Evidence map›Paper›PMID 32364296›Full record

Observational studyJournal of the European Academy of Dermatology and Venereology : JEADV2020

A multinational, prospective, observational study to estimate complete skin clearance in patients with moderate-to-severe plaque PSOriasis treated with BIOlogics in a REAL world setting (PSO-BIO-REAL).

J Seneschal, J-P Lacour, A Bewley, M Faurby, C Paul, G Pellacani, C De Simone, L Horne, A Sohrt, M Augustin and 2 more

Abstract readObservational Study
In one paragraph

Observational study in Journal of the European Academy of Dermatology and Venereology : JEADV, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. 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

12 authors.

J SeneschalDepartment of Dermatology and Paediatric Dermatology, National Reference Centre for Rare Skin Diseases, Saint-André Hospital, University of Bordeaux, Bordeaux, France.ORCID https://orcid.org/0000-0003-1139-0908
J-P LacourDepartment of Dermatology, Archet 2 Hospital, University Hospital of Nice, Nice, France.
A BewleyDepartment of Dermatology, Barts Health NHS Trust London, London, UK.
M FaurbyLEO Pharma A/S, Ballerup, Denmark.
C PaulToulouse University and Larrey Hospital, Toulouse, France.
G PellacaniDepartment of Dermatology, University of Modena and Reggio Emilia, Modena, Italy.
C De SimoneDepartment of Dermatology, Catholic University of the Sacred Heart, Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Rome, Italy.
L HorneAstraZeneca, Gaithersburg, MD, USA.
A SohrtLEO Pharma A/S, Ballerup, Denmark.
M AugustinInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Centre Hamburg-Eppendorf (UKE), Hamburg, Germany.ORCID https://orcid.org/0000-0002-4026-8728
E HammondAstraZeneca, Gaithersburg, MD, USA.
K ReichTranslational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany.ORCID https://orcid.org/0000-0001-5248-4332

Funding

AmgenAstraZenecaLEO Pharma Research Foundation
6 · The paper itself

Abstract

backgroundAnti-tumour necrosis factor (TNF) and anti-interleukin (IL)-12/23 biologics revolutionized plaque psoriasis treatment by enabling ≥75% improvement in the Psoriasis Area and Severity Index (PASI 75) in clinical trials. Modern biologics are now reported to achieve PASI 100 (complete skin clearance) in clinical trials. However, real-world evidence of skin clearance rates with biologics is limited. PSO-BIO-REAL was conducted to understand the real-world burden of plaque psoriasis.

objectiveThe primary objective of this observational study was to estimate the proportion of patients who achieved complete skin clearance at 6 months. Secondary objectives included maintenance of response and evaluation of complete skin clearance at 12 months.

methodsPSO-BIO-REAL was a multinational, prospective, real-world, non-interventional study of skin clearance and patient-reported outcomes (PROs) with biologics. A total of 846 patients from the United States (32%), France (28%), Italy (22%), the United Kingdom (11%) and Germany (8%) were enrolled and followed for one year. Eligible patients were aged ≥18 years with moderate-to-severe plaque psoriasis who had initiated a biologic for plaque psoriasis. Patients could be biologic-naïve or switching biologics (biologic-experienced). Assessments were made at baseline and at months 6 and 12.

resultsAt 6 and 12 months, 23% and 26% of patients achieved complete skin clearance, respectively. Prior to study entry, 60% were biologic-naïve. The proportion of patients achieving complete skin clearance was lower among biologic-experienced patients (20% at both months 6 and 12) compared with biologic-naïve patients (25% at month 6, 30% at month 12). The rate of complete skin clearance decreased as the number of prior biologics and baseline comorbidities increased.

conclusionOnly one in four patients achieved complete skin clearance after 6 months of treatment with biologics. The study indicates there still is an unmet need for more efficacious biologics for patients with psoriasis.

Indexed as

Biological ProductsPsoriasisAdolescentAdultFranceGermanyHumansItalyProspective StudiesUnited KingdomBiological Products

Identifiers

PMID32364296
PMCPMC7818467

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.