Evidence map›Paper›PMID 36509889›Full record

ArticleDermatology and therapy2023

Long-Term Health-Related Quality of Life in Patients with Plaque Psoriasis Treated with Certolizumab Pegol: Three-Year Results from Two Randomised Phase 3 Studies (CIMPASI-1 and CIMPASI-2).

Paolo Gisondi, Alice B Gottlieb, Boni Elewski, Matthias Augustin, Sandy McBride, Tsen-Fang Tsai, Christine de la Loge, Frederik Fierens, José M López Pinto, Nicola Tilt and 1 more

Erratum issued 2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 33% 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
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 7 countries.

Paolo GisondiDermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.
Alice B GottliebDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Boni ElewskiDepartment of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH, USA.
Matthias AugustinInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Sandy McBrideRoyal Free London NHS Foundation Trust, London, UK.
Tsen-Fang TsaiDepartment of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Christine de la LogePCOM Analytics, Avallon, France.
Frederik FierensUCB Pharma, Brussels, Belgium.
José M López PintoUCB Pharma, Madrid, Spain.
Nicola TiltUCB Pharma, Slough, UK.
Mark LebwohlDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.ORCID http://orcid.org/0000-0002-4705-5303
Icahn School of Medicine at Mount Sinai · USNational Taiwan University Hospital · TWRoyal Free London NHS Foundation Trust · GBUCB Pharma (Belgium) · BEUCB Pharma (Spain) · ESUCB Pharma (United Kingdom) · GBUniversität Hamburg · DEUniversity Hospitals of Cleveland · USUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCertolizumab pegol (CZP) is an Fc-free, PEGylated, anti-tumour necrosis factor biologic. Safety and efficacy data for CZP over 3 years have been previously reported. We report 3-year quality of life (QoL) outcomes for patients treated with CZP, pooled from two phase 3 trials.

methodsAdults with moderate-to-severe plaque psoriasis for ≥ 6 months were initially randomised 1:2:2 to double-blinded placebo every 2 weeks (Q2W), CZP 200 mg Q2W (loading dose of CZP 400 mg at weeks 0/2/4) or CZP 400 mg Q2W. All patients received open-label CZP (200 mg or 400 mg Q2W) from week 48. Dermatology Life Quality Index (DLQI), 36-Item Short Form Survey (SF-36), EuroQol 5-Dimensions 3-Level (EQ-5D-3L) and Work Productivity and Activity Impairment (WPAI) scores are reported as observed.

resultsAt week 0, 100 patients were randomised to placebo, 186 to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. For CZP-randomised patients, 60.9% had a DLQI score of 0 or 1 by week 48. Both the physical and mental component scores of SF-36 also improved from baseline to week 48 (mean change from baseline: 4.4 and 5.4, respectively). The proportion of patients with a score of 1 in the EQ-5D-3L Pain/Discomfort dimension increased (week 0, 21.1%; week 48, 66.2%), and WPAI Presenteeism, Work Impairment, and Activity Impairment improved from baseline to week 48, with the strongest gains observed for Activity Impairment (week 0, 33.3% of time impaired; week 48, 6.7%). Across patient-reported outcomes, gains were sustained through week 144, with durable improvements observed regardless of sex, psoriatic arthritis status or prior exposure to biologics.

conclusionCZP treatment was associated with sustained and tangible improvements in health-related QoL (DLQI and SF-36), health status (EQ-5D-3L) and functional impairment at work and in other daily activities (WPAI).

trial registrationClinicalTrials.gov NCT02326298 (CIMPASI-1) and NCT02326272 (CIMPASI-2).

Indexed as

BiologicCertolizumab pegolClinical trialPatient-reported outcomesPlaque psoriasisQuality of life

Identifiers

PMID36509889
PMCPMC9823190
OpenAlexW4311220073

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.