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Abstract
Background
The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine.
To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting.
Methods
An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months.
Results
In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication.
Conclusions
Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced.
Trial registration
BASEC ID 2018–02,375 in the Register of All Projects in Switzerland (RAPS).
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Details
1 ZURZACH Care, Department of Neurology and Neurorehabilitation, Bad Zurzach, Switzerland
2 Kopfwehzentrum Hirslanden, Zurich, Switzerland
3 Inselspital, University Hospital Bern and University of Bern, Department of Neurology, Bern, Switzerland (GRID:grid.411656.1) (ISNI:0000 0004 0479 0855); Neurocentre, Luzerner Kantonsspital, Lucerne, Switzerland (GRID:grid.413354.4) (ISNI:0000 0000 8587 8621)
4 Center for Pain Medicine, Nottwil, Switzerland (GRID:grid.413354.4)
5 Spital Thun, Department of Neurology, Thun, Switzerland (GRID:grid.413354.4)
6 University Hospital Zurich, Department of Reproductive Endocrinology, Zurich, Switzerland (GRID:grid.412004.3) (ISNI:0000 0004 0478 9977)
7 Neurozentrum Bern, Bern, Switzerland (GRID:grid.412004.3)
8 University Hospital Zurich, Department of Neurology, Zurich, Switzerland (GRID:grid.412004.3) (ISNI:0000 0004 0478 9977)
9 CHUV, Department of Clinical Neurosciences, Lausanne, Switzerland (GRID:grid.8515.9) (ISNI:0000 0001 0423 4662)
10 Inselspital, University Hospital Bern and University of Bern, Department of Neurology, Bern, Switzerland (GRID:grid.411656.1) (ISNI:0000 0004 0479 0855)
11 Private Practice, Sion, Switzerland (GRID:grid.411656.1)
12 Ente Ospedaliero Cantonale (EOC), Neurocenter of Southern Switzerland, Lugano, Switzerland (GRID:grid.469433.f) (ISNI:0000 0004 0514 7845); Università Della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland (GRID:grid.29078.34) (ISNI:0000 0001 2203 2861)
13 Novartis Pharma Schweiz AG, Rotkreuz, Switzerland (GRID:grid.29078.34)