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. 2024 Nov 21:15:1502475.
doi: 10.3389/fneur.2024.1502475. eCollection 2024.

Real-world experience of galcanezumab in the prevention of migraine in Spain: a systematic literature review

Patricia Pozo-Rosich  1   2 , David García-Azorín  3   4 , Silvia Díaz-Cerezo  5 , Julia Fernández-Montoya  5 , Héctor David de Paz  6 , Mercedes Núñez  5
Affiliations

Real-world experience of galcanezumab in the prevention of migraine in Spain: a systematic literature review

Patricia Pozo-Rosich et al. Front Neurol. .

Abstract

Introduction: In the context of migraine preventive therapy, new therapeutic modalities such as monoclonal antibodies targeting the calcitonin gene-related peptide receptor (CGRP) or ligand offer potential advantages over traditional preventive treatments.

Methods: This systematic literature review gathered recent real-world evidence from Spain on the use of galcanezumab, a CGRP-targeting treatment, in migraine patients. The review included observational studies in English or Spanish, published from August 2020 to August 2023, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Cochrane guidelines.

Results: A total of 29 publications involving 2,592 Spanish adult patients were identified, reporting relevant information on clinical outcomes (treatment effectiveness and safety), treatment persistence and patterns (switching from other therapies and time to discontinuation and restart), and patient-reported outcomes (including satisfaction with treatment). The most frequently reported variables were related to the clinical effectiveness of galcanezumab, demonstrating a significant reduction in monthly migraine days and monthly headache days. Additionally, adverse impact of headache per HIT-6 (Headache Impact Test-6) and disability per MIDAS (Migraine Disability Assessment) also improve. Studies also showed that up to 12-month persistence to galcanezumab ranged from 76.8 to 59.8%. Serious adverse events were rare. None of the publications included health-related quality of life data, either generic or migraine-specific. One study highlighted that galcanezumab treatment would offer high patient satisfaction for people with migraine.

Conclusion: The real-world evidence on the use of galcanezumab treatment among the Spanish population shows that its effectiveness, persistence, safety, and impact on health burden align with findings from clinical trials and observational studies conducted in other countries. Future studies should incorporate health-related quality of life data to gain a more holistic understanding of this treatment's impact.

Keywords: CGRP; calcitonin gene-related peptide-targeting therapies; migraine; monoclonal antibodies; observational studies; prophylaxis; systematic review.

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Conflict of interest statement

PP-R has received honoraria as a consultant and speaker from Abbvie, Amgen, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer, and Teva Pharmaceuticals. Her research group has received research grants from Instituto Salud Carlos III, EraNet Neuron, AbbVie, Novartis, Teva Pharmaceuticals, AGAUR, FEDER RIS3CAT, and has received funding for clinical trials from Abbvie, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals. DG-A has received research funding from the Regional Health Administration (Gerencia Regional de Salud SACYL) in Castilla y León and Carlos III Research Institute, Spain. Speaker/travel grants/ clinical trials from Teva, Abbvie, Amgen, Eli Lilly, Lundbeck, Novartis, Pfizer and Biohaven. DG-A is associate editor of The Journal of Headache and Pain and Neurological Sciences. DG-A is member of the Global Advisory Committee on Vaccine Safety of the World Health Organization. SD-C, JF-M and MN are employees of Eli Lilly. HP is employee of Outcomes’10. Eli Lilly and Company contract Outcomes’10 for medical writing and editorial services. The authors declare that this study received funding from Eli Lilly. The funder had the following involvement in the study: providing support for the study design, data analysis, and manuscript development.

Figures

Figure 1
Figure 1
PRISMA diagram showing the study selection progress.
Figure 2
Figure 2
Graphical representation of galcanezumab effectiveness in patients with migraine evaluated using reduction of MMDs, monthly headache days, HIT-6 score, and MIDAS score.
Figure 3
Figure 3
Galcanezumab persistence.
Figure 4
Figure 4
Summary of treatment switches.
Figure 5
Figure 5
Concomitant preventive treatments. OnabotA, Onabotulinumtoxin A; CM, chronic migraine; EM, episodic migraine.
See this image and copyright information in PMC

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