Results of two studies presented at the Migraine Trust International Symposium (MTIS) in London, UK, demonstrate the efficacy of fremanezumab in migraine patients who also experience depression or anxiety.
In both studies, quarterly and monthly dosing of fremanezumab demonstrated efficacy in reducing monthly migraine attacks by more than 50% compared to placebo.1,2 This is an important outcome because psychiatric disorders are a common comorbidity in patients suffering from migraine. Population-based samples of people with migraine show up to 47% have comorbid depression, and up to 58% have comorbid anxiety, with many patients experiencing both psychiatric conditions.
The first study1 relating to this patient cohort was led by Richard Lipton MD, Department of Neurology, Psychiatry and Behavioural Sciences at Albert Einstein College of Medicine, New York. This study is an analysis of pooled data from two previous six-month studies: HALO and FOCUS. The new study to be presented at MTIS sets out to analyse the efficacy of quarterly or monthly dosing of fremanezumab versus placebo in people with migraine and one or more psychiatric comorbidities.1
Results at three months showed that 32% of patients on quarterly fremanezumab (n=61) and 36% of patients on monthly fremanezumab (n=75) achieved a ≥ 50% reduction in monthly-migraine-days (MMD) compared to 19% of those taking placebo (n=42), and that proportion increased after continuing or switching to fremanezumab at month six.1
The second study2 is a sub-analysis of patients from the double-blind, placebo-controlled Phase IIIb FOCUS study led by Patricia Pozo-Rosich, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Research, Barcelona. The FOCUS study set out to evaluate the efficacy of quarterly or monthly fremanezumab in chronic or episodic migraine patients who had experienced an inadequate response to two to four classes of prior preventive migraine medication. The sub-analysis evaluated treatment efficacy on a sub-group of the migraine patients who had comorbid depression.2
Reductions were observed in both monthly-migraine-days and monthly-headache-days with both quarterly and monthly fremanezumab compared with placebo. Differences were also seen in patient-reported depressive symptoms using a PHQ-9 questionnaire – a brief self-reporting instrument incorporating recognised depression criteria and other depressive symptoms suggesting that effective treatment of migraine can also positively impact depressive symptoms in patients with this co-morbidity.
Reflecting on the outcome of his study, Dr Richard Lipton commented, “Clinicians are becoming increasingly aware of the impact that co-morbidities can have on the management of migraine patients. I believe that we need to move towards more personalised treatment decisions that are tailored to the patient’s profile and co-morbidities. As depression and anxiety are commonly associated with migraine, it will be very important for treatments to demonstrate efficacy and safety in migraine patients with these particular comorbidities.”
Details of enrolment progress into the UNITE study were also revealed at MTIS. The 28-week study, led by Dr. Richard Lipton and supported by Teva, will be assessing the efficacy and safety of fremanezumab in adult patients with chronic and episodic migraine and major depressive disorder.
Commenting on the study, Dr. Lipton said: “We are pleased to report that a total of 237 patients have so far enrolled in the UNITE study with 19% from the US, 61% from Europe, and 20% from the rest of the world. Assessing the efficacy of fremanezumab in patients with migraine and major depressive disorder will help inform treatment decisions to improve care in this important patient population. We look forward to sharing the results in due course.”
- Lipton et al. Efficacy of Quarterly and Monthly Fremanezumab in Patients With Migraine and Psychiatric Comorbidities. Abstract accepted for MTIS 2022. MTIS2022-229
- Pozo-Rosich et al. Fremanezumab Efficacy in Migraine Patients With Prior Inadequate Response to ≥3 Preventive Migraine Medication Classes and Depressive Symptoms. Abstract accepted for MTIS 2022. MTIS2022-230