The Management of High-Frequency Episodic and Chronic Migraines with Calcitonin Gene-Related Peptide Monoclonal Antibody
- Authors: Dobrynina L.A.1, Afanasev M.A.1, Belopasova A.V.1, Gubanova M.V.1, Baydina E.V.1
-
Affiliations:
- Research Center of Neurology
- Issue: Vol 17, No 2 (2023)
- Pages: 22-27
- Section: Original articles
- URL: https://journals.rcsi.science/2075-5473/article/view/131725
- DOI: https://doi.org/10.54101/ACEN.2023.2.3
- ID: 131725
Cite item
Full Text
Abstract
Introduction. High prevalence of migraine and its impact on quality of life requires the development of original agents. In 2020, fremanezumab, a new calcitonin gene-related peptide monoclonal antibody was authorized in Russia.
Objective: to evaluate safety and effectiveness of fremanezumab in patients with high-frequency episodic migraine (HF EM) and chronic migraine (CM).
Materials and methods. We assessed 60 patients at the age of 35.5 ± 8.96 years (85%, females) with HFEM and CM with and without aura who were either receiving preventive treatment or not. Fremanezumab was administered subcutaneously at a single dose of 675 mg. The study participants were followed-up for efficacy in 3 months. The investigators assessed change in the number of days with headache per month as well as headache intensity, its impact on the daily activities, anxiety, and depression.
Results. By the end of month 3 post dosing, the number of days with headache decreased by >50% in 76.7% of participants where 77.8% of individuals suffered from HF EM and 72.7% of individuals had CM while headache intensity decreased in all the patients equally. No response (decrease in the number of days with headache by < 30%) was reported in 15% of participants including 14.8% of individuals with HF EM and 15.2% of individuals with CM. By the end of study month 3, 81% of participants demonstrated no anxiety symptoms and 79% of participants showed no depression with significant MIDAS and HIT-6 score decline in both groups. Only 3 (5%) patients noted adverse events (redness, itching at the administration site).
Conclusion. We documented higher fremanezumab safety and effectiveness in patients with EM and CM in real-world practice as compared to fremanezumab safety and efficacy in randomized clinical trials. A single dose of fremanezumab (675 mg) resulted in effective migraine prevention, decline in comorbid anxiety and depression, and improved quality of life during 3-month follow-up.
Keywords
Full Text
##article.viewOnOriginalSite##About the authors
Larisa A. Dobrynina
Research Center of Neurology
Author for correspondence.
Email: dobrla@mail.ru
ORCID iD: 0000-0001-9929-2725
D. Sci. (Med.), chief researcher, Head, 3rd Neurological department, Institute of Clinical and Preventive Neurology
Russian Federation, MoscowMaksim A. Afanasev
Research Center of Neurology
Email: m.afan.doc@gmail.com
ORCID iD: 0000-0001-5552-3704
postgraduate student, neurologist, 3rd Neurological department, Institute of Clinical and Preventive Neurology
Russian Federation, MoscowAnastasia V. Belopasova
Research Center of Neurology
Email: mastusha@yandex.ru
ORCID iD: 0000-0003-3124-2443
Cand. Sci. (Med.), researcher, 3rd Neurological department, Institute of Clinical and Preventive Neurology
Russian Federation, MoscowMaria V. Gubanova
Research Center of Neurology
Email: m.v.gubanova@yandex.ru
ORCID iD: 0000-0002-9893-712X
Cand. Sci. (Med.), researcher, 3rd Neurological department, Institute of Clinical and Preventive Neurology
Russian Federation, MoscowEkaterina V. Baydina
Research Center of Neurology
Email: glavvrach@neurology.ru
ORCID iD: 0000-0001-5911-5855
Cand. Sci. (Med.), chief physician
Russian Federation, MoscowReferences
- GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018;17(11):954–976. doi: 10.1016/S1474-4422(18)30322-3
- Burch R.C., Buse D.C., Lipton R.B. Migraine: epidemiology, burden, and comorbidity. Neurol. Clin. 2019;37(4):631–649. doi: 10.1016/j.ncl.2019.06.001
- Cohen F., Yuan H., Silberstein S.D. Calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies and antagonists in migraine: current evidence and rationale. BioDrugs. 2022;36(3):341–358. doi: 10.1007/s40259-022-00530-0
