639
Views
6
CrossRef citations to date
0
Altmetric
Drug safety evaluation

Safety and tolerability evaluation of erenumab for the preventive treatment of migraine

, &
Pages 867-876 | Received 03 Feb 2021, Accepted 20 May 2021, Published online: 16 Jul 2021

References

  • Ashina M. Migraine. N Engl J Med. 2020 Nov 5;383(19):1866–1876.
  • Hepp Z, Dodick DW, Varon SF, et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015 May;35(6):478–488.
  • Evers S, Afra J, Frese A, et al. EFNS guideline on the drug treatment of migraine--revised report of an EFNS task force. Eur J Neurol. 2009 Sep;16(9):968–981.
  • Ashina M, Buse DC, Ashina H, et al. Migraine: integrated approaches to clinical management and emerging treatments. Lancet. 2021 Apr 17;397(10283):1505–1518.
  • Seng EK, Rains JA, Nicholson RA, et al. Improving medication adherence in migraine treatment. Curr Pain Headache Rep. 2015;19(6):24.
  • Charles A, Pozo-Rosich P. Targeting calcitonin gene-related peptide: a new era in migraine therapy. Lancet. 2019 Nov 9;394(10210):1765–1774.
  • Fa R, King R, SJ S, et al. Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev. 2014 Oct; 94(4):1099–1142.
  • Shi L, Lehto SG, Zhu DX, et al. Pharmacologic characterization of AMG 334, a potent and selective human monoclonal antibody against the calcitonin gene-related peptide receptor. J Pharmacol Exp Ther. 2016;356(1):223–231.
  • de Hoon J, Van Hecken A, Vandermeulen C, et al. Phase I, randomized,double-blind, placebo-controlled, single-dose, and multiple-dose studies of erenumab in healthy subjects and patients with migraine. Clin Pharmacol Ther. 2018;103(5):815–825.
  • Garg S, Vij M, Edward N, et al. A novel calcitonin gene-related peptide receptor antagonist developed specifically for migraine prevention. J Anaesthesiol Clin Pharmacol. 2020;36(1):104.
  • Amgen Inc. Erenumab (Aimovig™): US prescribing information. 2018. https://www.accessdata.fda.gov/drugsatfdadocs/label/2018/761077s000lbl.pdf Accessed 2018 Jun 8
  • European Medicines Agency. Summary of opinion (initial authorisation): aimovig (erenumab). 2018. http://www.ema.europa.eu Accessed 2018 Jun 8
  • Bussiere JL, Davies R, Dean C, et al. Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine. Regul Toxicol Pharmacol. 2019Aug;106:224–238.
  • Ohlsson L, Haanes KA, Kronvall E, et al. Erenumab (AMG 334), a monoclonal antagonist antibody against the canonical CGRP receptor, does not impair vasodilatory or contractile responses to other vasoactive agents in human isolated cranial arteries. Cephalalgia. 2019;39(14):1745–1752.
  • Vu T, Ma P, Chen JS, et al. Pharmacokinetic-Pharmacodynamic Relationship of Erenumab (AMG 334) and capsaicin-induced dermal blood flow in healthy and migraine subjects. Pharm Res. 2017 Sep;34(9):1784–1795. . Epub 2017 Jun 7.
  • de Hoon J, Hecken AV, Vandermeulen C, et al. Phase 1, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the effects of erenumab (AMG 334) and concomitant sumatriptan on blood pressure in healthy volunteers. Cephalalgia. 2019;39(1):100–110.
  • Xu Y, Gabriel K, Wang Y, et al. A multi-center, open-label, pharmacokinetic drug interaction study of erenumab and a combined oral contraceptive in healthy females. CNS Drugs. 2019;33(5):513–522.
  • Goadsby PJ, Reuter U, Hallstrom Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123–2132.
  • Dodick DW, Ashina M, Brandes JL, et al. ARISE: a phase 3 randomized trials of erenumab for episodic migraine. Cephalalgia. 2018;38(6):1026–1037.
  • Reuter U, Goadsby P, 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, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280–2287.
  • Sakai F, Takeshima T, Tatsuoka Y, et al. A randomized phase 2 study of erenumab for the prevention of episodic migraine in japanese adults. Headache. 2019 Nov;59(10):1731–1742.
  • Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382–390.
  • 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):425–434.
  • Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017 U.S. department of health and human services
  • Zhu C, Guan J, Xiao H, et al. safety and efficacy in migraine: a systematic review and meta-analysis of randomized clinical trials. Medicine (Baltimore). 2019 Dec;98(52):e18483.
  • Ashina M, Goadsby PJ, Reuter U. Long-term safety and tolerability of erenumab: three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019;39(11):1455–1464.
