One year experience with erenumab: real-life data in 30 consecutive patients
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One year experience with erenumab: real-life data in 30 consecutive patients Angelo Ranieri 1,2 & Gennaro Alfieri 1,2 & Massimo Napolitano 1 & Giovanna Servillo 1 & Paolo Candelaresi 1 & Walter Di Iorio 1 & Katia Longo 1 & Giorgia Teresa Maniscalco 1 & Rosaria Renna 1 & Mariana Rippa 1 & Simona Salvatore 1 & Anna Sagnelli 1 & Ciro Florio 1 & Valentino Manzo 1
# Fondazione Società Italiana di Neurologia 2020
Monoclonal antibodies (mAb) against calcitonine gene–related peptide (CGRP) and its receptors (CGRP/CGRP-R mAb) represent a novel therapeutic option for migraine prophylaxis [1]. Erenumab, the only fully human CGRP-R mAb, is the first mAb approved as migraine specific treatment in both episodic migraine (EM) and chronic migraine (CM). Although independent real-life studies confirmed erenumab efficacy and safety in difficult to treat EM and CM patients [2, 3] with a 6-month follow-up; in Italy, this therapeutic option is not used yet in routine practice due to the lack of regulation in drug reimbursement by the national health system. We present a prospective interventional study conducted on consecutive patients diagnosed with EM and CM aimed to assess the efficacy and safety of erenumab (70 and 140 mg) in a real-life scenario. Our study included 30 patients consecutively treated with erenumab from April 2019 to May 2020, diagnosed according to the International Classification of Headache Disorders third version (ICHD-3) with EM with more than 6 days with migraine (at least 4 of severe intensity) per month and CM; both groups had a documented unresponsiveness to at least 2 preventative treatments prescribed at our Headache Centre. All the patients were treated with erenumab 70 mg monthly for 3 months; after that, patients with poor response switched to erenumab 140 mg monthly. Patients were allowed to start, continue, or discontinue oral migraine preventative treatment on clinical basis. Data on monthly headache days (MHD), monthly severe migraine days (MSMD), and monthly acute medication
* Angelo Ranieri [email protected] 1
Department of Neurology and Stroke Unit - AORN “A. Cardarelli”, Via A. Cardarelli 9, 80131 Naples, Italy
2
Headache Centre - Department of Neurology and Stroke Unit AORN “A. Cardarelli”, Via A. Cardarelli 9, 80131 Naples, Italy
days (MAMD) have been collected with structured diaries during a run-in period of 28 days before treatment (baseline) and during follow-up. Main outcomes included the changes from baseline in MHD, MSMD, and MAMD at 3rd month (30 patients), at 6th month (28 patients), and at 12th month (16 patient). Statistical analysis have been performed comparing median of MHD, MSMD, and MAMD with nonparametric tests (significant p value was set < 0.05 and calculated with SPSS Statistic ver 22). Secondary outcomes included descriptive data: the incidence of any side effect and of treatment discontinuation due to any reason; the percentage of responders (MHD reduction ≥ 50%) at 3rd, 6th, and 12th month with respect to all the patients at that
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