Migraine is the third most prevalent disease in the world and is the most common neurological disorder in people under 50 years of age.1. According to the Spanish Society of Neurology (SEN), more than four million Spaniards suffer from migraine2of which a million suffer from chronic migraine.
Migraine is a potentially serious and chronic neurological disease characterized by episodes of severe headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. It affects three times as many women as men and has a high economic cost caused by high absenteeism and labor presenteeism. Patients with chronic migraine usually miss their job in Spain an average of 14.6 days a year, which implies direct, indirect and associated costs with the loss of productivity of 12,900 euros per patient and year3.
The approach to migraine is very complicated, although in recent years progress has been made in its treatment with the development of specific drugs, such as monoclonal antibodies directed at calcitonin gene-related peptide (CGRP)a neuropeptide that is key in the pathogenesis of this disease.
Efficacy of Eptinezumab
The scientific journal ‘Lancet Neurology’ has published the DELIVER study, which shows how between 42 and 49% of patients treated with eptinezumab cut their migraine days per month by half or more. The study shows the efficacy and safety of eptinezumab administered by intravenous infusion in patients with chronic or episodic migraine who had experienced between 2 and 4 previous preventive treatment failures due to lack of efficacy or adverse effects. Eptinezumab also demonstrated statistically significant superiority over placebo in reducing the number of migraine days per month over 12 weeks of treatment, reaching statistical significance for all key secondary endpoints.
Carmen Gonzalez Oria, neurologist and coordinator of the Headache Unit of the Virgen del Rocío Hospital (Seville) and member of the team that has participated in this study, positively values the conclusions that have been obtained with this antibody. “Eptinezumab is effective with a reduction in the number of migraine days per month between 4.8 and 5.3, being 2.1 in those treated with placebo. It is important to highlight the speed of action of the drug, which is effective from the first day. It also shows a good safety profile, with a percentage of severe effects of 1% in the groups treated with this drug”.
The neurologist highlights that between 42% and 49% of the patients who received eptinezumab achieved a reduction greater than or equal to 50% of the days with migraine per month in 12 weeks, a figure higher than other anti-CGPR.
“Regarding the ≥ 50% reduction in migraine days per month in patients treated with eptinezumab in the DELIVER study, the results were very interesting. Compared with other studies carried out in patients with previous preventive treatment failures, the percentage of reduction of 50% of days with migraine per month has been greater in DELIVER, than those achieved in LIBERTY4CONQUER5 y FOCUS6performed with each of the subcutaneous anti-CGRP antibodies”.
Quick onset of action
Subcutaneous administration plays an important role in these results, as it allows imminent access of the drug to the patient’s bloodstream, providing immediate and long-lasting relief from migraine. Its effects are perceived on the same day of infusion and are maintained for 12 weeks.7. In a 30-minute intravenous infusion, which does not require premedication or office observation time, migraine patients can regain their quality of life. It also has a good safety profile and tolerability for a period of up to 2 years.8.
“The rapid onset of action, which can be seen from day one, is probably due to the high affinity and selectivity of eptinezumab for CGRP.9 and its pharmacokinetic characteristics related to intravenous administration. Including its 100% bioavailability and the achievement of a maximum plasma concentration at the end of infusion10”, says the doctor.
Eptinezumab was approved by the US Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and received marketing authorization from the European Medicines Agency (EMA) in January 2022. .
Migraine is a disease usually trivialized. It is not just a headache, but patients who suffer from it have disabling symptoms that negatively affect their quality of life, both personally, at work or socially. In addition, it increases the risk of comorbidities such as sleep disorders, cardiovascular or gastrointestinal diseases.
Finally, as Dr. González Oria assures, “the arrival of eptinezumab may improve the quality of life of migraine patients, such as those with acute medication overuse, patients with psychiatric comorbidities, and patients refractory to previous treatments and frustrated by the lack of efficacy of other preventive treatments.
References:
1 Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z, Migraine is first cause of disability in under 50s: will health politicians now take notice. J Headache Pain 2018 Feb 21;19 (1):17
2 Ruiz M, León C, Castillo J, Martínez M, Sánchez S, Quintela E. Distribution by diagnosis of headaches attending primary care emergency services. Semer – Med Fam. 2010 Jan;36(1):10–5
3 https://www.sen.es/saladeprensa/pdf/Link276.pdf
4 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, double-blind, placebo-controlled, phase 3b study. Lancet 2018; 392: 2280–87.
5 Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol 2020; 19: 814–25.
6 Ferrari MD, Diener HC, Ning X, et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet 2019; 394: 1030–40.
7 International Headache Society. 2019. Available at: https://www.ichd-3.org/1- migraine
8 Kudrow, D., Cady, R.K., Allan, B. et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol 21, 126 (2021). https://doi.org/10.1186/s12883-021-02123-w
9 Ref: Ornello R, Sacco S. A new option for patients with treatment-resistant migraine. Lancet Neurol. 2022 Jul;21(7):578-579. ç
10 Garcia-Martinez LF, Raport CJ, Ojala EW, et al. Pharmacologic characterization of ALD403, a potent neutralizing humanized monoclonal antibody once morest the calcitonin gene-related peptide. J Pharmacol Exp Ther 2020; 374: 93–103.
Latham J, Karasek C, Ojala E, Allison D. Characterization of the intrinsic binding features of three anti-CGRP therapeutic antibodies effective in preventing migraine: a comparative case study of ALD403, Ly-2951742, TEV-48125. Headache 2016; 56: 8.
Wattiez AS, Sowers LP, Russo AF. Calcitonin gene-related peptide (CGRP): role in migraine pathophysiology and therapeutic targeting. Expert Opin Ther Targets 2020; 24: 91–100.
Baker B, Schaeffler B, Beliveau M, et al. Population pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migraine.
