Fabrizio Vernieri1, Claudia Altamura2, Nicoletta Brunelli2, Carmelina Maria Costa2, Cinzia Aurilia3, Gabriella Egeo3, Luisa Fofi3, Valentina Favoni4, Giulia Pierangeli4, Carlo Lovati5, Marco Aguggia6, Florindo d'Onofrio7, Alberto Doretti8, Paola Di Fiore9, Cinzia Finocchi10, Renata Rao11, Francesco Bono12, Angelo Ranieri13, Maria Albanese14,15, Sabina Cevoli4, Piero Barbanti3,16. 1. Headache and Neurosonology Unit, Campus Bio-Medico University Hospital, Via Alvaro del Portillo, 200, 00128, Rome, Italy. f.vernieri@unicampus.it. 2. Headache and Neurosonology Unit, Campus Bio-Medico University Hospital, Via Alvaro del Portillo, 200, 00128, Rome, Italy. 3. Headache and Pain Unit, IRCCS San Raffaele Pisana, Rome, Italy. 4. IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy. 5. Headache Center, Neurology Unit, University Hospital L. Sacco, Milan, Italy. 6. Neurology and Stroke Unit, Asti Hospital, Asti, Italy. 7. Neurology Unit, San Giuseppe Moscati Hospital, Avellino, Italy. 8. Department of Neurology, Stroke Unit and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS, Milan, Italy. 9. Headache Center, Neurology and Stroke Unit, S. Carlo Borromeo Hospital, Milan, Italy. 10. IRCCS Ospedale Policlinico San Martino, Genoa, Italy. 11. Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. 12. Center for Headache and Intracranial Pressure Disorders, Neurology Unit, A.O.U. Mater Domini, Catanzaro, Italy. 13. Headache Centre, Neurology and Stroke Unit, A. Cardarelli Hospital, Naples, Italy. 14. Headache Center, Neurology Unit, Tor Vergata University Hospital, Rome, Italy. 15. Department of Systems Medicine, Tor Vergata University, Rome, Italy. 16. San Raffaele University, Rome, Italy.
Abstract
BACKGROUND: The 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. METHODS: This 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. RESULTS: One 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. CONCLUSIONS: Galcanezumab 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 REGISTRATION: ClinicalTrials.gov NCT04803513 .
BACKGROUND: The 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. METHODS: This multicenter prospective observational cohort study was conducted between November 2019 and January 2021 at 13 Italian headache centers. Consecutive adult HFEM and CMpatients 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 CMpatients 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. RESULTS: One 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 CMpatients (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 CMpatients, 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 CMpatients converted to EM, and 82.0% ceased MO. Adverse events, none serious, were reported in up to 10.3% of patients during evaluation times. CONCLUSIONS:Galcanezumab 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 CMpatients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04803513 .
Entities:
Keywords:
Calcitonin gene-related peptide; Migraine treatment; Monoclonal antibodies; Real world
Authors: Luigi Francesco Iannone; Davide Fattori; Silvia Benemei; Alberto Chiarugi; Pierangelo Geppetti; Francesco De Cesaris Journal: CNS Drugs Date: 2022-02-11 Impact factor: 5.749