Evidence map›Paper›PMID 37490268›Full record

ArticleDermatology and therapy2023

Calcipotriene and Betamethasone Dipropionate PAD-Cream Demonstrates Greater Treatment Efficacy in Patients with Moderate-to-Severe Psoriasis Compared to Topical Suspension/Gel: A Subgroup Analysis of Two Phase 3 Studies.

Linda Stein Gold, Andreas Pinter, April Armstrong, Matthias Augustin, Petr Arenberger, Neil Bhatia, Morten Praestegaard, Lars Iversen, Adam Reich

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

Article in Dermatology and therapy, 2023. 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 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-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.

NCT03308799 phase3completednot on this map

A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris

TypeinterventionalSponsorMC2 TherapeuticsRan2017 to 2018Enrolled794ConditionsPsoriasis VulgarisArmsMC2-01 cream, Cal/BDP combination, Cream vehicle
NCT03802344 phase3completednot on this map

A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris

TypeinterventionalSponsorMC2 TherapeuticsRan2018 to 2019Enrolled498ConditionsPsoriasis VulgarisArmsMC2-01 cream, Cal/BDP combination, Vehicle
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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 8 institutions in 5 countries.

Linda Stein GoldDermatology Clinical Research, Henry Ford Health System, Detroit, MI, USA.
Andreas PinterDepartment of Dermatology, University Hospital Frankfurt am Main, Frankfurt am Main, Germany.
April ArmstrongUniversity of Southern California, Los Angeles, CA, USA.
Matthias AugustinUniversity Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Petr ArenbergerDepartment of Dermatology, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Neil BhatiaTherapeutics Clinical Research, San Diego, CA, USA.
Morten PraestegaardMC2 Therapeutics, Hørsholm, Denmark.
Lars IversenMC2 Therapeutics, Hørsholm, Denmark.
Adam ReichDepartment of Dermatology, University of Rzeszow, Aleja Tadeusza Rejtana 16C, Rzeszow, Poland. adamandrzejreich@gmail.com.ORCID http://orcid.org/0000-0002-5573-1754
MC2 Therapeutics (Denmark) · DKCharles University · CZGoethe University Frankfurt · DEHenry Ford Health System · USTherapeutics Clinical Research · USUniversität Hamburg · DEUniversity of Rzeszów · PLUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPsoriasis ranges from mild to severe with the majority of patients having mild disease. Mild to moderate disease is often treated with topical therapies while photo-, oral, and biologic therapies are generally reserved for moderate-to-severe disease. There is a strong scientific rationale for the combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) with respect to mode of action, efficacy, and safety and CAL/BDP has shown an inhibitory effect on key pathogenic cytokines in psoriasis including tumor necrosis factor-α, interleukin (IL)-17, and IL-23.

methodsThe objective of this pooled post hoc analysis is to investigate the efficacy of CAL/BDP polyaphron dispersion (PAD)-cream in subgroups of patients with moderate-to-severe psoriasis from two completed phase 3 studies conducted in the USA and Europe.

resultsThe proportion of patients achieving Physician Global Assessment (PGA) treatment success as well as a modified Psoriasis Area and Severity Index (mPASI)75 response was higher in the subgroup with a body surface area > 10% and mPASI > 10 and Dermatology Life Quality Index > 10 at baseline compared to the overall patient population. Furthermore, the numerical difference in treatment efficacy between CAL/BDP PAD-cream and CAL/BDP topical suspension/gel increased in patient subgroups with higher baseline severity. Similar patterns were shown for the patient-reported outcomes.

conclusionIn this subgroup analysis, patients who had higher disease severity at baseline achieved greater efficacy than the total patient population when treated with 8 weeks of CAL/BDP PAD-cream as compared to a currently marketed active comparator. Additionally, as indicated by this analysis, CAL/BDP PAD-cream treatment may also be more convenient and less greasy, which may reduce the burden of daily treatment and improve adherence to therapy.

trial registrationNCT03308799 and NCT03802344.

Indexed as

Betamethasone dipropionateCalcipotrieneCreamGelPAD Technology™PsoriasisSuspensionTopical

Identifiers

PMID37490268
PMCPMC10442307
OpenAlexW4385230567

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.