Evidence map›Paper›PMID 33413094›Full record

ReviewThe journal of headache and pain2021

Immunogenicity of biologic therapies for migraine: a review of current evidence.

Joshua M Cohen, Xiaoping Ning, Yoel Kessler, Michele Rasamoelisolo, Verena Ramirez Campos, Michael J Seminerio, Lynda J Krasenbaum, Honglue Shen, Jennifer Stratton

Open access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
5.8field-weighted citation impact, top 3% of its field
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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
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  12. The sense of stopping migraine prophylaxis.The journal of headache and pain · 2023
    Review
  13. Pharmacologic prevention of migraine.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2023
    Review
  14. Efficacy and safety of eptinezumab for migraine: A systematic review and meta-analysis.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2023
    Review
  15. Article
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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

9 authors at 1 institution in 1 country.

Joshua M CohenTeva Pharmaceuticals, West Chester, PA, USA. Joshua.Cohen05@tevapharm.com.
Xiaoping NingTeva Pharmaceuticals, West Chester, PA, USA.
Yoel KesslerTeva Pharmaceuticals, West Chester, PA, USA.
Michele RasamoelisoloTeva Pharmaceuticals, West Chester, PA, USA.
Verena Ramirez CamposTeva Pharmaceuticals, West Chester, PA, USA.
Michael J SeminerioTeva Pharmaceuticals, West Chester, PA, USA.
Lynda J KrasenbaumTeva Pharmaceuticals, West Chester, PA, USA.
Honglue ShenTeva Pharmaceuticals, West Chester, PA, USA.
Jennifer StrattonTeva Pharmaceuticals, West Chester, PA, USA.
Teva Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMonoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have been shown to be effective in migraine prevention. Eptinezumab, erenumab, fremanezumab, and galcanezumb have shown efficacy in clinical trials along with favorable safety and tolerability profiles. Although erenumab is a human mAb and the others have been humanized to varying degrees, they all have the capacity to provoke immune reactions. The present review article aims to discuss the current relationship between mAbs targeting the CGRP pathway (CGRP mAbs) and immunogenicity and their potential clinical implications.

findingsThe incidence of patients developing anti-drug antibodies (ADAs), their titer, and clinical significance are highly variable and depend on a variety of different drug and patient factors. Neutralizing ADAs (NAbs) bind to and inhibit or reduce the pharmacologic activity of the biologic drug molecule, whereas non-neutralizing antibodies (Non-NAbs) bind to the biologic drug molecule without affecting pharmacologic activity in an in vitro test, although pharmacokinetics and drug clearance may be affected. A direct comparison of immunogenicity data across clinical trials with different biologics is not possible due to a lack of standardized assays. Several phase 2, phase 3, and long-term studies evaluating CGRP mAbs for migraine prevention have reported immunogenicity data (5 studies each for eptinezumab, erenumab, fremanezumab, and galcanezumab). Across these studies, prevalence of ADAs varied, ranging from < 1% to ~ 18%. Neutralizing ADAs were slightly less common, with a prevalence ranging from 0 to 12%. Adverse events related to ADA formation were rare.

conclusionsAs more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications.

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersBiological TherapyCalcitonin Gene-Related PeptideHumansCalcitonin Gene-Related PeptideCalcitonin Gene-Related Peptide Receptor AntagonistsAnti-drug antibodiesCGRP pathway–targeted monoclonal antibodiesImmunogenicityMigraine preventionProphylaxis

Identifiers

PMID33413094
PMCPMC7791637
OpenAlexW3120300922

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.