Long-term (>48 weeks) safety and tolerability of erenumab in real-life

Aurilia, C.; Egeo, G.; Fofi, L.; Cevoli, S.; Messina, R.; Salerno, A.; Torelli, P.; Albanese, M.; Carnevale, A.; Bono, F.; D'Amico, D.; Filippi, M.; Altamura, C.; Vernieri, F.; Colombo, B.; Frediani, F.; Mercuri, B.; D'Onofrio, F.; Grazzi, L.; Aguggia, M.; Favoni, V.; Finocchi, C.; Fiore, P. D.; Costa, C. M.; Brunelli, N.; Fallacara, A.; Bertuzzo, D.; Zucco, M.; Di Clemente, L.; Trimboli, M.; Pascarella, A.; Manzo, L.; Barbanti, P.

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.