Evidence map›Paper›PMID 32407591›Full record

ArticleClinical and translational science2020

Evaluating Potential Disease-Mediated Protein-Drug Interactions in Patients With Moderate-to-Severe Plaque Psoriasis Receiving Subcutaneous Guselkumab.

Yaowei Zhu, Yan Xu, Yanli Zhuang, Alexa Piantone, Cathye Shu, Dion Chen, Honghui Zhou, Zhenhua Xu, Amarnath Sharma

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02397382 (A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Guselkumab), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 31% 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.

NCT02397382 phase1completednot on this map

A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Guselkumab (CNTO 1959) on Cytochrome P450 Enzyme Activities Following a Single Subcutaneous Administration in Subjects With Moderate to Severe Plaque-type Psoriasis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2015 to 2016Enrolled16ConditionsPsoriasisArmsGuselkumab, Midazolam, Warfarin, Omeprazole, Dextromethorphan
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Pharmaco-Omics in Psoriasis: Paving the Way towards Personalized Medicine.International journal of molecular sciences · 2023
    Review
  7. 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

9 authors at 1 institution in 1 country.

Yaowei ZhuJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Yan XuJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Yanli ZhuangJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Alexa PiantoneJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Cathye ShuJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Dion ChenJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Honghui ZhouJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Zhenhua XuJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Amarnath SharmaJanssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Janssen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This open-label, multicenter, phase I therapeutic protein-drug interaction study was designed to evaluate the potential effect of guselkumab, a fully human anti-interleukin-23 immunoglobulin G1 lambda monoclonal antibody, on the pharmacokinetics of a cocktail of representative cytochrome P450 (CYP) probe substrates (midazolam (CYP3A4), S-warfarin (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), and caffeine (CYP1A2)). Fourteen participants with psoriasis received a single subcutaneous dose of guselkumab 200 mg on day 8 and an oral probe cocktail on days 1, 15, and 36. Blood samples were collected for measuring plasma concentrations of these probe substrates on days 1, 15, and 36. No consistent trends in observed maximum plasma concentration and area under the curve from time 0 to infinity values of each probe CYP-substrate before (day 1) and after guselkumab treatment (days 15 and 36) could be identified in each individual patient, suggesting that the use of guselkumab in patients with psoriasis is unlikely to influence the systemic exposure of drugs metabolized by CYP isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2). The probe cocktail was generally well-tolerated when administered in combination with guselkumab in patients with psoriasis. Clinicaltrials.gov Identifiers: NCT02397382.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedArea Under CurveCaffeineCytochrome P-450 Enzyme InducersCytochrome P-450 Enzyme InhibitorsCytochrome P-450 Enzyme SystemDrug InteractionsFemaleHumansMaleMetabolic Clearance RateMidazolamMiddle AgedAntibodies, Monoclonal, HumanizedCaffeineCytochrome P-450 Enzyme InducersCytochrome P-450 Enzyme InhibitorsCytochrome P-450 Enzyme SystemguselkumabMidazolamOmeprazoleWarfarin

Identifiers

PMID32407591
PMCPMC7719363
OpenAlexW3025871334

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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.