Evidence map›Paper›PMID 26474452›Full record

Trial reportArthritis care & research2016

Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.

Paul Emery, Roy M Fleischmann, Ingrid Strusberg, Patrick Durez, Peter Nash, Eric Jason B Amante, Melvin Churchill, Won Park, Bernardo Pons-Estel, Chenglong Han and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis care & research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 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.

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

23 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
  4. Trial
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  6. Trial
  7. Review
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  9. Article
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  14. Current and Emerging DMARDs for the Treatment of Rheumatoid Arthritis.Open access rheumatology : research and reviews · 2021
    Review
  15. Review
  16. Review
  17. Golimumab for Rheumatoid Arthritis.Journal of clinical medicine · 2019
    Review
  18. Article
  19. Observational
  20. Observational
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

15 authors.

Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Hospitals NHS Trust, Leeds, UK.
Roy M FleischmannUniversity of Texas and Southwest Medical Center, Dallas, Texas.
Ingrid StrusbergInstituto Reumatológico Strusberg, Córdoba, Argentina.
Patrick DurezService et Pôle de Rhumatologie, Cliniques Universitaires Saint-Luc, and Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.
Peter NashUniversity of Queensland, Queensland, Australia.
Eric Jason B AmanteUniversity of the Philippines General Hospital, Manila, Philippines.
Melvin ChurchillArthritis Center of Nebraska, Lincoln.
Won ParkInha University Hospital, Incheon, South Korea.
Bernardo Pons-EstelSanatorio Parque, Santa Fe, Argentina.
Chenglong HanJanssen Global Services, LLC, Malvern, Pennsylvania.
Timothy A GathanyJanssen Global Services, LLC, Malvern, Pennsylvania.
Stephen XuJanssen Research & Development, Spring House, Pennsylvania.
Yiying ZhouJanssen Research & Development, Spring House, Pennsylvania.
Jocelyn H LeuJanssen Research & Development, Spring House, Pennsylvania.
Elizabeth C HsiaJanssen Research & Development, Spring House, Pennsylvania, and University of Pennsylvania School of Medicine, Philadelphia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and efficacy of golimumab through 5 years in adults with active rheumatoid arthritis (RA) who had not previously received methotrexate (MTX).

methodsIn the GO-BEFORE study, 637 MTX-naive adult patients with active RA were randomized (1:1:1:1) to placebo + MTX (group 1), golimumab 100 mg + placebo (group 2), golimumab 50 mg + MTX (group 3), or golimumab 100 mg + MTX (group 4). Inadequate responders in groups 1, 2, and 3 entered early escape at week 28 to golimumab 50 mg + MTX, golimumab 100 mg + MTX, or golimumab 100 mg + MTX, respectively; remaining patients in group 1 could cross over to golimumab 50 mg + MTX at week 52. Assessments included the American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) response, the Disease Activity Score in 28 joints (DAS28) using C-reactive protein (CRP) level, and the modified Sharp/van der Heijde score (SHS). Efficacy was analyzed using an intent-to-treat (ITT) analysis. Pharmacokinetics and immunogenicity were evaluated at selected visits.

resultsA total of 422 patients completed golimumab treatment through week 256. At week 256, 72.8%, 54.6%, and 38.0% of all patients in the full ITT population (n = 637) had an ACR20/50/70 response, respectively; 84.1% had a good or moderate DAS28-CRP response; and 72.7% had a clinically meaningful improvement in physical function. Radiographic progression was minimal in all treatment groups through week 256, and the overall mean change from baseline in SHS was 1.36. Serum trough golimumab concentrations were approximately dose proportional and maintained through week 256. Antibodies to golimumab occurred in 9.6% of patients through week 256. Infections were the most common type of adverse event (AE); 204 of 616 patients (33.1%) had ≥1 serious AE.

conclusionClinical efficacy with golimumab treatment was maintained through week 256 of the GO-BEFORE trial of MTX-naive RA patients. No unexpected AEs occurred; safety results through 5 years are consistent with earlier reports.

Indexed as

AdultAgedAntibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesHumansInjections, SubcutaneousMaleMethotrexateMiddle AgedTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsgolimumabMethotrexate

Identifiers

PMID26474452
PMCPMC5089605

What OpenQuestion holds

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Registered trials

None linked

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.