Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study)

Cinzia Finocchi,Carlo Lovati,Florindo d’Onofrio,Giulia Pierangeli,Francesco Bono,Angelo Ranieri,Renata Rao,Sabina Cevoli,Carmelina Maria Costa,Fabrizio Vernieri,Gabriella Egeo,Valentina Favoni,Claudia Altamura,Piero Barbanti,Nicoletta Brunelli,Cinzia Aurilia,Maria Albanese,Alberto Doretti,Paola Di Fiore,Luisa Fofi,Marco Aguggia

doi:10.1186/s10194-021-01247-1

Abstract

BackgroundThe clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life. This study aimed at evaluating the effectiveness, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic migraine (CM) in a real-life setting.MethodsThis multicenter prospective observational cohort study was conducted between November 2019 and January 2021 at 13 Italian headache centers. Consecutive adult HFEM and CM patients clinically eligible were enrolled and treated with galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg. The primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients after 6 months of therapy (V6). Secondary endpoints were the Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6 and MIDAS scores changes, ≥50% responder rates (RR), the conversion rate from CM to episodic migraine (EM) and Medication Overuse (MO) discontinuation.ResultsOne hundred sixty-three patients (80.5% female, 47.1 ± 11.7 years, 79.8% CM) were included. At V6, MMDs reduced by 8 days in HFEM and MHDs by 13 days in CM patients (both p < .001). NRS, MPI, HIT-6 and MIDAS scores significantly decreased (p < .001). Ten patients (6.1%) dropped out for inefficacy and classified as non-responders. Patients with ≥50%RRs, i.e. responders, were 76.5% in the HFEM and 63.5% in the CM group at V6. Among CM patients, the V6 responders presented a lower body mass index (p = .018) and had failed a lower number of preventive treatments (p = .013) than non-responders. At V6, 77.2% of CM patients converted to EM, and 82.0% ceased MO. Adverse events, none serious, were reported in up to 10.3% of patients during evaluation times.ConclusionsGalcanezumab in real life was safe, well tolerated and seemed more effective than in RCTs. Normal weight and a low number of failed preventives were positively associated with galcanezumab effectiveness in CM patients.Trial registrationClinicalTrials.govNCT04803513.

Highlights

The clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life
Normal weight and a low number of failed preventives were positively associated with galcanezumab effectiveness in chronic migraine (CM) patients
130 (79.8%) patients were affected by CM, 33 (20.2%) by high-frequency episodic migraine (HFEM), 117 subjects (71.8%) presented Medication Overuse (MO)

Summary

Introduction

The clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life. Migraine is a very disabling neurological disorder [1], mainly when attacks occur frequently and severely. In these cases, the prescription of preventive drugs is strongly recommended [2]. Randomized controlled trials (RCTs) have demonstrated that the designed monoclonal antibodies (mAbs) anti-CGRP receptor, i.e. erenumab [9, 10], and anti the CGRP ligand, i.e. galcanezumab [11,12,13], fremanezumab [14, 15], and eptinezumab [16] are effective and safe in the prevention of EM and CM. Real-life studies with erenumab have confirmed trials’ findings in clinical practice [17]

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