Evidence map›Paper›PMID 38123875›Full record

ArticleDermatology and therapy2024

Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis.

Leon Kircik, Matthew Zirwas, Shawn G Kwatra, G Michael Lewitt, Holly Glover, Tomas Chao, Philip M Brown, David S Rubenstein, Anna M Tallman

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT03956355 phase3completednot on this map

A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults

TypeinterventionalSponsorOrganon and CoRan2019 to 2020Enrolled510ConditionsPlaque PsoriasisArmsTapinarof, Vehicle Cream
NCT03983980 phase3completednot on this map

A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults

TypeinterventionalSponsorOrganon and CoRan2019 to 2020Enrolled515ConditionsPlaque PsoriasisArmsTapinarof, Vehicle Cream
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Novel Topical Treatments for Itch.Dermatology and therapy · 2024
    Review
  3. Article
  4. Review
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 4 institutions in 1 country.

Leon KircikIcahn School of Medicine at Mount Sinai, 5 E. 98th St., 5th Fl., New York, NY, 10029, USA. wedoderm@yahoo.com.ORCID http://orcid.org/0000-0002-0831-2151
Matthew ZirwasDOCS Dermatology, 2359 E Main St, Bexley, OH, 43209, USA.ORCID http://orcid.org/0000-0002-8380-8114
Shawn G KwatraJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0003-3736-1515
G Michael LewittIllinois Dermatology Institute, Chicago, IL, USA.
Holly GloverMetroplex Dermatology, Arlington, TX, USA.
Tomas ChaoAtlanta North Dermatology, Woodstock, GA, USA.
Philip M BrownDermavant Sciences, Inc., 3300 Paramount Parkway, Suite 150, Morrisville, NC, 27560, USA.
David S RubensteinDermavant Sciences, Inc., 3300 Paramount Parkway, Suite 150, Morrisville, NC, 27560, USA.ORCID http://orcid.org/0000-0003-0302-8722
Anna M TallmanDermavant Sciences, Inc., 3300 Paramount Parkway, Suite 150, Morrisville, NC, 27560, USA.ORCID http://orcid.org/0000-0001-9535-0414
Roivant Sciences (United States) · USIcahn School of Medicine at Mount Sinai · USJohns Hopkins University · USMetroplex Clinical Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with psoriasis report pruritus as their most bothersome symptom. Tapinarof cream 1% once daily demonstrated significant efficacy versus vehicle and was well tolerated in adults with mild to severe plaque psoriasis in two 12-week trials: PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980). Here, we present patient-reported pruritus outcomes from these trials.

methodsOutcomes included a Peak Pruritus Numerical Rating Scale (PP-NRS) score of 0 or 1 (itch-free state); Dermatology Life Quality Index (DLQI) itch item scores; and Psoriasis Symptom Diary (PSD) itch item scores.

resultsAnalyses included 683 tapinarof- and 342 vehicle-treated patients. At baseline, mean pruritus scores were similar across trials with only 7-11% of patients reporting an itch-free state. At week 12, the proportion of tapinarof-treated patients achieving an itch-free state was 50% in both trials compared with 32% (P = 0.0007) and 27% (P < 0.0001) in the vehicle groups. Improvements were apparent at the earliest assessments with continued improvement over the course of the trials. There were rapid and statistically significant improvements in the proportion of patients with a ≥ 4-point improvement in PP-NRS for tapinarof-treated patients versus vehicle from week 2 with 68% vs 46% (P = 0.0004) and 60% vs 31% (P = 0.0001) at week 12 achieving a response in each trial. Significantly greater reductions in itch with tapinarof versus vehicle were also demonstrated at week 12 for DLQI itch item 1 (P = 0.0026 and P < 0.0001), PSD item 1 (both P < 0.0001), and PSD item 2 (both P < 0.0001).

conclusionTapinarof was highly efficacious in reducing pruritus across multiple patient-reported outcome measures, with rapid, statistically significant, and clinically meaningful improvements. The high proportion of patients achieving the treatment target of an itch-free state at week 12 (50%) is a noteworthy clinical outcome for a non-steroidal topical cream in the treatment of mild to severe plaque psoriasis.

trial registrationClinical trial registration information: NCT03956355, NCT03983980.

Indexed as

Aryl hydrocarbon receptor agonistItchPhase 3 PSOARING trialsPlaque psoriasisPruritusTapinarof cream 1% QDTopical therapy

Identifiers

PMID38123875
PMCPMC10828461
OpenAlexW4390024315

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.