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Multicenter Study
. 2023 Jan;30(1):224-234.
doi: 10.1111/ene.15563. Epub 2022 Sep 26.

Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study

Fabrizio Vernieri  1 , Nicoletta Brunelli  1 , Marilena Marcosano  1 , Cinzia Aurilia  2 , Gabriella Egeo  2 , Carlo Lovati  3 , Valentina Favoni  4 , Armando Perrotta  5 , Ilaria Maestrini  6 , Renata Rao  7 , Luigi d'Onofrio  1 , Cinzia Finocchi  8 , Marco Aguggia  9 , Francesco Bono  10 , Angelo Ranieri  11 , Maria Albanese  12   13 , Vittorio Di Piero  6 , Sabina Cevoli  4 , Claudia Altamura  1 , Piero Barbanti  2   14 ; GARLIT Study Group
Collaborators, Affiliations
Multicenter Study

Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study

Fabrizio Vernieri et al. Eur J Neurol. 2023 Jan.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT0480351.

Keywords: CGRP; galcanezumab; migraine; monoclonal antibodies; real life.

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Conflict of interest statement

M.Ag. received grants from Novartis and Lilly. M.Al. received honoraria or travel grants from Novartis, Teva, Merck Serono, Almirall, and Biogen. C.Al. received grants and honoraria from Lusofarmaco, Laborest, Abbvie, Novartis, and Eli Lilly. C.Au. received travel grants and honoraria from FB‐Health, Lusofarmaco, Almirall, Eli‐Lilly, Novartis, and Teva. P.B. received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Alder, Allergan, Angelini, Assosalute, Bayer, ElectroCore, Eli‐Lilly, GSK, Lundbeck, Lusofarmaco, 1MED, MSD, New Penta, Noema Pharma, Novartis, Stx‐Med, Teva, Visufarma, and Zambon. F.B. received honoraria as a speaker or for participating in advisory boards from Teva, Novartis, and Ipsen. S.C. received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Novartis, Teva, Lilly, Allergan, Ibsa, Amgen, and Lundbeck. V.D.P. received grants and honoraria by Bayer, Biogen, Lilly, TEVA, and Novartis. G.E. received travel grants and honoraria from Eli‐Lilly, Novartis, New Penta, and Ecupharma. V.F. has received honoraria as speaker or for participating in advisory boards from Ely‐Lilly. C.F. received travel grants, honoraria Lilly, TEVA, and Aim Group. C.L. received grants from Novartis and Lilly. I.M. received honoraria from Eli Lilly. A.P. received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Allergan, Eli‐Lilly, Novartis, and Teva. A.R. received speaker honoraria from Teva and Lilly. R.R. received honoraria for speaker panels from Teva, Lilly, and Novartis. F.V. received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Allergan‐Abbvie, Amgen, Angelini, Eli‐Lilly, Lundbeck, Novartis, and Teva. N.B., L.d.O., and M.M. have no competing interest.

Figures

FIGURE 1
FIGURE 1
(Left) Mean monthly migraine days (MMDs) changes from baseline to V12 in high‐frequency episodic migraine (HFEM, dashed line) and chronic migraine (CM, solid line) patients. (Right) Monthly acute medication intake (MAMI) changes from baseline to V12 in HFEM (dashed line) and CM (solid line) patients. The levels of significance indicate the results of paired t tests for MMDs and MAMI along the evaluation times.
FIGURE 2
FIGURE 2
Frequency of patients achieving monthly migraine day 50% response rate (RR) for the first time during the observation period.
FIGURE 3
FIGURE 3
Percentage of high‐frequency episodic migraine (HFEM) (left) and chronic migraine (CM) (right) patients achieving 50%, 75%, and 100% response rate (RR) at V1, V3, V6, and V12.
FIGURE 4
FIGURE 4
Percentage of patients achieving monthly migraine day 50% response rate (RR) in at least 1 month up to 12 cumulative months of therapy.
FIGURE 5
FIGURE 5
Percentage of patients receiving add‐on standard therapies along the year of treatment.
See this image and copyright information in PMC

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References

    1. Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double‐blind, placebo‐controlled phase 2 trial. Lancet Neurol. 2017;16(6):425‐434. doi:10.1016/S1474-4422(17)30083-2 - DOI - PubMed
    1. Goadsby PJ, Reuter U, Hallstrom Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123‐2132. doi:10.1056/NEJMoa1705848 - DOI - PubMed
    1. Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE‐1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080‐1088. doi:10.1001/jamaneurol.2018.1212 - DOI - PMC - PubMed
    1. Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. 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 - DOI - PubMed
    1. Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: the randomized, double‐blind, placebo‐controlled REGAIN study. Neurology. 2018;91(24):E2211‐E2221. doi:10.1212/WNL.0000000000006640 - DOI - PMC - PubMed

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