Real-World Treatment Profiles, Clinical Outcomes, and Healthcare Resource Utilization of Patients with Migraine Prescribed Erenumab: A Multicenter Chart-Review Study of US Headache Centers

Abstract

Introduction Erenumab, a first-in-class monoclonal antibody targeting the calcitonin gene-related peptide pathway, was approved by the US Food and Drug Administration in 2018 for the prevention of migraine in adults. There is limited data available on its impact in real-world settings. The study aim was to characterize the real-world treatment profiles, clinical outcomes, and healthcare resource utilization of patients prescribed erenumab from select major US headache centers. Methods A retrospective chart review of patients with migraine treated with erenumab for at least 3 months across five major headache centers was conducted. Data was collected from patient charts between April 2019 and April 2020 and included patient and clinical characteristics, migraine medication use, and outpatient visits. The date of the first prescription fill of erenumab was defined as the index date. The baseline period comprised the 3 months prior to the index date and the study period comprised the at least 3 months on erenumab treatment. Results Data from a total of 1034 patients with chronic migraine with a mean of 9.3 months of erenumab treatment were analyzed. Patients were on average 48 years old, 86% were female, and 79% were white. Patients had a mean of 5 preventive treatment failures prior to erenumab initiation. Patients used a mean of 2 preventive treatments (excluding erenumab) and 2 acute treatments during baseline and study periods. Among patients with effectiveness data, 45% of patients had improvement in physician-reported migraine severity and 35% experienced at least 50% reduction in mean headache/migraine days per month. The average number of monthly outpatient visits was 0.43 and 0.30 before and after erenumab initiation, respectively. Conclusion In this predominantly refractory chronic migraine population treated in select headache centers, patients had fewer headache/migraine days per month and outpatient visits after initiating erenumab. However, patients largely continued to be managed via a polypharmacy approach after erenumab initiation.

Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes

“…A number of "real-world" studies and registries of migraine treatment with erenumab in North American (18)(19)(20)(21)(22)(23)(24)(25), European (26)(27)(28)(29)(30)(31)(32)(33), or Australian patients (34) have been published recently and included mainly patients with CM (Supplementary Table 1). With one exception (21), all the studies from North America were retrospective (18-20, 22, 23, 26), while all studies but two (26,30) studies from other geographic areas had a prospective design.…”

Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States

“…Previous real-world studies have demonstrated that CGRP pathway–targeted therapies are effective as preventive treatments for migraine in adults [ 19 – 22 ]. In a Spanish prospective observational study of 155 migraine patients with ≥ 8 headache days per month and ≥ 3 prior preventive medication failures, treatment with erenumab ( n = 109) or galcanezumab ( n = 46) for 3 months resulted in a ≥ 50% reduction in migraine days per month in 51.6% of patients (mean [SD] reduction in migraine days per month compared with baseline was −8.5 [7.7]) [ 20 ].…”

“…In a sample of 81 Italian patients with high-frequency EM and CM, treatment with galcanezumab for 3 months resulted in a significant decrease in monthly migraine days compared with baseline (EM, −8.5; CM, −11.5; both P < 0.0001) [ 21 ]. A multicenter retrospective chart review of US headache centers evaluated data from 1034 patients with CM [ 19 ]. Results showed that treatment with erenumab for ≥ 3 months resulted in a ≥ 50% reduction in mean headache/migraine days per month among 35% of patients.…”

Constipation Caused by Anti-calcitonin Gene-Related Peptide Migraine Therapeutics Explained by Antagonism of Calcitonin Gene-Related Peptide’s Motor-Stimulating and Prosecretory Function in the Intestine

“…Thirdly, in many studies the concomitant use of one or more preventive headache medications was permitted. If the migraine patients continue treatment by a polypharmacy approach including, for instance, opioid receptor agonists, the rate of constipation may be equally high before and after erenumab therapy ( Faust et al, 2021 ).…”

“…A straightforward explanation for the significantly higher constipation rates in migraine patients on a CGRP-targeting therapy under real world conditions as compared to RCT conditions is not yet available. Differences in the patient populations in terms of medical history and comorbidities as well as a more detailed assessment of adverse events and disturbances of life quality are likely to be contributory factors ( Lambru et al, 2020 ; Faust et al, 2021 ). Important information may also be deduced from a future comparison of the real world constipation rates associated with the long-term use of gepants, on the one hand, and antibodies targeting the CGRP system, on the other hand.…”