  • Ashina M, Goadsby PJ, Reuter U, et al. Long-term efficacy and safety of erenumab in migraine prevention: results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021 Jan 5;28(5):1716–1725. Epub ahead of print. PMID: 33400330.
  • Goadsby PJ, Reuter U, Hallstrom Y, et al. One-year sustained efficacy of erenumab in episodic migraine Results of the STRIVE study. Neurology. 2020;95(5):e469–e479.
  • Tepper SJ, Ashina M, Reuter U. et al., Long-term safety and efficacy of erenumab in patients with chronic migraine: results from a 52-week, openlabel extension study. Cephalalgia. 2020 May; 40(6):543-553. https://doi.org/10.1177/0333102420912726
  • Barbanti P, Aurilia C, Egeo G, et al. Erenumab: from scientific evidence to clinical practice—the first Italian real-life data. Neurol Sci. 2019 May;40(Suppl S1):177–179.
  • Gp B. Treatment of chronic migraine with erenumab alone or as an add on therapy: a real-world observational study. Anesth Pain Res. 2020;4(1):1–4.
  • Lambru G, Hill B, Murphy M, et al. A prospective real-world analysis of erenumab in refractory chronic migraine Lambru et al. J Headache Pain. 2020;21(1):61.
  • 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;21(1):32. https://doi.org/10.1186/s10194-020-01102-9
  • Raffaelli B, Kalantzis R, Mecklenburg J, et al. Erenumab in Chronic Migraine patients who previously failed five first-line oral prophylactics and OnabotulinumtoxinA: a dual-center retrospective observational study. Front Neurol. 2020;11:417.
  • Kudrow D, Pascual J, Winner PK, et al. Vascular safety of erenumab for migraine prevention. Neurology. 2020;94(5):e497–e510. 4. https://doi.org/10.1212/WNL.0000000000008743
  • Noseda R, Bedussi F, Gobbi C, et al. Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: analysis of the WHO pharmacovigilance database. Cephalalgia.2021 June; 41(7):789-798 DOI:https://doi.org/10.1177/0333102420983292
  • Fofi L, Egeo G, Aurilia C, et al. Erenumab during pregnancy: a case report in a patient with chronic migraine. Neurol Sci. 2020 Nov 26; https://doi.org/10.1007/s10072-020-04931-3.
  • Mahmoud AN, Mentias A, Elgendy AY, et al. Migraine and the risk of cardiovascular and cerebrovascular events: a meta-analysis of 16 cohort studies including 1 152 407 subjects. BMJ Open. 2018;8(3):e020498.
  • MaassenVanDenBrink A, Meijer J, Villalón CM, et al. Wiping out CGRP: potential cardiovascular risks. Trends Pharmacol Sci. 2016;37(9):779–788.
  • Depre C, Antalik L, Starling A, et al. A randomized, double-blind, placebo-controlled study to evaluate the effect of erenumab on exercise time during a treadmill test in patients with stable angina. Headache. 2018;58(5):715–723.
  • Saely S, Croteau D, Jawidzik L, et al. Kortepeter C Hypertension: a new safety risk for patients treated with Erenumab. Headache. 2021;61(1):1–7.
  • Constantinidis T, Arvaniti C, Fakas N, et al. A population-based survey for disabling headaches in Greece: prevalence, burden and treatment preferences. Cephalalgia: in press; 2021.
  • Drellia K, Kokoti L, Deligianni C, et al. Anti-CGRP monoclonal antibodies for migraine prevention: a systematic review and likelihood to help or harm analysis. Cephalalgia. 2021Feb;10:333102421989601.
  • Affaitati G, et al. Co-occurrence of pain syndromes. J Neural Transm (Vienna). 2020 Apr;127(4):625–646.
  • Lipton. et al, Estimating the clinical effectiveness and value-based price range of erenumab for the prevention of migraine in patients with prior treatment failures: a US societal perspective. J Med Econ. 2018Jul;21(7):666–675.
  • Mahon R, Lang A, Vo P, et al. Cost-effectiveness of erenumab for the preventive treatment of migraine in patients with prior treatment failures in swedenCost-effectiveness of erenumab for the preventive treatment of migraine in patients with prior treatment failures in sweden. Pharmacoeconomics. 2021 Mar;39(3):357–372.
  • Ruggeri M, Drago C, Rossielo F, et al. Economic evaluation of treatments for migraine: an assessment of the generalizability following a systematic review. Pharmacoeconomics. 2020 May;38(5):473–484.
  • Giannouchos TV, Mitsikostas DD, Ohsfeldt RL, et al. Cost-effectiveness analysis of erenumab versus onabotulinumtoxina for patients with chronic migraine attacks in greece. Clin Drug Investig. 2019 Oct;39(10):979–990.
  • Sussman M, Benner J, Neumann P, et al. Cost-effectiveness analysis of erenumab for the preventive treatment of episodic and chronic migraine: results from the US societal and payer perspectives. Cephalalgia. 2018 Sep;38(10):1644–1657.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.