Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2024 Apr 7;16(4):178.
doi: 10.3390/toxins16040178.

Reducing the Impact of Headache and Allodynia Score in Chronic Migraine: An Exploratory Analysis from the Real-World Effectiveness of Anti-CGRP Monoclonal Antibodies Compared to Onabotulinum Toxin A (RAMO) Study

Danilo Antonio Montisano  1 , Riccardo Giossi  2   3 , Mattia Canella  4   5 , Claudia Altamura  6   7 , Marilena Marcosano  6   7 , Fabrizio Vernieri  6   7 , Alberto Raggi  8 , Licia Grazzi  1   9
Affiliations
Observational Study

Reducing the Impact of Headache and Allodynia Score in Chronic Migraine: An Exploratory Analysis from the Real-World Effectiveness of Anti-CGRP Monoclonal Antibodies Compared to Onabotulinum Toxin A (RAMO) Study

Danilo Antonio Montisano et al. Toxins (Basel). .

Abstract

Background: Chronic migraine (CM) is a disabling and hard-to-treat condition, associated with high disability and high cost. Among the preventive treatments, botulinum toxin A (BoNT-a) and monoclonal antibodies against the calcitonin gene-related protein (anti-CGRP mAbs) are the only disease-specific ones. The assessment of the disease burden is complex, and among others, tools such as the allodynia symptoms checklist (ASC-12) and headache impact test (HIT-6) are very useful. This exploratory study analysed the impact of these two therapies on migraine burden.

Methods: The RAMO study was a multicentre, observational, retrospective investigation conducted in two headache centres: the Fondazione IRCCS Istituto Neurologico Carlo Besta (Milan) and the Fondazione Policlinico Campus Bio-Medico (Rome). This study involved patients with chronic migraine treated with mAbs or BoNT-A. We conducted a subgroup exploratory analysis on HIT-6 and ASC-12 scores in the two groups. The Wilcoxon rank-sum test, Fisher's exact test, and ANOVA were performed.

Results: Of 126 patients, 36 on mAbs and 90 on BoNT-A had at least one available follow-up. mAbs resulted in a mean reduction of -11.1 and -11.4 points, respectively, in the HIT-6 at 6 and 12 months, while BoNT-A was reduced -3.2 and -3.6 points, respectively; the mAbs arm resulted in mean reductions in ASC-12 at 6 and 12 months of follow-up of -5.2 and -6.0 points, respectively, while BoNT-A showed lesser mean changes of -0.5 and -0.9 points, respectively. The adjusted analysis confirmed our results.

Conclusions: In this exploratory analysis, anti-CGRP mAbs showed superior effectiveness for HIT-6 and ASC12 compared to BoNT-A. Reductions in terms of month headache days (MHD), migraine disability assessment test (MIDAS), and migraine acute medications (MAM) were clinically relevant for both treatments.

Keywords: ASC-12; HIT-6; allodynia; erenumab; fremanezumab; galcanezumab; migraine; onabotulinum toxin A.

PubMed Disclaimer

Conflict of interest statement

Riccardo Giossi received support for congress participation from Mylan and acted as a consultant for Daiichi-Sankyo outside this work. Claudia Altamura is an associated editor for the Frontiers of Human Neuroscience and received travel grants and/or personal fees for advisory boards and speaker panels from Novartis, Eli-Lilly, Lundbeck, Teva, Lusofarmaco, Laborest, Abbvie/Allergan, Almirall, and Pfizer. Fabrizio Vernieri received travel grants and honoraria for advisory boards, speaker panels, and clinical investigation studies from Abbvie/Allergan, Amgen, Angelini, Eli-Lilly, Lundbeck, Novartis, Pfizer, and Teva. Licia Grazzi received consultancy and advisory fees from Abbvie, Eli-Lilly, Lundbeck, Novartis AG, Pfizer, and TEVA Pharm Ind. The other authors have nothing to disclose.

References

    1. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd Edition. Cephalalgia. 2018;38:1–211. doi: 10.1177/0333102417738202. - DOI - PubMed
    1. Ferrari M.D., Goadsby P.J., Burstein R., Kurth T., Ayata C., Charles A., Ashina M., van den Maagdenberg A.M.J.M., Dodick D.W. Migraine. Nat. Rev. Dis. Primers. 2022;8:2. doi: 10.1038/s41572-021-00328-4. - DOI - PubMed
    1. Global Burden of 369 Diseases and Injuries in 204 Countries and Territories, 1990-2019: A Systematic Analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396:1204–1222. doi: 10.1016/S0140-6736(20)30925-9. - DOI - PMC - PubMed
    1. Grazzi L., Raggi A., Guastafierro E., Passavanti M., Marcassoli A., Montisano D.A., D’Amico D. A Preliminary Analysis on the Feasibility and Short-Term Efficacy of a Phase-III RCT on Mindfulness Added to Treatment as Usual for Patients with Chronic Migraine and Medication Overuse Headache. Int. J. Environ. Res. Public Health. 2022;19:4116. doi: 10.3390/ijerph192114116. - DOI - PMC - PubMed
    1. Steiner T.J., Stovner L.J., Jensen R., Uluduz D., Katsarava Z. Migraine Remains Second among the World’s Causes of Disability, and First among Young Women: Findings from GBD2019. J. Headache Pain. 2020;21:137. doi: 10.1186/s10194-020-01208-0. - DOI - PMC - PubMed

Substances