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.

Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study / Vernieri, Fabrizio; Brunelli, Nicoletta; Marcosano, Marilena; Aurilia, Cinzia; Egeo, Gabriella; Lovati, Carlo; Favoni, Valentina; Perrotta, Armando; Maestrini, Ilaria; Rao, Renata; D'Onofrio, Luigi; Finocchi, Cinzia; Aguggia, Marco; Bono, Francesco; Ranieri, Angelo; Albanese, Maria; Di Piero, Vittorio; Cevoli, Sabina; Altamura, Claudia; Barbanti, Piero; for the GARLIT Study, Group; Filippi, Massimo. - In: EUROPEAN JOURNAL OF NEUROLOGY. - ISSN 1351-5101. - 30:1(2023), pp. 224-234. [10.1111/ene.15563]

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

Filippi, Massimo
2023-01-01

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.
2023
CGRP
galcanezumab
migraine
monoclonal antibodies
real life
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11768/134769
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