Evidence map›Paper›PMID 30157880›Full record

ArticleTrials2018

A small population, randomised, placebo-controlled trial to determine the efficacy of anakinra in the treatment of pustular psoriasis: study protocol for the APRICOT trial.

Victoria Cornelius, Rosemary Wilson, Suzie Cro, Jonathan Barker, David Burden, Christopher E M Griffiths, Helen Lachmann, Helen McAteer, Nick Reynolds, Andrew Pink and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.0field-weighted citation impact, top 26% 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

12 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Pustular Psoriasis: The Dawn of a New Era.Acta dermato-venereologica · 2020
    Review
  10. Skin manifestations in spondyloarthritis.Therapeutic advances in musculoskeletal disease · 2020
    Review
  11. Review
  12. 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 8 institutions in 1 country.

Victoria CorneliusImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK. v.cornelius@imperial.ac.uk.ORCID http://orcid.org/0000-0002-0080-1065
Rosemary WilsonSt John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, 9th Floor Tower Wing, Guy's Hospital, London, UK.
Suzie CroImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
Jonathan BarkerSt John's Institute of Dermatology, Faculty of Life Sciences and Medicine, King's College London, London, UK.
David BurdenDepartment of Dermatology, Royal Infirmary, Edinburgh, UK.
Christopher E M GriffithsThe Dermatology Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Helen LachmannNational Amyloidosis Centre, University College London, Royal Free Campus, London, UK.
Helen McAteerThe Psoriasis Association, Dick Coles House, 2 Queensbridge, Northampton, UK.
Nick ReynoldsInstitute of Cellular Medicine, Department of Dermatology, Newcastle University, Newcastle upon Tyne, UK.
Andrew PinkSt John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, 9th Floor Tower Wing, Guy's Hospital, London, UK.
Richard B WarrenThe Dermatology Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Francesca CaponDepartment of Medical & Molecular Genetics, King's College London, 9th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, UK.
Catherine SmithSt John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, 9th Floor Tower Wing, Guy's Hospital, London, UK.
Guy's Hospital · GBImperial College London · GBManchester Academic Health Science Centre · GBEdinburgh Royal Infirmary · GBKing's College London · GBNewcastle University · GBPsoriasis Association · GBThe Royal Free Hospital · GB

Funding

Department of Health EME/13/50/17Efficacy and Mechanism Evaluation Programme 13/50/17
6 · The paper itself

Abstract

backgroundPalmoplantar pustulosis is a rare but painful and debilitating disease. It consistently ranks the highest of all psoriasis phenotypic variants in terms of symptoms and functional impairment. Management of plaque-type psoriasis has been revolutionised in the last 10 years with the advent of biologic therapies, but treatment options for pustular psoriasis remain profoundly limited. On the basis of mechanistic findings which suggest a key pathogenic role for interleukin (IL)-1 in pustular psoriasis, we hypothesise that anakinra (IL-1 blockade) will be an efficacious treatment for pustular psoriasis. METHODS/

designWe will conduct a two-stage, adaptive, double-blind, randomised, placebo-controlled trial to test the hypothesis that anakinra, self-administered daily by subcutaneous injection over 8 weeks, will deliver therapeutic benefit in palmoplantar pustular psoriasis, a localised form of pustular psoriasis typically involving the palms and/or soles. Safety outcomes will be collected for 20 weeks. A total of 64 participants will be randomised to anakinra or placebo in a 1:1 ratio. At the end of stage 1, a decision to progress to stage 2 will be made. This decision will take place after 24 participants have been randomised and followed for 8 weeks and will be based on the ordering of the observed mean outcome values in both treatment arms. At the end of stage 1, the reliability of outcome measurements and method to collect the data will also be assessed, and the primary outcome will be confirmed for stage 2. DISCUSSION: We have undertaken an adaptive approach in which we will gain proof-of-concept data prior to completing a powered efficacy trial because pustular psoriasis is a rare disease, no validated outcome measures to detect change exist, and limited safety data for anakinra exist in this population. To our knowledge, this will be the first randomised controlled trial that will provide valuable evidence for the efficacy and safety of IL-1 blockade for treatment in pustular psoriasis.

trial registrationISRCTN13127147 . Registered on 1st August 2016. EudraCT, 2015-003600-23 . Registered on 1st April 2016.

Indexed as

Adaptive Clinical Trials as TopicDouble-Blind MethodHumansImmunologic FactorsInjections, SubcutaneousInterleukin 1 Receptor Antagonist ProteinPsoriasisRandomized Controlled Trials as TopicRemission InductionSelf AdministrationTreatment OutcomeImmunologic FactorsInterleukin 1 Receptor Antagonist ProteinAdaptive trialAnakinraPustular psoriasisRandomised controlled trialSmall population trial

Identifiers

PMID30157880
PMCPMC6116430
OpenAlexW2889429561

What OpenQuestion holds

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LicenceCC BY
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.