Evidence map›Paper›PMID 28153828›Full record

Trial reportAnnals of the rheumatic diseases2017

Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation: 2-year results of the C-OPERA study, a phase III randomised trial.

Tatsuya Atsumi, Yoshiya Tanaka, Kazuhiko Yamamoto, Tsutomu Takeuchi, Hisashi Yamanaka, Naoki Ishiguro, Katsumi Eguchi, Akira Watanabe, Hideki Origasa, Shinsuke Yasuda and 10 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2017. 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 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 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 4 countries.

Tatsuya AtsumiHokkaido University Graduate School of Medicine, Sapporo, Japan.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.
Kazuhiko YamamotoDepartment of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Hisashi YamanakaTokyo Women's Medical University, Tokyo, Japan.
Naoki IshiguroNagoya University Graduate School and Faculty of Medicine, Nagoya, Japan.
Katsumi EguchiRheumatic and Collagen Disease Center, Sasebo Chuo Hospital, Sasebo, Nagasaki, Japan.
Akira WatanabeTohoku University, Sendai, Japan.
Hideki OrigasaDivision of Biostatistics and Clinical Epidemiology, The University of Toyama Graduate School of Medicine, Toyama, Japan.
Shinsuke YasudaHokkaido University Graduate School of Medicine, Sapporo, Japan.
Yuji YamanishiHiroshima Rheumatology Clinic, Hiroshima, Japan.
Yasuhiko KitaYokohama Rosai Hospital, Yokohama, Japan.
Tsukasa MatsubaraMatsubara Mayflower Hospital, Kato, Japan.
Masahiro IwamotoDivision of Rheumatology and Clinical Immunology, Jichi Medical University, Tochigi, Japan.
Toshiharu ShojiUCB Pharma, Tokyo, Japan.
Osamu TogoUCB Pharma, Tokyo, Japan.
Toshiyuki OkadaAstellas Pharma Inc., Tokyo, Japan.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-5781-158X
Nobuyuki MiyasakaDepartment of Rheumatology, Tokyo Medical and Dental University, Tokyo, Japan.
Takao KoikeHokkaido University Graduate School of Medicine, Sapporo, Japan.
Hokkaido University · JPUCB Pharma (Japan) · JPAstellas Pharma (Japan) · JPJichi Medical University · JPKeio University · JPLeiden University Medical Center · NLMatsubara Mayflower Hospital · JPNagoya University · JPSasebo City General Hospital · JPThe University of Tokyo · JPTohoku University · JPTokyo Medical and Dental University · JPTokyo Women's Medical University · JPUniversity of Occupational and Environmental Health Japan · JPUniversity of Toyama · JPYokohama Rosai Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year methotrexate (MTX) therapy, compared with 2-year therapy with MTX alone.

methodsMTX-naïve patients with early rheumatoid arthritis (RA) with poor prognostic factors were eligible to enter Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA), a multicentre, randomised, controlled study, which consisted of a 52-week double-blind (DB) period and subsequent 52-week post treatment (PT) period. Patients were randomised to optimised MTX+CZP (n=159) or optimised MTX+placebo (PBO; n=157). Following the DB period, patients entered the PT period, receiving MTX alone (CZP+MTX→MTX; n=108, PBO+MTX→MTX; n=71). Patients who flared could receive rescue treatment with open-label CZP.

results34 CZP+MTX→MTX patients and 14 PBO+MTX→MTX patients discontinued during the PT period. From week 52 through week 104, significant inhibition of total modified total Sharp score progression was observed for CZP+MTX versus PBO+MTX (week 104: 84.2% vs 67.5% (p<0.001)). Remission rates decreased after CZP discontinuation; however, higher rates were maintained through week 104 in CZP+MTX→MTX versus PBO+MTX→MTX (41.5% vs 29.3% (p=0.026), 34.6% vs 24.2% (p=0.049) and 41.5% vs 33.1% (p=0.132) at week 104 in SDAI, Boolean and DAS28(erythrocyte sedimentation rate) remission. CZP retreated patients due to flare (n=28) showed rapid clinical improvement. The incidence of overall adverse events was similar between groups.

conclusionsIn MTX-naïve patients with early RA with poor prognostic factors, an initial 1 year of add-on CZP to 2-year optimised MTX therapy brings radiographic and clinical benefit through 2 years, even after stopping CZP. TRIAL REGISTRATION NUMBER: NCT01451203.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidCertolizumab PegolDeprescriptionsDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationEarly Medical InterventionFemaleHumansMaleMethotrexateMiddle AgedPrognosisRemission InductionAntirheumatic AgentsCertolizumab PegolMethotrexateAnti-TNFDMARDs (biologic)Early Rheumatoid ArthritisMethotrexate

Identifiers

PMID28153828
PMCPMC5738604
OpenAlexW2583802323

What OpenQuestion holds

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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.