Evidence map›Paper›PMID 23897769›Full record

Trial reportAnnals of the rheumatic diseases2014

Insights into the efficacy of golimumab plus methotrexate in patients with active rheumatoid arthritis who discontinued prior anti-tumour necrosis factor therapy: post-hoc analyses from the GO-AFTER study.

Josef S Smolen, Jonathan Kay, Eric L Matteson, Robert Landewé, Elizabeth C Hsia, Stephen Xu, Yiying Zhou, Mittie K Doyle

Abstract readRandomized Controlled Trial
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. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

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

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
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  8. Review
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  15. Article
  16. Golimumab in unresponsive ulcerative colitis.Biologics : targets & therapy · 2014
    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

8 authors.

Josef S SmolenDivision of Rheumatology, Department of Medicine III, Medical University of Vienna, and 2nd Department of Medicine, Hietzing Hospital, Vienna, Austria.
Jonathan KayDivision of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
Eric L MattesonDivision of Rheumatology, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.
Robert LandewéDivision of Rheumatology, Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, The Netherlands.
Elizabeth C HsiaClinical Immunology, Janssen Research & Development, LLC., Spring House Pennsylvania, USA Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Stephen XuBiologics Biostatistics, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA.
Yiying ZhouBiologics Biostatistics, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA.
Mittie K DoyleTranslational Medicine Group, Alexion Pharmaceuticals, Cambridge, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveEvaluate golimumab in patients with active rheumatoid arthritis (RA) and previous tumour necrosis factor-α (TNF) inhibitor use.

methodsPatients (n=461) previously receiving ≥1 TNF inhibitor were randomised to subcutaneous injections of placebo, golimumab 50 mg or golimumab 100 mg q4 weeks. Primary endpoint (≥20% improvement in American College of Rheumatology (ACR20) criteria at week 14) findings have been reported for all patients in the trial. Reported herein are further assessments of efficacy/safety among patients receiving golimumab+methotrexate (MTX).

resultsAmong efficacy-evaluable patients who received MTX at baseline, more receiving golimumab+MTX (n=201) than placebo+MTX (n=103) achieved ACR20 (40.8% vs 14.6%), ACR50 (20.9% vs 3.9%), and ACR70 (11.4% vs 2.9%) responses at week 24. Among the 137 patients who had received only one prior TNF inhibitor (adalimumab, n=33; etanercept, n=47; and infliximab, n=57), week 24 ACR20 rates were 30.3%, 46.8% and 50.9%, respectively, and thus lowest among those who previously used adalimumab. ACR20 response rates were 44.5% (61/137), 36.2% (17/47) and 23.5% (4/17) among patients who had received one, two or three TNF inhibitors, respectively. Adverse event (AE) rates were comparable across type/number of prior anti-TNF agents, but appeared somewhat higher among patients who discontinued previous TNF inhibitor(s) due to intolerance (37/49, 75.5%) versus lack of efficacy (LOE, 113/191, 59.2%).

conclusionsPatients with active RA previously treated with ≥1 TNF inhibitor had clinically relevant improvement with golimumab+MTX, which appeared somewhat enhanced among those who received only etanercept or infliximab as their prior TNF inhibitor. Golimumab+MTX safety appeared similar across patients, regardless of TNF inhibitor(s) previously used, with fewer AEs occurring among patients who discontinued prior therapy for LOE.

Indexed as

AdalimumabAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDrug Administration ScheduleDrug SubstitutionDrug Therapy, CombinationEtanerceptFemaleHumansImmunoglobulin GInfliximabInjections, SubcutaneousAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsEtanerceptgolimumabImmunoglobulin GInfliximabMethotrexateReceptors, Tumor Necrosis FactorTumor Necrosis Factor-alphaAnti-TNFDAS28Rheumatoid Arthritis

Identifiers

PMID23897769
PMCPMC4173740

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.