A eficácia do Galcanezumabe na profilaxia de cefaleia crônica migrânea: uma revisão integrativa
DOI:
https://doi.org/10.34117/bjdv9n3-041Keywords:
eficácia, galcanezumabe, migrânea crônicaAbstract
Introdução: A Migrânea Crônica (MC) é a segunda principal causa de anos vividos com incapacidade em todo o mundo. Apesar de sua ampla prevalência, a enxaqueca é frequentemente subtratada e inadequadamente reconhecida. Atualmente, apesar das variadas opções profiláticas para migrânea crônica, pesquisas observacionais sugerem que a população com enxaqueca permanece com alto nível de prejuízo funcional. Sendo assim, visando minimizar as repercussões socioeconômicas oriundas da patologia em questão, torna-se necessário o aprofundamento constante sobre seus métodos profiláticos. No cenário atual, os anticorpos monoclonais surgem como opção para profilaxia da migrânea, dentre eles, o Galcanezumabe (GMB), escolhido neste estudo. Objetivos: Compreender a eficácia do Galcanezumab no tratamento profilático da dor de cabeça crônica, com foco no subtipo migrânea. Métodos: Trata-se de uma revisão integrativa de ensaios clínicos e estudos clínicos controlados e randomizados. Foi realizada uma busca sistemática de artigos na base de dados MEDLINE/Pubmed utilizando “chronic migraine” AND “Galcanezumab” como descritores. Os critérios de inclusão aplicados consistiram de: estudos clínicos randomizados que avaliam os resultados da administração de Galcanezumab para o tratamento de cefaleia migrânea crônica, aplicados os filtros: Full text, Clinical Trial, Randomized Controlled Trial, nos últimos 5 anos Resultados: Após busca avançada na referida base de dados, foram encontrados um total de 37 resultados, sendo 32 pré-selecionados com base em seus títulos e resumos. Destes, 28 foram selecionados, após análise conjunta dos pesquisadores, para compor o estudo. Conclusão: O medicamento Galcanezumabe mostrou-se uma opção promissora no tratamento preventivo da Migrânea Crônica, com eficácia refletida na diminuição média de dias de crise e no aumento da capacidade funcional.
References
AILANI, J. et al. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). The Journal of Headache and Pain, v. 21, n. 1, 17 out. 2020. Disponível em: https://pubmed.ncbi.nlm.nih.gov/33069214/
AILANI, J. et al. Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of three randomized double-blind studies. European Journal of Neurology, v.27, n.3, p. 542-549, 10 dez. 2019
AILANI, J. et al. Does “wearing off” of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle?
Post hoc analyses of four phase III randomized trials. Headache, v. 62, n. 2, p. 198–207, 1 fev. 2022. Disponível em: https://pubmed.ncbi.nlm.nih.gov/35076090/
AMBROSINI, A. et al. Changes in acute headache medication use and health care resource utilization: Results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). Journal of Managed Care & Specialty Pharmacy, v. 28, n. 6, p. 645–656, 1 jun. 2022. Disponível em: https://pubmed.ncbi.nlm.nih.gov/35451858/
AMENT, M. et al. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. The Journal of Headache and Pain, v. 22, n. 1, 6 fev. 2021. Disponível em: https://pubmed.ncbi.nlm.nih.gov/33549036/
CAMPOREALE, A. et al. A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. BMC Neurology, v. 18, 9 nov. 2018. Disponível em:https://pubmed.ncbi.nlm.nih.gov/30413151/
CITROME, L. et al. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Advances in Therapy, v. 38, n. 8, p. 4442–4460, 1 ago. 2021 Disponível em: https://pubmed.ncbi.nlm.nih.gov/34264500/
DETKE, H. C. et al. Galcanezumab in chronic migraine. Neurology, v. 91, n. 24, p. e2211–e2221, 16 nov. 2018.
DODICK, D. W. et al. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia, v. 41, n. 3, p. 340–352, 3 nov. 2020.
DURHAM PL. CGRP-receptor antagonists--a fresh approach to migraine therapy? Engl J Med, v.11, p. 1073-1075, 11 Mar. 2004.
FÖRDERREUTHER, S. et al. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. The Journal of Headache and Pain, v. 19, n. 1, dez. 2018. Disponível em: https://pubmed.ncbi.nlm.nih.gov/30594122/
FORD, J. et al. Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN). Quality of Life Research, 15 set. 2020. Disponível em: https://pubmed.ncbi.nlm.nih.gov/32930994/
FORD, J. H. et al. Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, v. 30, n. 2, p. 455–464, 1 fev. 2021.
