Efficacy of Galcanezumab in Migraine Central Sensitization

Overview

Journal Sci Rep

Specialty Science

Date 2024 Sep 18

PMID 39294310

Authors

Daisuke Danno

Noboru Imai

Shigekazu Kitamura

Kumiko Ishizaki

Shoji Kikui

Takao Takeshima

Affiliations

Soon will be listed here.

Abstract

Galcanezumab, a monoclonal antibody targeting the calcitonin gene-related peptide pathway (CGRP mAb), acts peripherally due to its large size. However, recent studies have suggested that CGRP mAbs may also have a central mode of action. This study aimed to evaluate the central effects of galcanezumab on migraine central sensitization.This prospective real-world study was conducted at three headache centers in Japan between May 2021 and May 2022. Patients treated with galcanezumab for migraines were included in the study. The primary outcome was the change in the validated Central Sensitization Inventory (CSI) score from baseline to six months of treatment. We also assessed changes in the Allodynia Symptom Checklist (ASC-12) score. Eighty-six patients with migraine (73 female and 13 male) were analyzed. At 6 months, CSI and ASC-12 scores were significantly reduced compared to baseline (CSI: 36.0 vs. 29.3, p < 0.001; and ASC-12: 5.55 vs. 4.26, p < 0.01). Furthermore, these effects were observed as early as three months of treatment. In this study, we demonstrated the real-world efficacy of galcanezumab in improving central sensitization in migraine, with significant effects seen in the early phase of treatment. Trial registration: This study was registered with UMIN-CTR on May 2, 2021 (UMIN000044096).

Citing Articles

The effect of calcitonin gene-related peptide monoclonal antibodies on restless legs syndrome in patients with migraine.

Suzuki K, Suzuki S, Fujita H, Kobayashi S, Shioda M, Hida R J Headache Pain. 2025; 26(1):36.

PMID: 39972460 PMC: 11837639. DOI: 10.1186/s10194-025-01976-7.

References

. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018; 38(1):1-211. DOI: 10.1177/0333102417738202. View

Skljarevski V, Matharu M, Millen B, Ossipov M, Kim B, Yang J . Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018; 38(8):1442-1454. DOI: 10.1177/0333102418779543. View

Iannone L, De Cesaris F, Ferrari A, Benemei S, Fattori D, Chiarugi A . Effectiveness of anti-CGRP monoclonal antibodies on central symptoms of migraine. Cephalalgia. 2022; 42(13):1323-1330. DOI: 10.1177/03331024221111526. View

Barbanti P, Egeo G, Aurilia C, Altamura C, dOnofrio F, Finocchi C . Predictors of response to anti-CGRP monoclonal antibodies: a 24-week, multicenter, prospective study on 864 migraine patients. J Headache Pain. 2022; 23(1):138. PMC: 9623966. DOI: 10.1186/s10194-022-01498-6. View

Messina R, Rocca M, Goadsby P, Filippi M . Insights into migraine attacks from neuroimaging. Lancet Neurol. 2023; 22(9):834-846. DOI: 10.1016/S1474-4422(23)00152-7. View

Takizawa T, Ihara K, Watanabe N, Takemura R, Takahashi N, Miyazaki N . CGRP-monoclonal antibodies in Japan: insights from an online survey of physician members of the Japanese headache society. J Headache Pain. 2024; 25(1):39. PMC: 10941476. DOI: 10.1186/s10194-024-01737-y. View

Albanese M, Mercuri N . Could the New Anti-CGRP Monoclonal Antibodies Be Effective in Migraine Aura? Case Reports and Literature Review. J Clin Med. 2022; 11(5). PMC: 8911201. DOI: 10.3390/jcm11051228. View

Loeser J, Treede R . The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008; 137(3):473-477. DOI: 10.1016/j.pain.2008.04.025. View

Barbanti P, Aurilia C, Egeo G, Proietti S, dOnofrio F, Torelli P . Ultra-late response (> 24 weeks) to anti-CGRP monoclonal antibodies in migraine: a multicenter, prospective, observational study. J Neurol. 2024; 271(5):2434-2443. PMC: 11055785. DOI: 10.1007/s00415-023-12103-4. View

10.

