Evidence map›Paper›PMID 25387477›Full record

Trial reportAnnals of the rheumatic diseases2015

Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year results of the GO-RAISE study.

Atul Deodhar, Jürgen Braun, Robert D Inman, Désirée van der Heijde, Yiying Zhou, Stephen Xu, Chenglong Han, Benjamin Hsu

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00265083 (A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis), which is not on this map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 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.

NCT00265083 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorCentocor, Inc.Ran2005 to 2012Enrolled356ConditionsSpondylitis, AnkylosingArmsgolimumab, Golimumab (CNTO 148), placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Patients with ankylosing spondylitis treatment by golimumab: a systematic review and meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2020
    Pooled it
  3. Pooled it
  4. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
    Pooled it
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  19. Skin manifestations in spondyloarthritis.Therapeutic advances in musculoskeletal disease · 2020
    Review
  20. Article
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.

Atul DeodharDivision of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.
Jürgen BraunDepartment of Rheumatology, Rheumazentrum Ruhrgebiet, Herne, Germany.
Robert D InmanDepartments of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-5781-158X
Yiying ZhouDepartment of Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Stephen XuDepartment of Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Chenglong HanPatient Reported Outcomes, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
Benjamin HsuDepartment of Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAssess golimumab efficacy/safety through 5 years in patients with active ankylosing spondylitis (AS).

methods356 patients with AS were randomly assigned to placebo, golimumab 50 mg or 100 mg every 4 weeks. At week 16, patients with inadequate response early escaped with blinded dose adjustments (placebo to 50 mg, 50 mg to 100 mg). At week 24, all patients receiving placebo crossed over to 50 mg. Blinded active therapy continued through week 104; from week 104 to week 252, the golimumab dose could be adjusted. Intent-to-treat and observed efficacy data were assessed by randomised treatment groups.

resultsAt week 256, and with >4.5 years of golimumab, overall intent-to-treat Assessment in SpondyloArthritis international Society criteria for 20% improvement (ASAS20) and ASAS40 response rates were 66.0% (235/356) and 57.0% (203/356), respectively; Bath AS Disease Activity Index 50% improvement response was 55.9% (199/356). Observed response rates among the 255 (72%) patients who continued golimumab through week 252 were consistent, albeit somewhat higher. Among patients who increased golimumab from 50 to 100 mg, 60.6% (20/33) and 44.7% (17/38) achieved ASAS20/ASAS40 responses, respectively, following ≥2 consecutive doses of golimumab 100 mg. Golimumab safety through week 268 was similar to that through week 24 regardless of dose.

conclusionsClinical improvements observed in patients treated with golimumab through week 24 were sustained through week 256 (5 years). Long-term golimumab safety is consistent with that of other established tumour-necrosis-factor-antagonists. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT00265083.

Indexed as

Antibodies, MonoclonalAntirheumatic AgentsDouble-Blind MethodHumansInjections, SubcutaneousLongitudinal StudiesSpondylitis, AnkylosingTreatment OutcomeAntibodies, MonoclonalAntirheumatic Agentsgolimumab

Identifiers

PMID25387477
PMCPMC4392310

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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.