Gabriella Egeo, Davide Bertuzzo, Adriana Fallacara, Maurizio Zucco, Roberta Messina, Antonio Carnevale, L. Di Clemente, Bruno Colombo, Claudia Altamura, Carmelina Maria Costa, Piero Barbanti, Massimo Filippi, Cinzia Finocchi, Angelo Pascarella, Fabrizio Vernieri, Sabina Cevoli, Maria Albanese, Nicoletta Brunelli, Paola Torelli, Bruno Mercuri, Francesco Bono, Marco Aguggia, Licia Grazzi, Luisa Fofi, Lucia Manzo, Michele Trimboli, Cinzia Aurilia, Paola Di Fiore, Valentina Favoni, Antonio Salerno, Fabio Frediani, Florindo d’Onofrio, and D. D’Amico
Background and aims: Erenumab proved to be safe and well tolerated in a 5-year continuation of a 1-year double-blind, placebo-controlled study. Aim: to assess >48-week erenumab tolerability and safety in a real-world setting. Methods: In this long term (>48-week), multicenter (n = 15), longitudinal cohort real life study, we monitored all the adverse events emerged in consecutive adult patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) treated with monthly erenumab 70 mg or 140 mg from 20 December 2018 to 15 December 2020. Results: 442 patients (HFEM: 115;CM: 327) were treated with erenumab for >48 weeks: 209 (47.3%) patients were treated for 49–60 weeks, 132 (29.9%) for 61–72 weeks;73 (16.5%) for 73–84 weeks;21 (4.7%) for 85–100 weeks. Overall, >1 treatment emergent adverse event (TEAE) was reported by 136 (30.8%) [HFEM: 43 (37.4%);CM: 93 (28.4%)]. Most common TEAE were constipation (n = 66;14.9%), injection site erythema (n = 15;3.4%), and influenza (n = 7;1.6%). Serious adverse events (SAE) were reported by 8 patients (1.8%) and led to treatment discontinuation: severe constipation (n = 3), abdominal pain (n = 1), NSTEMI (n = 3), Covid-19 infection (n = 1). Only severe constipation was considered treatment-related SAE (0.45%). Conclusions: Conclusion: Erenumab is safe and well tolerated also in long-term treatment (>48 weeks) in real life.