Use of erenumab in real clinical practice


DOI: https://dx.doi.org/10.18565/therapy.2024.3.164-174

Berdnikova A.V., Kadymova N.B., Latysheva N.V., Naprienko M.V., Filatova E.G.

1) Academician A. Vein Clinic of Headache and Autonomic Disturbances, Moscow; 2) I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University)
Abstract. Migraine is a primary headache (PH), and it is the one of the leading causes of disability in the world. Currently, a division into episodic and chronic migraine is accepted, however, the boundary between these forms is arbitrary, and the presence of one or more comorbid diseases in a patient increases the risk of chronic episodic migraine and may reduce the efficacy of therapy. Tablet medications approved for the preventive treatment of migraine are nonspecific, poorly tolerated, and patient adherence to such kind of treatment is extremely low. Monoclonal antibodies to calcitonin gene-related peptide (CGRP) or its receptor (anti-CGRP mAb) have become the first targeted preventive therapy for migraine.
The aim: to determine the efficacy and safety of anti-CGRP mAb of erenumab in real clinical practice in patients with episodic and chronic migraine.
Material and methods. 76 patients diagnosed with diagnoses chronic and episodic migraine were included in the study according to the criteria of the International classification of headache disorders, 3rd revision. During 3 months all the participants were given erenumab 70 mg subcutaneously for every month. From the beginning and every month, a clinical interview, estimation of the headache diary, and completion of questionnaires for anxiety, depression, impact of headache on the quality of life, and sleep quality assessment were performed.
Results. In patients with both chronic and episodic migraine after 1 and 3 months of erenumab therapy, there was a significant reduction in the frequency of headaches in general, migraine headaches, days with analgesics, as well as positive changes in questionnaire data. Treatment-arising adverse events were of low prevalence.
Conclusion. Erenumab is an effective and safe drug when used in real clinical practice in patients with both episodic and chronic migraine, including multimorbid patients.

Literature


1. 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): 954–76.


https://doi.org/10.1016/S1474-4422(18)30322-3. PMID: 30353868. PMCID: PMC6191530.


2. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018; 38(1): 1–211.


https://doi.org/10.1177/0333102417738202. PMID: 29368949.


3. Ishii R., Schwedt T.J., Dumkrieger G. et al. Chronic versus episodic migraine: The 15-day threshold does not adequately reflect substantial differences in disability across the full spectrum of headache frequency. Headache. 2021; 61(7): 992–1003.


https://doi.org/10.1111/head.14154. PMID: 34081791.


4. Castro Zamparella T., Carpinella M., Peres M. et al. Specific cognitive and psychological alterations are more strongly linked to increased migraine disability than chronic migraine diagnosis. J Headache Pain. 2024; 25(1): 37.


https://doi.org/10.1186/s10194-024-01734-1. PMID: 38486142. PMCID: PMC10941545.


5. Buse D.C., Fanning K.M., Reed M.L. et al. Life with migraine: effects on relationships, career, and finances from the chronic migraine epidemiology and outcomes (CaMEO) study. Headache. 2019; 59(8): 1286–99.


https://doi.org/10.1111/head.13613. PMID: 31407321. PMCID: PMC6771487.


6. Torres-Ferrús M., Quintana M., Fernandez-Morales J. et al. When does chronic migraine strike? A clinical comparison of migraine according to the headache days suffered per month. Cephalalgia. 2017; 37(2): 104–13.


https://doi.org/10.1177/0333102416636055. PMID: 26961321.


7. Di Antonio S., Castaldo M., Ponzano M. et al. Disability, burden, and symptoms related to sensitization in migraine patients associate with headache frequency. Scand J Pain. 2021; 21(4): 766–77.


https://doi.org/10.1515/sjpain-2021-0050. PMID: 34253003.


8. Lipton R.B., Fanning K.M., Buse D.C. et al. Migraine progression in subgroups of migraine based on comorbidities: Results of the CaMEO Study. Neurology. 2019; 93(24): e2224–e2236.


https://doi.org/10.1212/wnl.0000000000008589. PMID: 31690685. PMCID: PMC6937494.


9. Hepp Z., Dodick D.W., Varon S.F. et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35(6): 478–88.


https://doi.org/10.1177/0333102414547138. PMID: 25164920.


10. Клинические рекомендации. Мигрень. Всероссийское общество неврологов, межрегиональная общественная организация «Российское общество по изучению головной боли». Рубрикатор клинических рекомендаций Минздрава России. 2021. ID: 295. Доступ: https://cr.minzdrav.gov.ru/schema/295_2 (дата обращения – 22.04.2024). (Clinical guidelines. Migraine. All-Russian Society of Neurologists, Russian Society for the Study of Headache. Rubricator of clinical guidelines of the Ministry of Healthcare of Russia. 2021. ID: 295. URL: https://cr.minzdrav.gov.ru/schema/295_2 (date of access – 22.04.2024) (In Russ.)).


11. Charles A., Pozo-Rosich P. Targeting calcitonin gene-related peptide: A new era in migraine therapy. Lancet. 2019; 394(10210): 1765–74.


https://doi.org/10.1016/s0140-6736(19)32504-8. PMID: 31668411.


12. Сергеев А.В., Табеева Г.Р., Филатова Е.Г. с соавт. Применение новой биологической патогенетической терапии мигрени в клинической практике: консенсус экспертов Российского общества по изучению головной боли. Неврология, нейропсихиатрия, психосоматика. 2022; 14(5): 109–116. (Sergeev A.V., Tabeeva G.R., Filatova E.G. et al. Application of a new biological pathogenetic therapy of migraine in clinical practice: Expert consensus of the Russian Headache Research Society. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2022; 14(5): 109–116 (In Russ.)).


https://doi.org/10.14412/2074-2711-2022-5-109-116. EDN: RDYMSJ.


