Evidence map›Paper›PMID 34543474›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2022

Quality of life and patient-perceived symptoms in patients with psoriasis undergoing proactive or reactive management with the fixed-dose combination Cal/BD foam: A post-hoc analysis of PSO-LONG.

A Jalili, P Calzavara-Pinton, L Kircik, D Lons-Danic, A Pink, S Tyring, P de la Cueva, M Gooderham, S Segaert, N Nyholm and 3 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.7field-weighted citation impact, top 34% 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.

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

8 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Topical proactive therapy in dermatology. A scoping review.Postepy dermatologii i alergologii · 2023
    Article
  7. Article
  8. Article
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

13 authors at 10 institutions in 9 countries.

A JaliliDermatology & Skin Care Clinic, Buochs, Switzerland.ORCID https://orcid.org/0000-0002-8349-4530
P Calzavara-PintonDepartment of Dermatology, University of Brescia, Brescia, Italy.ORCID https://orcid.org/0000-0002-0935-7204
L KircikIndiana University School of Medicine, Indianapolis, IN, USA.
D Lons-DanicDepartment of Dermatology, Fondation Hôpital Saint Joseph, Paris, France.
A PinkSt John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.ORCID https://orcid.org/0000-0001-5151-5539
S TyringDepartment of Dermatology, University of Texas Health Science Center at Houston, Houston, TX, USA.
P de la CuevaDepartment of Dermatology, University Hospital Infanta Leonor de Madrid, Madrid, Spain.ORCID https://orcid.org/0000-0003-4807-3551
M GooderhamDivision of Dermatology, Department of Medicine, School of Medicine, Queen's University, Kingston, Ontario, Canada.ORCID https://orcid.org/0000-0001-8926-0113
S SegaertConsultant Dermatologist, Bonheiden, Belgium.ORCID https://orcid.org/0000-0003-0708-7279
N NyholmLEO Pharma A/S, Ballerup, Denmark.
H ThoningLEO Pharma A/S, Ballerup, Denmark.
B PetersenLEO Pharma A/S, Ballerup, Denmark.
D ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Leo Pharma (Denmark) · DKGuy's and St Thomas' NHS Foundation Trust · GBHôpital Saint Joseph · FRHospital Universitario Infanta Leonor · ESImelda Hospital · BEIndiana University School of MedicineQueen's University · CAThe University of Texas Health Science Center at Houston · USUniversity of Brescia · ITUniversity of Lübeck · DE

Funding

LEO Pharma
6 · The paper itself

Abstract

backgroundPsoriasis has important physical and psychosocial effects that extend beyond the skin. Understanding the impact of treatment on health-related quality of life (HRQoL) and patient-perceived symptom severity in psoriasis is key to clinical decision-making.

objectivesThis post hoc analysis of the PSO-LONG trial data assessed the impact of long-term proactive or reactive management with fixed-dose combination calcipotriene 50 µg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) foam on patient-reported outcomes (PROs) in patients with psoriasis vulgaris.

methodsFive hundred and twenty-one patients from the Phase 3, randomized, double-blind PSO-LONG trial were included. An initial 4-week, open-label phase of fixed-dose combination Cal/BD foam once daily (QD) was followed by a 52-week maintenance phase, at the start of which patients were randomized to a proactive management arm (Cal/BD foam twice weekly) or reactive management arm (vehicle foam twice weekly). Patient-perceived symptom severity and HRQoL were assessed using the Psoriasis Symptom Inventory (PSI), the Dermatology Life Quality Index (DLQI) and the EuroQol-5D for psoriasis (EQ-5D-5L-PSO).

resultsStatistically and clinically significant improvements were observed across all PRO measures. The mean difference (standard deviation) from baseline to Week 4 was -8.97 (6.18) for PSI, -6.02 (5.46) for DLQI and 0.11 (0.15) for EQ-5D-5L-PSO scores. During maintenance, patients receiving reactive management had significantly higher DLQI (15% [p = 0.007]) and PSI (15% [p = 0.0128]) and a numerically lower EQ-5D-5L-PSO mean area under the curve score than patients receiving proactive management (1% [p = 0.0842]).

conclusionsCal/BD foam significantly improved DLQI, EQ-5D-5L-PSO and PSI scores during the open-label and maintenance phases. Patients assigned to proactive management had significantly better DLQI and PSI scores and numerically better EQ-5D-5L-PSO versus reactive management. Additionally, baseline flare was associated with worse PROs than the start of a relapse, and patients starting a relapse also had worse PROs than patients in remission.

Indexed as

Dermatologic AgentsPsoriasisBetamethasoneDrug CombinationsHumansQuality of LifeTreatment OutcomeBetamethasoneDermatologic AgentsDrug Combinationsbetamethasone dipropionatecalcipotriolpsoriasistopical administration

Identifiers

PMID34543474
PMCPMC9298373
OpenAlexW3201090734

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.