Galcanezumab effects on incidence of headache after occurrence of triggers, premonitory symptoms, and aura in responders, non-responders, super-responders, and super non-responders
- PMID: 36927366
- PMCID: PMC10018924
- DOI: 10.1186/s10194-023-01560-x
Galcanezumab effects on incidence of headache after occurrence of triggers, premonitory symptoms, and aura in responders, non-responders, super-responders, and super non-responders
Abstract
Background: The goal of this observational, open-label, cohort study was to determine whether prophylactic migraine treatment with galcanezumab, a peripherally acting drug, alters the incidence of premonitory symptoms, and/or occurrence of headache after exposure to triggers or aura episodes in treatment-responders (≥ 50% reduction in monthly migraine days [MMD]), super-responders (≥ 70%), non-responders (< 50%) and super non-responders (< 30%).
Methods: Participants were administered electronic daily headache diaries to document migraine days and associated symptoms one month before and during the three months of treatment. Questionnaires were used to identify conscious prodromal and trigger events that were followed by headache prior to vs. after 3 months of treatment.
Results: After 3 months of galcanezumab treatment, (a) the incidence of premonitory symptoms that were followed by headache decreased by 48% in the 27 responders vs. 28% in the 19 non-responders, and by 50% in the 11 super-responders vs. 12% in the 8 super non-responders; (b) the incidence of visual and sensory aura that were followed by headache was reduced in responders, non-responders, and super-responders, but not in super non-responders; (c) the number of triggers followed by headache decreased by 38% in responders vs. 13% in non-responders, and by 31% in super-responders vs. 4% in super non-responders; and (d) some premonitory symptoms (e.g., cognitive impairment, irritability, fatigue) and triggers (e.g., stress, sleeping too little, bright light, aura) were followed by headache only in super non-responders.
Conclusions: Mechanistically, these findings suggest that even a mild decrease in migraine frequency is sufficient to partially reverse the excitability and responsivity of neurons involved in the generation of certain triggers and potentially premonitory symptoms of migraine.
Trial registration: ClinicalTrials.gov: NCT04271202. Registration date: February 10, 2020.
Keywords: CGRP monoclonal antibodies; Central sensitization; Hypothalamus; Migraine; Trigeminal.
© 2023. The Author(s).
Conflict of interest statement
All authors have completed the ICMJE uniform disclosure form at
S.A. received honoraria for consulting from Allergan/AbbVie, Amgen, Biohaven, Eli Lilly, Impel NeuroPharma, Novartis, Satsuma, Supernus, Theranica, Percept.
R.B. is the John Hedley-Whyte Professor of Anesthesia and Neuroscience at the Beth Israel Deaconess Medical Center and Harvard Medical School. He has received research support from the NIH: R01 NS094198-01A1, R37 NS079678, R01NS095655, R01 NS104296, R21 NS106345, Allergan, Teva, Dr. Reddy, Eli Lilly, Trigemina and the Migraine Research Foundation. He is a reviewer for NINDS, holds stock options in AllayLampand Percept; serves as consultant, advisory board member, or has received honoraria from: Alder, Allergan, Amgen, Autonomic Technologies, Avanir, Biohaven, CGRP Diagnostic, Dr. Reddy’s Laboratory, ElectroCore, Eli Lilly, GlaxoSmithKline, Merck, Pernix, Theranica, Teva, and Trigemina. CME fees from Healthlogix, Medlogix, WebMD/Medscape, and Patents 9061025, 11732265.1, 10806890, US2021-0015908, WO21007165, US2021-0128724, WO21005497.
DB has served as a consultant for Eli Lilly, Redpin Rx, and Luminous Mind.
Other authors declare that they have no competing interests.
Figures
Similar articles
-
Peripherally acting anti-CGRP monoclonal antibodies alter cortical gray matter thickness in migraine patients: A prospective cohort study.Neuroimage Clin. 2023;40:103531. doi: 10.1016/j.nicl.2023.103531. Epub 2023 Oct 14. Neuroimage Clin. 2023. PMID: 37866119 Free PMC article.
-
Pre-treatment non-ictal cephalic allodynia identifies responders to prophylactic treatment of chronic and episodic migraine patients with galcanezumab: A prospective quantitative sensory testing study (NCT04271202).Cephalalgia. 2023 Mar;43(3):3331024221147881. doi: 10.1177/03331024221147881. Cephalalgia. 2023. PMID: 36786278 Clinical Trial.
-
Impact of anti-CGRP monoclonal antibodies on migraine attack accompanying symptoms: A real-world evidence study.Cephalalgia. 2023 Aug;43(8):3331024231177636. doi: 10.1177/03331024231177636. Cephalalgia. 2023. PMID: 37555331
-
Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review.Adv Ther. 2020 May;37(5):2034-2049. doi: 10.1007/s12325-020-01319-9. Epub 2020 Apr 21. Adv Ther. 2020. PMID: 32319039 Free PMC article. Review.
-
Insights from triggers and prodromal symptoms on how migraine attacks start: The threshold hypothesis.Cephalalgia. 2024 Oct;44(10):3331024241287224. doi: 10.1177/03331024241287224. Cephalalgia. 2024. PMID: 39380339 Review.
Cited by
-
Calcitonin Gene-Related Peptide Monoclonal Antibodies: Key Lessons from Real-World Evidence.Brain Sci. 2024 Sep 22;14(9):948. doi: 10.3390/brainsci14090948. Brain Sci. 2024. PMID: 39335442 Free PMC article. Review.
-
Efficacy of galcanezumab in migraine central sensitization.Sci Rep. 2024 Sep 18;14(1):21824. doi: 10.1038/s41598-024-72282-6. Sci Rep. 2024. PMID: 39294310 Free PMC article.
-
Intervening in the Premonitory Phase to Prevent Migraine: Prospects for Pharmacotherapy.CNS Drugs. 2024 Jul;38(7):533-546. doi: 10.1007/s40263-024-01091-2. Epub 2024 May 31. CNS Drugs. 2024. PMID: 38822165 Review.
-
Nine-Month Continuous Fremanezumab Prophylaxis on the Response to Triptans and Also on the Incidence of Triggers, Hypersensitivity and Prodromal Symptoms of Patients with High-Frequency Episodic Migraine.J Clin Med. 2024 Jan 10;13(2):386. doi: 10.3390/jcm13020386. J Clin Med. 2024. PMID: 38256516 Free PMC article.
-
Long-term effectiveness and tolerability of galcanezumab in patients with migraine excluded from clinical trials: real world evidence of 1055 patients with 1 year follow-up from the Galca-Only registry.J Headache Pain. 2023 Nov 22;24(1):157. doi: 10.1186/s10194-023-01690-2. J Headache Pain. 2023. PMID: 37993795 Free PMC article.
References
Publication types
MeSH terms
Substances
Associated data
Grants and funding
LinkOut - more resources
Full Text Sources
Medical
Research Materials
Miscellaneous