Sustained Efficacy, Safety and High Adherence Rate of Onabotulinum Toxin Type A in Chronic Migraine Patients: A Multicentric Prospective Real-Life Study
Ilenia Corbelli,
Angela Verzina,
Ilaria Leone De Magistris,
Gioacchino De Vanna,
Paolo Eusebi,
Giorgia Mataluni,
Antonio Pisani,
Addolorata Maria Pia Prudenzano,
Maria Trojano,
Marianna Delussi,
Marina De Tommaso,
Antonio Russo,
Marcello Silvestro,
Gioacchino Tedeschi,
Paolo Calabresi,
Paola Sarchielli
Affiliations
Ilenia Corbelli
Neurological Clinic, S. Maria Misericordia Hospital, Department of Medicine, University of Perugia, 06129 Perugia, Italy
Angela Verzina
Neurological Clinic, S. Maria Misericordia Hospital, Department of Medicine, University of Perugia, 06129 Perugia, Italy
Ilaria Leone De Magistris
Neurological Clinic, S. Maria Misericordia Hospital, Department of Medicine, University of Perugia, 06129 Perugia, Italy
Gioacchino De Vanna
Neurological Clinic, S. Maria Misericordia Hospital, Department of Medicine, University of Perugia, 06129 Perugia, Italy
Paolo Eusebi
Neurological Clinic, S. Maria Misericordia Hospital, Department of Medicine, University of Perugia, 06129 Perugia, Italy
Giorgia Mataluni
Neurology Unit, Department of Systems Medicine, University of Tor Vergata, 00133 Rome, Italy
Antonio Pisani
Neurology Unit, Department of Systems Medicine, University of Tor Vergata, 00133 Rome, Italy
Addolorata Maria Pia Prudenzano
Headache Center, Neurological Clinic “L. Amaducci”, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, 70121 Bari, Italy
Maria Trojano
Headache Center, Neurological Clinic “L. Amaducci”, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, 70121 Bari, Italy
Marianna Delussi
Applied Neurophysiology and Pain (ANP) Unit, University of Bari Aldo Moro, 70121 Bari, Italy
Marina De Tommaso
Applied Neurophysiology and Pain (ANP) Unit, University of Bari Aldo Moro, 70121 Bari, Italy
Antonio Russo
Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 81100 Caserta, Italy
Marcello Silvestro
Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 81100 Caserta, Italy
Gioacchino Tedeschi
Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 81100 Caserta, Italy
Paolo Calabresi
The Institute of Neurology, Agostino Gemelli University Policlinic IRCCS, 00168 Rome, Italy
Paola Sarchielli
Neurological Clinic, S. Maria Misericordia Hospital, Department of Medicine, University of Perugia, 06129 Perugia, Italy
Guidelines regarding long-term use with onabotulinumtoxinA (onaBT-A) in chronic migraine (CM) prophylaxis are lacking. This multicentric prospective real-life study aimed to assess the efficacy and safety of a long-term treatment. A total of 195 chronic migraine patients were treated with onaBT-A, every 3 months for 5 cycles (Phase 1). In the Phase 2 of the study, depending on response rate, patients were divided into “responders” (R), “partially responders” (PR) and “non-responders” (NR). Then, we proposed to R and PR patients to continue with an additional 12 months of treatment (additional 4 sessions). Response to treatment and adverse events were collected for the entire duration of the study. Of the 195 patients included (females 82.1%, mean age 47.4 ± 12.4), at the end of Phase 1 there were 52.3% of R patients, 17.9% of PR patients, 15.4% of NR patients and 14.4% drop-outs. During Phase 2 of treatment, R patients presented a maintenance of the improvement achieved during the first year of treatment, as well as PR patients. Except for three serious adverse events not related to treatment, all other adverse events were mild or moderate in severity and resolved without sequelae. In the literature, adherence to oral migraine-preventive medications among patients with CM was found to be less than 25%. The results of this prospective real-life multicenter study show efficacy, safety and adherence to a long-term treatment with onaBT-A.
