Real-world evidence following a mandatory treatment break after a 1-year prophylactic treatment with calcitonin gene-related peptide (pathway) monoclonal antibodies

Brain Behav. 2022 Jul;12(7):e2662. doi: 10.1002/brb3.2662. Epub 2022 Jun 10.

Abstract

Background: Current German and European guidelines suggest migraine patients undertake a treatment break after 9 to 12 months of treatment with CGRP (pathway) monoclonal antibodies.

Methods: Clinical routine data of highly resistant migraine patients were analyzed before treatment with CGRP monoclonal antibodies (baseline), after 12 months of treatment, and following a treatment break between November 2018 and December 2020 in the West German Headache Centre, University Hospital Essen, Germany. Monthly migraine days (MMD), monthly headache days (MHD), and days of acute medication intake (AMD) were assessed.

Results: Complete clinical data from 46 migraine patients (14 episodic migraine (EM), 32 chronic migraine (CM) patients) treated with erenumab (n = 40), galcanezumab (n = 4), and fremanezumab (n = 2) were analyzed. The mean number of MMDs among EM and CM patients after 12 months of CGRP antibody treatment increased during the treatment break by 5.18 (SE 0.92, p < .001) and 5.06 (SE 1.22, p = .003) days, respectively. There was an increased intake of acute medications among episodic (4.72, SE 0.87, p = .004) and chronic migraine patients (3.01, SE 1.08, p = .013) during treatment break. Eighty-three percent of patients (n = 38) were dissatisfied with the mandatory treatment break. All patients continued with a CGRP (pathway) monoclonal antibody after the mandatory treatment break.

Conclusion: A mandatory break in CGRP (pathway) monoclonal antibody therapy had a negative short-term impact on migraine patients.

Keywords: CGRP (pathway) antibodies; disease modification; guidelines; migraine; one-year prophylactic treatment; treatment break.

MeSH terms

  • Antibodies, Monoclonal / pharmacology
  • Antibodies, Monoclonal / therapeutic use
  • Calcitonin Gene-Related Peptide Receptor Antagonists / pharmacology
  • Calcitonin Gene-Related Peptide Receptor Antagonists / therapeutic use
  • Calcitonin Gene-Related Peptide*
  • Headache
  • Humans
  • Migraine Disorders* / drug therapy
  • Migraine Disorders* / prevention & control
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Calcitonin Gene-Related Peptide Receptor Antagonists
  • Calcitonin Gene-Related Peptide