Evidence map›Paper›PMID 32531798›Full record

ArticleThe British journal of dermatology2021

Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies.

A Blauvelt, C Paul, P van de Kerkhof, R B Warren, A B Gottlieb, R G Langley, F Brock, C Arendt, M Boehnlein, M Lebwohl and 1 more

3 registry-linked trialsOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The British journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 20% 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.

NCT02326272 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind 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.Ran2014 to 2018Enrolled227ConditionsPsoriasis, Plaque PsoriasisArmsCertolizumab Pegol, Placebo
NCT02326298 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind 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.Ran2014 to 2018Enrolled234ConditionsPsoriasis, Plaque PsoriasisArmsCertolizumab Pegol, Placebo
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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
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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

11 authors at 10 institutions in 7 countries.

A BlauveltOregon Medical Research Center, Portland, OR, USA.ORCID 0000-0002-2633-985X
C PaulPaul Sabatier University, Toulouse, France.ORCID 0000-0003-0165-5263
P van de KerkhofRadboud University, Nijmegen, the Netherlands.ORCID 0000-0003-0084-3131
R B WarrenDermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.
A B GottliebIcahn School of Medicine at Mount Sinai, New York, NY, USA.
R G LangleyDalhousie University, Halifax, NS, Canada.
F BrockUCB Pharma, Slough, UK.
C ArendtUCB Pharma, Brussels, Belgium.
M BoehnleinUCB Pharma, Monheim, Germany.
M LebwohlIcahn School of Medicine at Mount Sinai, New York, NY, USA.
K ReichTranslational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0001-5248-4332
Icahn School of Medicine at Mount Sinai · USDalhousie University · CAOregon Medical Research Center · USRadboud University Nijmegen · NLSalford Royal NHS Foundation Trust · GBUCB Pharma (Belgium) · BEUCB Pharma (Germany) · DEUCB Pharma (United Kingdom) · GBUniversität Hamburg · DEUniversité Toulouse III - Paul Sabatier · FR

Funding

Dermira IncUCB Pharma
6 · The paper itself

Abstract

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

objectivesTo report 3-year safety data from three phase III trials of CZP in adults with plaque psoriasis.

methodsData were pooled from CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272) and CIMPACT (NCT02346240). Included patients had moderate-to-severe plaque psoriasis of ≥ 6 months' duration; had been randomized to CZP 200 mg every 2 weeks (Q2W) (400 mg at weeks 0, 2 and 4) or CZP 400 mg Q2W; and had received at least one dose of CZP with up to 144 weeks of exposure. Treatment-emergent adverse events (TEAEs) were classified using MedDRA v18·1. Reported incidence rates (IRs) are incidence of new cases per 100 patient-years (PY).

resultsOver 144 weeks, 995 patients received at least one dose of CZP (exposure: 2231·3 PY); 731 and 728 received at least one dose of CZP 200 mg Q2W (1211·4 PY) and/or 400 mg Q2W (1019·9 PY), respectively. The IR [95% confidence interval (CI)] of TEAEs was 144·9 (135·3-155·0) for all patients, 134·1 (123·2-145·7) for CZP 200 mg Q2W and 158·3 (145·5-171·9) for CZP 400 mg Q2W. The IR (95% CI) of serious TEAEs for all patients was 7·5 (6·4-8·8); the IRs were 6·7 (5·2-8·3) and 8·7 (6·9-10·8) for CZP 200 mg and 400 mg Q2W, respectively. Overall, 3·2% of patients reported serious infections (2·2% within each of the CZP 200 and 400 mg Q2W groups). Overall, there was one case of active tuberculosis, 16 malignancies in 14 patients and seven deaths (two considered treatment-related). The cumulative IR of TEAEs did not increase over time.

conclusionsNo new safety signals were identified compared with previously reported data. Risk did not increase with longer or higher CZP exposure.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidPsoriasisAdultCertolizumab PegolClinical Trials as TopicDouble-Blind MethodHumansRandomized Controlled Trials as TopicTreatment OutcomeTumor Necrosis Factor-alphaAntirheumatic AgentsCertolizumab PegolTumor Necrosis Factor-alpha

Identifiers

PMID32531798
PMCPMC8246928
OpenAlexW3034204123

What OpenQuestion holds

Textmetadata
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.