Evidence map›Paper›PMID 40628864›Full record

SynthesisScientific reports2025

Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment.

Junchen Chen, Shunqiu Huang, Yashi Chen, Cheng Luo, Yong Li

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Junchen ChenDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Shantou, 515041, Guangdong, China.
Shunqiu HuangDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Shantou, 515041, Guangdong, China.
Yashi ChenDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Shantou, 515041, Guangdong, China.
Cheng LuoDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Shantou, 515041, Guangdong, China.
Yong LiDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical College, No. 57 Changping Road, Shantou, 515041, Guangdong, China. yli8@stu.edu.cn.

Funding

Guangdong Provincial Medical Science and Technology Research Fund Project A2024353Shantou Medical Healthcare Science and Technology Program 220519126490399
6 · The paper itself

Abstract

Migraine significantly impacts quality of life, with eptinezumab emerging as a promising calcitonin gene-related peptide-targeting therapy. Real-world data and clinical trials are crucial for evaluating its safety and effectiveness comprehensively. This study evaluated its safety using a dual approach: pharmacovigilance analysis of the FDA's Adverse Event Reporting System (FAERS) database (2020-2024) and a systematic review with meta-analysis of clinical trials. FAERS data identified 5,306 adverse event (AE) reports, with "drug ineffective" (ROR = 6.71) and "migraine" (ROR = 67.45) as the strongest signals. Serious adverse events (SAEs) included anaphylactic reactions (ROR = 4.19) and rare events like increased intracranial pressure. Most AEs occurred within the first treatment month. A meta-analysis of six trials (n = 3,148) found no increased overall AE risk versus placebo (RR = 1.02, 95% CI 0.95-1.10) but a higher SAE incidence (RR = 2.87, 95% CI 1.27-6.48). Upper respiratory infections were more frequent (RR = 1.49, P = 0.04), while dizziness, nausea, and fatigue showed no significant differences. Eptinezumab shows promise but warrants further research on safety in vulnerable populations and real-world settings.

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersAdverse Drug Reaction Reporting SystemsFemaleHumansMalePharmacovigilanceQuality of LifeAntibodies, Monoclonal, HumanizedeptinezumabAdverse eventsCGRPEptinezumabFAERSMeta-analysisMigrainePharmacovigilanceReal-world evidence

Identifiers

PMID40628864
PMCPMC12238354

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.