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Fremanezumab tolerability in cardiovascular patients with migraine

Presented by
Dr Gianluca Coppola, Sapienza University of Rome, Italy
EAN 2020
Phase 3, HALO, FOCUS
In a pooled analysis of 3 phase 3 trials, fremanezumab treatment over 12 weeks was well tolerated, with a low rate of cardiovascular adverse events (AEs) similar to placebo in migraine patients using cardiovascular medication at baseline [1]. There were no new safety signals over 12 weeks of double-blind treatment.

Fremanezumab is a a fully-humanised monoclonal antibody that selectively targets calcitonin gene-related peptide. The 3 trials included were HALO EM, HALO CM, and FOCUS, in which patients were randomised to subcutaneous quarterly or monthly fremanezumab, or placebo over 12 weeks. Overall, 280/2,842 trial participants were receiving cardiovascular medications at baseline, accounting for 9-11% of every treatment group. The most common type of cardiovascular medications used were agents acting on the renin-angiotensin system (3-4%) and beta blockers (3-4%).

The rates of patients with ‚Č•1 AE were:

  • placebo, 53%;
  • quarterly fremanezumab (675 mg/placebo/placebo), 66%;
  • monthly fremanezumab (675/225/225 mg), 70%;
  • monthly fremanezumab (225/225/225 mg), 54%.

The most common AEs were injection site-related (pain, erythema, and induration). Cardiac disorder as well as vascular disorder AEs were infrequent across treatment groups. Their respective AE rates were:

  • placebo, <1% and 0%;
  • quarterly fremanezumab (675 mg/placebo/placebo), 0% and 1%;
  • monthly fremanezumab (675/225/225 mg), 2% and 6%;
  • monthly fremanezumab (225/225/225 mg), 0% and 0%.

Results of another pooled analysis showed that fremanezumab treatment over 12 weeks was well tolerated in patients with migraine and concomitant triptan use, with similar cardiovascular tolerability to those who did not use triptans [2].

  1. Coppola G, et al. Abstract EPR1092, EAN 2020.
  2. Kärppä M, et al. Abstract EPR2065, EAN 2020.

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