Evidence map›Paper›PMID 34192387›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2021

Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial.

R B Warren, M Lebwohl, H Sofen, V Piguet, M Augustin, F Brock, C Arendt, F Fierens, A Blauvelt

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02346240 (A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 40% 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.

NCT02346240 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorUCB Biopharma S.P.R.L.Ran2015 to 2018Enrolled559ConditionsPsoriasis, Plaque PsoriasisArmsCertolizumab Pegol, Etanercept, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. 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

9 authors at 8 institutions in 5 countries.

R B WarrenDermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.ORCID https://orcid.org/0000-0002-2918-6481
M LebwohlIcahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID https://orcid.org/0000-0002-4705-5303
H SofenDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA.ORCID https://orcid.org/0000-0001-7789-6915
V PiguetDivision of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada.ORCID https://orcid.org/0000-0001-6079-4517
M AugustinInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.ORCID https://orcid.org/0000-0002-4026-8728
F BrockUCB Pharma, Slough, UK.
C ArendtUCB Pharma, Brussels, Belgium.
F FierensUCB Pharma, Brussels, Belgium.
A BlauveltOregon Medical Research Center, Portland, OR, USA.ORCID https://orcid.org/0000-0002-2633-985X
UCB Pharma (Belgium) · BEIcahn School of Medicine at Mount Sinai · USOregon Medical Research Center · USSalford Royal NHS Foundation Trust · GBUCB Pharma (United Kingdom) · GBUniversität Hamburg · DEUniversity of California, Los Angeles · USUniversity of Toronto · CA

Funding

Dermira, IncUCB Pharma
6 · The paper itself

Abstract

backgroundCertolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumor necrosis factor biologic.

objectivesTo report 3-year outcomes from the CIMPACT (NCT02346240) phase 3, CZP in moderate to severe plaque psoriasis, randomized controlled trial.

methodsAdults were randomized 3:3:3:1 to CZP 200 mg every other week (Q2W), CZP 400 mg Q2W, etanercept biweekly or placebo. At Week 16, CZP- and etanercept-treated PASI 75 responders were re-randomized to CZP 200 mg Q2W, CZP 400 mg Q4W, CZP 400 mg Q2W or placebo for maintenance treatment; PASI 75 non-responders entered an open-label escape CZP 400 mg Q2W arm. Patients entering the open-label extension (OLE; Weeks 48-144) from blinded treatment received CZP 200 mg Q2W.

resultsDouble-blinded results have been reported previously. 261 patients received 200 mg Q2W upon OLE entry. PASI 75 response was maintained in patients continuing 200 mg Q2W treatment through Weeks 16-144 (Week 144: 96.2%). In patients dosed down at Week 48 (double-blinded 400 mg to 200 mg Q2W), PASI 75 decreased (Week 48: 98.7%; Week 144: 85.9%). In patients who received placebo through Weeks 16-48, PASI 75 response decreased (Week 48: 60.4%), then increased following Week 48 switch to 200 mg Q2W (Week 144: 95.1%). 48 and 36 patients initially randomized to 200 and 400 mg Q2W, respectively, were Week 16 PASI 75 non-responders and entered the escape arm; at Week 144, 71.8% and 78.2% achieved PASI 75. No new safety signals were identified.

conclusionsResponse to CZP was durable over three years; no new safety signals were identified.

Indexed as

PsoriasisAdultCertolizumab PegolDouble-Blind MethodEtanerceptHumansTreatment OutcomeCertolizumab PegolEtanerceptcertolizumab pegolclinical triallong termplaque psoriasis

Identifiers

PMID34192387
PMCPMC9290019
OpenAlexW3174239144

What OpenQuestion holds

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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.