Fremanezumab for Preventive Treatment of Migraine: Functional Status on Headache-free Days

Overview

Journal Neurology

Specialty Neurology

Date 2018 Aug 19

PMID 30120138

Citations 14

Authors

Juliana VanderPluym

David W Dodick

Richard B Lipton

Yuju Ma

Pippa S Loupe

Marcelo E Bigal

Affiliations

Soon will be listed here.

Abstract

Objective: To evaluate the effect of fremanezumab on the functional status on headache-free days in phase 2 episodic migraine (EM) and chronic migraine (CM) studies.

Methods: Functional status data were collected prospectively via the electronic headache diary on all headache-free days by patients answering questions regarding work/school/household chore performance, speed of work completion, concentration, and feeling of fatigue. Individuals with EM receiving monthly doses of fremanezumab 225 mg (n = 96) or 675 mg (n = 97) or placebo (n = 104) were compared. Individuals with CM receiving fremanezumab 675 mg followed by monthly 225 mg (n = 88) and 900 mg (n = 86) were also independently compared to those receiving placebo (n = 89).

Results: In patients with EM, compared to patients receiving placebo, those receiving fremanezumab experienced an increased number of headache-free days with normal function in work/school/household chore performance and concentration/mental fatigue measures compared to their baseline over the entire treatment period (all < 0.005). An increased number of headache-free days with normal functional performance for some measures was also found in the CM group in those treated with fremanezumab.

Conclusion: There was an increased number of headache-free days with normal functional performance on all measures for the patients with EM and some measures for patients with CM in the fremanezumab-treated groups. Further research is required to confirm these findings in a prospective study and to clarify the underlying mechanism(s).

Clinicaltrialsgov Identifier: NCT02025556 and NCT02021773.

Classification Of Evidence: This study provides Class II evidence that for patients with migraine, fremanezumab increases normal functional performance on headache-free days.

Citing Articles

Molecular Mechanisms of Migraine: Nitric Oxide Synthase and Neuropeptides.

Karsan N, Gosalia H, Goadsby P Int J Mol Sci. 2023; 24(15).

PMID: 37569369 PMC: 10418996. DOI: 10.3390/ijms241511993.

Neuroimaging in the pre-ictal or premonitory phase of migraine: a narrative review.

Karsan N, Goadsby P J Headache Pain. 2023; 24(1):106.

PMID: 37563570 PMC: 10416375. DOI: 10.1186/s10194-023-01617-x.

Revisiting Migraine: The Evolving Pathophysiology and the Expanding Management Armamentarium.

Gawde P, Shah H, Patel H, Bharathi K, Patel N, Sethi Y Cureus. 2023; 15(2):e34553.

PMID: 36879707 PMC: 9985459. DOI: 10.7759/cureus.34553.

Monoclonal Antibodies Targeting CGRP: From Clinical Studies to Real-World Evidence-What Do We Know So Far?.

Mavridis T, Deligianni C, Karagiorgis G, Daponte A, Breza M, Mitsikostas D Pharmaceuticals (Basel). 2021; 14(7).

PMID: 34358126 PMC: 8308667. DOI: 10.3390/ph14070700.

Efficacy and safety of fremanezumab for episodic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients.

Sakai F, Suzuki N, Kim B, Tatsuoka Y, Imai N, Ning X Headache. 2021; 61(7):1102-1111.

PMID: 34323290 PMC: 8457233. DOI: 10.1111/head.14178.

References

Lipton R, Varon S, Grosberg B, McAllister P, Freitag F, Aurora S . OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. Neurology. 2011; 77(15):1465-72. DOI: 10.1212/WNL.0b013e318232ab65. View

Maniyar F, Sprenger T, Monteith T, Schankin C, Goadsby P . Brain activations in the premonitory phase of nitroglycerin-triggered migraine attacks. Brain. 2013; 137(Pt 1):232-41. DOI: 10.1093/brain/awt320. View

Burton W, Landy S, Downs K, Runken M . The impact of migraine and the effect of migraine treatment on workplace productivity in the United States and suggestions for future research. Mayo Clin Proc. 2009; 84(5):436-45. PMC: 2676126. DOI: 10.1016/S0025-6196(11)60562-4. View

