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Fremanezumab (Ajovy) has the potential to reduce the symptoms and cumulative burden of migraine and associated depression, according to new research.
Data from the UNITE study, which was presented today at the World Congress of Neurology (WCN) in Montreal, Canada today, suggests that fremanezumab reduces migraine attacks and depression symptoms in migraine patients with major depressive disorder.
Depression is one of the most prevalent psychiatric co-morbidities in migraine, with almost half of all migraine patients experiencing depression and anxiety.
A reduction in Monthly Migraine Days
UNITE is a double-blind, randomised, placebo-controlled, Phase 4 study sponsored by Teva. It investigated the efficacy, safety, and impact of fremanezumab on patients with migraine and major depressive disorder in a 12-week double-blind period.
Dr Verena Ramirez Campos, Global Senior Medical Director at Teva, who presented the study’s findings, said patients in the study treated with fremanezumab experienced a significant reduction in Monthly Migraine Days (MMD) compared to patients on placebo, at –5.1 MMDs for fremanezumab vs –2.9 for placebo.
Furthermore, a significantly higher number of patients receiving fremanezumab achieved ≥50% reduction in MMD compared to placebo (33% vs 13%), with a sustained reduction over the longer-term.
Meaningful improvements in depression and disability
The study also had two secondary endpoints: reducing the impact of depression and disability.
The authors of the study used two common depression rating scores to measure reductions in depression symptoms, and found the mean change after 12 weeks to be -6.7 with fremanezumab vs -5.4 with placebo using the Hamilton Rating Scale for Depression, and -7.8 vs -6.3 respectively using the Patient Health Questionnaire-9 (PHQ-9) score.
Fremanezumab also demonstrated clinically meaningful improvements in disability outcomes, with reductions on both the Headache Impact Test score (-8.8 vs -5.2) and the Clinical Global Impression-Severity (CGI-S) score (-1.1 vs -0.8).
Dr Verena Ramirez Campos, Global Senior Medical Director at Teva said: “Patients who suffer from migraine and mental health disorders such as depression face a far greater burden than those suffering from either migraine or depression alone.
“The UNITE data presented at WCN provides further insights into the potential efficacy, safety, and quality of life benefits of Ajovy for people with migraine and major depressive disorder.”
Fremanezumab could be offered as a personalised treatment option
While fremanezumab is already available on the NHS as a treatment for migraine in adults, the authors of the study say these findings indicate that fremanezumab has the potential to reduce the symptoms and cumulative burden of migraine and associated depression, and this should inform prescribing decisions.
Study lead author, Richard Lipton MD, said: “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 it is very important for treatments to demonstrate efficacy and safety in migraine patients with this particular co-morbidity.”