Evidence map›Paper›PMID 31355921›Full record

Trial reportClinical pharmacology and therapeutics2020

Exposure-Response Relationships for Efficacy and Safety of Risankizumab in Phase II and III Trials in Psoriasis Patients.

Amit Khatri, Ahmed A Suleiman, Akshanth R Polepally, Ahmed A Othman

Abstract readClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–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

11 citing papers in PubMed.

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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

4 authors.

Amit KhatriClinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.
Ahmed A SuleimanClinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.
Akshanth R PolepallyClinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.ORCID 0000-0002-5938-6062
Ahmed A OthmanClinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.ORCID 0000-0002-4937-2775

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Risankizumab has demonstrated efficacy in phase III trials in patients with moderate-to-severe plaque psoriasis. The exposure-response relationships for risankizumab efficacy (Psoriasis Area and Severity Index (PASI)75, PASI90, PASI100, and static Physician's Global Assessment (sPGA)0/1) at week 16 (N = 1,732) and week 52 (N = 598) as well as safety (incidence of any adverse event, serious adverse event, infection and infestation, or serious infection) over up to 52 weeks were characterized using the data from risankizumab phase II and III clinical trials in patients with moderate-to-severe plaque psoriasis. Impact of clinically relevant covariates was evaluated. Risankizumab phase III regimen (150 mg subcutaneously at weeks 0, 4, and every 12 weeks thereafter) achieved the plateau of the exposure-efficacy relationships with model-estimated PASI90 and sPGA0/1 response probabilities of 77%, and 87%, respectively, at week 16 and 85%, and 88%, respectively, at week 52. There was no apparent relationship between risankizumab plasma exposure and the evaluated safety variables.

Indexed as

AdultAntibodies, MonoclonalDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedPsoriasisSeverity of Illness IndexAntibodies, Monoclonalrisankizumab

Identifiers

PMID31355921
PMCPMC7006881

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.