Evidence map›Paper›PMID 27114562›Full record

Trial reportRheumatology (Oxford, England)2016

Prediction of remission and low disease activity in disease-modifying anti-rheumatic drug-refractory patients with rheumatoid arthritis treated with golimumab.

Nathan Vastesaeger, Abraham Garcia Kutzbach, Howard Amital, Karel Pavelka, María Alicia Lazaro, Robert J Moots, Jürgen Wollenhaupt, Cristiano A F Zerbini, Ingrid Louw, Bernard Combe and 8 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Rheumatology (Oxford, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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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

18 authors.

Nathan VastesaegerDepartment of Medical Affairs, MSD Danmark ApS, Ballerup, Denmark nathan.vastesaeger@merck.com.
Abraham Garcia KutzbachDepartment of Rheumatology, AGAR Francisco Marroquin University, Guatemala City, Guatemala.
Howard AmitalDepartment of Internal Medicine B and Research Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel.
Karel PavelkaInstitute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic.
María Alicia LazaroInstituto de Asistencia Reumatologica Integral, Buenos Aires, Argentina.
Robert J MootsDepartment of Rheumatology, Clinical Sciences Centre, University Hospital Aintree, Liverpool, UK.
Jürgen WollenhauptDepartment of Rheumatology, Klinik für Rheumatologie, Schön Klinik Hamburg-Eilbek, Hamburg, Germany.
Cristiano A F ZerbiniDepartment of Rheumatology, Centro Paulista de Investigação Clinica, São Paulo, Brazil.
Ingrid LouwPanorama Medical Centre, Cape Town, South Africa.
Bernard CombeDepartement de Rhumatologie, Hôpital Lapeyronie, Montpellier University Hospital, Montpellier, France.
Andre BeaulieuCentre de Rhumatologie St-Louis, Québec, Canada.
Hendrik Schulze-KoopsDivision of Rheumatology and Clinical Immunology, Department of Medicine IV, University of Munich, Munich, Germany.
Bhaskar DasguptaDepartment of Rheumatology, Southend University Hospital, Westcliff-on-Sea, Essex, UK.
Bo FuDepartment of Biostatistics.
Susan HuyckDepartment of Biostatistics.
Haoling H WengClinical Development, Merck & Co, Inc., Kenilworth, NJ, USA.
Marinella GovoniDepartment of Immunology, MSD Italy, Global Medical Affairs, Rome, Italy.
Patrick DurezDepartment of Rheumatology, Université Catholique de Louvain, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo create a tool to predict probability of remission and low disease activity (LDA) in patients with RA being considered for anti-TNF treatment in clinical practice.

methodsWe analysed data from GO-MORE, an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ⩾3.2) despite DMARD therapy. Patients received 50 mg s.c. golimumab (GLM) once monthly for 6 months. In secondary analyses, regression models were used to determine the best set of baseline factors to predict remission (DAS28-ESR <2.6) at month 6 and LDA (DAS28-ESR ⩽3.2) at month 1.

resultsIn 3280 efficacy-evaluable patients, of 12 factors included in initial regression models predicting remission or LDA, six were retained in final multivariable models. Greater likelihood of LDA and remission was associated with being male; younger age; lower HAQ, ESR (or CRP) and tender joint count (or swollen joint count) scores; and absence of comorbidities. In models predicting 1-, 3- and 6-month LDA or remission, area under the receiver operating curve was 0.648-0.809 (R(2) = 0.0397-0.1078). The models also predicted 6-month HAQ and EuroQoL-5-dimension scores. A series of matrices were developed to easily show predicted rates of remission and LDA.

conclusionA matrix tool was developed to show predicted GLM treatment outcomes in patients with RA, based on a combination of six baseline characteristics. The tool could help provide practical guidance in selection of candidates for anti-TNF therapy.

Indexed as

Antibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidChronic DiseaseFemaleHumansMaleMiddle AgedPredictive Value of TestsProspective StudiesRegression AnalysisRemission InductionTreatment OutcomeAntibodies, MonoclonalAntirheumatic Agentsgolimumabbiologicpredictors of responseremissionrheumatoid arthritistumour necrosis factor

Identifiers

PMID27114562
PMCPMC4957672

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Registered trials

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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.