Efficacy and Safety of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Children and Adolescents: Outcomes from Two Randomized, Double-blind, Placebo-controlled, Phase 3 Studies
Andrew Hershey1, Christina Szperka2, Piero Barbanti3, Patricia Pozo-Rosich4, Thomas Li5, Suzy-Erin Collins6, Juline Bryson7, Yoel Kessler5, Yael Carmeli Schwartz5, Verena Ramirez Campos7, Xiaoping Ning7
1Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA, 2Children’s Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA, 3Headache and Pain Unit, IRCCS San Raffaele and San Raffaele University, Rome, Italy, 4Headache Unit and Research Group, Vall d’Hebron Hospital and Research Institute, Universitat Autonoma de Barcelona, Barcelona, Spain, 5Teva Pharmaceutical Industries Ltd, Tel Aviv, Israel, 6Veramed Limited, Twickenham, UK, 7Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA
Objective:
To evaluate the efficacy and safety of fremanezumab in children and adolescents with episodic (EM; NCT04458857) or chronic migraine (CM; NCT04464707).
Background:
Migraine is common in children and adolescents, causing school absences, impaired educational performance, and missed social activities. Fremanezumab, a calcitonin gene-related peptide pathway monoclonal antibody, has demonstrated efficacy and safety in multiple randomized controlled trials in adults with EM and CM. However, efficacy and safety data for fremanezumab in children and adolescents are limited.
Design/Methods:
In two multicenter, Phase 3 trials, eligible participants (aged 6–17 years; migraine diagnosis for ≥6 months; history of ≤14 [EM] or ≥15 headache days/month [CM]), were randomized 1:1 to monthly fremanezumab (<45kg, 120 mg; ≥45kg, 225 mg) or placebo for 3 months. Primary endpoint: least squares mean change from baseline in average monthly migraine days (MMD) during the 3-month double-blind period. Secondary endpoints included mean change from baseline in monthly headache days of at least moderate severity (MHD), ≥50% MMD response rates, and safety.
Results:
In total, 234 and 289 participants from the EM and CM studies, respectively, were included in the efficacy analyses. Fremanezumab significantly reduced MMD versus placebo (–2.5 vs –1.4; p=0.0210) in the EM study; no significant difference was observed between treatment groups in the CM study (–3.8 vs –3.7; p=0.8484). In the EM study, MHD reduction was significantly greater with fremanezumab versus placebo (–2.6 vs –1.5; p=0.0172), as was the ≥50% MMD response rate (47.2% vs 27.0%; p=0.0016). Adverse event frequency was similar for fremanezumab and placebo; serious AEs and AEs leading to discontinuation were infrequent.
Conclusions:
Treatment with fremanezumab led to statistically significant reductions in MMD and MHD in children and adolescents with EM, but not in children and adolescents with CM. Safety findings were consistent with those observed in pivotal adult trials.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.