FORD, J.H. et al. Migraine Headache Day Response Rates and the Implications to Patient Functioning: An Evaluation os 3 Randomized Phase 3 Clinical Trials of Galcanezumab in Patients With Migraine. Headache, v.60, n.10, p.2304-2319, 1 nov. 2020. Disponível em: https://pubmed.ncbi.nlm.nih.gov/33249580/
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders. 3 ed., 2018
HIRATA, K. et al. A long-term open-label safety study of galcanezumab in Japanese patients with migraine. Expert Opinion on Drug Safety, p. 1–13, 4 jan. 2021. Disponível em: https://www.tandfonline.com/doi/full/10.1080/14740338.2021.1866536
KOWACS, F. et al. CLASSIFICAÇÃO INTERNACIONAL DAS CEFALEIAS 3a EDIÇÃO Tradução da Sociedade Brasileira de Cefaleia com autorização da Sociedade Internacional de Cefaleia. [s.l: s.n.]. Disponível em: <https://ihs-headache.org/wp-content/uploads/2021/03/ICHD-3-Brazilian-Portuguese.pdf>.
KURUPPU, D. K. et al. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurology, v. 21, n. 1, 23 abr. 2021. Disponível em: https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-021-02196-7
MULLENERS, W. M. et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomized, double-blind, placebo-controlled, phase 3b trial. The Lancet Neurology, v. 19, n. 10, p. 814–825, out. 2020. Disponível em: https://pubmed.ncbi.nlm.nih.gov/32949542/
NICHOLS, R. et al. Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. Headache: The Journal of Head and Face Pain, v. 59, n. 2, p. 192–204, 21 nov. 2018. Disponível em: https://pubmed.ncbi.nlm.nih.gov/30462830/
OAKES, T. M. et al. Evaluation of Cardiovascular Outcomes in Adult Patients With Episodic or Chronic Migraine Treated With Galcanezumab: Data From Three Phase 3, Randomized, Double‐Blind, Placebo‐Controlled EVOLVE‐1, EVOLVE‐2, and REGAIN Studies. Headache: The Journal of Head and Face Pain, v. 60, n. 1, p. 110–123, 13 nov. 2019. Disponível em: https://pubmed.ncbi.nlm.nih.gov/31721185/
POZO-ROSICH, P. et al. Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis. Advances in Therapy, v. 38, n. 6, p. 3154–3165, 1 jun. 2021. Disponível em: https://pubmed.ncbi.nlm.nih.gov/33950375/
REUTER, U. et al. Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial. Advances in Therapy, v. 38, n. 11, p. 5465–5483, 2021. Disponível em: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8523004/
RUFF, D. D. et al. Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure. Cephalalgia: An International Journal of Headache, v. 39, n. 8, p. 931–944, 1 jul. 2019. Disponível em: https://pubmed.ncbi.nlm.nih.gov/31104507/
SCHWEDT, T. J. et al. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. The Journal of Headache and Pain, v. 22, n. 1, 25 mar. 2021. Disponível em: https://pubmed.ncbi.nlm.nih.gov/33765912/
SMITHERMAN, T. A. et al. Efficacy of Galcanezumab for Migraine Prevention in Patients With a Medical History of Anxiety and/or Depression: A Post Hoc Analysis of the Phase 3, Randomized, Double‐Blind, Placebo‐Controlled REGAIN, and Pooled EVOLVE‐1 and EVOLVE‐2 Studies. Headache: The Journal of Head and Face Pain, v. 60, n. 10, p. 2202–2219, 16 out. 2020. Disponível em: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756873/
STAUFFER, V. L. et al. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. The Journal of Headache and Pain, v. 21, n. 1, 23 jun. 2020. Disponível em: https://pubmed.ncbi.nlm.nih.gov/32576229/
TEPPER, S. J. et al. Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER). Clinical Drug Investigation, v. 42, n. 3, p. 263–275, 1 mar. 2022. Disponível em: https://pubmed.ncbi.nlm.nih.gov/35041159/
TOBIN, J. A. et al. Reductions in acute medication use and healthcare resource utilization in patients with chronic migraine: a secondary analysis of a phase 3, randomized, double-blind, placebo-controlled study of galcanezumab with open-label extension (REGAIN). Journal of Medical Economics, v. 25, n. 1, p. 1030–1038, 1 jan. 2022.
Disponível em: https://pubmed.ncbi.nlm.nih.gov/35971655/
TOBIN, J. et al. Annual indirect cost savings in patients with episodic or chronic migraine: post-hoc analyses from multiple galcanezumab clinical trials. Journal of Medical Economics, v. 25, n. 1, p. 630–639, 1 jan. 2022. Disponível em: https://pubmed.ncbi.nlm.nih.gov/35510376/
YANG, C.-P. et al. Safety and efficacy of galcanezumab in Taiwanese patients: a post-hoc analysis of phase 3 studies in episodic and chronic migraine. Current Medical
Research and Opinion, v. 36, n. 10, p. 1653–1666, 1 out. 2020. Disponível em: https://pubmed.ncbi.nlm.nih.gov/32845740/

