New research on an option for treating migraines and depression hand-in-hand

Recommended as first-line treatment for episodic and chronic migraine in adults by the latest guidelines from the American College of Physicians and the Headache Society of Canada, the monoclonal antibody fremanezumab has also demonstrated beneficial effects on depression, which is often comorbid with migraine. A post-hoc analysis of the HALO CM study in 2021, published in the journal Headache, showed that, compared with placebo, treatment with fremanezumab was associated with a reduction in the number of monthly migraine days and migraine-related disability in patients suffering from migraine and comorbid depression, as well as improvements in quality-of-life measures and a reduction in depressive symptoms. However, this work involved only a small number of patients with moderate to severe depressive symptoms at baseline, rather than those meeting the diagnostic criteria for major depressive disorder.Dr. Richard Lipton of Albert Einstein College of Medicine in New York, co-author of the 2021 study, therefore conducted further work in collaboration with a team of international investigators to examine the efficacy and safety of treatment with fremanezumab on migraine and depressive symptoms in patients with episodic or chronic migraine and comorbid major depressive disorder. The Phase IV UNITE2 trial is a 28-week randomized, double-blind, placebo-controlled, multi-centre clinical trial involving 353 patients from 12 countries, published in JAMA Neurology. Nearly all participants (98%) in the fremanezumab and placebo groups used one or more concomitant medications during the double-blind period. Around 76% of patients had previously used medications to treat depression, and around 64% had used a single medication to treat depression at a stable dose for eight weeks or more prior to selection and continued this medication during the study.50% migraine reductionAccording to the results of the UNITE trial, treatment with monthly doses of fremanezumab (Ajovy, 225 mg) for 12 weeks reduced depressive symptoms and monthly migraine attacks in participants with both conditions. A total of 33% of patients in the fremanezumab group achieved a 50% or greater reduction from baseline in the number of migraine days per month during the 12-week double-blind period, compared with 13% of participants treated with placebo (95% CI, 1.89-5.62; P < 0.001). At week 12, 40% of patients in the freemanezumab group achieved a 50% or greater reduction in the number of migraine days per month, compared with 25% of patients in the placebo group (95% CI, 1.33-3.38).In detail, the mean change from baseline in the monthly number of migraine days during the 12-week double-blind period was -5.1 days (0.50; 95% CI, -6.09 to -4.13) for freemanezumab and -2.9 days (0.49; 95% CI, -3.89 to -1.96) for placebo ( P < 0.001). The mean change from baseline in the Hamilton Depression Rating Scale-17 (HAM-D 17) score at 8 weeks was -6.0 points (0.55; 95% CI, -7.10 to -4.95) for freemanezumab and -4.6 points (0.54; 95% CI, -5.66 to -3.55) for placebo. The mean difference in HAM-D 17 scores at week 8 was -1.4 points (95% CI -2.61 to -0.22, P = 0.02). HAM-D 17 scores ranged from 0 to 52, with higher scores indicating more severe depression.Finally, 70 out of 176 patients (40%) in the fremanezumab group and 48 out of 177 patients (27%) in the placebo group reported one or more adverse events during the double-blind period, most of them of mild or moderate intensity.“Treatment with fremanezumab, compared with placebo, resulted in a significant reduction in the number of monthly migraine days and in depressive symptoms,” concluded the authors, noting that no new safety issues were observed. This is the first randomized placebo-controlled clinical trial to demonstrate significant improvements in migraine and depressive symptoms with a single pharmacological intervention.The authors said it's imperative to treat depression at the same time as migraine in patients suffering from both conditions, as “the comorbidity of migraine and depression predicts migraine chronicity, increases the likelihood of medication overuse, headache-related disability and medical costs, and decreases quality of life.”This article has been translated from its original French and first appeared on our sister site Profession Santé.

New research on an option for treating migraines and depression hand-in-hand

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