Galcanezumab effect on "whole pain burden" and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience.
CGRP
Galcanezumab
Migraine
Monoclonal antibodies
Real-world
Journal
The journal of headache and pain
ISSN: 1129-2377
Titre abrégé: J Headache Pain
Pays: England
ID NLM: 100940562
Informations de publication
Date de publication:
13 Jun 2022
13 Jun 2022
Historique:
received:
17
02
2022
accepted:
22
04
2022
entrez:
13
6
2022
pubmed:
14
6
2022
medline:
16
6
2022
Statut:
epublish
Résumé
Clinical trials have demonstrated galcanezumab as safe and effective in migraine prevention. However, real-life data are still lacking and overlook the impact of galcanezumab on those different migraine facets strongly contributing to migraine burden. Herein we report the clinical experience from an Italian real-world setting using galcanezumab in patients with migraine experiencing previous unsuccessful preventive treatments. Forty-three patients with migraine and failure of at least 3 migraine preventive medication classes received monthly galcanezumab 120 mg s.c. At the first administration and after 3 and 6 months, patients underwent extensive interviews to assess clinical parameters of disease severity. Furthermore, validated questionnaires were administered to explore migraine-related disability, impact, and quality of life as well as symptoms of depression or anxiety, pain catastrophizing, sleep quality and the ictal cutaneous allodynia. After the third and the sixth administration of monthly galcanezumab 120 mg s.c., headache attacks frequency reduced from 20.56 to 7.44 and 6.37 headache days per month, respectively. Moreover, a significant improvement in headache pain intensity (from 8.95 to 6.84 and 6.21) and duration (from 9.03 to 3.75 and 2.38) as well as in scores assessing migraine related disability and impact, depressive and anxious symptoms, and pain catastrophizing was observed. Furthermore, we demonstrated a significant reduction in the values of "whole pain burden", a composite score derived from the product of the average of headache frequency, intensity, and duration in the last three months. Real-world data support monthly galcanezumab 120 mg s.c. as a safe and effective preventive treatment in reducing headache frequency, intensity, and duration as well as comorbid depressive or anxious symptoms, pain catastrophizing and quality of life in both episodic and chronic migraine patients with previous unsuccessful preventive treatments. Furthermore, we demonstrated that monthly galcanezumab 120 mg s.c. is able to induce a significant improvement in the scores of "whole pain burden". The latter is a reliable and easy-to-handle tool to be employed in clinical setting to evaluate the effectiveness of preventive drugs (in this case, galcanezumab) or when the decision of continuing the treatment with anti-CGRP mAbs is mandatory.
Sections du résumé
BACKGROUND
BACKGROUND
Clinical trials have demonstrated galcanezumab as safe and effective in migraine prevention. However, real-life data are still lacking and overlook the impact of galcanezumab on those different migraine facets strongly contributing to migraine burden. Herein we report the clinical experience from an Italian real-world setting using galcanezumab in patients with migraine experiencing previous unsuccessful preventive treatments.
METHODS
METHODS
Forty-three patients with migraine and failure of at least 3 migraine preventive medication classes received monthly galcanezumab 120 mg s.c. At the first administration and after 3 and 6 months, patients underwent extensive interviews to assess clinical parameters of disease severity. Furthermore, validated questionnaires were administered to explore migraine-related disability, impact, and quality of life as well as symptoms of depression or anxiety, pain catastrophizing, sleep quality and the ictal cutaneous allodynia.
RESULTS
RESULTS
After the third and the sixth administration of monthly galcanezumab 120 mg s.c., headache attacks frequency reduced from 20.56 to 7.44 and 6.37 headache days per month, respectively. Moreover, a significant improvement in headache pain intensity (from 8.95 to 6.84 and 6.21) and duration (from 9.03 to 3.75 and 2.38) as well as in scores assessing migraine related disability and impact, depressive and anxious symptoms, and pain catastrophizing was observed. Furthermore, we demonstrated a significant reduction in the values of "whole pain burden", a composite score derived from the product of the average of headache frequency, intensity, and duration in the last three months.
CONCLUSION
CONCLUSIONS
Real-world data support monthly galcanezumab 120 mg s.c. as a safe and effective preventive treatment in reducing headache frequency, intensity, and duration as well as comorbid depressive or anxious symptoms, pain catastrophizing and quality of life in both episodic and chronic migraine patients with previous unsuccessful preventive treatments. Furthermore, we demonstrated that monthly galcanezumab 120 mg s.c. is able to induce a significant improvement in the scores of "whole pain burden". The latter is a reliable and easy-to-handle tool to be employed in clinical setting to evaluate the effectiveness of preventive drugs (in this case, galcanezumab) or when the decision of continuing the treatment with anti-CGRP mAbs is mandatory.
