Evidence map›Paper›PMID 32584415›Full record

Observational studyRheumatology (Oxford, England)2021

Effectiveness and safety of 12-month certolizumab pegol treatment for axial spondyloarthritis in real-world clinical practice in Europe.

Xenofon Baraliakos, Torsten Witte, Luc De Clerck, Bruno Frediani, Eduardo Collantes-Estévez, Gkikas Katsifis, Brenda VanLunen, Elisabeth Kleine, Bengt Hoepken, Lars Bauer and 1 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02354105 (A Noninterventional Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Practice), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-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.

NCT02354105 completednot on this map

A Noninterventional Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Practice

TypeobservationalSponsorUCB Biopharma S.P.R.L.Ran2015 to 2018Enrolled680ConditionsAxial Spondyloarthritis
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

11 authors at 9 institutions in 7 countries.

Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University, Bochum.
Torsten WitteHannover Medical School, Hannover Medical School, Hanover, Germany.
Luc De ClerckAntwerp University Hospital, Antwerp, Belgium.
Bruno FredianiUniversity of Siena, Siena, Italy.
Eduardo Collantes-EstévezUniversity of Córdoba and University Hospital Reina Sofia, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Córdoba, Spain.
Gkikas KatsifisNaval Hospital of Athens, Athens, Greece.
Brenda VanLunenUCB Pharma, Raleigh, NC, USA.
Elisabeth KleineUCB Pharma, Monheim am Rhein, Germany.
Bengt HoepkenUCB Pharma, Monheim am Rhein, Germany.
Lars BauerUCB Pharma, Monheim am Rhein, Germany.
Nicola GoodsonAintree University Hospital NHS Foundation Trust, Liverpool, UK.
UCB Pharma (Germany) · DEAntwerp University Hospital · BEAthens Naval & Veterans Hospital · GRInstituto Maimónides de Investigación Biomédica de Córdoba · ESMedizinische Hochschule Hannover · DERheumazentrum Ruhrgebiet · DEUCB Pharma (United States) · USUniversity of Liverpool · GBUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA.

methodsCIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12 months in a real-world axSpA cohort. The primary outcome was change from baseline in BASDAI to week 52, with additional outcomes pertaining to effectiveness and safety. Patients who received ≥1 dose CZP were followed up for adverse events, and those with baseline and ≥1 post-baseline BASDAI assessment were included in effectiveness analyses.

resultsA total of 672 patients (r-axSpA: 469; nr-axSpA: 201; unconfirmed diagnosis: 2) from 101 sites received ≥1 dose of CZP, of whom 564 (r-axSpA: 384; nr-axSpA: 179; unconfirmed: 1) were included in the effectiveness analyses. The mean baseline BASDAI was 6.1 in the overall axSpA population and r-axSpA and nr-axSpA subpopulations. At week 52, the mean (s.d.) change in BASDAI was -2.9 (2.3; n = 439); for r-axSpA and nr-axSpA, it was -2.9 (2.2; n = 301) and -2.8 (2.4; n = 137), respectively (P <0.0001 for all). Similar improvements were seen across other axSpA disease measures. In total, 37.9% (255/672) patients experienced adverse events, and 1.8% (12/672) experienced ≥1 serious adverse events.

conclusionImprovements observed in signs and symptoms of axSpA following one year of CZP treatment in real-world clinical practice were similar to those from previous randomized clinical trials, with no new safety concerns.

Indexed as

AdultAgedAntirheumatic AgentsCertolizumab PegolFemaleHumansMaleMiddle AgedProspective StudiesSeverity of Illness IndexSpondylarthritisYoung AdultAntirheumatic AgentsCertolizumab Pegolaxial spondyloarthritiscertolizumab pegolnon-interventional

Identifiers

PMID32584415
PMCPMC7785316
OpenAlexW3037181798

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.