r-n-jРоссийский неврологический журналRussian neurological journal2658-79472686-7192МИА10.30629/2658-7947-2022-27-1-43-50r-n-j-265Research ArticleИССЛЕДОВАНИЯ И КЛИНИЧЕСКИЕ НАБЛЮДЕНИЯCLINICAL RESEARCHES AND CASE REPORTSЭффективность и безопасность эренумаба в реальной практике: проспективное исследование 80 пациентов в специализированном центре лечения головной болиReal-world efficacy and safety of Erenumab: a prospective study of 80 patients in a specialized headache centerhttps://orcid.org/0000-0002-4447-2152БердниковаА. В.BerdnikovaA. V.

Москва

Moscow

asimcin@mail.ruКадымоваН. Б.KadymovaN. V.

Москва

Moscow

natagubanova@mail.ruhttps://orcid.org/0000-0001-9600-5540ЛатышеваН. В.LatyshevaN. V.

Латышева Нина Владимировна — д.м.н., доцент кафедры нервных болезней

Москва

Nina V. Latysheva

Moscow

ninalat@gmail.comhttps://orcid.org/0000-0003-4204-2279НаприенкоМ. В.NaprienkoM. V.

Москва

Moscow

mv_naprienko@mail.ruhttps://orcid.org/0000-0001-9978-4180ФилатоваЕ. Г.FilatovaE. G.

Москва

Moscow

eg-filatova@mail.ruКлиника головной боли и вегетативных расстройств имени академика Александра ВейнаРоссияAlexander Vein Headache ClinicRussian FederationКлиника головной боли и вегетативных расстройств имени академика Александра Вейна; Клиника головной боли и вегетативных расстройств имени академика Александра ВейнаРоссияAlexander Vein Headache Clinic; I.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation2022070320222714350Copyright © Бердникова А.В., Кадымова Н.Б., Латышева Н.В., Наприенко М.В., Филатова Е.Г., 20222022Бердникова А.В., Кадымова Н.Б., Латышева Н.В., Наприенко М.В., Филатова Е.Г.Berdnikova A.V., Kadymova N.V., Latysheva N.V., Naprienko M.V., Filatova E.G.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.r-n-j.com/jour/article/view/265

Моноклональные антитела против кальцитонин-ген-родственного пептида (КГРП) и его рецептора в целом и эренумаб в частности, являясь первыми препаратами с подобной точкой приложения, продемонстрировали высокую эффективность и безопасность в рандомизированных клинических исследованиях.

Цель исследования — проспективное исследование эффективности и безопасности эренумаба у пациентов с эпизодической мигренью (ЭМ) и хронической мигренью (ХМ).

Материал и методы

Материал и методы. В исследование включались пациенты в возрасте от 18 до 85 лет, имеющие диагноз ЭМ или ХМ согласно критериям Международной классификации головной боли (ГБ) 3-го пересмотра и проходившие лечение эренумабом с ноября 2020 г. по декабрь 2021 г. Для каждого пациента собирались демографические данные, анамнез мигрени и предшествующего лечения и заполнялись шкалы и опросники. Динамика состояния с анализом дневника ГБ проводилась ежемесячно.

Результаты

Результаты. Через 3 мес. лечения отмечено выраженное снижение частоты ГБ, снижение частоты ГБ на 50% и более в месяц имели 53,5% пациентов. Через 6 мес. терапии наблюдалось дальнейшее нарастание эффекта — у 57% пациентов достигнуто снижение частоты ГБ в 2 раза и более, у 74% пациентов — как минимум на 30%. Констипация наблюдалась у 3,8% пациентов.

Заключение

Заключение. Эренумаб является эффективным и безопасным методом лечения ЭМ средней и высокой частоты, а также ХМ и лекарственно-индуцированной головной боли.

Anti-CGRP monoclonal antibodies and particularly Erenumab become the first migraine-specific treatment and have demonstrated high efficacy and safety in the randomized clinical trials.

Aim

Aim. The aim of this study is the prospective evaluation of the efficacy and safety of Erenumab in patients with episodic migraine (EM) and chronic migraine (CM).

Material and мethods

Material and мethods. We recruited patients aged 18–85 diagnosed with EM and CM according to the International Classification of Headache Disorders, 3rd edition. All patients were from November 2020 to December 2021. Demographic data, history of migraine and previous migraine treatment were collected for each patient. All patients filled out scales and questionnaires, headache frequency dynamics was followed up monthly with headache diaries.

Results

Results. After three months of treatment reduction marked reduction of headache frequency was observed, and 53.5% of patients became ≥ 50% responders. After six months of treatment a further increase in the effect was observed: 57% of patients had at least a two-fold reduction in headache frequency, 74% of patients became ≥ 30% responders. Constipation was observed in 3.8% of patients.

Conclusion

Conclusion. Erenumab is safe and effective in the treatment of moderate- and high-frequency EM, CM and medication-overuse headache.

