Erenumab in the prevention of high‐frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real‐life study

• DOI: 10.1111/head.14032
• Publication Date: 2020-12-18T19:15:33Z
• Authors: Piero Barbanti; Cinzia Aurilia; Gabriella Egeo; Luisa Fofi; Sabina Cevoli; Bruno Colombo; Massimo Filippi; Fabio Frediani; Francesco Bono; Licia Grazzi; Antonio Salerno; Bruno Mercuri; Antonio Carnevale; Claudia Altamura; Fabrizio Vernieri
• Keywords: Tolerability; Chronic Migraine; Clinical endpoint

To assess the effectiveness, safety, and tolerability of erenumab in a real-life migraine population, while trying to identify responsiveness predictors.Erenumab is fully human Ig-2 monoclonal antibody blocking calcitonin gene-related peptide receptor, indicated for prophylaxis. Phase II III trials demonstrated that effective, safe, well tolerated prevention episodic chronic (CM), showing an early onset action.This multicenter, prospective, cohort, study. We considered enrolment all consecutive patients aged 18-65 affected by high-frequency (HFEM) or CM, with without medication overuse, visited at nine Italian Headache Centers from December 20, 2018 September 30, 2019. Each patient was treated 70 mg, administered subcutaneously every 4 weeks. Treatment duration planned last 6 12 months, depending on patient's response. The primary endpoint change monthly days (MMDs) weeks 9-12 compared baseline. Secondary endpoints included changes analgesics intake, ≥50%, ≥75%, 100% responder rates any variation Visual Analog Scale (VAS) Impact Test scores (HIT).In total, 372 were least one dose mg. At 9-12, decreased MMDs 4.5 ± 4.1 (mean SD) HFEM 9.3 9.1 those CM VAS score reduced 1.9 SD), HIT 10.7 8.8 median intake passed 12.0 (interquartile range [IQR] 10.0-14.0) 5.0 (IQR 3.0-7.0) HFEM. In patients, 1.7 2.0 9.7 10.4 20.0 15.0-30.0) 8.0 5.0-15.0). week 12, ≥50% responders 60/101 (59.4%) 146/263 (55.5%) ≥75% 17/101 (16.8%) 59/263 (22.4%) 1/101 (1.0%) 3/263 (1.1%), respectively. Erenumab positively associated unilateral pain localization (OR: 3.03, 95% CI: 1.24-7.40; p = 0.015), whereas baseline frequency 1.06, CI:1.02-1.11; 0.031), dopaminergic symptoms 2.01, 1.14-3.52; negatively psychiatric comorbidities 0.43, 0.20-0.93; 0.003).Erenumab mg real life. Easily obtainable clinical features might be help predicting responsiveness.