Hepp Z, Bloudek L, Varon S . Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2013; 20(1):22-33. PMC: 10437641. DOI: 10.18553/jmcp.2014.20.1.22. View

Bigal M, Edvinsson L, Rapoport A, Lipton R, Spierings E, Diener H . 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. 2015; 14(11):1091-100. DOI: 10.1016/S1474-4422(15)00245-8. View

Blau J . Migraine postdromes: symptoms after attacks. Cephalalgia. 1991; 11(5):229-31. DOI: 10.1046/j.1468-2982.1991.1105229.x. View

Vaeroy H, Sakurada T, Forre O, Kass E, Terenius L . Modulation of pain in fibromyalgia (fibrositis syndrome): cerebrospinal fluid (CSF) investigation of pain related neuropeptides with special reference to calcitonin gene related peptide (CGRP). J Rheumatol Suppl. 1989; 19:94-7. View

. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016; 388(10053):1545-1602. PMC: 5055577. DOI: 10.1016/S0140-6736(16)31678-6. View

Schorscher-Petcu A, Austin J, Mogil J, Quirion R . Role of central calcitonin gene-related peptide (CGRP) in locomotor and anxiety- and depression-like behaviors in two mouse strains exhibiting a CGRP-dependent difference in thermal pain sensitivity. J Mol Neurosci. 2009; 39(1-2):125-36. DOI: 10.1007/s12031-009-9201-z. View

10.

Sink K, Walker D, Yang Y, Davis M . Calcitonin gene-related peptide in the bed nucleus of the stria terminalis produces an anxiety-like pattern of behavior and increases neural activation in anxiety-related structures. J Neurosci. 2011; 31(5):1802-10. PMC: 3088995. DOI: 10.1523/JNEUROSCI.5274-10.2011. View

11.

Eftekhari S, Salvatore C, Johansson S, Chen T, Zeng Z, Edvinsson L . Localization of CGRP, CGRP receptor, PACAP and glutamate in trigeminal ganglion. Relation to the blood-brain barrier. Brain Res. 2014; 1600:93-109. DOI: 10.1016/j.brainres.2014.11.031. View

12.

Shao B, Zhou Y, Wang H, Lin Y . The role of calcitonin gene-related peptide in post-stroke depression in chronic mild stress-treated ischemic rats. Physiol Behav. 2014; 139:224-30. DOI: 10.1016/j.physbeh.2014.11.049. View

13.

Giffin N, Lipton R, Silberstein S, Olesen J, Goadsby P . The migraine postdrome: An electronic diary study. Neurology. 2016; 87(3):309-13. PMC: 4955275. DOI: 10.1212/WNL.0000000000002789. View

14.

Lipton R, Rosen N, Ailani J, DeGryse R, Gillard P, Varon S . OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program. Cephalalgia. 2016; 36(9):899-908. PMC: 4959035. DOI: 10.1177/0333102416652092. View

15.

Dodick D, Turkel C, DeGryse R, Diener H, Lipton R, Aurora S . Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example. J Pain. 2014; 16(2):164-75. DOI: 10.1016/j.jpain.2014.11.004. View

16.

Bigal M, Dodick D, Krymchantowski A, VanderPluym J, Tepper S, Aycardi E . TEV-48125 for the preventive treatment of chronic migraine: Efficacy at early time points. Neurology. 2016; 87(1):41-8. PMC: 4932236. DOI: 10.1212/WNL.0000000000002801. View

17.

Evangelista S . Capsaicin receptor as target of calcitonin gene-related peptide in the gut. Prog Drug Res. 2014; 68:259-76. DOI: 10.1007/978-3-0348-0828-6_10. View

18.

Silberstein S . Topiramate in Migraine Prevention: A 2016 Perspective. Headache. 2016; 57(1):165-178. DOI: 10.1111/head.12997. View

19.

Lipton R, Stewart W, Diamond S, Diamond M, Reed M . Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001; 41(7):646-57. DOI: 10.1046/j.1526-4610.2001.041007646.x. View

20.

Giannini G, Zanigni S, Grimaldi D, Melotti R, Pierangeli G, Cortelli P . Cephalalgiaphobia as a feature of high-frequency migraine: a pilot study. J Headache Pain. 2013; 14:49. PMC: 3686604. DOI: 10.1186/1129-2377-14-49. View