Evidence map›Paper›PMID 39222436›Full record

Trial reportRheumatology (Oxford, England)2024

Impact of high rheumatoid factor levels on treatment outcomes with certolizumab pegol and adalimumab in patients with rheumatoid arthritis.

Josef S Smolen, Peter C Taylor, Yoshiya Tanaka, Tsutomu Takeuchi, Motomu Hashimoto, Carlos Cara, Bernard Lauwerys, Nicola Tilt, Baran Ufuktepe, Ricardo M Xavier and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IV
In one paragraph

Trial report in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01500278 (A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01500278 phase4completednot on this map

A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate

TypeinterventionalSponsorUCB Pharma SARan2011 to 2016Enrolled915ConditionsRheumatoid ArthritisArmsCertolizumab Pegol (CZP), Adalimumab (ADA), Methotrexate (MTX)
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  7. Ozoralizumab, a trivalent anti-TNFα NANOBODYFrontiers in immunology · 2026
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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

14 authors.

Josef S SmolenDivision of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria.
Peter C TaylorNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.ORCID 0000-0001-7766-6167
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Tsutomu TakeuchiDepartment of Rheumatology and Applied Immunology, Saitama Medical University, Saitama, Japan.
Motomu HashimotoDepartment of Clinical Immunology, Osaka Metropolitan University, Osaka, Japan.ORCID 0000-0002-9241-060X
Carlos CaraUCB Pharma, Madrid, Spain.
Bernard LauwerysUCB Pharma, Brussels, Belgium.
Nicola TiltUCB Pharma, Slough, UK.
Baran UfuktepeUCB Pharma, Istanbul, Turkey.
Ricardo M XavierFaculdade de Medicina, Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Brazil.ORCID 0000-0001-6570-4533
Alejandro BalsaRheumatology Unit, La Paz University Hospital, Madrid, Spain and Institute for Health Research (IdiPAZ), Madrid, Spain.
Jeffrey R CurtisDivision of Clinical Immunology and Rheumatology, University of Alabama, Birmingham, AL, USA.ORCID 0000-0002-8907-8976
Ted R MikulsDivision of Rheumatology and Immunology, University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha, NE, USA.
Michael WeinblattDivision of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Funding

Advisory Board for ImmunovantAstraZenecaBristol-Myers SquibbCostello MedicalErin ClarksonGood Publication Practice GPP 2022Merck Sharp & DohmeUCB Pharma
6 · The paper itself

Abstract

objectivesTo assess the impact of baseline RF level on drug concentrations and efficacy of certolizumab pegol [CZP; TNF inhibitor (TNFi) without a crystallizable fragment (Fc)] and adalimumab (ADA; Fc-containing TNFi) in patients with RA.

methodsThe phase 4 EXXELERATE study (NCT01500278) was a 104-week, randomized, single-blind (double-blind until week 12; investigator-blind thereafter), head-to-head study of CZP vs ADA in patients with RA. In this post hoc analysis, we report drug concentration and efficacy outcomes stratified by baseline RF quartile (≤Q3 or >Q3).

resultsBaseline data by RF quartiles were available for 453 CZP-randomized and 454 ADA-randomized patients (≤Q3: ≤204 IU/ml; >Q3: >204 IU/ml). From week 12, the area under the curve (AUC) of ADA concentration was lower in patients with RF >204 IU/ml vs patients with RF ≤204 IU/ml; the AUC of CZP concentration was similar in patients with RF ≤204 IU/ml and >204 IU/ml. For patients with RF ≤204 IU/ml, disease activity score (DAS28)-CRP was similar between CZP- and ADA-treated patients through week 104. For patients with RF >204 IU/ml, mean DAS28-CRP was lower in CZP- vs ADA-treated patients at week 104. The proportion of patients with RF >204 IU/ml achieving DAS28-CRP low disease activity at week 104 was greater in CZP- vs ADA-treated patients.

conclusionCZP was associated with maintained drug concentration and efficacy in patients with RA and high RF and may therefore be a more suitable therapeutic option than TNFis with an Fc fragment in these patients.

trial registrationClinicaltrials.gov, http://clinicaltrials.gov, NCT01500278.

Indexed as

AdalimumabAntirheumatic AgentsArthritis, RheumatoidCertolizumab PegolRheumatoid FactorAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedSingle-Blind MethodTreatment OutcomeAdalimumabAntirheumatic AgentsCertolizumab PegolRheumatoid FactorRARFTNF inhibitor

Identifiers

PMID39222436
PMCPMC11534142

What OpenQuestion holds

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LicenceCC BY
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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.