Evidence map›Paper›PMID 31957303›Full record

Trial reportInternational journal of rheumatic diseases2020

Factors associated with successful discontinuation of certolizumab pegol in early rheumatoid arthritis.

Yoshiya Tanaka, Tatsuya Atsumi, Kazuhiko Yamamoto, Tsutomu Takeuchi, Hisashi Yamanaka, Naoki Ishiguro, Katsumi Eguchi, Akira Watanabe, Hideki Origasa, Toshiharu Shoji and 2 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of rheumatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01451203 (A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 34% 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.

NCT01451203 phase3completednot on this map

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors

TypeinterventionalSponsorAstellas Pharma IncRan2011 to 2014Enrolled319ConditionsRheumatoid ArthritisArmsPlacebo, CZP, methotrexate (MTX)
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. 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

12 authors at 11 institutions in 1 country.

Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Tatsuya AtsumiHokkaido University Graduate School of Medicine, Sapporo, Japan.
Kazuhiko YamamotoCenter for Integrative Medical Sciences, RIKEN, Kanagawa, Japan.
Tsutomu TakeuchiKeio University School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0003-1111-8218
Hisashi YamanakaInstitute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.
Naoki IshiguroFaculty of Medicine, Nagoya University Graduate School, Nagoya, Japan.
Katsumi EguchiRheumatic and Collagen Disease Center, Sasebo Chuo Hospital, Sasebo, Japan.
Akira WatanabeTohoku Bunka Gakuen University, Sendai, Japan.
Hideki OrigasaDivision of Biostatistics and Clinical Epidemiology, The University of Toyama Graduate School of Medicine, Toyama, Japan.
Toshiharu ShojiUCB Pharma, Tokyo, Japan.
Nobuyuki MiyasakaTokyo Medical and Dental University, Tokyo, Japan.
Takao KoikeHokkaido University Graduate School of Medicine, Sapporo, Japan.
Hokkaido University · JPKeio University · JPNagoya University · JPRIKEN Center for Integrative Medical Sciences · JPSasebo City General Hospital · JPTohoku Bunka Gakuen University · JPTokyo Medical and Dental University · JPTokyo Women's Medical University · JPUCB Pharma (Japan) · JPUniversity of Occupational and Environmental Health Japan · JPUniversity of Toyama · JP

Funding

UCB Pharma
6 · The paper itself

Abstract

aimThe Certolizumab-Optimal Prevention of joint damage for Early Rheumatoid Arthritis (C-OPERA) study demonstrated that in methotrexate (MTX)-naïve early RA patients with poor prognostic factors, 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year optimized MTX therapy brings radiographic and clinical benefits through 2 years even after stopping CZP. This exploratory analysis aimed to identify factors at baseline and at CZP discontinuation associated with successful CZP discontinuation.

methodsMTX-naïve early RA patients with poor prognostic factors entered C-OPERA (NCT01451203), a multicenter, randomized controlled trial. Patients were randomized to CZP + MTX (n = 159) or PBO + MTX (n = 157); those who completed the 1-year, double-blind period received MTX alone in Year 2 (CZP + MTX→MTX, n = 108; PBO + MTX→MTX, n = 71). Association between factors at baseline or at discontinuation of CZP and clinical/radiographic outcomes were evaluated by multiple logistic regression analysis. Predictive value cut-offs were calculated using receiver operating characteristic analysis.

resultsSex (male) and low baseline Disease Activity Score of 28 joints - erythrocyte sedimentation rate (DAS28-ESR) were associated with simple disease activity index (SDAI) remission (≤3.3), whereas high baseline DAS28-ESR and modified total Sharp score (mTSS) were associated with clinically relevant radiographic progression (yearly progression mTSS > 3) at Week 104 (across both treatment arms). Low DAS28-ESR (<2.1) and rheumatoid factor (RF; <74 IU/mL) at discontinuation of CZP were associated with SDAI remission at Week 104. At Week 104, SDAI remission was achieved by 75.0% (42/56) of patients with low DAS28-ESR and RF at discontinuation, compared to 15.4% (2/13) of patients with high DAS28-ESR and RF.

conclusionPatients with low RF and low disease activity after treatment with CZP + MTX may be able to discontinue CZP without risk of loss of response.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidCertolizumab PegolDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansJapanMaleMethotrexateRemission InductionTime FactorsTreatment OutcomeAntirheumatic AgentsCertolizumab PegolMethotrexateanti-TNFcertolizumab pegoldiscontinuationearly rheumatoid arthritisprognostic factor

Identifiers

PMID31957303
PMCPMC7065202
OpenAlexW3001197417

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.