мигреньмоноклональные антителаэренумабэпизодическая мигреньхроническая мигренькальцитонин-ген-родственный пептидмigrainemonoclonal antibodiesErenumabepisodic migrainechronic migraineCGRPReferencesAshina M., Katsarava Z., Do T.P., Buse D.C., Pozo-Rosich P., Özge A. et al. Migraine: epidemiology and systems of care. Lancet. 2021;1397(10283):1485–1495. https://doi.org/10.1016/S0140-6736(20)32160-7Ashina M., Katsarava Z., Do T.P., Buse D.C., Pozo-Rosich P., Özge A. et al. Migraine: epidemiology and systems of care. Lancet. 2021;1397(10283):1485–1495. https://doi.org/10.1016/S0140-6736(20)32160-7Tepper S.J. CGRP and headache: a brief review. Neurol. Sci. 2019;40(Suppl.1):99–105. https://doi.org/10.1007/s10072-019-03769-8Tepper S.J. CGRP and headache: a brief review. Neurol. Sci. 2019;40(Suppl.1):99–105. https://doi.org/10.1007/s10072-019-03769-8Sacco S., Bendtsen L., Ashina M., Reuter U., Terwindt G., Mitsikostas D.D., Martelletti P. 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. 2019;20(1):6. https://doi.org/10.1186/s10194-018-0955-ySacco S., Bendtsen L., Ashina M., Reuter U., Terwindt G., Mitsikostas D.D., Martelletti P. 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. 2019;20(1):6. https://doi.org/10.1186/s10194-018-0955-yMartelletti P. Erenumab is effective in reducing migraine frequency and improving physical functioning. BMJ Evid. Based Med. 2019;24(2):76. https://doi.org/10.1136/bmjebm-2018-110937Martelletti P. Erenumab is effective in reducing migraine frequency and improving physical functioning. BMJ Evid. Based Med. 2019;24(2):76. https://doi.org/10.1136/bmjebm-2018-110937Barbanti P., Aurilia C., Egeo G., Fofi L. Erenumab: from scientific evidence to clinical practice — the first Italian real-life data. Neurol. Sci. 2019;40(1.Suppl.):177–179. https://doi.org/10.1007/s10072-019-03839-xBarbanti P., Aurilia C., Egeo G., Fofi L. Erenumab: from scientific evidence to clinical practice — the first Italian real-life data. Neurol. Sci. 2019;40(1.Suppl.):177–179. https://doi.org/10.1007/s10072-019-03839-xOrnello R., Casalena A., Frattale I., Gabriele A., Affaitati G., Giamberardino M.A., Assetta M. et al. Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J. Headache Pain. 2020;21(1):32. https://doi.org/10.1186/s10194-020-01102-9Ornello R., Casalena A., Frattale I., Gabriele A., Affaitati G., Giamberardino M.A., Assetta M. et al. Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J. Headache Pain. 2020;21(1):32. https://doi.org/10.1186/s10194-020-01102-9Barbanti P., Aurilia C., Egeo G., Fofi L., Cevoli S., Colombo B. 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):363–372. https://doi.org/10.1111/head.14032Barbanti P., Aurilia C., Egeo G., Fofi L., Cevoli S., Colombo B. 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):363–372. https://doi.org/10.1111/head.14032Matteo E., Favoni V., Pascazio A., Pensato U., Benini M., Asioli G.M. et al. Erenumab in 159 high frequency and chronic migraine patients: real-life results from the Bologna Headache Center. Neurol. Sci. 2020;41(Suppl.2):483–484. https://doi.org/10.1007/s10072-020-04667-0Matteo E., Favoni V., Pascazio A., Pensato U., Benini M., Asioli G.M. et al. Erenumab in 159 high frequency and chronic migraine patients: real-life results from the Bologna Headache Center. Neurol. Sci. 2020;41(Suppl.2):483–484. https://doi.org/10.1007/s10072-020-04667-0Екушева Е.В., Артеменко А.Р., Ширшова Е.B., Соков П.Е., Плиева А.М. Применение Эренумаба у пациентов с хронической мигренью в реальной клинической практике. Российский неврологический журнал. 2021;26(5):44–50.Ekusheva E.V., Artemenko A.R., Shirshova E.V., Sokov P.E., Plieva A.M. The use of the monoclonal antibody Erenumab in patients with chronic migraine in real clinical experience. Russian neurological journal. 2021;26(5):44–50. (In Russ.). https://doi.org/10.30629/2658-7947-2021-26-5-44-50Ващенко Н.В., Ужахов А.М., Богородская М.В., Коробкова Д.З., Азимова Ю.Э., Скоробогатых К.В. 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., Korobkova D.Z., Azimova J.E., Skorobogatykh K.V. Six-month therapy of CGRP monoclonal antibodies in real-world clinical practice: an interim analysis of efficacy and safety data. Medical Council (Meditsinskiy Sovet). 2021;21(1):64–70. (In Russ.). https://doi.org/10.21518/2079-701X-2021-21-1-64-70Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629–808. https://doi.org/10.1177/0333102413485658Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629–808. https://doi.org/10.1177/0333102413485658Всероссийское общество неврологов, межрегиональная общественная организация «Российское общество по изучению головной боли». Клинические рекомендации: мигрень. https://cr.minzdrav.gov.ru/schema/295_2, 2022.Russian Society of Neurologists, Interregional Public Organization “Russian Headache Society”. Clinical guidelines: migraine. https://cr.minzdrav.gov.ru/schema/295_2, 2022Tepper S.J., Diener H.C., Ashina M., Brandes J.L., Friedman D.I., Reuter U. et al. Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial. Neurology. 2019;92(20):e2309–e2320. https://doi.org/10.1212/WNL.0000000000007497Tepper S.J., Diener H.C., Ashina M., Brandes J.L., Friedman D.I., Reuter U. et al. Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial. Neurology. 2019;92(20):e2309–e2320. https://doi.org/10.1212/WNL.0000000000007497Reuter U., Goadsby P.J., Lanteri-Minet M., Wen S., Hours-Zesiger P., Ferrari M.D., Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018;392(10161):2280–2287. https://doi.org/10.1016/S0140-6736(18)32534-0Reuter U., Goadsby P.J., Lanteri-Minet M., Wen S., Hours-Zesiger P., Ferrari M.D., Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018;392(10161):2280–2287. https://doi.org/10.1016/S0140-6736(18)32534-0Dodick D.W., Ashina M., Brandes J.L., Kudrow D., LanteriMinet M., Osipova V. et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38(6):1026–1037. https://doi.org/10.1177/0333102418759786Dodick D.W., Ashina M., Brandes J.L., Kudrow D., LanteriMinet M., Osipova V. et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38(6):1026–1037. https://doi.org/10.1177/0333102418759786Straube A., Stude P., Gaul C., Schuh K., Koch M. Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany. J. Headache Pain. 2021;22(1):133. doi: 10.1186/s10194-021-01344-1Straube A., Stude P., Gaul C., Schuh K., Koch M. Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany. J. Headache Pain. 2021;22(1):133. doi: 10.1186/s10194-021-01344-1de Vries Lentsch S., Verhagen I.E., van den Hoek T.C., Maassen van den Brink A., Terwindt G.M. Treatment with the monoclonal calcitonin gene-related peptide receptor antibody erenumab: A real-life study. Eur. J. Neurol. 2021;28(12):4194–4203. https://doi.org/10.1111/ene.15075de Vries Lentsch S., Verhagen I.E., van den Hoek T.C., Maassen van den Brink A., Terwindt G.M. Treatment with the monoclonal calcitonin gene-related peptide receptor antibody erenumab: A real-life study. Eur. J. Neurol. 2021;28(12):4194–4203. https://doi.org/10.1111/ene.15075Dworkin R.H., Turk D.C., Wyrwich K.W., Beaton D., Cleeland C.S., Farrar J.T. et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J. Pain. 2008;9(2):105–121. https://doi.org/10.1016/j.jpain.2007.09.005Dworkin R.H., Turk D.C., Wyrwich K.W., Beaton D., Cleeland C.S., Farrar J.T. et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J. Pain. 2008;9(2):105–121. https://doi.org/10.1016/j.jpain.2007.09.005Hepp Z., Bloudek L.M., Varon S.F. Systematic review of migraine prophylaxis adherence and persistence. J. Manag. Care Pharm. 2014;20(1):22–33. https://doi.org/10.18553/jmcp.2014.20.1.22Hepp Z., Bloudek L.M., Varon S.F. Systematic review of migraine prophylaxis adherence and persistence. J. Manag. Care Pharm. 2014;20(1):22–33. https://doi.org/10.18553/jmcp.2014.20.1.22Naprienko M.V., Smekalkina L.V. Strategies for Improving the Efficacy of Treatment of Chronic Migraine. Neurosci. Behav. Physi. 2017;47:813–816. https://doi.org/10.1007/s11055-017-0473-4Naprienko M.V., Smekalkina L.V. Strategies for Improving the Efficacy of Treatment of Chronic Migraine. Neurosci. Behav. Physi. 2017;47:813–816. https://doi.org/10.1007/s11055-017-0473-4Katsarava Z., Schneeweiss S., Kurth T., Kroener U., Fritsche G., Eikermann A. et al. Incidence and predictors for chronicity of headache in patients with episodic migraine. Neurology. 2004;62(5):788–90. https://doi.org/10.1212/01.wnl.0000113747.18760.d2Katsarava Z., Schneeweiss S., Kurth T., Kroener U., Fritsche G., Eikermann A. et al. Incidence and predictors for chronicity of headache in patients with episodic migraine. Neurology. 2004;62(5):788–90. https://doi.org/10.1212/01.wnl.0000113747.18760.d2Ornello R., Tiseo C., Frattale I., Perrotta G., Marini C., Pistoia F., Sacco S. The appropriate dosing of erenumab for migraine prevention after multiple preventive treatment failures: a critical appraisal. J. Headache Pain. 2019;20(1):99. https://doi.org/10.1186/s10194-019-1054-4Ornello R., Tiseo C., Frattale I., Perrotta G., Marini C., Pistoia F., Sacco S. The appropriate dosing of erenumab for migraine prevention after multiple preventive treatment failures: a critical appraisal. J. Headache Pain. 2019;20(1):99. https://doi.org/10.1186/s10194-019-1054-4

The authors declare that there are no conflicts of interest present.