Pharmacokinetics and safety of erenumab in pediatric patients with migraine: A phase I, randomized, open‐label, multiple‐dose study

• DOI: 10.1111/cts.13755
• Publication Date: 2024-03-13T07:35:01Z
• Authors: Andrew D. Hershey; Gabriel Paiva da ...; Nicola Pannacciulli; Mia Mackowski; Reija Koukakis; Jennifer Williams...
• Keywords: Open label

Abstract Erenumab, a fully human monoclonal antibody targeting the calcitonin gene‐related peptide receptor, is efficacious and safe for prevention of attacks migraine in adults. This phase I, randomized, open‐label, multiple‐dose study evaluated safety, tolerability, pharmacokinetics (PK) erenumab children adolescents with migraine. The initial treatment lasted 12 weeks, followed by an optional 40‐week extension adolescents. Primary end points were PK erenumab, incidence treatment‐emergent adverse events (TEAEs), changes clinical laboratory assessments. Participants received 35 mg ( n = 4), 70 17), or 140 32) q4w. mean age was 14.1 years. Of 53 participants, 48 (90.6%) completed 36 (67.9%) during phase. Mean exposures to based on maximum observed concentration area under drug concentration–time curve dosing interval increased approximately dose‐proportionally. A total 42 participants (79.2%) reported TEAEs (307.2 per 100 participant‐years); four (7.5%) serious not considered treatment‐related. most common upper respiratory tract infection, headache, vomiting. No clinically significant vital signs, electrocardiograms, neurological Overall, profile consistent that adults when body weight differences are taken into consideration. safety