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Monoclonal antibodies targeting calcitonin gene-related peptide pathway \u2013 including erenumab \u2013 offer the opportunity of investigating potential migraine biomarkers due to their specific mechanism of action in preventing both episodic (EM) and chronic (CM) migraine. Our study aims at evaluating the expression levels of circulating microRNAs (miRNAs) according to migraine type, before and after treatment with erenumab and based on treatment response, in order to identify miRNAs with potential role as epigenetic biomarkers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study included women aged 25\u201350\u00a0years with EM or CM treated with erenumab according to clinical indications. MiRNAs expression levels were assessed before (baseline) and after a 16-week treatment with erenumab, 140\u00a0mg every four weeks (post-treatment). An extensive miRNAs profiling was performed by qRT-PCR in small, pooled groups of\u2009\u2264\u20098 women each, classified according to migraine frequency (EM and CM) and the degree of response to erenumab. The expression levels of selected miRNAs were also validated using single miRNA assays in each woman with EM and CM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      During the study, 36 women with migraine (19 with EM and 17 with CM) out of 40 who were initially screened, performed the assessment of miRNA expression at baseline and post-treatment, Erenumab treatment significantly improved migraine burden in both EM and CM. MiRNA profiling revealed differential expression levels of a wide set of miRNAs (\n                      <jats:italic>hsa-let-7d-3p, hsa-miR-106b-3p, hsa-miR-122-5p, hsa-miR-143-3p, hsa-miR-144-3p, hsa-miR-16-5p, hsa-miR-181a-5p, hsa-miR-221-3p, hsa-miR-25-3p, hsa-miR-29b-2-5p, hsa-miR-326, miR-363-3p, hsa-miR-424-5p, hsa-miR-485-3p, hsa-miR-532-5p, hsa-miR-543, hsa-miR-629-5p, hsa-miR-660-5p, hsa-miR-92a-3p)<\/jats:italic>\n                      depending on treatment response. Among them, single miRNA assays confirmed the progressive decrease of\n                      <jats:italic>hsa-miR-143-3p<\/jats:italic>\n                      expression levels in relation to increasing response to erenumab in women with EM (7 with low, 6 with medium, and 6 with high response;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.02). Additionally, single assays showed higher\n                      <jats:italic>hsa-miR-34a-5p<\/jats:italic>\n                      and\n                      <jats:italic>hsa-miR-382-5p<\/jats:italic>\n                      expression levels at baseline in women with CM compared with those with EM (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0002 and\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0007, respectively), as well as their expression level decrease in women with CM from baseline to follow-up (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.04 and\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.02, respectively).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our study suggests that targeting the CGRP pathway in migraine changes the expression levels of certain miRNAs. These miRNA levels are linked to the levels of response to CGRP receptor blockage. Future research challenges include assigning specific functions to the modulated miRNAs to unravel pathways modulated by the disease and the treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>The study was registered in clinicaltrials.gov with code NCT04659226 and in the Novartis database with code CAMG334AIT05T.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s10194-024-01787-2","type":"journal-article","created":{"date-parts":[[2024,5,16]],"date-time":"2024-05-16T09:02:02Z","timestamp":1715850122000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["MicroRNA profiling in women with migraine: effects of CGRP-targeting treatment"],"prefix":"10.1186","volume":"25","author":[{"given":"Raffaele","family":"Ornello","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronica","family":"Zelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Compagnoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valeria","family":"Caponnetto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"De Matteis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Tiseo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Tessitore","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Sacco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,5,16]]},"reference":[{"issue":"2","key":"1787_CR1","doi-asserted-by":"publisher","first-page":"e293","DOI":"10.1097\/j.pain.0000000000002275","volume":"163","author":"S Safiri","year":"2022","unstructured":"Safiri S, Pourfathi H, Eagan A, Mansournia MA, Khodayari MT, Sullman MJM, Kaufman J, Collins G, Dai H, Bragazzi NL et al (2022) Global, regional, and national burden of migraine in 204 countries and territories, 1990 to 2019. 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All patients signed informed consent for inclusion in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"SS reports grants, personal fees and\/or non-financial support from Allergan, Novartis, Teva, Eli Lilly, Astrazeneca, Medscape, Pfizer, Bayer, Medtronic, Starmed, Bristol-Myers-Squibb, and Daiichi-Sankyo. RO reports personal fees from AbbVie, Eli Lilly, Novartis, Pfizer, Teva, and non-financial support from Allergan-AbbVie, Eli Lilly, Novartis, and Teva. All other Authors report no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"80"}}