Evidence map›Paper›PMID 31017657›Full record

Trial reportThe British journal of dermatology2019

Sustained long-term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis from a randomized, double-blind, phase III study.

D Thaçi, K Papp, D Marcoux, L Weibel, A Pinter, P-D Ghislain, I Landells, P H Hoeger, K Unnebrink, M M B Seyger and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in The British journal of dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Therapeutic challenges in managing pediatric psoriasis.International journal of women's dermatology · 2021
    Review
  11. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 6 countries.

D ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Ratzeburger Allee 160, 23435, Lübeck, Germany.
K PappK Papp Clinical Research and Probity Medical Research, University of Western Ontario, Waterloo, ON, Canada.ORCID 0000-0001-9557-3642
D MarcouxCHU Sainte-Justine Montreal, Montreal, QC, Canada.
L WeibelPediatric Dermatology Department, University Children's Hospital Zurich, and Dermatology Department, University Hospital Zurich, Zurich, Switzerland.
A PinterUniversity Clinic of Frankfurt am Main, Department of Dermatology, Venereology and Allergology, Frankfurt am Main, Germany.
P-D GhislainUCL St Luc, Brussels, Belgium.
I LandellsNexus Clinical Research and Memorial University of Newfoundland, St John's, NL, Canada.
P H HoegerDepartment of Pediatric Dermatology, Catholic Children's Hospital, Hamburg, Germany.ORCID 0000-0003-3268-7479
K UnnebrinkAbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
M M B SeygerDepartment of Dermatology and Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.
D A WilliamsAbbVie Inc., North Chicago, IL, U.S.A.
S RubantAbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
S PhilippDepartment of Dermatology, Venerology and Allergy, Charité Universitätsmedizin Berlin, Berlin, Germany.
AbbVie (Germany) · DEAbbVie (United States) · USCentre Hospitalier Universitaire Sainte-Justine · CACharité - Universitätsmedizin Berlin · DEGoethe University Frankfurt · DEKinderkrebs-Zentrum Hamburg · DEMemorial University of Newfoundland · CARadboud University Nijmegen · NLUCLouvain Saint-Louis Brussels · BEUniversity Children's Hospital Zurich · CHUniversity of Lübeck · DEWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdalimumab (ADA) (Humira

objectivesTo evaluate the long-term efficacy and safety of ADA in children with severe plaque psoriasis.

methodsResults are presented from the 52-week long-term extension (LTE) of the randomized, double-blind, double-dummy, phase III trial, in children with severe plaque psoriasis (results from prior periods have been published). Patients aged ≥ 4 and < 18 years were randomized 1 : 1 : 1 to ADA 0·8 mg kg

resultsOf the 114 patients randomized in the IT period, 108 entered the LTE (n = 36 in each group); 93 received ADA 0·8 mg kg

conclusionsAfter 52 weeks of long-term ADA treatment in children aged 4-18 years with severe plaque psoriasis, disease severity was reduced and maintained or further improved, as demonstrated by efficacy outcomes. No new safety risks were identified. What's already known about this topic? The results from the first three periods of this phase III trial in children aged 4-18 years with severe plaque psoriasis suggest that adalimumab is a safe and efficacious treatment option in this population. What does this study add? This is the first study to evaluate long-term treatment of adalimumab in children with severe psoriasis, and the first to evaluate switching from methotrexate to adalimumab in this population.

Indexed as

Severity of Illness IndexAdalimumabAdolescentBiological FactorsChildChild, PreschoolChronic DiseaseDouble-Blind MethodFemaleHumansLong-Term CareMaleMethotrexatePsoriasisTime FactorsTreatment OutcomeAdalimumabBiological FactorsMethotrexate

Identifiers

PMID31017657
PMCPMC6916374
OpenAlexW2942228012

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.