Ajovy significantly reduces depressive symptoms of and migraine days in patients with migraine and depression: Phase 4 study

The findings from the study were presented on October 17, 2023, at the World Congress of Neurology in Montreal, Canada.

Depression is among the most prevalent psychiatric co-morbidities in migraine and patients with comorbid depression experience an increased risk of migraine ‘chronification’. This is characterized by a greater degree of headache disability, an increase in the number of headache days, a poorer response to migraine treatments, and reduced quality of life.

Ajovy (fremanezumab) is a humanized monoclonal antibody (mAb) developed by Teva Pharmaceuticals that selectively targets the calcitonin gene-related peptide (CGRP), and is approved for migraine prevention in adults who have at least 4 migraine days per month.

Study lead author Richard Lipton M.D., Department of Neurology, Psychiatry and Behavioural Sciences at Albert Einstein College of Medicine, New York said in a press release: “Depression is commonly associated with migraine, and clinicians are increasingly aware of the impact of co-morbidities. We are moving towards more personalised treatment decisions in migraine which are tailored to the patient’s profile, and treatments need to demonstrate efficacy and safety in migraine patients with this particular co-morbidity.”

UNITE is a double-blind, randomised, placebo-controlled, Phase 4 study sponsored by Teva Pharmaceutical investigating the safety, efficacy, and impact of fremanezumab on patients with major depressive disorder and migraine.

The key findings of the trial are as follows:

• Patients in the study treated with fremanezumab experienced a significant reduction in Monthly Migraine Days (MMD) compared to patients on placebo, with a reduction in MMD of –5.1 vs –2.9 for fremanezumab vs placebo.
• On the Hamilton Rating Scale for Depression, the mean score change at week 12 was –6.7 for those treated with fremanezumab and –5.4 for placebo. On the Patient Health Questionnaire-9, the mean changes were –7.8 and –6.3, respectively.
• A significantly higher number of patients (33%), receiving fremanezumab achieved ≥50% reduction in MMD compared to placebo (13%) during the 12-week double-blind period, with a sustained reduction over the longer-term.
• At week 12, participants’ mean change in Headache Impact Test score was –8.8 and –5.2 for fremanezumab and placebo, respectively, and the mean change in Clinical Global Impression-Severity score was –1.1 and –0.8

The results suggest fremanezumab “has the potential to reduce the symptoms and cumulative burden of migraine and associated depression,” the company said in the release.