Preview

Neurology, Neuropsychiatry, Psychosomatics

Advanced search

Efficacy and safety of anti-CGRP(r) monoclonal antibodies in real clinical practice: preliminary analysis after three months of therapy

https://doi.org/10.14412/2074-2711-2021-6-62-66

Full Text:

Abstract

Monoclonal antibodies inhibiting calcitonin gene related peptide (CGRP) or its receptor have been widely used for migraine prophylactic therapy for the past three years. Evaluation of their efficacy and safety of therapy in real clinical practice is needed.
Objective: to evaluate the efficacy and safety of Erenumab, a monoclonal antibody inhibiting the CGRP receptor during three months of therapy.
Patients and methods. Sixty-eight patients (58 women and 10 men, mean age 37±10.4 years) with episodic or chronic migraine who were treated with Erenumab were observed. Patients were assessed with MIDAS, WPAI, and HADS scales; the presence of cutaneous allodynia was evaluated with ASC-12 questionnaire. Patients kept a headache diary and marked adverse events during the whole treatment period.
Results and discussion. 47 patients (69%) had chronic migraine and 32 (71.9%) had medication overuse headache. In 48 patients (70%) after 3 injections of Erenumab the number of days with migraine decreased by 50% or more. In 7 patients (10%), the reduction in headache days was more than 75%; 20 (29%) did not experience sufficient effect after three months of therapy. Nineteen adverse events were noted in 15 (22%) patients. Severe constipation led to discontinuation of treatment in two patients (3%).
Conclusion. The study showed the efficacy and safety of Erenumab for migraine prophylaxis in both patients with episodic and chronic migraine.

About the Authors

N. V. Vashchenko
Department of Nervous System Diseases and Neurosurgery, N.V. Sklifosovsky Institute of Clinical Medicine, I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia; OOO «University Headache Clinic»
Russian Federation

 1, Rossolimo St., Build. 1, Moscow 119021, Russia 

2, Molodogvardeiskaya St., Build. 1, Moscow 121467, Russia



D. Z. Korobkova
OOO «University Headache Clinic»
Russian Federation

2, Molodogvardeiskaya St., Build. 1, Moscow 121467, Russia



K. V. Skorobogatykh
OOO «University Headache Clinic»
Russian Federation

2, Molodogvardeiskaya St., Build. 1, Moscow 121467, Russia



Yu. E. Azimova
OOO «University Headache Clinic»; Research Institute of General Pathology and Pathophysiology
Russian Federation

2, Molodogvardeiskaya St., Build. 1, Moscow 121467, Russia

8, Baltiyskaya St., Moscow 125315, Russia 



References

1. Steiner TJ, Stovner LJ, Jensen R, et al. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137. doi: 10.1186/s10194-020-01208-0

2. Ashina M. Migraine. N Engl J Med. 2020 Nov 5;383(19):1866-76. doi: 10.1056/NEJMra1915327

3. Natoli JL, Manack A, Dean B, et al. Global prevalence of chronic migraine: a systematic review. Cephalalgia. 2010 May;30(5):599-609. doi: 10.1111/j.1468-2982.2009.01941.x

4. Ayzenberg I, Katsarava Z, Sborowski A, et al. The prevalence of primary headache disorders in Russia: a countrywide survey. Cephalalgia. 2012 Apr;32(5):373-81. doi: 10.1177/0333102412438977. Epub 2012 Mar 6.

5. Mulder EJ, van Baal C, Gaist D, et al. Genetic and environmental influences on migraine: a twin study across six countries. Twin Res. 2003 Oct;6(5):422-31. doi: 10.1375/136905203770326420

6. Azimova YuE. Migraine: modern view of the classification, pathophysiology and specific therapy. Meditsinskiy sovet = Medical Council. 2014;(5):27-9. doi: 10.21518/2079-701X-2014-5-27-29 (In Russ.).

7. Filatova EG, Osipova VV, Tabeeva GR, et al. Diagnosis and treatment of migraine: Russian experts' recommendations. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2020;12(4):4-14. doi: 10.14412/2074-2711-2020-4-4-14 (In Russ.).

8. Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014 Jan;20(1):22-33. doi: 10.18553/jmcp.2014.20.1.22

9. Ford JH, Jackson J, Milligan G, et al. A Real-World Analysis of Migraine: A Cross-Sectional Study of Disease Burden and Treatment Patterns. Headache. 2017 Nov;57(10):1532-44. doi: 10.1111/head.13202. Epub 2017 Oct 6.

10. Martelletti P, Edvinsson L, Ashina M. Shaping the future of migraine targeting Calcitonin-Gene-Related-Peptide with the Disease-Modifying Migraine Drugs (DMMDs). J Headache Pain. 2019 May 23;20(1):60. doi: 10.1186/s10194-019-1009-9

11. Sacco S, Bendtsen L, Ashina M, et al. 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. doi: 10.1186/s10194-018-0955-y

12. Martelletti P. Erenumab is effective in reducing migraine frequency and improving physical functioning. BMJ Evid Based Med. 2019 Apr;24(2):76. doi: 10.1136/bmjebm-2018-110937. Epub 2018 Aug 14.

13. 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 Jun;16(6):425-34. doi: 10.1016/S1474-4422(17)30083-2. Epub 2017 Apr 28.

14. Goadsby PJ, Reuter U, Hallström Y, et al. A controlled trial of Erenumab for episodic migraine. N Engl J Med. 2017 Nov 30;377(22):2123-32. doi: 10.1056/NEJMoa1705848

15. Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, doubleblind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-7. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.

16. Dodick DW, Ashina M, Brandes JL, et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-37. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.

17. Lipton RB, Tepper SJ, Reuter U, et al. Erenumab in chronic migraine: Patient-reported outcomes in a randomized double-blind study. Neurology. 2019 May 7;92(19):e2250-e2260. doi: 10.1212/WNL.0000000000007452. Epub 2019 Apr 17.

18. Ornello R, Casalena A, Frattale I, et al. Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J Headache Pain. 2020 Apr 7;21(1):32. doi: 10.1186/s10194-020-01102-9

19. Benatto MT, Florencio LL, Carvalho GF, et al. Cutaneous allodynia is more frequent in chronic migraine, and its presence and severity seems to be more associated with the duration of the disease. Arq Neuropsiquiatr. 2017 Mar;75(3):153-9. doi: 10.1590/0004-282X20170015

20. Louter MA, Bosker JE, van Oosterhout WP, et al. Cutaneous allodynia as a predictor of migraine chronification. Brain. 2013 Nov;136(Pt 11):3489-96. doi: 10.1093/brain/awt251. Epub 2013 Sep 29.


For citation:


Vashchenko N.V., Korobkova D.Z., Skorobogatykh K.V., Azimova Yu.E. Efficacy and safety of anti-CGRP(r) monoclonal antibodies in real clinical practice: preliminary analysis after three months of therapy. Neurology, Neuropsychiatry, Psychosomatics. 2021;13(6):62-66. (In Russ.) https://doi.org/10.14412/2074-2711-2021-6-62-66

Views: 334


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


ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)