Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study.
CGRP
galcanezumab
migraine
monoclonal antibodies
real life
Journal
European journal of neurology
ISSN: 1468-1331
Titre abrégé: Eur J Neurol
Pays: England
ID NLM: 9506311
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
received:
06
07
2022
accepted:
23
08
2022
pubmed:
14
9
2022
medline:
17
12
2022
entrez:
13
9
2022
Statut:
ppublish
Résumé
To evaluate the 1-year effectiveness and tolerability of galcanezumab in real life and the prognostic indicators of persistent response. High-frequency episodic migraine (HFEM) and chronic migraine (CM) patients treated with galcanezumab who completed a 1-year observation were enrolled. The primary outcomes assessed during the 12 months (V1-V12) were the change in monthly migraine days (MMDs) from baseline and the response rates ≥50% in MMDs (MMD ≥50% RR). The secondary outcomes were changes in pain intensity (numerical rating scale [NRS]) and in monthly acute medication intake (MAMI). We enrolled 191 patients (77.5% CM). Twenty-three patients (12%) dropped out, two for nonserious adverse events. At least 40% of patients took add-on standard preventives from baseline to V12. At V12, MMDs were reduced by 6.0 days in HFEM and by 11.9 days in CM patients (both p < 0.00001); NRS and MAMI were also decreased in both groups (p < 0.00001). One-hundred eight (56.5%) patients presented MMD ≥50% RR for 9 cumulative months (interquartile range=8): we defined this value as the cutoff for a persistent response. Persistent responders were less likely to have a higher body mass index (BMI) (p = 0.007) but more frequently had a good response to triptans (p = 0.005) and MMD ≥50% RR at V1 (p < 0.0000001). Patients without a persistent response were on add-on therapy for longer periods of time (p < 0.001). Galcanezumab was effective and well-tolerated in the 1-year term, with most patients presenting MMD ≥50% RR for at least 9 months. Triptan response, lower BMI, and MMD ≥50% RR in the first month emerged as predictive factors for a persistent response.
Sections du résumé
BACKGROUND AND PURPOSE
To evaluate the 1-year effectiveness and tolerability of galcanezumab in real life and the prognostic indicators of persistent response.
METHODS
High-frequency episodic migraine (HFEM) and chronic migraine (CM) patients treated with galcanezumab who completed a 1-year observation were enrolled. The primary outcomes assessed during the 12 months (V1-V12) were the change in monthly migraine days (MMDs) from baseline and the response rates ≥50% in MMDs (MMD ≥50% RR). The secondary outcomes were changes in pain intensity (numerical rating scale [NRS]) and in monthly acute medication intake (MAMI).
RESULTS
We enrolled 191 patients (77.5% CM). Twenty-three patients (12%) dropped out, two for nonserious adverse events. At least 40% of patients took add-on standard preventives from baseline to V12. At V12, MMDs were reduced by 6.0 days in HFEM and by 11.9 days in CM patients (both p < 0.00001); NRS and MAMI were also decreased in both groups (p < 0.00001). One-hundred eight (56.5%) patients presented MMD ≥50% RR for 9 cumulative months (interquartile range=8): we defined this value as the cutoff for a persistent response. Persistent responders were less likely to have a higher body mass index (BMI) (p = 0.007) but more frequently had a good response to triptans (p = 0.005) and MMD ≥50% RR at V1 (p < 0.0000001). Patients without a persistent response were on add-on therapy for longer periods of time (p < 0.001).
CONCLUSIONS
Galcanezumab was effective and well-tolerated in the 1-year term, with most patients presenting MMD ≥50% RR for at least 9 months. Triptan response, lower BMI, and MMD ≥50% RR in the first month emerged as predictive factors for a persistent response.
