Abstract

Background: German authorities reimburse migraine prevention with erenumab only in patients who previously did not have therapeutic success with at least five oral prophylactics or have contraindications to such. In this real-world analysis, we assessed treatment response to erenumab in patients with chronic migraine (CM) who failed five oral prophylactics and, in addition, onabotulinumtoxinA (BoNTA).Methods: We analyzed retrospective data of 139 CM patients with at least one injection of erenumab from two German headache centers. Patients previously did not respond sufficiently or had contraindications to β-blockers, flunarizine, topiramate, amitriptyline, valproate, and BoNTA. Primary endpoint of this analysis was the mean change in monthly headache days from the 4-weeks baseline period over the course of a 12-weeks erenumab therapy. Secondary endpoints were changes in monthly migraine days, days with severe headache, days with acute headache medication, and triptan intake in the treatment period.Results: Erenumab (starting dose 70 mg) led to a reduction of −3.7 (95% CI 2.4–5.1) monthly headache days after the first treatment and −4.7 (95% CI 2.9–6.5) after three treatment cycles (p < 0.001 for both). All secondary endpoint parameters were reduced over time. Half of patients (51.11%) had a >30% reduction of monthly headache days in weeks 9–12. Only 4.3% of the patients terminated erenumab treatment due to side effects.Conclusion: In this treatment-refractory CM population, erenumab showed efficacy in a real-world setting similar to data from clinical trials. Tolerability was good, and no safety issues emerged. Erenumabis is a treatment option for CM patients who failed all first-line preventives in addition to BoNTA.

Highlights

  • Migraine prevention is hampered by poor tolerability of available oral drugs, low therapeutic adherence, and insufficient efficacy in a substantial percentage of patients [1, 2]

  • Prior to the approval of the calcitonin gene-related peptide (CGRP)(receptor) monoclonal antibodies, topiramate, and onabotulinumtoxinA (BoNTA) had been the only approved preventative medications in the United States and Europe for the prophylaxis of chronic migraine (CM) [3]. mAbs have shown in clinical trials a favorable profile in terms of safety and efficacy, along with significant improvement in daily functioning and quality of life [4, 5]

  • Erenumab and other CGRP antibodies have not been studied in a migraine population with more than four treatment failures

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Summary

Introduction

Migraine prevention is hampered by poor tolerability of available oral drugs, low therapeutic adherence, and insufficient efficacy in a substantial percentage of patients [1, 2]. MAbs have shown in clinical trials a favorable profile in terms of safety and efficacy, along with significant improvement in daily functioning and quality of life [4, 5] They have several potential advantages compared to standard oral preventives, including a rapid onset of efficacy, ease of use, persistent therapeutic effect, and lack of pharmacological interactions with other medications [6,7,8]. German authorities reimburse migraine prevention with erenumab only in patients who previously did not have therapeutic success with at least five oral prophylactics or have contraindications to such In this real-world analysis, we assessed treatment response to erenumab in patients with chronic migraine (CM) who failed five oral prophylactics and, in addition, onabotulinumtoxinA (BoNTA)

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