- Bigal M.E., Walter S., Rapoport A.M. Calcitonin gene-related peptide (CGRP) and migraine current understanding and state of development. Headache. 2013;53(8):1230–44. doi: 10.1111/head.12179
- Hoy S.M. Fremanezumab: first global approval. Drugs. 2018;78(17):1829–1834. doi: 10.1007/s40265-018-1004-5
- Silberstein S.D., Dodick D.W., Bigal M.E. et al. Fremanezumab for the preventive treatment of chronic migraine. N. Engl. J. Med. 2017;377:2113–2122. doi: 10.1056/NEJMoa1709038
- Dodick D.W., Silberstein S.D., Bigal M.E. et al. Еffect of Fremanezumab compared with placebo for prevention of episodic migraine: arandomized clinical trial. JAMA. 2018;319:1999–2008. doi: 10.1001/jama.2018.4853
- Ferrari M.D., Diener H.C., Ning X. et al. 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. 2019;394(10203):1030–1040. doi: 10.1016/S0140-6736(19)31946-4
- Sakai F., Suzuki N., Kim B.K. et al. Efficacy and safety of fremanezumab for chronic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache. 2021;61(7):1092–1101. doi: 10.1111/head.14169
- Lipton R.B., Cohen J.M., Galic M. et al. Effects of fremanezumab in patients with chronic migraine and comorbid depression: subgroup analysis of the randomized HALO CM study. Headache. 2021;61(4):662–672. doi: 10.1111/head.14097
- Goadsby P.J., Silberstein S.D., Yeung P.P. et al. Long-term safety, tolerabi- lity, and efficacy of fremanezumab in migraine: а randomized study. Neurology. 2020;95(18):e2487–e2499. doi: 10.1212/WNL.0000000000010600
- Ashina M., Amin F.M., Kokturk P. et al. PEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine. Pain Manag. 2021;11(6):647–654. doi: 10.2217/pmt-2021-0015
- Driessen M.T., Cohen J.M., Thompson S.F. et al. Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine. J. Headache Pain. 2022;23(1):56. doi: 10.1186/s10194-022-01415-x
- Krasenbaum L.J., Pedarla V.L., Thompson S.F. et al. A real-world study of acute and preventive medication use, adherence, and persistence in patients prescribed fremanezumab in the United States. J. Headache Pain. 2022;23(1):54. doi: 10.1186/s10194-022-01413-z
- Barbanti P., Egeo G., Aurilia C. et al. Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J. Headache Pain. 2022;23(1):46. doi: 10.1186/s10194-022-01396-x
- Diener H.C., Ashina M., Durand-Zaleski I. et al. Health technology assessment for the acute and preventive treatment of migraine: а position statement of the International Headache Society. Cephalalgia. 2021;41(3):279–293. doi: 10.1177/0333102421989247
- Stewart W.F., Lipton R.B., Dowson A.J., Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(1):20–28. doi: 10.1212/wnl.56.suppl_1.s20
- Kosinski M., Bayliss M.S., Bjorner J.B. et al. A six-item short-form survey for measuring headache impact: the HIT-6. Qual. Life Res. 2003;12(8):963–974. doi: 10.1023/a:1026119331193
- Сыропятов О.Г., Дзеружинская Н.А., Астапов Ю.Н., Иванцова Г.В. Ранняя диагностика и лечение депрессии в общей медицинской практике. Киев; 2003. Syropyatov O.G., Dzeruzhinskaya N.A., Astapov Yu.N., Ivantsova G.V. Early diagnostic and treatment of depression in general medicine practice. Kiev; 2003. (In Russ.)
- Blumenfeld A.M., Bloudek L.M., Becker W.J. et al. 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. 2013;53(4):644–655. doi: 10.1111/head.12055
- Филатова Е.Г., Осипова В.В., Табеева Г.Р. и др. Диагностика и лечение мигрени: рекомендации российских экспертов. Неврология, нейропсихиатрия, психосоматика. 2020;12(4):4–14. Filatova E.G., Osipova V.V., Tabeeva G.R. et al. Diagnosis and treatment of migraine: Russian experts’ recommendations. Neurology, Neuropsychiatry, Psychosomatics. 2020;12(4):4–14. (In Russ.) doi: 10.14412/2074-2711-2020-4-4-14
- Sacco S., Amin F.M., Ashina M. et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention — 2022 update. J. Headache Pain. 2022;23(1):67. doi: 10.1186/s10194-022-01431-x
- Breslau N., Lipton R.B., Stewart W.F. et al. Comorbidity of migraine and depression: investigating potential etiology and prognosis. Neurology. 2003;60(8):1308–1312. doi: 10.1212/01.wnl.0000058907.41080.54
- Yang Y., Zhao H., Heath A.C. et al. Shared genetic factors underlie migraine and depression. Twin Res. Hum. Genet. 2016;19(4):341–350. doi: 10.1017/thg.2016.46
Supplementary files
![](/img/style/loading.gif)