Evidence map›Paper›PMID 32155317›Full record

ArticlePharmacology research & perspectives2020

Population pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migraine.

Brian Baker, Barbara Schaeffler, Martin Beliveau, Igor Rubets, Susan Pederson, MyMy Trinh, Jeff Smith, John Latham

Abstract read
In one paragraph

Article in Pharmacology research & perspectives, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 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

43 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

8 authors.

Brian BakerLundbeck Seattle BioPharmaceuticals, Bothell, WA, USA.
Barbara SchaefflerLundbeck Seattle BioPharmaceuticals, Bothell, WA, USA.
Martin BeliveauCertara Strategic Consulting, Montreal, Canada.
Igor RubetsCertara Strategic Consulting, Montreal, Canada.
Susan PedersonLundbeck Seattle BioPharmaceuticals, Bothell, WA, USA.
MyMy TrinhCertara Strategic Consulting, Montreal, Canada.
Jeff SmithLundbeck Seattle BioPharmaceuticals, Bothell, WA, USA.
John LathamLundbeck Seattle BioPharmaceuticals, Bothell, WA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Eptinezumab is a humanized mAb that targets calcitonin gene-related peptide and is under regulatory review for the prevention of episodic and chronic migraine (EM, CM). It is important to determine whether exposures achieved with intravenous (IV) administration of eptinezumab achieve desired pharmacologic effects. Population pharmacokinetics, including dose- and exposure-response analyses, were performed using patient-level data from the eptinezumab clinical trial program with IV doses ranging from 10 to 1000 mg in pharmacokinetic analyses or 10 to 300 mg in phase 2/3 clinical studies in patients with EM or CM. Exposure-response analysis explored the relationship between eptinezumab exposure metrics and efficacy parameters including monthly migraine days. The pharmacokinetic profile of eptinezumab was characterized by rapid attainment of maximum plasma concentration (ie, end of IV administration) and a terminal half-life of 27 days. Covariate analysis found that patient characteristics had no clinically significant effects on pharmacokinetic parameters and were insufficient to influence dosing. Dose- and exposure-response analyses found exposure with single doses ≥100 mg was associated with greater efficacy compared with doses ≤30 mg and a plateau of effect between 100 and 300 mg. A saturable inhibitory E

Indexed as

Models, BiologicalAdolescentAdultAgedAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideChronic DiseaseDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedMigraine DisordersYoung AdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptideeptinezumabcalcitonin gene-related peptideCGRPdrug dose-response relationshipeptinezumabintravenous administrationmigraine disordersmonoclonal antibodypharmacokinetics

Identifiers

PMID32155317
PMCPMC7064329

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.