Evidence map›Paper›PMID 25627338›Full record

Trial reportArthritis research & therapy2015

Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study.

Josef S Smolen, Jonathan Kay, Mittie Doyle, Robert Landewé, Eric L Matteson, Norman Gaylis, Jürgen Wollenhaupt, Frederick T Murphy, Stephen Xu, Yiying Zhou and 1 more

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

Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00299546 (A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 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.

NCT00299546 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)

TypeinterventionalSponsorCentocor, Inc.Ran2006 to 2012Enrolled461ConditionsArthritis, RheumatoidArmsPlacebo, Golimumab 50 mg, Golimumab 100 mg
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Golimumab for Rheumatoid Arthritis.Journal of clinical medicine · 2019
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. 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

11 authors.

Josef S SmolenDepartment of Medicine, Medical University of Vienna, Hietzing Hospital, Vienna, Austria. josef.smolen@wienkav.at.
Jonathan KayUniversity of Massachusetts Medical School and UMass Memorial Center, Rheumatology Center, Memorial Campus, 119 Belmont Street, Worcester, MA, 01605, USA. jonathan.kay@umassmemorial.org.
Mittie DoyleTranslational Medicine Group, Alexion Pharmaceuticals, 75 Sidney Street, Cambridge, MA, 02139, USA. mittiekdoyle@hotmail.com.
Robert LandewéAcademic Medical Center/University of Amsterdam & Atrium Medical Center Heerlen, Henri Dunantstraat 5, Heerlen, PC, 6419, The Netherlands. landewe@rlandewe.nl.
Eric L MattesonDivisions of Rheumatology and Epidemiology, Mayo Clinic College of Medicine, 200 1st St. S.W., Rochester, MN, 55905, USA. matteson.eric@mayo.edu.
Norman GaylisArthritis & Rheumatic Disease Specialties, 21097 NE 27th Court, Suite 200, Aventura, FL, 33180, USA. ngaylis@aol.com.
Jürgen WollenhauptSchoen Klinik Hamburg Eilbek, Dehnhaide 120, Hamburg, 22081, Germany. j.wollenhaupt@t-online.de.
Frederick T MurphyAltoona Center of Clinical Research, 175 Meadowbrook Lane, PO Box 1018, Duncansville, PA, 16635, USA. ftmurphy8@gmail.com.
Stephen XuJanssen Research & Development, LLC, 1400 McKean Road, PO Box 776, Spring House, PA, 19477, USA. sxu2@its.jnj.com.
Yiying ZhouJanssen Research & Development, LLC, 1400 McKean Road, PO Box 776, Spring House, PA, 19477, USA. yzhou45@its.jnj.com.
Elizabeth C HsiaDivision of Rheumatology, University of Pennsylvania Medical School and Hospital of the University of Pennsylvania, Perelman Center 1 South, 3400 Civic Center Blvd., Philadelphia, PA, 19104, USA. ehsia@its.jnj.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor-α (TNF)-inhibitor(s).

methodsPatients enrolled into this multicenter, randomized, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) received placebo (Group 1) or golimumab 50 mg (Group 2) or 100 mg (Group 3) injections every 4 weeks. Patients in Groups 1 and 2 with inadequate response at week 16 escaped to golimumab 50 and 100 mg, respectively. At week 24, Group 1 patients crossed-over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status, and Group 3 maintained dosing. During the long-term-extension (LTE), golimumab 50 mg could be increased to 100 mg, and 100 mg could be decreased to 50 mg. Data through 5 years are reported for all patients (safety) and patients using methotrexate (efficacy, intention-to-treat (ITT) analysis with last-observation-carried-forward for missing data and non-responder imputation for unsatisfactory efficacy discontinuations).

resultsIn total, 459 of 461 randomized patients received the study agent, 304 of whom were methotrexate-treated and included in efficacy analyses. Through week 256, the proportions of methotrexate-treated patients achieving American-College-of-Rheumatology (ACR) responses were 37.6% to 47.0% for ACR20, 21.4% to 35.0% for ACR50, and 7.8% to 17.0% for ACR70 response across randomized groups. Golimumab safety through week 268 was generally consistent with that at week 24 and week 160 and other anti-TNF agents.

conclusionsIn some patients with active RA discontinuing previous TNF-antagonist therapy, golimumab safety and efficacy, assessed conservatively with ITT analyses, was confirmed through 5 years.

trial registrationClinicaltrials.gov NCT00299546 . Registered 03 March 2006.

Indexed as

Antibodies, MonoclonalArthritis, RheumatoidDouble-Blind MethodHumansImmunologic FactorsTreatment OutcomeTumor Necrosis Factor-alphaAntibodies, MonoclonalgolimumabImmunologic FactorsTumor Necrosis Factor-alpha

Identifiers

PMID25627338
PMCPMC4382834

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.