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Study, monoclonal effective in migraine from overuse of medications

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Helsinki, 23 June (Adnkronos Salute) - In patients with chronic migraine and medication-overuse headache (Moh) who also received a standardized brief educational intervention, eptinezumab demonstrated a statistically significant reduction in the number of me...

Helsinki, 23 June (Adnkronos Salute) – In patients with chronic migraine and medication-overuse headache (Moh) who also received a standardized brief educational intervention, eptinezumab demonstrated a statistically significant reduction in the mean number of monthly migraine days (MMD) per month in the first 4 weeks of therapy.

Compared to those who received a placebo, patients treated with the monoclonal antibody reported a rapid reduction in pain severity by the second week, as well as a significant reduction in the use of symptomatic migraine medications. These are the results of the phase IV Resolution study presented by Lundbeck today in Helsinki, on the occasion of the 11th Congress of the European Academy of Neurology (EAN), ongoing until June 24.

Migraine is a complex and disabling neurological disorder characterized by recurrent episodes of severe headache typically accompanied by a range of symptoms, including nausea, vomiting, and sensitivity to light and sound. It affects nearly 50 million people in Europe. Patients with chronic migraine and medication-overuse headache represent a specific subgroup of the migraine population in which the disease has a severe impact. These patients are trapped in a cycle of worsening migraine, where increasing use of symptomatic medications reduces their effectiveness and increases the burden of the disease. This patient population is often difficult to treat, due to the complexity of the disease.

“Patient education is often used as a treatment strategy for patients with chronic migraine and medication-overuse headache, while preventive anti-CGRP treatments are reserved for later stages,” says Rigmor Højland Jensen, associate professor at the University of Copenhagen, director of the Danish Headache Center, and principal investigator of the Resolution study, which shows, “for the first time, that adding early-stage anti-CGRP treatment, together with patient education about medication-overuse headache, can provide significant and rapid prevention of migraine. This is good news for patients severely affected by migraine complicated by medication-overuse.”

In the randomized, placebo-controlled Resolution study (n=608), which evaluated the efficacy of eptinezumab versus placebo, the monoclonal antibody met both primary and secondary endpoints, showing significantly greater reductions in the number of monthly migraine days (MMD) in weeks 1 to 4 with eptinezumab versus placebo. Over a mean of 21 days, the change from baseline in MMD was -6,9 days with eptinezumab versus -3,7 days with placebo (p<0,0001). Additionally, treated patients, and those with a standardized educational intervention, reduced their use of symptomatic medications by more than half: the change from baseline in the number of days per month in which patients used symptomatic treatment for migraine was -11,2 with eptinezumab, compared with -7,8 days with placebo (in weeks 1 to 12, p<0,0001, days of symptomatic use at baseline were 20,1 for eptinezumab and 20,1 for placebo).

The data also showed a reduction in daily pain severity in patients on treatment, as early as the second week of therapy: the change from baseline in the daily pain intensity score with eptinezumab was -0,6 versus -0,3 with placebo (p<0,0001). In addition to reductions in monthly migraine days (MMD), use of symptomatic medications, and pain severity, greater improvements were observed with eptinezumab versus placebo in patient-reported outcomes (PROs), which measure headache burden, quality of life, migraine-related disability, work productivity, and impairment of daily activities. The percentage of patients with treatment-emergent adverse events was similar between the two study groups (41,9% versus 36,9% for placebo). This finding indicates that eptinezumab was well tolerated, similar to previous studies of the drug in the prevention of migraine and consistent with current safety information in the summary of product characteristics.

"The Resolution study," said Johan Luthman, EVP and Head of Research and Development at Lundbeck, "provides further evidence to support eptinezumab as an effective treatment option for patients severely impacted by migraine. We have seen significant benefits with eptinezumab, even in addition to patient education. These results highlight Lundbeck's commitment to raising the bar for expectations in migraine treatment, ensuring that even the most difficult-to-treat patients have access to effective solutions."

Eptinezumab is a humanized monoclonal antibody that binds to the α- and β-forms of Cgrp. It is indicated for the prophylaxis of migraine in adults with at least 4 days of illness per month. The recommended dose is 100 mg, administered intravenously every 12 weeks. Some patients may benefit from a dose of 300 mg, administered by intravenous infusion every 12 weeks.

According to the Global Burden of Disease study, migraine is the second leading cause of Years Lived with Disability (YLD) among all diseases, and is the first cause of YLD in people aged 15 to 49. Precisely for this reason it imposes both a social and economic burden: according to the Cost of Brain Disorders in Europe study, the disease has an economic impact of 18 billion euros per year, without taking into account the indirect costs associated with presenteeism, i.e. the loss of productivity due to the reduced efficiency of people who are not sick enough to be absent from work.

Repeated migraine attacks, and often the constant fear of the next attack, disrupt family, social and work life. In addition, increased use of headache relievers can lead to central sensitization and reduced effectiveness of the relievers. The result is a cycle of increasing headache days, requiring further increases in the amount of reliever medication. Without adequate management of migraine, this process results in worsening of the condition and can lead to the development of chronic migraine and Moh's. Secondary Moh's headache is a common complication among patients with primary headache disorders, such as chronic migraine.