Effectiveness, safety, and tolerability of galcanezumab in a real-life setting in patients with migraine in Italy (the G
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Effectiveness, safety, and tolerability of galcanezumab in a real-life setting in patients with migraine in Italy (the GARLIT study) Fabrizio Vernieri 1 & Claudia Altamura 1 & Cinzia Aurilia 2 & Nicoletta Brunelli 1 & Gabriella Egeo 2 & Luisa Fofi 2 & Carmelina Maria Costa 1 & Adriana Fallacara 1 & Valentina Favoni 3 & Giulia Pierangeli 3 & Marco Aguggia 4 & Davide Bertuzzo 4 & Maria Albanese 5 & Paola Di Fiore 6 & Fabio Frediani 6 & Sabina Cevoli 3 & Piero Barbanti 2
# Fondazione Società Italiana di Neurologia 2020
The development of drugs targeting the trigeminal sensory calcitonin gene-related peptide (CGRP) or its receptor is actually opening a new era for the treatment of migraine. Quite a number of randomized controlled trials demonstrated that the anti-CGRP receptor, erenumab, and the anti-CGRP antibodies, galcanezumab, fremanezumab, and eptinezumab, are effective and safe in patients with migraine. Recently, real-life studies with erenumab have also confirmed trial data in a realworld setting. Efficacy and safety of galcanezumab has been established in 3 phase III clinical trials. In two similarly designed studies, EVOLVE 1 and 2 [1, 2] patients with episodic migraine (EM) received monthly subcutaneous injection of 120 mg (after an initial loading dose of 240 mg) or galcanezumab 240 mg or placebo. Endpoints were mean change from baseline during months 1–6 in the number of monthly migraine headache days (MHDs); percentage of patients with ≥ 50%, ≥ 75%, and 100% reduction in monthly MHDs; and reduction in monthly MHDs requiring acute migraine treatments. Both doses of galcanezumab met the objectives in the 2 studies and were superior to placebo. The same study protocol was performed
* Fabrizio Vernieri [email protected] 1
Unità Cefalee e Neurosonologia, Policlinico Universitario Campus Bio-Medico, Rome, Italy
2
Unità Cefalee e Dolore, IRCCS San Raffaele Pisana, Rome, Italy
3
IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy
4
SOC Neurologia e Stroke Unit, Ospedale Cardinal Massaia, Asti, Italy
5
Centro Cefalee, U.O.C di Neurologia, Policlinico Tor Vergata, Rome, Italy
6
Centro Cefalee, S. Carlo Borromeo, Milan, Italy
in the REGAIN study [3], in patients with chronic migraine (CM), but this time changes from baseline were measured at the end of the 3-month double-blind treatment phase. In the REGAIN study, both galcanezumab doses were superior to placebo only in reduction of monthly MHDs and on proportion of patients with 50% reduction in monthly MHDs. No clinically meaningful differences in the 3 studies were observed in safety comparing galcanezumab groups with placebo. Injection site reaction, pruritus, and erythema were higher for galcanezumab compared with placebo. The aim of the present open, multicenter, prospective study is to observe the effectiveness, safety, and tolerability of galcanezumab in a real-life setting in CM and highfrequency (i.e., 8–14 migraine days per month) EM (HFEM) patients treated at 6 Italian headache centers (the GARLI
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