Multicentre Real-World Case-Control Study of Effectiveness, Tolerability, and Anti-Calcitonin Gene-Related Peptide Response Predictors in the Elderly - European Medical Journal

Multicentre Real-World Case-Control Study of Effectiveness, Tolerability, and Anti-Calcitonin Gene-Related Peptide Response Predictors in the Elderly

1 Mins
Neurology
Authors:
*Alicia Gonzalez-Martinez,1,2 Ancor Sanz-García,3 Jaime Samuel Rodríguez-Vico,4 Alex Jaimes,4 Andrea Gomez García,4 Javier Casas Limón,5 Javier Díaz de Terán,6 María Sastre,6 Javier Membrilla,6 Germán Latorre,7 Carlos Calle de Miguel,7 Sonia Quintas,1,2 Patricia Heredia,1,2 Sendoa Gil Luque,8 Cristina Trevino-Peinado,9 Ana Echevarría,10 David García-Azorín,10 Ángel Luis Guerrero-Peral,10 Álvaro Sierra Mencía,10 Nuria González-García,11 Jesús Porta,11 Ana-Beatriz Gago-Veiga1,2
  • 1. Headache Unit, Neurology Department, Hospital Universitario de la Princesa & Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Madrid, Spain
  • 2. Universidad Autónoma de Madrid, Spain
  • 3. Data Analysis Unit, Hospital Universitario de la Princesa & Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Madrid, Spain
  • 4. Headache Unit, Neurology Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
  • 5. Headache Unit, Neurology Department, Hospital Universitario Fundación Alcorcón, Madrid, Spain
  • 6. Hospital Universitario La Paz, Madrid, Spain
  • 7. Headache Unit, Neurology Department, Hospital Universitario de Fuenlabrada, Madrid, Spain
  • 8. Headache Unit, Neurology Department, Hospital Universitario de Burgos, Castilla y León, Spain
  • 9. Headache Unit, Neurology Department, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain
  • 10. Headache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, Castilla y León, Spain
  • 11. Headache Unit, Neurology Department, Hospital Clínico San Carlos, Madrid, Spain
Disclosure:

Gonzalez-Martinez has received speaker honoraria from TEVA; and reports no disclosures relevant to the manuscript. García-Azorín reports payment or honoraria for lectures from TEVA, Eli Lilly, Allergan-AbbVie, Novartis, and Lundbeck; and has served on an advisory board for Allergan-AbbVie. Rodríguez-Vico has received speaker honoraria from Abbvie, Novartis, Eli Lilly, TEVA, and UCB; has served on advisory boards for Eli Lilly, Novartis, and AbbVie; and has received research support from Abbvie. Díaz de Terán has received speaker honoraria from Novartis, Eli Lilly, and TEVA. Quintas has received speaker honoraria from Eli Lilly and Novartis. Casas Limón has received speaker honoraria from Novartis, Eli Lilly, and TEVA. Latorre has received speaker honoraria from Eli Lilly, Novartis, TEVA, Chiesi, and Allergan. Guerrero-Peral has received honoraria from Eli Lilly, TEVA, Novartis, Allergan-AbbVie, and Exeltis; and research support from Allegan-AbbVie and TEVA. Trevino-Peinado has received speaker honoraria from TEVA. Gago-Veiga has received honoraria from Eli Lilly, Novartis, TEVA, AbbVie-Allergan, Exeltis, and Chiesi. Porta has received speaker honoraria from Allergan, Chiesi, Eli Lilly, Novartis, and TEVA. Sanz-García, Jaimes, Gómez García, González-García, Calle de Miguel, Sastre, Membrilla, Heredia, Gil Luque, Echevarría, and Sierra Mencía declare no conflicts of interest.

Acknowledgements:

To the patients and health care workers. To Instituto de Salud Carlos III (ISCIII) and the European Union (ESF+) through a Río Hortega Fellowship (CM21/00178) to A.G.M.

Citation:
EMJ Neurol. ;11[1]:49-51. DOI/10.33590/emjneurol/10304642. https://doi.org/10.33590/emjneurol/10304642.
Keywords:
Adverse events, calcitonin gene-related peptide (CGRP), elderly, migraine, response.

Each article is made available under the terms of the Creative Commons Attribution-Non Commercial 4.0 License.

BACKGROUND AND AIMS

Anti-calcitonin gene-related peptide (CGRP) therapies have demonstrated effectiveness and safety in patients with chronic1-3 and episodic4-10 migraine in several clinical trials. However, there is limited information regarding clinical characteristics, effectiveness, and safety in the elderly under CGRP therapies, which may prevent clinicians from using these treatments in older patients. Migraine tends to improve with age; however, a substantial proportion of older adults may still suffer from migraine. Besides that, these patients are more likely to have relevant comorbidities and polypharmacy, with potential drug–drug interactions, and are more vulnerable to adverse effects.11 This cohort could potentially benefit from therapies with a better tolerability profile. In addition, older adults may have tried multiple migraine-preventive drugs over their lives, reducing the therapeutic armamentarium.11

MATERIALS AND METHODS

To address this gap, the authors performed a retrospective multicentre study nested in a prospectively collected cohort of cases, in which patients were individuals over 65 years old with migraine, who were receiving anti-CGRP therapies. Sex- and age-matched controls under 55 years old were used. Demographics, effectiveness, and safety variables were collected. Effectiveness, defined by the reduction in the number of headache (HDM) and migraine days per month (MDM); and responder rate, defined as 30%, 50%, and 75% reduction in the number of HDM and MDM at 3-, 6-, and 12 months, were collected. Adverse events (AE) were also evaluated at each time point.

RESULTS

In this study, a total of 228 patients were included: 114 cases and 114 controls. Among these, 84% were female, mean age was 70.1 years (range: 66–86), and approximately 80% of cases had chronic migraine. The authors found a higher percentage of vascular risk factors among the elderly, such as hypertension and dyslipidaemia, and also migraine with aura; higher age of migraine onset; and higher prior number of prophylactic treatments and medication overuse rates in the elderly. However, there were no major differences regarding effectiveness. The authors found that, in these cases, a 50% response rate was achieved by 59% at 20–24 weeks. A lower reduction in HDM was observed in the elderly regarding number of headaches at 3 months, and MDM at 6- and 12 months. The percentage of AEs was similar in the two groups, without serious AEs. The most common AE was constipation, without differences between groups. In this series, independent characteristics associated with the elderly were age of migraine onset and number of prior preventive treatments.

CONCLUSION

This case-control study provides real-world evidence of effectiveness and safety of anti-CGRP therapies for patients with migraine over 65 years old compared with younger patients. These results highlight that anti-CGRP therapies are not only effective as in the elderly, but also have a good tolerability profile in this special population.

References
Tepper S et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425-34. Detke HC et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-21. Silberstein SD et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377(22):2113-22. Dodick DW et al. ARISE: a Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38(6):1026-37. Skljarevski V et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-54. Torres-Ferrús M et al. The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study. J Neurol. 2021;268(10):3789-98. Barbanti P et al. Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache. 2021;61(2):363-72. Vernieri F et al.; GARLIT Study Group. Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study). J Headache Pain. 2021;22(1):35. Ashina M et al. PEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine. Pain Manag. 2021;11(6):647-54. Gonzalez-Martinez A et al. Machine-learning-based approach for predicting response to anti-calcitonin gene-related peptide (CGRP) receptor or ligand antibody treatment in patients with migraine: A multicenter Spanish study. Eur J Neurol. 2022;29(10):3102-11. Turnheim K. Drug dosage in the elderly. Is it rational? Drugs Aging. 1998;13(5):357-79.

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