Correction: Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study)

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Abstract

Correction: J Headache Pain 23, 46 (2022) https://doi.org/10.1186/s10194-022-01396-x Following the publication of the original article [1], we were notified of a mistake in the abstract: the 100% response rate in HFEM at week 12 is 5.9% (as correctly reported in figure 3) and NOT 9.9% as reported in the abstract and page 5. The original article has been corrected.

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Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study)

Piero Barbanti, Gabriella Egeo, Cinzia Aurilia … (2022)

Background Fremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explores the effectiveness, safety, and tolerability of fremanezumab in a real-life population of individuals affected by high-frequency episodic (HFEM: 8–14 days/month) or CM. Methods This is a 12-week multicenter, prospective, cohort, real-life study. We considered all consecutive patients affected by HFEM or CM visited at 9 Italian headache centers from 28/07/2020 to 11/11/2020. Eligible patients were given subcutaneous fremanezumab at the doses of 225 mg monthly or 675 mg quarterly, according to their preference. Primary study endpoints were the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients at weeks 9–12 compared to baseline. Secondary endpoints encompassed variation in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), HIT-6 and MIDAS scores, and ≥ 50%, ≥ 75% and 100% responder rates at the same time intervals. Results Sixty-seventh number migraine patients had received ≥ 1 subcutaneous fremanezumab dose and were considered for safety analysis, while 53 patients completed 12 weeks of treatment and were included also in the effectiveness analysis. Fremanezumab was effective in both HFEM and CM, inducing at week 12 a significant reduction in MMDs (-4.6, p < 0.05), MHDs (-9.4, p < 0.001), MAI (-5.7, p < 0.05; -11.1, p < 0.001), NRS (-3.1, p < 0.001; -2.5, p < 0.001), and MIDAS scores (-58.3, p < 0.05; -43.7; p < 0.001). HIT-6 was significantly reduced only in HFEM patients (-18.1, p < 0.001). Remission from CM to episodic migraine and from MO to no-MO occurred in 75% and 67.7% of the patients. The ≥ 50%, ≥ 75% and 100% responder rates at week 12 were 76.5%, 29.4% and 9.9% in HFEM and 58.3%, 25% and 0% in CM. Younger age emerged as a positive response predictor (OR = 0.91; 95% CI 0.85–0.98, p = 0.013). Treatment-emergent adverse events were uncommon (5.7%) and mild. No patient discontinued fremanezumab for any reason. Conclusions Fremanezumab seems more effective in real-life than in RCTs. Younger age emerges as a potential response predictor. Supplementary Information The online version contains supplementary material available at 10.1186/s10194-022-01396-x.

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Author and article information

Contributors

Piero Barbanti: piero.barbanti@sanrafaele.it

Journal

Journal ID (nlm-ta): J Headache Pain

Journal ID (iso-abbrev): J Headache Pain

Title: The Journal of Headache and Pain

Publisher: Springer Milan (Milan )

ISSN (Print): 1129-2369

ISSN (Electronic): 1129-2377

Publication date (Electronic): 7 June 2022

Publication date PMC-release: 7 June 2022

Publication date Collection: 2022

Volume: 23

Issue: 1

Electronic Location Identifier: 64

Affiliations

[1 ]GRID grid.414603.4, Headache and Pain Unit, IRCCS San Rafaele Pisana, ; Rome, Italy

[2 ]San Rafaele University, Rome, Italy

[3 ]GRID grid.415069.f, ISNI 0000 0004 1808 170X, Neurology Unit, , San Giuseppe Moscati Hospital, ; Avellino, Italy

[4 ]GRID grid.413009.f, Regional Referral Headache CenterNeurology Unit, , University Hospital Tor Vergata, ; Rome, Italy

[5 ]GRID grid.6530.0, ISNI 0000 0001 2300 0941, Department of Systems Medicine, , University of Rome Tor Vergata, ; Rome, Italy

[6 ]GRID grid.15496.3f, ISNI 0000 0001 0439 0892, Headache Unit, Department of Neurology, , Scientifc Institute San Rafaele Hospital, Vita-Salute University, ; Via Olgettina, 48, Milan, Italy

[7 ]Headache Center, ASST Santi Paolo Carlo, Milan, Italy

[8 ]GRID grid.416308.8, ISNI 0000 0004 1805 3485, Headache Center, Neurlogy Unit, , San Camillo-Forlanini Hospital, ; Rome, Italy

[9 ]GRID grid.15496.3f, ISNI 0000 0001 0439 0892, Neurology Unit, IRCCS San Rafaele Scientifc Institute, , Vita-Salute San Raffaele University, ; Milan, Italy

[10 ]Center for Headache and Intracranial Pressure Disorders, Neurology Unit, A.O.U. Mater Domini, Catanzaro, Italy

[11 ]GRID grid.488514.4, ISNI 0000000417684285, Headache and Neurosonology Unit, , Policlinico Universitario Campus Bio-Medico, ; Rome, Italy

[12 ]GRID grid.414603.4, Clinical and Molecular Epidemiology, IRCCS San Rafaele, ; Roma, Italy

[13 ]Department of Human Sciences and Quality of Life Promotion, San Rafaele University, Rome, Italy

[14 ]GRID grid.9657.d, ISNI 0000 0004 1757 5329, Headache and Neurosonology Unit, , Campus BioMedico University Hospital, ; Rome, Italy

Article

Publisher ID: 1434

DOI: 10.1186/s10194-022-01434-8

PMC ID: 9172000

SO-VID: b9fdcbea-08df-4c75-9a6a-1922ce508227

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Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

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