Monthly versus quarterly fremanezumab for the prevention of migraine: a systemic review and meta-analysis from randomized controlled trials.
Chronic migraine
Episodic migraine
Fremanezumab
Meta-analysis
Monthly administration
Quarterly administration
Journal
Naunyn-Schmiedeberg's archives of pharmacology
ISSN: 1432-1912
Titre abrégé: Naunyn Schmiedebergs Arch Pharmacol
Pays: Germany
ID NLM: 0326264
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
received:
04
08
2020
accepted:
22
10
2020
pubmed:
3
11
2020
medline:
6
11
2021
entrez:
2
11
2020
Statut:
ppublish
Résumé
Fremanezumab (TEV-48125) is a novel therapeutic drug for migraine prevention. Previous randomized controlled trials have proved the efficacy of fremanezumab; however, no systematic review has been performed to compare the differences between monthly and quarterly administration of fremanezumab. This meta-analysis aims to probe into the safety and efficacy of monthly fremanezumab for the prevention of migraine versus quarterly fremanezumab. We searched Pubmed, Embased, and Cochrane Library from December 1999 to December 2019 for randomized controlled trials (RCTs). Our meta-analysis finally pooled three RCTs with 1884 patients. We combined 1884 patients from three randomized controlled trials; the primary endpoint was mean monthly migraine days, from baseline to week 12. We concluded that the monthly administration of fremanezumab brought about a significant reduction in migraine days versus quarterly fremanezumab (P = 0.0008). Besides, monthly and quarterly fremanezumab have the same risk with mild and severe adverse events (P = 0.50; P = 0.39). Monthly administration of fremanezumab shows better outcomes for preventing migraines than quarterly fremanezumab and will not let to more adverse events. Patients with episodic migraine (EM) benefit more from monthly fremanezumab than patients with chronic migraine (CM).
Identifiants
pubmed: 33136176
doi: 10.1007/s00210-020-02009-7
pii: 10.1007/s00210-020-02009-7
doi:
Substances chimiques
Antibodies, Monoclonal
0
fremanezumab
0
Calcitonin Gene-Related Peptide
JHB2QIZ69Z
Types de publication
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
819-828Subventions
Organisme : Suzhou Health Talents Training Project
ID : GSWS2019002
Commentaires et corrections
Type : CommentIn
Références
Bigal ME, Lipton RB (2008) Clinical course in migraine: conceptualizing migraine transformation. Neurology 71(11):848–855. https://doi.org/10.1212/01.wnl.0000325565.63526.d2
doi: 10.1212/01.wnl.0000325565.63526.d2
pubmed: 18779513
Bigal ME, Dodick DW, Rapoport AM, Silberstein SD, Ma Y, Yang R, Loupe PS, Burstein R, Newman LC, Lipton RB (2015a) 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. Lancet Neurol 14(11):1081–1090. https://doi.org/10.1016/s1474-4422(15)00249-5
doi: 10.1016/s1474-4422(15)00249-5
pubmed: 26432182
Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC, Burstein R, Loupe PS, Ma Y, Yang R, Silberstein SD (2015b) Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol 14(11):1091–1100. https://doi.org/10.1016/S1474-4422(15)00245-8
doi: 10.1016/S1474-4422(15)00245-8
pubmed: 26432181
Bigal ME, Walter S, Rapoport AM (2019) Fremanezumab as a preventive treatment for episodic and chronic migraine. Expert Rev Neurother 19(8):719–728. https://doi.org/10.1080/14737175.2019.1614742
doi: 10.1080/14737175.2019.1614742
pubmed: 31043094
Bixi Gao NS, Yang Y, Sun Y, Chen M, Chen Z, Wang Z (2020) Safety and efficacy of fremanezumab for the prevention of migraine: a meta-analysis from randomized controlled trials. Front Neurol 11. https://doi.org/10.3389/fneur.2020.00435
Blumenfeld AM, Bloudek LM, Becker WJ, Buse DC, Varon SF, Maglinte GA, Wilcox TK, Kawata AK, Lipton RB (2013) Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache 53(4):644–655. https://doi.org/10.1111/head.12055
doi: 10.1111/head.12055
pubmed: 23458496
Buse DC, Lipton RB (2013) Global perspectives on the burden of episodic and chronic migraine. Cephalalgia 33(11):885–890. https://doi.org/10.1177/0333102413477736
doi: 10.1177/0333102413477736
pubmed: 23482725
Buse DC, Scher AI, Dodick DW, Reed ML, Fanning KM, Manack Adams A, Lipton RB (2016) Impact of migraine on the family: perspectives of people with migraine and their spouse/domestic partner in the CaMEO study. Mayo Clin Proc 91:596–611. https://doi.org/10.1016/j.mayocp.2016.02.013
doi: 10.1016/j.mayocp.2016.02.013
