Evidence map›Paper›PMID 23740226›Full record

Trial reportAnnals of the rheumatic diseases2014

Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study.

Bernard Combe, Bhaskar Dasgupta, Ingrid Louw, Sarvajeet Pal, Jürgen Wollenhaupt, Cristiano A F Zerbini, Andre D Beaulieu, Hendrik Schulze-Koops, Patrick Durez, Ruji Yao and 3 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00975130 (An Open-Label Study Assessing the Addition of Subcutaneous Golimumab), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT00975130 phase3completednot on this map

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2009 to 2012Enrolled3,366ConditionsArthritis, RheumatoidArmsSC golimumab, IV golimumab
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Golimumab for Rheumatoid Arthritis.Journal of clinical medicine · 2019
    Review
  7. Article
  8. Predictive factors related to the efficacy of golimumab in patients with rheumatoid arthritis.Clinical medicine insights. Arthritis and musculoskeletal disorders · 2015
    Article
  9. Review
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

13 authors.

Bernard CombeHôpital Lapeyronie, Hôpital Lapeyronie, Université Montpellier I, Montpellier, France.
Bhaskar DasguptaSouthend University Hospital, Westcliff-on-Sea, UK.
Ingrid LouwPanorama Medical Centre, Cape Town, South Africa.
Sarvajeet PalAdvance Rheumatology Clinic, Hyderabad, India.
Jürgen WollenhauptSchön Klinik Hamburg-Eilbek, Hamburg, Germany.
Cristiano A F ZerbiniHospital Heliópolis, Serviço de Reumatologia, São Paulo, Brazil.
Andre D BeaulieuCentre de Rhumatologie, St-Louis, Québec, Canada.
Hendrik Schulze-KoopsRheumaeinheit, Med. Klinik and Poliklinik IV, University of Munich, Munich, Germany.
Patrick DurezService et Pôle de Rhumatologie, Cliniques Universitaires Saint-Luc, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Brussels, Belgium.
Ruji YaoMerck Sharp and Dohme, Kenilworth, New Jersey, USA.
Nathan VastesaegerMerck Sharp and Dohme, Brussels, Belgium.
Haoling H WengMerck Sharp and Dohme, Kenilworth, New Jersey, USA.
GO-MORE Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy and safety of subcutaneous golimumab as add-on therapy in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) treatment. To evaluate an intravenous plus subcutaneous (IV+SC) golimumab strategy in patients who had not attained remission.

methodsGO-MORE was an open-label, multinational, prospective study in patients with active RA in typical clinical practice settings. In part 1, patients received add-on monthly 50-mg subcutaneous golimumab for 6 months. The percentage of patients with good/moderate European League Against Rheumatism (EULAR) 28-joint disease activity score (DAS28)-erythrocyte sedimentation rate (ESR) response was compared in patient subgroups with various concurrent or previous DMARD treatments. In part 2, patients with EULAR responses but not remission were randomly assigned to receive IV+SC or subcutaneous golimumab to month 12; DAS28-ESR remission was measured.

results3366 patients were enrolled. At baseline of part 1, 3280 efficacy-evaluable patients had mean disease duration of 7.6 years and mean DAS28-ESR of 5.97 (SD=1.095). At month 6, 82.1% achieved good/moderate EULAR responses and 23.9% attained remission. When EULAR responses were analysed by the number of previously failed DMARD or the concomitant methotrexate dose, DMARD type, or corticosteroid use, no statistically significant differences were observed. Part 2 patients (N=490) who received IV+SC or subcutaneous golimumab achieved similar remission rates (∼25%). Adverse events were consistent with previous reports of golimumab and other tumour necrosis antagonists in this population.

conclusionsAdd-on monthly subcutaneous golimumab resulted in good/moderate EULAR response in most patients; 25% achieved remission after 6 more months of golimumab, but an IV+SC regimen provided no additional efficacy over the subcutaneous regimen.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidDrug Therapy, CombinationFemaleHumansInjections, IntravenousInjections, SubcutaneousMaleMiddle AgedProspective StudiesSeverity of Illness IndexAntibodies, MonoclonalAntirheumatic AgentsgolimumabDMARDs (biologic)MethotrexateRheumatoid Arthritis

Identifiers

PMID23740226
PMCPMC4112444

What OpenQuestion holds

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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.