Fremanezumab prevents pediatric episodic migraine better
Monthly fremanezumab reduced migraine and headache days in children and adolescents compared with placebo.
*Randomized placebo-controlled trial; Level 1b (OCEBM).
Citation
Hershey AD, Szperka CL, Barbanti P, et al. Fremanezumab in Children and Adolescents with Episodic Migraine. N Engl J Med. 2026;394:243-252. doi:10.1056/NEJMoa2504546.
Background
Preventive options for pediatric migraine are limited, and evidence for newer targeted medicines in children has been scarce. This trial tested whether fremanezumab can prevent episodic migraine in ages 6 to 17 years.
Patients
Children and adolescents (6–17 years) with episodic migraine (4 to 14 headache days per month).
Intervention
Monthly under-the-skin fremanezumab for 3 months (120 mg if <45 kg; 225 mg if ≥45 kg).
Control
Matched placebo injections monthly for 3 months.
Outcome
Change in migraine days per month; key secondary outcomes included moderate-or-worse headache days, 50% response, and acute medicine-use days.
Follow-up Period
3 months (double-blind treatment period).
Results
| Outcome (over 3 months) |
Fremanezumab |
Placebo |
Effect |
| Migraine days per month (primary) |
−2.5 days |
−1.4 days |
Difference −1.1 days (95% CI, −1.9 to −0.2) |
| Moderate-or-worse headache days per month |
−2.6 days |
−1.5 days |
Difference −1.1 days (95% CI, −2.1 to −0.2) |
| Acute headache medicine-use days per month |
−2.1 days |
−1.0 days |
Difference −1.1 days (95% CI, −1.8 to −0.4) |
| ≥50% reduction in migraine days |
47.2% |
27.0% |
Odds ratio 2.5 (95% CI, 1.4 to 4.4); NNT=5 |
Injection-site redness was the most common side effect (9.8% vs 5.4%).
Limitations
Only 3 months of blinded follow-up; longer-term safety unknown. Sponsor funded and performed statistical analyses. Some patient-centered scores did not improve versus placebo.
Funding
Teva Pharmaceuticals; sponsor provided drug and conducted statistical analyses.
Clinical Application
For pediatric episodic migraine needing prevention, consider monthly fremanezumab; benefits are modest but clinically meaningful, with mainly injection-site reactions and limited short-term safety data.