Identifiants
pubmed: 36097739
doi: 10.1111/ene.15563
pmc: PMC10086852
doi:
Substances chimiques
galcanezumab
55KHL3P693
Tryptamines
0
Banques de données
ClinicalTrials.gov
['NCT0480351']
Types de publication
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
224-234Investigateurs
Carmelina Maria Costa
(CM)
Luisa Fofi
(L)
Francesca Schiano Di Cola
(FS)
Florindo d'Onofrio
(F)
Davide Bertuzzo
(D)
Fabio Bombardieri
(F)
Roberta Messina
(R)
Bruno Colombo
(B)
Massimo Filippi
(M)
Alberto Doretti
(A)
Gianluca Demirtzidis
(G)
Stefano Messina
(S)
Informations de copyright
© 2022 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.
Références
Cephalalgia. 2016 Dec;36(14):1334-1340
pubmed: 26858260
J Headache Pain. 2021 Jul 17;22(1):74
pubmed: 34273947
Neurology. 2007 May 22;68(21):1851-61
pubmed: 17515549
Neurology. 2018 Dec 11;91(24):e2211-e2221
pubmed: 30446596
Lancet Neurol. 2020 Oct;19(10):814-825
pubmed: 32949542
JAMA Neurol. 2018 Sep 1;75(9):1080-1088
pubmed: 29813147
Cephalalgia. 2021 Jan;41(1):90-98
pubmed: 32867533
J Neurol. 2022 Feb;269(2):1032-1034
pubmed: 34455469
J Headache Pain. 2021 May 3;22(1):35
pubmed: 33941080
JAMA. 2018 May 15;319(19):1999-2008
pubmed: 29800211
Cephalalgia. 2001 Dec;21(10):947-52
pubmed: 11843865
Headache. 2020 Jan;60(1):28-39
pubmed: 31811654
Cephalalgia. 2018 Jan;38(1):1-211
pubmed: 29368949
Headache. 2020 Feb;60(2):348-359
pubmed: 31710104
Drug News Perspect. 2010 Mar;23(2):112-7
pubmed: 20369076
CNS Drugs. 2022 Feb;36(2):191-202
pubmed: 35146696
N Engl J Med. 2017 Nov 30;377(22):2123-2132
pubmed: 29171821
Headache. 2021 Feb;61(2):363-372
pubmed: 33337544
Eur J Neurol. 2023 Jan;30(1):224-234
pubmed: 36097739
Cephalalgia. 2018 Jul;38(8):1442-1454
pubmed: 29848108
J Headache Pain. 2019 Jan 16;20(1):6
pubmed: 30651064
Adv Ther. 2021 Mar;38(3):1614-1626
pubmed: 33544305
Front Hum Neurosci. 2021 Apr 20;15:640574
pubmed: 33958992
Pain Ther. 2021 Dec;10(2):809-826
pubmed: 33880725
Headache. 2019 Jan;59(1):1-18
pubmed: 30536394
J Neurosci. 1999 May 1;19(9):3423-9
pubmed: 10212302
J Clin Pharmacol. 2020 Feb;60(2):229-239
pubmed: 31482569
Eur J Neurol. 2022 Apr;29(4):1198-1208
pubmed: 34826192
Lancet Neurol. 2017 Jun;16(6):425-434
pubmed: 28460892
N Engl J Med. 2017 Nov 30;377(22):2113-2122
pubmed: 29171818
Neurology. 2020 Mar 31;94(13):e1365-e1377
pubmed: 32209650
J Headache Pain. 2021 Jan 06;22(1):1
pubmed: 33407070
Headache. 2021 Oct;61(9):1351-1363
pubmed: 34309862
Eur J Neurol. 2021 May;28(5):1716-1725
pubmed: 33400330
J Headache Pain. 2021 Oct 7;22(1):120
pubmed: 34620085
Cephalalgia. 2017 Apr;37(5):470-485
pubmed: 27837173
Clin Ther. 2022 Mar;44(3):389-402
pubmed: 35131090
J Headache Pain. 2018 Dec 29;19(1):121
pubmed: 30594122
Neurol Sci. 2022 Feb;43(2):1273-1280
pubmed: 34224026
Clin Neurol Neurosurg. 1992;94 Suppl:S73-7
pubmed: 1320526