Migraine is the third most common disease in the world and is the most common neurological disease in people under the age of 50.1. According to the Spanish Society of Neurology (SEN), more than four million Spaniards suffer from migrainestwoof which a million suffer from chronic migraine.
Migraine is a potentially serious and chronic neurological disorder characterized by episodes of severe headache, often accompanied by nausea, vomiting, and sensitivity to light and sound. It affects three times more women than men and has a high economic cost caused by high absenteeism and work performance. Patients with chronic migraine usually miss work in Spain an average of 14.6 days per year, implying direct, indirect and associated costs with lost productivity of €12,900 per patient per year3.
The approach to migraine is very complex, albeit in recent years progress has been made in its treatment with the development of specific drugs such as monoclonal antibodies targeting calcitonin gene-related peptide (CGRP)neuropeptide that is key in the pathogenesis of this disease.
Efficacy of Eptinezumab
The scientific journal “Lancet Neurology” published the DELIVER study, which showed 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 have had between 2 and 4 previous preventive treatments that have failed 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 Hospital Virgen del Rocío (Seville) and a member of the team who participated in this study, positively evaluates the conclusions obtained with this antibody. “Eptinezumab was effective in reducing the number of migraine days per month between 4.8 and 5.3, compared to 2.1 in those treated with placebo. It is important to emphasize the speed of action of the drug, which is effective from the first day. It also shows a good safety profile, with a rate of severe effects of 1% in the groups treated with this drug.
The neurologist emphasized that between 42% and 49% of patients who received eptinezumab achieved a reduction greater than or equal to 50% of migraine days per month over 12 weeks, a figure higher than other anti-CGPRs .
“In terms of a ≥ 50% reduction in migraine days per month in patients treated with eptinezumab in the DELIVER study, the results were very interesting. Compared to other studies conducted in patients with failed prior preventive treatment, the rate of 50% reduction in migraine days per month was greater with DELIVER than that achieved with LIBERTY4CONQUER5 and FOCUS6performed with each of the subcutaneous anti-CGRP antibodies”.
Fast onset of action
Subcutaneous administration plays an important role in these results, as it allows the drug to enter the patient’s bloodstream immediately, providing immediate and long-lasting migraine relief. Its effects are felt on the day of the infusion and persist for 12 weeks.7. With a 30-minute intravenous infusion that requires no premedication or office observation time, migraine patients can regain their quality of life. It also has a good safety and tolerability profile for up to 2 years.8.
“The rapid onset of action seen from day one is likely 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 reaching the maximum plasma concentration at the end of the infusion10says 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 that is often underestimated. It is not just a headache, but patients who suffer from it have debilitating symptoms that negatively affect their quality of life, both personally and at work or in society. It also increases the risk of co-morbidities such as sleep disorders, cardiovascular or gastrointestinal diseases.
Finally, as Dr. Gonzalez 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.
1 Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z, Migraine is the first cause of disability in people under 50: will health policymakers pay attention now. 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 headache attending emergency departments for primary care. Semer – Med Fam. 2010 Jan;36(1):10–5
4 Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Efficacy and tolerability of erenumab in patients with episodic migraine who have failed two to four prior preventive treatments: a randomized, double-blind, placebo-controlled, phase 3b study. Lancet 2018; 392: 2280–87.
5 Mulleners WM, Kim BK, Lainez MJA, et al. Safety and efficacy of galcanezumab in patients who have failed prior treatment for the prevention of category two to four migraine (CONQUER): a multicenter, randomized, 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 of up to four classes of migraine prevention medications (FOCUS): a randomized, double-blind, placebo-controlled phase 3b study. Lancet 2019; 394: 1030–40.
7 International Headache Society. 2019. Available at: https://www.ichd-3.org/1-migraine
8 Kudrow, D., Cady, RK, 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. July 2022; 21 (7): 578-579. ° С
10 Garcia-Martinez LF, Raport CJ, Ojala EW, et al. Pharmacological characterization of ALD403, a potent neutralizing humanized monoclonal antibody against 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 characteristics 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 Opinion 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.