Cohen-Barak O, Weiss S, Rasamoelisolo M, Faulhaber N, Yeung PP, Loupe PS, Yoon E, Gandhi MD, Spiegelstein O, Aycardi E (2018) A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects. Cephalalgia 38(13):1960–1971. https://doi.org/10.1177/0333102418771376
doi: 10.1177/0333102418771376
pubmed: 29667896
Disease GBD, Injury I, Prevalence C (2017) Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 390(10100):1211–1259. https://doi.org/10.1016/S0140-6736(17)32154-2
doi: 10.1016/S0140-6736(17)32154-2
Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E (2018) Effect of Fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA 319(19):1999–2008. https://doi.org/10.1001/jama.2018.4853
doi: 10.1001/jama.2018.4853
pubmed: 29800211
Estemalik E, Tepper S (2013) Preventive treatment in migraine and the new US guidelines. Neuropsychiatr Dis Treat 9:709–720. https://doi.org/10.2147/NDT.S33769
doi: 10.2147/NDT.S33769
pubmed: 23717045
pmcid: 3663475
Fakharian E, Abedzadeh-Kalahroudi M, Atoof F (2018) Effect of tranexamic acid on prevention of hemorrhagic mass growth in patients with traumatic brain injury. World Neurosurg 109:e748–e753. https://doi.org/10.1016/j.wneu.2017.10.075
doi: 10.1016/j.wneu.2017.10.075
pubmed: 29074420
Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M (2019) Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet 394(10203):1030–1040. https://doi.org/10.1016/S0140-6736(19)31946-4
doi: 10.1016/S0140-6736(19)31946-4
pubmed: 31427046
Goadsby PJ, Holland PR, Martins-Oliveira M, Hoffmann J, Schankin C, Akerman S (2017) Pathophysiology of migraine: a disorder of sensory processing. Physiol Rev 97(2):553–622. https://doi.org/10.1152/physrev.00034.2015
doi: 10.1152/physrev.00034.2015
pubmed: 28179394
pmcid: 5539409
Headache Classification Committee of the International Headache S (2013) The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia 33(9):629–808. https://doi.org/10.1177/0333102413485658
doi: 10.1177/0333102413485658
Hoy SM (2018) Fremanezumab: first global approval. Drugs 78(17):1829–1834. https://doi.org/10.1007/s40265-018-1004-5
doi: 10.1007/s40265-018-1004-5
pubmed: 30406901
pmcid: 6422958
Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF, Group AA (2007) Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 68(5):343–349. https://doi.org/10.1212/01.wnl.0000252808.97649.21
doi: 10.1212/01.wnl.0000252808.97649.21
pubmed: 17261680
Lipton RB, Munjal S, Alam A, Buse DC, Fanning KM, Reed ML, Schwedt TJ, Dodick DW (2018) Migraine in America Symptoms and Treatment (MAST) study: baseline study methods, treatment patterns, and gender differences. Headache 58(9):1408–1426. https://doi.org/10.1111/head.13407
doi: 10.1111/head.13407
pubmed: 30341895
Raffaelli B, Neeb L, Reuter U (2019) Monoclonal antibodies for the prevention of migraine. Expert Opin Biol Ther 19(12):1307–1317. https://doi.org/10.1080/14712598.2019.1671350
doi: 10.1080/14712598.2019.1671350
pubmed: 31550937
Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD, Martelletti P (2019) European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain 20(1):6. https://doi.org/10.1186/s10194-018-0955-y
doi: 10.1186/s10194-018-0955-y
pubmed: 30651064
pmcid: 6734227
Saper JR, Da Silva AN (2013) Medication overuse headache: history, features, prevention and management strategies. CNS Drugs 27(11):867–877. https://doi.org/10.1007/s40263-013-0081-y
doi: 10.1007/s40263-013-0081-y
pubmed: 23925669
Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E (2017) Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 377(22):2113–2122. https://doi.org/10.1056/NEJMoa1709038
doi: 10.1056/NEJMoa1709038
pubmed: 29171818
Silberstein SD, McAllister P, Ning X, Faulhaber N, Lang N, Yeung P, Schiemann J, Aycardi E, Cohen JM, Janka L, Yang R (2019) Safety and tolerability of fremanezumab for the prevention of migraine: a pooled analysis of phases 2b and 3 clinical trials. Headache 59(6):880–890. https://doi.org/10.1111/head.13534
doi: 10.1111/head.13534
pubmed: 30977520
Tepper SJ (2018) History and review of anti-calcitonin gene-related peptide (CGRP) therapies: from translational research to treatment. Headache 58(Suppl 3):238–275. https://doi.org/10.1111/head.13379
doi: 10.1111/head.13379
pubmed: 30242830
Walter S, Bigal ME (2015) TEV-48125: a review of a monoclonal CGRP antibody in development for the preventive treatment of migraine. Curr Pain Headache Rep 19(3):6. https://doi.org/10.1007/s11916-015-0476-1
doi: 10.1007/s11916-015-0476-1
pubmed: 25754596