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This study aimed at evaluating the effectiveness, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic migraine (CM) in a real-life setting.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This multicenter prospective observational cohort study was conducted between November 2019 and January 2021 at 13 Italian headache centers. Consecutive adult HFEM and CM patients clinically eligible were enrolled and treated with galcanezumab subcutaneous injection 120\u2009mg monthly with the first loading dose of 240\u2009mg. The primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients after 6 months of therapy (V6). Secondary endpoints were the Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6 and MIDAS scores changes, \u226550% responder rates (RR), the conversion rate from CM to episodic migraine (EM) and Medication Overuse (MO) discontinuation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>One hundred sixty-three patients (80.5% female, 47.1\u2009\u00b1\u200911.7\u2009years, 79.8% CM) were included. At V6, MMDs reduced by 8\u2009days in HFEM and MHDs by 13\u2009days in CM patients (both <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001). NRS, MPI, HIT-6 and MIDAS scores significantly decreased (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001). Ten patients (6.1%) dropped out for inefficacy and classified as non-responders. Patients with \u226550%RRs, i.e. responders, were 76.5% in the HFEM and 63.5% in the CM group at V6. Among CM patients, the V6 responders presented a lower body mass index (<jats:italic>p<\/jats:italic>\u2009=\u2009.018) and had failed a lower number of preventive treatments (<jats:italic>p<\/jats:italic>\u2009=\u2009.013) than non-responders. At V6, 77.2% of CM patients converted to EM, and 82.0% ceased MO. Adverse events, none serious, were reported in up to 10.3% of patients during evaluation times.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Galcanezumab in real life was safe, well tolerated and seemed more effective than in RCTs. Normal weight and a low number of failed preventives were positively associated with galcanezumab effectiveness in CM patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04803513?cond=NCT04803513&amp;draw=2&amp;rank=1\">NCT04803513<\/jats:ext-link>.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s10194-021-01247-1","type":"journal-article","created":{"date-parts":[[2021,5,3]],"date-time":"2021-05-03T11:03:03Z","timestamp":1620039783000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":116,"title":["Galcanezumab for the 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The study was approved by the Campus Bio-Medico University Ethical Committee n.30\/20, mutually recognized by the other local ethical committees.","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":"Fabrizio Vernieri received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Allergan, Amgen, Angelini, Eli-Lilly, Lundbeck, Novartis, and Teva. Claudia Altamura received grants and honoraria from Novartis, Eli Lilly. Cinzia Aurilia received travel grants and honoraria from FB-Health, Lusofarmaco, Almirall, Eli-Lilly Novartis and Teva. Gabriella Egeo received travel grants and honoraria from Eli-Lilly, Novartis, New Penta and Ecupharma. Luisa Fofi received travel grants and honoraria from Teva, Eli-Lilly and Novartis. Valentina Favoni received honoraria as speaker or for participating in advisory boards from Ely-Lilly, Novartis and Teva. Giulia Pierangeli received grants and honoraria from Teva, Lilly, Allergan, Novartis, Lundbeck, Amgen, IBSA. Carlo Lovati received grants from Novartis and Lilly. Marco Aguggia received grants from Novartis and Lilly. Florindo d\u2019Onofrio received grants and honoraria from Lilly, Teva, Novartis, Neopharmed. Alberto Doretti received grants and honoraria from Novartis, Eli Lilly. Paola Di Fiore received grants and honoraria from Teva, Novartis, IBSA. Cinzia Finocchi received grants and honoraria from Novartis, Eli Lilly, AIM group. Renata Rao received honoraria for speaker panels from Teva, Lilly, Novartis. Francesco Bono received honoraria as a speaker or for participating in advisory boards from Teva, Novartis, Ipsen. Angelo Ranieri received speaker honoraria from Teva, Lilly. Sabina Cevoli received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Novartis, Teva, Lilly, Allergan, Ibsa, Amgen and Lundbeck. Piero Barbanti received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Alder, Allergan, Angelini, Bayer, ElectroCore, Eli-Lilly, GSK, Lusofarmaco, MSD, Novartis, Stx-Med, Teva, Visufarma, Zambon. Nicoletta Brunelli, Carmelina Maria Costa, Maria Albanese have nothing to disclose.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"35"}}