Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Chronic Migraine in Adults

Authors: Fiedler-Kelly J, Passarell JA, Ludwig EA, Yang R, Aycardi E, Levi M, Cohen-Barak O
Conference: AHS
Keywords: chronic migraine (CM), fremanezumab exposure, preventive therapy
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Objectives

  • Fremanezumab is a fully humanized IgG2Δa/kappa monoclonal antibody that selectively targets calcitonin
    gene-related peptide (CGRP).1
  • Previously, fremanezumab was found to be effective and well-tolerated as a preventive treatment for migraine in
    3-month phase 2 and 3 episodic and chronic migraine studies.2,3,4,5
  • Modeling and simulation were used to support dose selection for fremanezumab in patients with chronic migraine
    (CM).

    • An exposure-efficacy response model was developed to describe the relationship between fremanezumab exposure
      and the reduction in the monthly moderate-to-severe (M/S) headache days in patients with CM.
    • Simulations were performed to predict fremanezumab efficacy over 3 months, including the percent of patients with at
      least a 50% reduction from baseline in the number of M/S headache days at each month and as an average over
      3 months.

Presented at American Headache Society 60 the Annual Scientific Meeting, June 28-July 1, 2018, San Francisco, CA, USA

By Jill Fiedler-Kelly, Julie A Passarell, Elizabeth A Ludwig, Ronghua Yang, Ernesto Aycardi, Micha Levi, Orit Cohen-Barak