Ozarslan M, Matur Z, Tuzun E, Oge A . Cutaneous allodynia and thermal thresholds in chronic migraine: The effect of onabotulinumtoxinA. Clin Neurol Neurosurg. 2022; 220:107357. DOI: 10.1016/j.clineuro.2022.107357. View

11.

Basedau H, Sturm L, Mehnert J, Peng K, Schellong M, May A . Migraine monoclonal antibodies against CGRP change brain activity depending on ligand or receptor target - an fMRI study. Elife. 2022; 11. PMC: 9126581. DOI: 10.7554/eLife.77146. View

12.

Lipton R, Buse D, Sandoe C, Ford J, Hand A, Jedynak J . Changes in migraine interictal burden following treatment with galcanezumab: Results from a phase III randomized, placebo-controlled study. Headache. 2023; 63(5):683-691. DOI: 10.1111/head.14460. View

13.

Edvinsson L . CGRP receptor antagonists and antibodies against CGRP and its receptor in migraine treatment. Br J Clin Pharmacol. 2015; 80(2):193-9. PMC: 4541967. DOI: 10.1111/bcp.12618. View

14.

Schuttert I, Timmerman H, Petersen K, McPhee M, Arendt-Nielsen L, Reneman M . The Definition, Assessment, and Prevalence of (Human Assumed) Central Sensitisation in Patients with Chronic Low Back Pain: A Systematic Review. J Clin Med. 2021; 10(24). PMC: 8703986. DOI: 10.3390/jcm10245931. View

15.

Danno D, Wolf J, Ishizaki K, Kikui S, Hirata K, Takeshima T . Cranial autonomic symptoms in migraine are related to central sensitization: a prospective study of 164 migraine patients at a tertiary headache center. BMC Neurol. 2022; 22(1):89. PMC: 8919542. DOI: 10.1186/s12883-022-02610-8. View

16.

Mayer T, Neblett R, Cohen H, Howard K, Choi Y, Williams M . The development and psychometric validation of the central sensitization inventory. Pain Pract. 2011; 12(4):276-85. PMC: 3248986. DOI: 10.1111/j.1533-2500.2011.00493.x. View

17.

Overeem L, Peikert A, Hofacker M, Kamm K, Ruscheweyh R, Gendolla A . Effect of antibody switch in non-responders to a CGRP receptor antibody treatment in migraine: A multi-center retrospective cohort study. Cephalalgia. 2021; 42(4-5):291-301. PMC: 8988456. DOI: 10.1177/03331024211048765. View

18.

Sacco S, Braschinsky M, Ducros A, Lampl C, Little P, Brink A . European headache federation consensus on the definition of resistant and refractory migraine : Developed with the endorsement of the European Migraine & Headache Alliance (EMHA). J Headache Pain. 2020; 21(1):76. PMC: 7296705. DOI: 10.1186/s10194-020-01130-5. View

19.

Irimia P, Garcia-Azorin D, Nunez M, Diaz-Cerezo S, de Polavieja P, Panni T . Persistence, use of resources and costs in patients under migraine preventive treatment: the PERSEC study. J Headache Pain. 2022; 23(1):78. PMC: 9261063. DOI: 10.1186/s10194-022-01448-2. View

20.

Szabo E, Ashina S, Melo-Carrillo A, Bolo N, Borsook D, Burstein R . Peripherally acting anti-CGRP monoclonal antibodies alter cortical gray matter thickness in migraine patients: A prospective cohort study. Neuroimage Clin. 2023; 40:103531. PMC: 10623369. DOI: 10.1016/j.nicl.2023.103531. View