Preview

Russian neurological journal

Advanced search

Real-world efficacy and safety of Erenumab: a prospective study of 80 patients in a specialized headache center

https://doi.org/10.30629/2658-7947-2022-27-1-43-50

Abstract

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

About the Authors

A. V. Berdnikova
Alexander Vein Headache Clinic
Russian Federation

Moscow



N. V. Kadymova
Alexander Vein Headache Clinic
Russian Federation

Moscow



N. V. Latysheva
Alexander Vein Headache Clinic; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Nina V. Latysheva

Moscow



M. V. Naprienko
Alexander Vein Headache Clinic; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Moscow



E. G. Filatova
Alexander Vein Headache Clinic; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Moscow



References

1. Ashina 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)32160-7

2. Tepper S.J. CGRP and headache: a brief review. Neurol. Sci. 2019;40(Suppl.1):99–105. https://doi.org/10.1007/s10072-019-03769-8

3. Sacco 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-y

4. Martelletti 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-2018-110937

5. Barbanti 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-x

6. Ornello 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/s10194-020-01102-9

7. Barbanti 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.14032

8. Matteo 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/s10072-020-04667-0

9. 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/10.30629/2658-7947-2021-26-5-44-50

10. 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-2021-21-1-64-70

11. Headache 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/10.1177/0333102413485658

12. Russian Society of Neurologists, Interregional Public Organization “Russian Headache Society”. Clinical guidelines: migraine. https://cr.minzdrav.gov.ru/schema/295_2, 2022

13. Tepper 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.0000000000007497

14. Reuter 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)32534-0

15. Dodick 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/10.1177/0333102418759786

16. Straube 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/s10194-021-01344-1

17. de 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.15075

18. Dworkin 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.2007.09.005

19. Hepp 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.2014.20.1.22

20. Naprienko 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/s11055-017-0473-4

21. Katsarava 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.d2

22. Ornello 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


Review

For citations:


Berdnikova A.V., Kadymova N.V., Latysheva N.V., Naprienko M.V., Filatova E.G. Real-world efficacy and safety of Erenumab: a prospective study of 80 patients in a specialized headache center. Russian neurological journal. 2022;27(1):43-50. (In Russ.) https://doi.org/10.30629/2658-7947-2022-27-1-43-50

Views: 666


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2658-7947 (Print)
ISSN 2686-7192 (Online)