Aimovig Safe and Effective in Patients with Episodic Migraine and Prior Treatment Failures According to OLE Study Results

Analysis of 3-year open-label extension (OLE) results assessing the long-term safety and efficacy of Aimovig (erenumab-aooe; Amgen, Dublin, Ireland/Novartis, East Hanover, NJ) in patients with episodic migraine (EM) demonstrated sustained improvement in the reduction of monthly migraine days (MMDs) and a safety profile that was consistent with previous studies. Results were published in the May 2024 issue of Neurology. Aimovig, an autoinjectable monoclonal antibody (mAB) that blocks the calcitonin gene-related peptide (CGRP) receptor, is approved by the Food and Drug Administration for the preventive treatment of migraine in adults.

The 12-week double-blind treatment phase (DBTP) of the LIBERTY trial (NCT03096834) included individuals aged 18-65 years with EM and 2-4 prior preventive treatment failures who were randomized to receive Aimovig 140 mg or placebo. Those who completed the DBTP were eligible to enter the OLE phase (OLEP), and participants received Aimovig 140 mg once monthly for 3 years. The primary outcomes included the proportion of participants achieving a ≥50% reduction in MMDs (ie, responders), mean MMD change from baseline, and the tolerability and safety of Aimovig.

• 52.3% (79/151) of participants with valid data points achieved a ≥50% reduction in MMDs at week 168.
• 29.9% (35/117) of participants in the continuous Aimovig group were responders at week 12 of the DBTP, and 74.3% (26/35) retained responder status in at least half of OLE visits.
• Of the 70.1% (82/117) of participants in the continuous Aimovig group who were not responders at week 12 of the DBTP, 20.7% (17/82) achieved responder status in at least half of OLE visits.
• Of the 85.8% (103/120) of participants in the placebo group who were not responders at week 12 of the DBTP, 40.8% (42/103) achieved responder status in at least half of OLE visits after switching to Aimovig.
• The mean (SD) MMD change from baseline showed sustained improvement over the 3-year OLEP (-4.4 [3.9] days at week 168).
• The safety and tolerability profile remained consistent with earlier studies, with the most common treatment-emergent adverse events ([AEs] per 100 person-years) being nasopharyngitis (28.8), influenza (7.5), and back pain (5.8). Additional reported treatment-emergent AEs (per 100 person-years) included hypertension (3.9) and constipation (2.7).