Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: the multicenter prospective cohort RE-DO study

Fabrizio Vernieri^{1

2}, Nicoletta Brunelli³, Simona Guerzoni⁴, Luigi Francesco Iannone⁵, Carlo Baraldi⁴, Renata Rao⁶, Francesca Schiano di Cola⁶, Raffaele Ornello⁷, Sabina Cevoli⁸, Carlo Lovati⁹, Maria Albanese^{10

11}, Armando Perrotta¹², Ilaria Cetta^{13

14}, Sergio Soeren Rossi¹⁵, Valentina Taranta⁷, Massimo Filippi^{13

14}, Pierangelo Geppetti⁵, Simona Sacco⁷, Claudia Altamura^{3

15}

Affiliations

¹ Unità Cefalee e Neurosonologia, Fondazione Policlinico Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy. f.vernieri@policlinicocampus.it.
² Neurologia, Dipartimento di Medicina e Chirurgia, Università Campus Bio-Medico di Roma, Rome, Italy. f.vernieri@policlinicocampus.it.
³ Unità Cefalee e Neurosonologia, Fondazione Policlinico Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
⁴ Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology, Headache Center and Drug Abuse, Laboratory of Clinical Pharmacology and Pharmacogenomics, Department of Specialist Medicines, AOU Policlinico di Modena, Modena, Italy.
⁵ Headache Center, Section of Clinical Pharmacology and Oncology, Department of Health Sciences, Careggi University Hospital, University of Florence, Florence, Italy.
⁶ Headache Center, ASST Spedali Civili of Brescia, Department Continuity of Care and Fragility, Department of Clinical and Experimental Sciences, Neurological Clinic, University of Brescia, Brescia, Italy.
⁷ Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
⁸ IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
⁹ Headache Center, Neurology Unit, L. Sacco University Hospital, Milan, Italy.
¹⁰ Neurology Unit, Headache Center, Tor Vergata University Hospital, Rome, Italy.
¹¹ Department of Systems Medicine, Tor Vergata University, Rome, Italy.
¹² IRCCS Neuromed, Pozzilli, Isernia, Italy.
¹³ Neuroimaging Research Unit, Division of Neuroscience; Neurology Unit and Neurophysiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
¹⁴ Vita-Salute San Raffaele University, Milan, Italy.
¹⁵ Neurologia, Dipartimento di Medicina e Chirurgia, Università Campus Bio-Medico di Roma, Rome, Italy.

PMID: 37468621
DOI: 10.1007/s00415-023-11872-2

Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: the multicenter prospective cohort RE-DO study

Fabrizio Vernieri et al. J Neurol. 2023 Nov.

. 2023 Nov;270(11):5436-5448.

doi: 10.1007/s00415-023-11872-2. Epub 2023 Jul 19.

Authors

Affiliations

¹ Unità Cefalee e Neurosonologia, Fondazione Policlinico Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy. f.vernieri@policlinicocampus.it.
² Neurologia, Dipartimento di Medicina e Chirurgia, Università Campus Bio-Medico di Roma, Rome, Italy. f.vernieri@policlinicocampus.it.
³ Unità Cefalee e Neurosonologia, Fondazione Policlinico Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
⁴ Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology, Headache Center and Drug Abuse, Laboratory of Clinical Pharmacology and Pharmacogenomics, Department of Specialist Medicines, AOU Policlinico di Modena, Modena, Italy.
⁵ Headache Center, Section of Clinical Pharmacology and Oncology, Department of Health Sciences, Careggi University Hospital, University of Florence, Florence, Italy.
⁶ Headache Center, ASST Spedali Civili of Brescia, Department Continuity of Care and Fragility, Department of Clinical and Experimental Sciences, Neurological Clinic, University of Brescia, Brescia, Italy.
⁷ Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
⁸ IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
⁹ Headache Center, Neurology Unit, L. Sacco University Hospital, Milan, Italy.
¹⁰ Neurology Unit, Headache Center, Tor Vergata University Hospital, Rome, Italy.
¹¹ Department of Systems Medicine, Tor Vergata University, Rome, Italy.
¹² IRCCS Neuromed, Pozzilli, Isernia, Italy.
¹³ Neuroimaging Research Unit, Division of Neuroscience; Neurology Unit and Neurophysiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
¹⁴ Vita-Salute San Raffaele University, Milan, Italy.
¹⁵ Neurologia, Dipartimento di Medicina e Chirurgia, Università Campus Bio-Medico di Roma, Rome, Italy.

PMID: 37468621
DOI: 10.1007/s00415-023-11872-2

Abstract

Background: The outcome of migraine patients retreated with monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (anti-CGRP) or its receptor (anti-CGRPr) is not completely known.

Methods: This multicentric prospective observational cohort study assessed monthly migraine days (MMDs), migraine acute medication intake (MAMI), and HIT-6 at baseline, after 90-112 days (Rev-1), after 84-90 days since Rev-1 (Rev-2) and 30 days after the last injection of anti-CGRP/CGRPr mAbs (Year-end), in the first and the second year after a discontinuation period.

Results: We enrolled 226 patients (79.6% with chronic migraine; 55.3% on erenumab and 44.7% on galcanezumab or fremanezumab). MMDs, MAMI, and HIT-6-did not differ at the respective first and second-year evaluations in the entire cohort, and comparing anti-CGRP with anti-CGRPr Abs. MMDs (18.1 ± 7.8 vs. 3.4 ± 7.8), MAMI (26.7 ± 28.3 vs.17.7 ± 17.2), and HIT-6 scores (63.1 ± 5.9 vs. 67.1 ± 10.3) were lower in the second year than in the pre-treatment baseline (consistently, p < 0.0001). Second-year baseline MMDs were lower in patients on anti-CGRP mAbs (p = 0.001) and with lower pre-treatment baseline MMDs (p ≤ 0.001).

Conclusion: Anti-CGRP/CGRPr mAbs are effective in the second as in the first year. The use of anti-CGRP or CGRPr mAbs influenced the second-year baseline MMDs, but their effectiveness did not differ during the two treatment years.

Keywords: CGRP; Discontinuation; Migraine; Monoclonal antibodies; Real life; Retreatment.

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References

1. Sacco S, Amin FM, Ashina M et al (2022) European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention—2022 update. J Headache Pain 23:67. https://doi.org/10.1186/s10194-022-01431-x - DOI - PubMed - PMC
1. Ashina M, Goadsby PJ, Reuter U et al (2019) Long-term safety and tolerability of erenumab: three-plus year results from a 5-year open-label extension study in episodic migraine. Cephalalgia 39:1455–1464. https://doi.org/10.1177/0333102419854082 - DOI - PubMed - PMC
1. Pozo-Rosich P, Detke HC, Wang S et al (2022) Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. https://doi.org/10.1080/03007995.2022.2059975 - DOI - PubMed
1. Ashina M, Goadsby PJ, Reuter U et al (2021) Long-term efficacy and safety of erenumab in migraine prevention: results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol 28:1716–1725. https://doi.org/10.1111/ENE.14715 - DOI - PubMed - PMC
1. Drellia K, Kokoti L, Deligianni CI et al (2021) Anti-CGRP monoclonal antibodies for migraine prevention: a systematic review and likelihood to help or harm analysis. Cephalalgia 41:851–864. https://doi.org/10.1177/0333102421989601 - DOI - PubMed

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Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: the multicenter prospective cohort RE-DO study

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Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: the multicenter prospective cohort RE-DO study

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