13. Adewuyi E.O., Sapkota Y., International Endogene Consortium Iec et al. Shared molecular genetic mechanisms underlie endometriosis and migraine comorbidity. Genes (Basel). 2020; 11(3): 268.


https://doi.org/10.3390/genes11030268. PMID: 32121467. PMCID: PMC7140889.


14. Государственный реестр лекарственных средств Минздрава России. Инструкция по применению лекарственного препарата Иринэкс (70 мг/мл). РУ: ЛП-006083 от 31.01.2024. Доступ: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=64a23485-bcc5-442f-8bed-2e4a82a9dae9 (дата обращения – 22.04.2024). (State register of medicines of the Ministry of Healthcare of Russia. Instructions for use of the drug Irinex (70 mg/ml). Registration certificate: ЛП-006083 dated 01/31/2024. URL: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=64a23485-bcc5-442f-8bed-2e4a82a9dae9 (date of access – 22.04.2024) (In Russ.)).


15. Goadsby P.J., Reuter U., Hallstrom Y. et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017; 377(22): 2123–32.


https://doi.org/10.1056/nejmoa1705848. PMID: 29171821.


16. Tepper S., Ashina M., Reuter U. et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: A randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017; 16(6): 425–34.


https://doi.org/10.1016/s1474-4422(17)30083-2. PMID: 28460892.


17. Добрынина Л.А., Губанова М.В., Белопасова А.В. с соавт. Эффективность и безопасность эренумаба у пациентов с частой эпизодической мигренью по данным российского исследования реальной клинической практики Научного центра неврологии. Журнал неврологии и психиатрии им. C.C. Корсакова. 2022; 122(2): 74–80. (Dobrynina L.A., Gubanova M.V., Belopasova A.V. et al. The efficacy and safety of erenumab in patients with high-frequency episodic migraine according to the first Russian real-life study of the Research Center of Neurology. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova = S.S. Korsakov Journal of Neurology and Psychiatry. 2022; 122(2): 74–80 (In Russ.)).


https://doi.org/10.17116/jnevro202212202174. EDN: LSTAJF.


18. Ващенко Н.В., Ужахов А.М., Богородская М.В. с соавт. Полугодовое применение CGRP-моноклональных антител в клинической практике: промежуточный анализ эффективности и безопасности. Медицинский совет. 2021; (21–1): 64–70. (Vashchenko N.V., Uzhakhov A.M., Bogorodskaya M.V. et al. Six-month therapy of CGRP monoclonal antibodies in real-world clinical practice: an interim analysis of efficacy and safety data. Meditsinskiy sovet = Medical Council. 2021; (21–1): 64–70 (In Russ.)).


https://doi.org/10.21518/2079-701X-2021-21-1-64-70. EDN: VZLZDO.


19. Barbanti P., Aurilia C., Egeo G. et al. Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache. 2021; 61(2): 363–72.


https://doi.org/10.1111/head.14032. PMID: 33337544.


20. Driessen M.T., Cohen J.M., Patterson-Lomba O. et al. Real-world effectiveness of fremanezumab in migraine patients initiating treatment in the United States: Results from a retrospective chart study. J Headache Pain. 2022; 23(1): 47.


https://doi.org/10.1186/s10194-022-01411-1. PMID: 35410121. PMCID: PMC9004075.


About the Autors


Anna V. Berdnikova, MD, assistant at the Department of nervous diseases of Institute of Professional Education, I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University), neurologist at Academician A. Vein Clinic of Headache and Autonomic Disturbances (“CEPHALGOLOGIST” LLC). Address: 125130, Moscow, 10B Staropetrovsky Drive.
E-mail: asimcin@mail.ru
ORCID: https://orcid.org/0000-0002-4447-2152
Natalia B. Kadymova, MD, PhD (Medicine), neurologist at Academician A. Vein Clinic of Headache and Autonomic Disturbances (“CEPHALGOLOGIST” LLC). Address: 125130, Moscow, 10B Staropetrovsky Drive.
E-mail: natagubanova@mail.ru
ORCID: https://orcid.org/0009-0005-8965-9980
Nina V. Latysheva, MD, Dr. Sci. (Medicine), associate professor, professor of the Department of nervous diseases of Institute of Professional Education, I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University), neurologist at Academician A. Vein Clinic of Headache and Autonomic Disturbances (“CEPHALGOLOGIST” LLC). Address: 125130, Moscow, 10B Staropetrovsky proezd Drive.
Email: ninalat@gmail.com
ORCID: https://orcid.org/0000-0001-9600-5540
Margarita V. Naprienko, MD, Dr. Sci. (Medicine), associate professor, professor of the Department of sports medicine and medical rehabilitation of N.V. Sklifosovsky Institute of Clinical Medicine, I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University), neurologist at Academician A. Vein Clinic of Headache and Autonomic Disturbances (“CEPHALGOLOGIST” LLC). Address: 125130, Moscow, 10B Staropetrovsky proezd Drive.
E-mail: mv_naprienko@mail.ru
ORCID: https://orcid.org/0000-0003-4204-2279
Elena G. Filatova, MD, Dr. Sci. (Medicine), professor, professor of the Department of nervous diseases of Institute of Professional Education, I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University), neurologist at Academician A. Vein Clinic of Headache and Autonomic Disturbances (“CEPHALGOLOGIST” LLC). Address: 125130, Moscow, 10B Staropetrovsky proezd Drive.
E-mail: eg-filatova@mail.ru
ORCID: https://orcid.org/0000-0001-9978-4180


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