To report the efficacy and safety of erenumab 140 mg at completion of the LIBERTY study (NCT03096834).

Erenumab (erenumab-aooe in US) is a fully human monoclonal antibody targeting the canonical calcitonin gene-related peptide receptor for the prevention of migraine. The double-blind treatment phase (DBTP) of LIBERTY demonstrated efficacy of erenumab 140 mg in patients with episodic migraine (EM) failing 2−4 prior preventive treatments. Interim analyses demonstrated that efficacy was maintained throughout first and second years of the open-label extension phase (OLEP).

Of 240/246 (97.6%) patients entering OLEP (118 continuing erenumab, 122 switching from placebo), 169 (70.4%) completed the 3-year OLEP; all 36 (15.0%) completed PTA. Discontinuations were mainly due to lack of efficacy (12.5%, n=30), patient decision (10.8%, n=26), and adverse events (AEs; 4.6%; n=11, single case per AE). The ≥30%, ≥50%, ≥75%, and 100% responder rates at 3-year completion were 72.8%, 52.3%, 33.1%, and 13.2%, respectively. Mean (SD) change in MMD from baseline at 3-year completion was −4.4 (3.9). Mean (SD) change in HIT-6, MPFID-EA, and MPFID-PI scores from baseline at 3-year completion was –9.7 (8.9), –6.1 (8.2) and –5.1 (7.6), respectively. Common AEs (>10%) were nasopharyngitis, influenza, and back pain.

Efficacy was sustained over 3 years in patients with EM and 2–4 prior non successful migraine preventive therapies. Erenumab was well-tolerated, with no new safety signals reported after three years exposure.