Migraine days, depression symptoms significantly reduced in Ajovy phase 4 study
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Key takeaways:
- Ajovy significantly reduced depression symptoms, monthly migraine days and brought sustained reductions in disability.
- The drug could ease the cumulative burden of migraine and depression.
Ajovy significantly reduced depression symptoms and monthly migraine days in a phase 4 study, with clinically meaningful improvements in disability outcomes, manufacturer Teva Pharmaceuticals announced in a press release.
“Depression is commonly associated with migraine, and clinicians are increasingly aware of the impact of comorbidities,” Richard B. Lipton, MD, professor at Albert Einstein College of Medicine and lead author of the study, said in the release. “We are moving towards more personalized treatment decisions in migraine, which are tailored to the patient’s profile.”
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The 12-week, double-blind, randomized, placebo-controlled study, sponsored by Teva, tested the safety and efficacy of Ajovy (fremanezumab, Teva) in patients with migraine and major depressive disorder. The humanized monoclonal antibody is currently approved for prevention of migraines.
According to the release, patients treated with fremanezumab had “a reduction” of –5.1 monthly migraine days at 12 weeks, compared with a –2.9-day reduction in those treated with placebo (P < .0001).
Two depression rating scales also registered significant symptom reductions: 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 (P = .0228). On the Patient Health Questionnaire-9, the mean changes were –7.8 and –6.3, respectively (P = .0108).
In addition, clinically meaningful improvements in disability outcomes were sustained “over the longer term,” the release stated.
At week 12, participants’ mean change in Headache Impact Test score was –8.8 and –5.2 for fremanezumab and placebo, respectively (P < .0001), and mean change in Clinical Global Impression-Severity score was –1.1 and –0.8 (P = .003).
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.