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Real-world patients with migraine and comorbid depression and anxiety were able to ditch their antidepressant after starting treatment with injectable fremanezumab (Ajovy), a researcher reported.

The study looked at 6-month outcomes of patients with either episodic or chronic migraines who were on the agent for migraine and who had comorbid depression, anxiety, or hypertension. Among the 172 patients with baseline comorbid depression, there was a 12.2% reduction in the proportion using an antidepressant after starting fremanezumab (68.6% at baseline vs 56.4%, P=0.0025), reported Andrea Hinds, PhD, of Teva Pharmaceuticals in West Chester, Pennsylvania.

This reduction in antidepressant use was largely driven by patients with episodic migraine, dropping 12.6% (74.8% vs 62.1%, P=0.0072). In addition, there was a trend toward patients with chronic migraines also giving up antidepressants (-11.6%, 59.4% vs 47.8%, P=0.11), Hinds and colleagues reported in a poster at the Psych Congress, held virtually and in San Antonio, Texas.

However, patients with migraine and comorbid hypertension did not experience a greater benefit from fremanezumab treatment. Among this group of 142 patients, there were no significant changes in mean systolic blood pressure (BP, 127.32 mmHg vs 126.98 mmHg) or mean diastolic BP (78.43 mmHg vs 77.84 mmHg) during the 6-month follow-up.

Fremanezumab is a fully humanized monoclonal antibody selectively targeting calcitonin gene-related peptide (CGRP), and won FDA approval in 2018 for the in adults, making it the second drug approved in this class after erenumab (Aimovig). Two more anti-CGRP monoclonal antibodies for migraine prevention -- galcanezumab (Emgality) and eptinezumab (Vyepti) -- have also gained FDA approval, as have two oral CGRP receptor antagonists, rimegepant (Nurtec ODT) and atogepant (Qulipta).

The current analysis comes on the heels of FDA analysis of postmarketing case reports suggesting that erenumab was tied to 61 cases of hypertension.

"Because CGRP receptors are found in the blood vessels of the heart, understanding the effect of medications targeting CGRP on cardiovascular outcomes is key," Hinds explained.

She noted that "Depression affects up to 47% of patients with migraine and anxiety affects up to 58% of patients with migraine," adding that "comorbid depression and anxiety, as well as hypertension, have been associated with an increase in headache frequency and greater headache severity."

The researchers gathered data from the Veradigm Health Insights Database, from 2014 to 2019, and included 172 patients in the comorbid depression subgroup, 180 patients in the comorbid anxiety subgroup, and 142 patients with comorbid hypertension. All patients were at least age 18 years with a diagnosis of migraine. Those who were treated with any other CGRP pathway-targeted therapy prior to the study were excluded.

More than 75% of patients in each of the three comorbidity subgroups were female, and ranged in mean age from 45 to 54.

About 20% of each subgroup also had comorbid back pain and/or fibromyalgia. Other common comorbidities included high cholesterol, insomnia, and ulcers.

The researchers reported a significant decline in the number of antidepressant prescriptions used among these migraine patients with comorbid depression (-0.22, 1.05 vs 0.84, P=0.008).

A significant proportion of patients with comorbid anxiety also were able to cease use of their anxiolytics within the 6 months of starting treatment with fremanezumab (-7.8%, 55% vs 47.2%, P=0.04). This was marked by a 7.6% and 8.1% drop in the proportion of patients using an anxiolytics with episodic migraine and chronic migraine, respectively.

Although not statistically significant, there was a trend toward a decline in the number of anxiolytic medication prescriptions among all migraine patients with comorbid anxiety (-0.09, 0.75 vs 0.66, P=0.2).

"Taken together, these results show in a real-world setting, fremanezumab treatment results in reductions in antidepressant and anxiolytic use in patients with migraine and comorbid depression and anxiety, respectively," Hinds concluded, and the agent "was associated with nonsignificant decreases in blood pressure among patients with migraine and comorbid hypertension."

The supported fremanezumab as preventive treatment of chronic migraine, and showed a reduction in headache impact in patients with comorbid depression.

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