Identifiants
pubmed: 35698070
doi: 10.1186/s10194-022-01436-6
pii: 10.1186/s10194-022-01436-6
pmc: PMC9195341
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
galcanezumab
55KHL3P693
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
69Informations de copyright
© 2022. The Author(s).
Références
Lancet Neurol. 2010 Mar;9(3):285-98
pubmed: 20170842
Headache. 2021 Jul;61(7):992-1003
pubmed: 34081791
Neurology. 2005 Nov 8;65(9):1419-22
pubmed: 16275830
Qual Life Res. 2003 Dec;12(8):963-74
pubmed: 14651415
J Headache Pain. 2019 Jan 16;20(1):6
pubmed: 30651064
Brain. 2013 Nov;136(Pt 11):3489-96
pubmed: 24080152
J Headache Pain. 2021 May 3;22(1):35
pubmed: 33941080
Cephalalgia. 2018 Jan;38(1):1-211
pubmed: 29368949
J Headache Pain. 2020 Oct 17;21(1):123
pubmed: 33069214
J Headache Pain. 2019 Apr 17;20(1):37
pubmed: 30995909
Int J Environ Res Public Health. 2018 Nov 26;15(12):
pubmed: 30486273
J Headache Pain. 2020 Dec 2;21(1):137
pubmed: 33267788
Headache. 1998 Apr;38(4):295-302
pubmed: 9595870
Cephalalgia. 2016 Apr;36(4):358-70
pubmed: 26122646
Headache. 2010 Oct;50(9):1464-72
pubmed: 20572880
Neurology. 2012 Apr 24;78(17):1337-45
pubmed: 22529202
CNS Drugs. 2022 Feb;36(2):191-202
pubmed: 35146696
Acta Neurol Scand. 2021 Sep;144(3):325-333
pubmed: 34019304
Cephalalgia. 2018 Jul;38(8):1442-1454
pubmed: 29848108
Continuum (Minneap Minn). 2021 Jun 1;27(3):613-632
pubmed: 34048395
J Neurol Neurosurg Psychiatry. 2010 Apr;81(4):428-32
pubmed: 20164501
J Headache Pain. 2021 Oct 25;22(1):128
pubmed: 34696711
BMJ. 2007 Oct 20;335(7624):806-8
pubmed: 17947786
Neurology. 2019 Dec 10;93(24):e2224-e2236
pubmed: 31690685
Neurology. 2018 Dec 11;91(24):e2211-e2221
pubmed: 30446596
Cephalalgia. 2009 Dec;29(12):1285-93
pubmed: 19438916
Lancet Neurol. 2020 Oct;19(10):814-825
pubmed: 32949542
Cephalalgia. 2022 Feb;42(2):162-165
pubmed: 34407643
JAMA Neurol. 2018 Sep 1;75(9):1080-1088
pubmed: 29813147
J Headache Pain. 2021 Oct 2;22(1):114
pubmed: 34600468
N Engl J Med. 2000 Jun 22;342(25):1887-92
pubmed: 10861325
J Psychosom Res. 2015 Nov;79(5):458-63
pubmed: 26526323
Clin J Pain. 2001 Jun;17(2):165-72
pubmed: 11444718
J Affect Disord. 1988 Jan-Feb;14(1):61-8
pubmed: 2963053
Headache. 2005 Jul-Aug;45(7):904-10
pubmed: 15985108
J Headache Pain. 2012 Nov;13(8):615-24
pubmed: 23007859
Sleep Med. 2009 May;10(5):531-9
pubmed: 18805054
Pain. 2005 Jan;113(1-2):45-50
pubmed: 15621363
Neurol Clin. 2019 Nov;37(4):753-770
pubmed: 31563231
Neurology. 2001;56(6 Suppl 1):S20-8
pubmed: 11294956
Chronic Illn. 2013 Sep;9(3):202-19
pubmed: 23172888
Adv Ther. 2021 Jun;38(6):3154-3165
pubmed: 33950375
J Headache Pain. 2021 Oct 7;22(1):120
pubmed: 34620085
Expert Opin Drug Saf. 2015 May;14(5):667-81
pubmed: 25676133
J Headache Pain. 2016;17:59
pubmed: 27245683
J Headache Pain. 2020 Jun 9;21(1):69
pubmed: 32517693
Headache. 2014 Jun;54(6):987-95
pubmed: 24673487