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Fremanezumab effective in patients with migraine and comorbid depression - Medical Conferences

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Fremanezumab effective in patients with migraine and comorbid depression

Presented By
Prof. Dawn C. Buse, Albert Einstein College of Medicine, NY, USA

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Conference
MTIS 2020
Trial
Phase 3, FOCUS, HALO


 

Fremanezumab, a fully humanised monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP), was effective in patients with migraine and comorbid moderate-to-severe depression and was associated with improvement in depressive symptoms over long-term treatment and in patients with difficult-to-treat migraine [1].

Up to 30% of patients with episodic migraine and up to 57% of patients with chronic migraine have comorbid depression. Patients with migraine and comorbid depression experience reduced quality of life and may experience reduced efficacy with treatment.

FOCUS and HALO studies

In the 12-week, placebo-controlled FOCUS study, patients with episodic or chronic migraine and inadequate response to 2-4 prior migraine preventive medication classes were randomised to:

  • quarterly fremanezumab: 675 mg in month 1 and placebo in months 2 and 3;

  • monthly fremanezumab: 675 mg in patients with chronic migraine and 225 mg in patients with episodic migraine in month 1, and thereafter 225 mg in months 2 and 3; or

  • matched monthly placebo.

In the 52-week HALO study, chronic migraine patients received monthly fremanezumab (225 mg monthly, with a starting dose of 675 mg) or quarterly fremanezumab (675 mg every 3 months).

For both studies, post-hoc subgroup analyses evaluated efficacy in patients with comorbid moderate-to-severe depression based on a Patient Health Questionnaire (PHQ)-9 score ≥10 at baseline. Changes from baseline in average monthly migraine days (MMDs), headache days of at least moderate severity (HDs), and PHQ-9 scores were evaluated in these subgroups.

12-week FOCUS study

In the 12-week FOCUS study, 154/838 (18.4%) randomised patients had moderate-to-severe depression. Mean reductions from baseline in MMDs and HDs were significantly greater with fremanezumab versus placebo at 12 weeks. During that period, fremanezumab treatment was also associated with greater mean reductions from baseline in the PHQ-9 score versus placebo, although those differences were not statistically significant.

52-week HALO study

In the 52-week HALO study, 219/1,103 (19.9%) of chronic migraine patients had moderate-to-severe depression. Compared with baseline, mean MMDs, HDs, and PHQ-9 score were reduced at week 52 after treatment with quarterly and monthly fremanezumab.

Fremanezumab was effective in patients with migraine and comorbid moderate-to-severe depression and was associated with improvement in depressive symptoms over long-term treatment and in patients with difficult-to-treat migraine.

 

  1. Buse DC. Efficacy of fremanezumab in patients with migraine and comorbid depression. MTIS Virtual Symposium 2020, abstract MTV20-DP-065.




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