Erenumab efficacy in chronic migraine and medication overuse: a real-life multicentric Italian observational study
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Erenumab efficacy in chronic migraine and medication overuse: a real-life multicentric Italian observational study Francesca Schiano di Cola 1 & Renata Rao 1 & Salvatore Caratozzolo 1 & Marco Di Cesare 1 & Elisabetta Venturelli 2 & Ubaldo Balducci 3 & Vincenzo Sidoti 3 & Elisa Pari 4 & Chiara Costanzi 4 & Alfonsina di Summa 5 & Gabriele Johanna Sixt 5 & Elisabetta D’Adda 6 & Paolo Liberini 1 & Alessandro Padovani 1
# Fondazione Società Italiana di Neurologia 2020
Erenumab is a monoclonal antibody targeting the calcitonin gene–related peptide receptor. Randomized, placebocontrolled trials demonstrated that erenumab is effective in migraine prevention, both episodic and chronic [1, 2]. Moreover, erenumab has a demonstrated clinically relevant efficacy in chronic migraine (CM) patients with associated medication overuse (MO), which is a renowned hard-to-treat group of patients. According to the current classification of the International Headache Society (ICHD-3) [3], medication overuse headache is defined as a headache occurring for at least 15 days per month in a patient with a pre-existing primary headache that develops because of regular overuse of symptomatic headache medication (use for ≥ 10 or 15 days per month depending on the medication) for more than 3 months. The term medication overuse is used to describe the frequent intake of headache medication in a person with a primary headache disorder without causing an increase in headache frequency. At present, real-life clinical evidence regarding erenumab efficacy is still missing. The aim of the present
* Francesca Schiano di Cola [email protected] 1
Neurology Unit, University and Spedali Civili Clinical and Experimental Sciences Department, Piazzale Spedali Civili 1, 25123 Brescia, Italy
2
Neurology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy
3
Neurology Unit, P.O. Chiari, ASST Franciacorta, Franciacorta, Italy
4
Neurology Unit, Ospedale di Cremona, ASST Cremona, Cremona, Italy
5
Neurology Unit, Ospedale Centrale di Bolzano, Azienda Sanitaria dell’Alto Adige, Bolzano, Italy
6
Neurology Unit, Ospedale Maggiore di Crema, ASST Crema, Crema, Italy
study is to assess erenumab efficacy in patients with CM and MO. An observational multicenter study was performed in six Italian hospitals. Inclusion criteria were the following: age ≥ 18 years old; diagnosis of CM and MO according to the ICHD-3; previous treatment failures of at least 3 prophylaxes; no cardio- and/or cerebro-vascular disorders. Patients were treated with erenumab 70 mg every 4 weeks. If no clinical response was observed after 12 weeks, a dose increase to 140 mg was attempted. Data about outcome, adverse events, abortive medication consumption, and disability (Migraine Disability Assessment Score Questionnaire [MIDAS]; Headache Impact Test [HIT-6]) were collected on a monthly basis. The primary endpoint was to evaluate the reduction in the headache frequency at 4, 12, and 24 weeks of treatment. Secondary endpoints were the following: reduction in headache
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