한국임상약학회지 (Korean Journal of Clinical Pharmacy)

  • 제29권2호
  • /
  • Pages.71-78
  • /
  • 2019
  • /
  • 1226-6051(pISSN)
  • /
  • 2508-786X(eISSN)
한국임상약학회 (Korean College Of Clinical Pharmacy)
권호 표지
DOI QR코드

DOI QR Code

편두통 예방을 위한 erenumab의 유효성 및 안전성에 관한 체계적 고찰

Systematic Review on the Efficacy and Safety of Erenumab for the Prevention of Migraine

  • 투고 : 2019.03.19
  • 심사 : 2019.06.13
  • 발행 : 2019.06.30
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Objective: This study aimed to provide efficacy and safety information on the use of erenumab for prevention of episodic and chronic migraines. Methods: The keywords "Erenumab and migraine" were used to search the PubMed database to then compile efficacy and safety data for erenumab. Data from relevant Phase 2 and Phase 3 clinical trials were analyzed, using RevMan for statistical analysis. Results: Three clinical trials (one Phase 2 and two Phase 3 studies) were retrieved. All three trials used the same primary endpoint (change from baseline in monthly migraine days (CBMD)) to evaluate efficacy and safety of erenumab use for prevention of episodic and chronic migraines. Subcutaneous doses of erenumab (70 or 140 mg) were administered monthly in each trial, for 3 months (Studies 2, and 3) or 6 months (Study 1). The mean differences in CBMD in the 70 mg and 140 mg erenumab arms were -1.36 and -1.98, respectively, compared to that in the placebo arm. Some adverse events, such as nasopharyngitis and upper respiratory tract infection, were reported, but no differences in safety between erenumab and placebo were found to be significant. Conclusions: Erenumab showed superior efficacy in prevention of migraines compared to placebo. However, additional information regarding the long-term safety of erenumab should be collected. Therefore, post-marketing surveillance for adverse events is needed.

키워드

참고문헌

  1. Stovner L, Hagen K, Jensen R, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia 2007;27(3):193-210. https://doi.org/10.1111/j.1468-2982.2007.01288.x
  2. Lipton RB, Manack A, Buse DC, et al. A comparison of the Chronic Migraine Epidemiology and Outcomes (CaMEO) study and American Migraine Prevalence and Prevention (AMPP) study: demographics and headache-related disability. Headache 2016;56(8):1280-9. https://doi.org/10.1111/head.12878
  3. Buse DC, Manack AN, Fanning KM, et al. Chronic migraine prevalence, disability, and sociodemographic factors: results from the american migraine prevalence and prevention study. Headache 2012;52(10):1456-70. https://doi.org/10.1111/j.1526-4610.2012.02223.x
  4. 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
  5. NICE (National Institute for Health and Care Excellence). Management of migraine (with or wihout aura). Available from https://pathways.nice.org.uk/pathways/headaches/management-ofmigraine-with-or-without-aura. Accessed March 15, 2019.
  6. Raffaelli B and Reuter U. The biology of monoclonal antibodies: focus on calcitonin gene-related peptide for prophylactic migraine therapy. Neurotherapeutics 2018;15(2):324-35. https://doi.org/10.1007/s13311-018-0622-7
  7. Giamberardino MA, Affaitati G, Costantini R, et al. Calcitonin generelated peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab. J Pain Res 2017;10:2751-60. https://doi.org/10.2147/JPR.S128143
  8. Tepper SJ. History and review of anti-Calcitonin Gene-Related Peptide(CGRP) Therapies: from translational research to treatment. Headache 2018;58 Suppl 3:238-75. https://doi.org/10.1111/head.13379
  9. Food and Drug Administration. News and events. Available from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm. Accessed March 15, 2019.
  10. Edvinsson L, Haanes KA, Warfvinge K, et al. CGRP as the target of new migraine therapies-successful translation from bench to clinic. Nat Rev Neurol 2018;14(6):338-50. https://doi.org/10.1038/s41582-018-0003-1
  11. Taylor FR. Antigens and antibodies in disease with specifics about CGRP immunology. Headache 2018;58 Suppl 3:230-7. https://doi.org/10.1111/head.13409
  12. Yuan H, Lauritsen CG, Kaiser EA, et al. CGRP monoclonal antibodies for migraine: rationale and progress. BioDrugs 2017;31(6):487-501. https://doi.org/10.1007/s40259-017-0250-5
  13. Bigal ME and Walter S. Monoclonal antibodies for migraine: preventing calcitonin gene-related peptide activity. CNS Drugs 2014;28(5):389-99. https://doi.org/10.1007/s40263-014-0156-4
  14. Goadsby PJ, Reuter U, Hallström 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
  15. Dodick DW, Ashina M, Brandes JL, et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia 2018;38(6):1026-37. https://doi.org/10.1177/0333102418759786
  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
  17. Clinicaltrials.gov (NCT02456740). Available from https://clinicaltrials.gov/. Accessed March 15, 2019.
  18. Clinicaltrials.gov (NCT02483585). Available from https://clinicaltrials.gov/. Accessed March 15, 2019.
  19. Clinicaltrials.gov (NCT02066415). Available from https://clinicaltrials.gov/. Accessed March 15, 2019.