Evidence map›Paper›PMID 31237727›Full record

Trial reportThe Journal of dermatology2019

Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial.

Mamitaro Ohtsuki, Hideki Fujita, Mitsunori Watanabe, Keiko Suzaki, Mary Flack, Xin Huang, Susumu Kitamura, Joaquin Valdes, Atsuyuki Igarashi

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03000075 (A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066), which is not on this map. Cited by 49 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 10 pooled it
4.5field-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.

NCT03000075 phase2completednot on this map

A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients With Moderate to Severe Chronic Plaque Type Psoriasis.

TypeinterventionalSponsorAbbVieRan2016 to 2018Enrolled182ConditionsPsoriasisArmsrisankizumab, placebo for risankizumab
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 10 syntheses or guidelines pooled it, 92 citations in OpenAlex.

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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 7 institutions in 2 countries.

Mamitaro OhtsukiJichi Medical University, Shimotsuke, Japan.
Hideki FujitaNihon University, Tokyo, Japan.
Mitsunori WatanabeNippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan.
Keiko SuzakiNippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan.
Mary FlackBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
Xin HuangAbbVie Inc., North Chicago, Illinois, USA.
Susumu KitamuraAbbVie G.K., Tokyo, Japan.ORCID https://orcid.org/0000-0002-6823-532X
Joaquin ValdesAbbVie Inc., North Chicago, Illinois, USA.
Atsuyuki IgarashiNTT Medical Center Tokyo, Tokyo, Japan.
AbbVie (United States) · USBoehringer Ingelheim (Japan) · JPABB (Japan) · JPBoehringer Ingelheim (United States) · USJichi Medical University · JPNihon University · JPNTT Medical Center · JP

Funding

AbbVieBoehringer Ingelheim
6 · The paper itself

Abstract

Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, selectively inhibits interleukin-23, a key cytokine in the pathogenesis of psoriasis, by binding to its p19 subunit. In SustaIMM (ClinicalTrials.gov/NCT03000075), a phase 2/3, double-blinded, placebo-controlled study, Japanese patients with moderate to severe plaque psoriasis (n = 171) were stratified by bodyweight and concomitant psoriatic arthritis and randomized 2:2:1:1 to 75 mg risankizumab, 150 mg risankizumab, placebo with cross-over to 75 mg risankizumab and placebo with cross-over to 150 mg risankizumab. Dosing was at weeks 0, 4, 16, 28 and 40, with placebo cross-over to risankizumab at week 16. The primary end-point was 90% or more improvement from baseline in Psoriasis Area and Severity Index (PASI-90) at week 16 for risankizumab versus placebo. Missing data were imputed as non-response. All primary and psoriasis-related secondary end-points were met for both risankizumab doses (P < 0.001). At week 16, PASI-90 responses were significantly higher in patients receiving 75 mg (76%) or 150 mg (75%) risankizumab versus placebo (2%). Corresponding response rates were 86%, 93% and 10% for static Physician Global Assessment (sPGA) score of clear/almost clear; 90%, 95% and 9% for PASI-75; and 22%, 33% and 0% for PASI-100, with significantly higher responses for both risankizumab doses versus placebo. Through week 52, PASI and sPGA responses increased or were maintained and treatment-emergent adverse events were comparable across treatment groups. Both doses of risankizumab were superior to placebo in treating patients with moderate to severe plaque psoriasis. The safety profile was consistent with previous risankizumab trials, with no new or unexpected safety findings.

Indexed as

AdultAgedAntibodies, MonoclonalCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansInterleukin-23 Subunit p19JapanMaleMiddle AgedPlacebosPsoriasisSeverity of Illness IndexAntibodies, MonoclonalIL23A protein, humanInterleukin-23 Subunit p19Placebosrisankizumabinterleukin-23Japanese patientplaque psoriasispsoriasisrisankizumab

Identifiers

PMID31237727
PMCPMC6771602
OpenAlexW2955490990

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.