Erenumab efficacy in highly resistant chronic migraine: a real-life study

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Erenumab efficacy in highly resistant chronic migraine: a real-life study Umberto Pensato 1 & Valentina Favoni 2 & Alessia Pascazio 1 & Matteo Benini 1 & Gian Maria Asioli 1 & Elena Merli 1 & Calogero Calabrò 1 & Pietro Cortelli 1,2 & Giulia Pierangeli 1,2 & Sabina Cevoli 2

# Fondazione Società Italiana di Neurologia 2020

Chronic migraine (CM) with medication overuse (MOH) is a disabling condition affecting millions of people worldwide, thus requiring both acute and prophylactic effective treatments. Nonetheless, a substantial subgroup of CM patients is resistant to potentially successful and optimal treatment options. Calcitonin gene-related peptide (CGRP) antagonists have proven their efficacy and safety in CM, but they have not yet been prospectively tested in resistant CM with MOH. Hereby, we present preliminary results of an ongoing prospective study evaluating monoclonal antibody anti-CGRP receptor erenumab efficacy and safety in a subgroup of CM with MOH patients who failed at least 10 migraine preventive treatments, including onabotulinumtoxinA (BoNTA). In our Tertiary Headache Centre in Bologna, Italy, we selected consecutive patients with a ICHD-3 diagnosis of CM with MOH who received erenumab monthly between May 2019 and May 2020. We included in the analysis only patients who had failed at least 10 pharmacological and non-pharmacological commonly used preventive treatments for CM. Furthermore, all included patients failed to respond to BoNTA, the only approved preventive treatment for CM. This was a prospective, mono-centric, real-life, cohort study. Patients were treated with a monthly subcutaneous injection of 70 mg of erenumab for the first 2 months, and then, we

* Sabina Cevoli [email protected] 1

Department of Biomedical and NeuroMotor Sciences (DiBiNeM), Alma Mater Studiorum - University of Bologna Italy, Bologna, Italy

2

IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, 40139 Bologna, Italy

evaluated whether to continue with erenumab 70 mg or with erenumab 140-mg subcutaneous injection for the third month, according to the reduction in monthly migraine days (MMDs). We evaluated changes in MMDs, monthly pain medication intake (MPMI), disability measured with Headache Impact Test-6 (HIT-6), pain measured with numeric rating scale (NRS), and > 50%, > 75% reduction in MMDs at week 12 compared with baseline. At last, we evaluated the safety of the treatment. The study was approved by the local ethics committee of the health service of Bologna (n. CE 20073). The statistical analysis was performed with IBM SPSS Statistics Version 26. Normal distribution of data was assessed with the Kolmogorov-Smirnov normality test. The non-parametric numerical variable is reported as the median and interquartile range (IQR) and compared with the Wilcoxon signed-rank test, whereas the parametric variable was reported as mean and standard deviation (SD) and compared with paired t test. The categorical variable was reported as a percentage and compared with Fisher’s exact test.