Effects of fremanezumab in patients with chronic migraine and comorbid depression: Subgroup analysis of the randomized HALO CM study.

Abstract

OBJECTIVE:

To evaluate the efficacy of fremanezumab in patients with chronic migraine (CM) and moderate to severe depression.

BACKGROUND:

Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, has been approved for the preventive treatment of migraine in adults. CM and depression are highly comorbid.

METHODS:

The 12-week, Phase 3 HALO trial randomized patients with CM to fremanezumab quarterly (675 mg/placebo/placebo), fremanezumab monthly (675/225/225 mg), or placebo. Post hoc analyses evaluated the effects of fremanezumab in patients with moderate to severe depression (baseline 9-item Patient Health Questionnaire sum score ≥10) on monthly number of headache days of at least moderate severity; monthly migraine days; Patient Global Impression of Change (PGIC); 6-item Headache Impact Test (HIT-6) scores; and depression.

RESULTS:

For the 219/1121 (19.5%) patients with moderate to severe depression at baseline, fremanezumab was associated with a significant reduction in monthly number of headache days of at least moderate severity for active treatment versus placebo (least-squares mean change ± standard error for quarterly dosing: -5.3 ± 0.77; for monthly dosing: -5.5 ± 0.72; and for placebo: -2.2 ± 0.81; both p < 0.001). More patients achieved a ≥50% reduction in headache days of at least moderate severity with fremanezumab (quarterly: 31/78 [39.7%]; monthly: 39/96 [40.6%]) than placebo (9/67 [13.4%]; both p < 0.001). Compared with placebo, fremanezumab improved PGIC and HIT-6 scores.

CONCLUSIONS:

Fremanezumab demonstrated efficacy in the preventive treatment of CM and reduced headache impact in patients with comorbid depression.

• Authors: Richard B Lipton, Joshua M Cohen, Maja Galic, Michael J Seminerio, Paul P Yeung, Ernesto Aycardi, Marcelo E Bigal, Kristen Bibeau, Dawn C Buse
• Journal: Headache (Headache) Vol. 61 Issue 4 Pg. 662-672 (Apr 2021) ISSN: 1526-4610 [Electronic] United States
• PMID: 33891348 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• fremanezumab

Topics

• Adult
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Comorbidity
• Depression (epidemiology)
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy, epidemiology)
• Patient Acuity
• Treatment Outcome