PMID- 36482037 OWN - NLM STAT- MEDLINE DCOM- 20230113 LR - 20230113 IS - 1179-1918 (Electronic) IS - 1173-2563 (Linking) VI - 43 IP - 1 DP - 2023 Jan TI - Long-Term Safety and Effectiveness of Erenumab in Patients with Migraine: A Systematic Review and Single-Arm Meta-analysis. PG - 45-59 LID - 10.1007/s40261-022-01230-x [doi] AB - BACKGROUND AND OBJECTIVE: Several studies on use of erenumab for migraine treatment have been published over recent years. However, its long-term safety and effectiveness have not been consistently established in the literature yet. We aimed to perform a qualitative and quantitative analysis of the long-term safety and effectiveness of erenumab for the treatment of migraine headaches. METHODS: Long-term follow-up was defined as >/= 1 year. PubMed, Embase and Cochrane Library were systematically searched from inception to 14 June 2022 for studies meeting the inclusion criteria. Risk of bias was assessed using the Newcastle-Ottawa Scale. RESULTS: Fourteen studies, comprising 3574 patients, were included. The total follow-up period ranged from 48 to 268 weeks (i.e., 1 year to 5.6 years). Pooled estimate rates for all adverse events (AEs) were 63% (95% CI 46-78); for serious AEs, 3% (95% CI 1-7); and for AEs leading to discontinuation of erenumab, 3% (95% CI 2-5). Reduction in monthly migraine days (MMDs) was -6.98 (95% CI -8.90 to -5.05) and in migraine-specific medication days (MSMDs) was - 6.09 (95% CI - 9.43 to - 2.75). More than half (57%; 95% CI 51-63) and around one-third (35%; 95% CI 28-42) of patients presented with reductions of >/= 50% and >/= 75% in MMDs, respectively. Headache Impact Test-6 (HIT-6) score was decreased by -9.68 points (95% CI - 12.03 to - 7.34). Nine studies were considered of poor methodological quality and five of fair quality. CONCLUSIONS: Erenumab has a favorable safety profile, with a low incidence of serious AEs, and sustained efficacy over >/=1 year of follow-up in the treatment of migraine. CI - (c) 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG. FAU - Bomtempo, Fernanda Ferreira AU - Bomtempo FF AUID- ORCID: 0000-0001-7268-6695 AD - School of Medicine, Faculdade Ciencias Medicas de Minas Gerais (CMMG), Alameda Ezequiel Dias, 275, Centro, Belo Horizonte, MG, 30130-110, Brazil. febomtempo16@gmail.com. FAU - Rocha, Rebeka Bustamante AU - Rocha RB AD - School of Medicine, Universidade Federal do Amazonas (UFAM), Manaus, AM, Brazil. FAU - Cenci, Giulia Isadora AU - Cenci GI AD - School of Medicine, Faculdade Meridional (IMED), Passo Fundo, RS, Brazil. FAU - Nager, Gabriela Borges AU - Nager GB AD - School of Medicine, Universidade Federal do Estado do Rio de Janeiro (UNIRIO), Rio de Janeiro, RJ, Brazil. FAU - Telles, Joao Paulo Mota AU - Telles JPM AD - Department of Neurology, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP), Sao Paulo, SP, Brazil. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20221208 PL - New Zealand TA - Clin Drug Investig JT - Clinical drug investigation JID - 9504817 RN - I5I8VB78VT (erenumab) RN - 0 (Calcitonin Gene-Related Peptide Receptor Antagonists) RN - 0 (Antibodies, Monoclonal, Humanized) SB - IM MH - Humans MH - *Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects MH - *Migraine Disorders/drug therapy MH - Antibodies, Monoclonal, Humanized/adverse effects EDAT- 2022/12/10 06:00 MHDA- 2023/01/14 06:00 CRDT- 2022/12/09 00:30 PHST- 2022/11/16 00:00 [accepted] PHST- 2022/12/10 06:00 [pubmed] PHST- 2023/01/14 06:00 [medline] PHST- 2022/12/09 00:30 [entrez] AID - 10.1007/s40261-022-01230-x [pii] AID - 10.1007/s40261-022-01230-x [doi] PST - ppublish SO - Clin Drug Investig. 2023 Jan;43(1):45-59. doi: 10.1007/s40261-022-01230-x. Epub 2022 Dec 8.