Evidence map›Paper›PMID 30574672›Full record

Trial reportClinical pharmacokinetics2019

Lack of Effect of 12-Week Treatment with Risankizumab on the Pharmacokinetics of Cytochrome P450 Probe Substrates in Patients with Moderate to Severe Chronic Plaque Psoriasis.

Amit Khatri, Ling Cheng, Anne Camez, Stanislav Ignatenko, Yinuo Pang, Ahmed A Othman

Registry-linked trialOpen access · hybridAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02772601 (The Effect of Multiple Subcutaneous Doses of Risankizumab on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% 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.

NCT02772601 phase1completednot on this map

The Effect of Multiple Subcutaneous Doses of Risankizumab on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) Administered Orally in an Open-label, One-sequence Trial in Patients With Plaque Psoriasis With or Without Concomitant Psoriatic Arthritis

TypeinterventionalSponsorAbbVieRan2016 to 2017Enrolled21ConditionsPsoriasisArmsCaffeine, Warfarin, Omeprazole, Metoprolol, Midazolam
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
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  5. Risankizumab.Hospital pharmacy · 2023
    Review
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  10. 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

6 authors at 3 institutions in 2 countries.

Amit KhatriClinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Ling ChengData and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.
Anne CamezImmunology Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.
Stanislav IgnatenkoCharité Research Organisation GmbH, Berlin, Germany.
Yinuo PangClinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Ahmed A OthmanClinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. ahmed.othman@abbvie.com.
AbbVie (United States) · USAbbVie (Germany) · DECharité - Universitätsmedizin Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study was to characterize the effects of risankizumab on the in vivo activity of cytochrome P450 (CYP) 1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A in psoriasis patients using a cocktail approach.

methodsPatients with moderate to severe chronic plaque psoriasis (n = 21) received single oral doses of sensitive probe substrates for CYP1A2 (caffeine 100 mg), CYP2C9 (warfarin 10 mg), CYP2C19 (omeprazole 20 mg), CYP2D6 (metoprolol 50 mg), and CYP3A (midazolam 2 mg) on day 1, followed by 12 weeks of subcutaneous risankizumab treatment of 150 mg once every 4 weeks from day 8 to day 92, and again the same cocktail of substrates on day 98. Serial blood samples were collected for determination of the CYP probe drugs and metabolites with and without risankizumab. Trough samples were collected for risankizumab.

resultsThe 90% confidence intervals (CIs) for the area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC

conclusionsRisankizumab did not affect the in vivo activity of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A enzymes in patients with moderate or severe plaque psoriasis and therefore has no potential for drug interactions through these enzymes. CLINICAL

trial registrationClinicalTrials.gov Identifier: NCT02772601.

Indexed as

Antibodies, MonoclonalArea Under CurveCaffeineChronic DiseaseCytochrome P-450 Enzyme SystemDose-Response Relationship, DrugDrug InteractionsFemaleHumansInjections, SubcutaneousMaleMidazolamOmeprazolePsoriasisSeverity of Illness IndexSubstrate SpecificityAntibodies, MonoclonalCaffeineCytochrome P-450 Enzyme SystemMidazolamOmeprazolerisankizumabWarfarin

Identifiers

PMID30574672
OpenAlexW2905608605

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.