 cases in placebo group) were finally included after excluding duplicates and those not meeting the inclusion criteria. The results were as follows: 1) compared with placebo, erenumab (70 mg/4 weeks or per month, 140 mg/4 weeks) was more effective (effective defined as ≥ 50% reduction from baseline migraine days per month) and showed significantly higher efficacy in reducing migraine days per month, the use of migraine-specific medication, Migraine Physical Function Impact Diary on Everyday Activities and Physical Impairment (MPFID-EA and MPFID-PI) in treating migraine patients. 2) The incidence of adverse reactions was low and mild, and there was no significant difference compared with placebo. Common adverse reactions included injection site pain, upper respiratory tract infection, nasopharyngitis, etc. There were very few patients who discontinued treatment due to adverse drug reactions. Conclusions Erenumab is safe and effective in the preventive treatment of migraine in adults.

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