Evidence map›Paper›PMID 26474192›Full record

Trial reportModern rheumatology2016

Clinical efficacy, radiographic progression, and safety through 156 weeks of therapy with subcutaneous golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis despite prior methotrexate therapy: final results of the randomized GO-FORTH trial.

Yoshiya Tanaka, Masayoshi Harigai, Tsutomu Takeuchi, Hisashi Yamanaka, Naoki Ishiguro, Kazuhiko Yamamoto, Nobuyuki Miyasaka, Takao Koike, Daniel Baker, Yutaka Ishii and 2 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Modern rheumatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

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

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Observational
  8. 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

12 authors.

Yoshiya Tanakaa The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health, Japan , Kitakyushu , Japan .
Masayoshi Harigaib Department of Pharmacovigilance , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan .
Tsutomu Takeuchic Division of Rheumatology, Department of Internal Medicine , School of Medicine, Keio University , Tokyo , Japan .
Hisashi Yamanakad Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan .
Naoki Ishiguroe Department of Orthopedic Surgery , Graduate School & Faculty of Medicine, Nagoya University , Nagoya , Japan .
Kazuhiko Yamamotof Department of Allergy and Rheumatology , Graduate School of Medicine, The University of Tokyo , Tokyo , Japan .
Nobuyuki Miyasakag Department of Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan .
Takao Koikeh NTT Sapporo Medical Center and Department of Medicine II , Hokkaido University Graduate School of Medicine , Sapporo , Japan .
Daniel Bakeri Janssen Research & Development, LLC, Spring House , PA , USA .
Yutaka Ishiij Janssen Pharmaceutical K.K. , Tokyo , Japan , and.
Toru Yoshinarik Development Planning and Coordination Department , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.
GO-FORTH study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and efficacy of golimumab + methotrexate (MTX) in Japanese patients with active rheumatoid arthritis (RA).

methodsJapanese patients with active RA despite MTX were randomized to placebo + MTX (Group 1, n = 88), golimumab 50 mg + MTX (Group 2, n = 86), or golimumab 100 mg + MTX (Group 3, n = 87). Patients with <20% improvement in swollen/tender joint counts entered early escape at week 16. At week 24, all remaining placebo patients crossed over to golimumab 50 mg. Efficacy assessments included ACR20, DAS28-ESR, and HAQ-DI. Radiographic progression was assessed with the van der Heijde-modified Sharp (vdH-S) score.

resultsACR20 response rates in Group 1, Group 2, and Group 3 were 67.9, 86.1, and 82.4%, respectively, at week 52 and were maintained through week 104 (87.1, 94.0, and 88.7%) and week 156 (97.1, 94.1, and 89.5%). Proportions of patients with good/moderate DAS28-ESR response or clinically meaningful improvement in HAQ-DI were also maintained through week 156. The majority of patients did not experience radiographic progression through week 156. Among 257 golimumab-treated patients, 251 (97.7%) had ≥1 AE; 54 (21.0%) had ≥1 serious AE through week 156. Infections were the most common type of AE.

conclusionsResponse to golimumab + MTX was maintained over 3 years in Japanese patients with active RA despite MTX. Safety results were consistent with the known safety profile of golimumab.

Indexed as

Antibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidCross-Over StudiesDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationFoot JointsHand JointsHumansMethotrexateRadiographyTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsgolimumabMethotrexateAnti-tumor necrosis factorAsianGolimumabRheumatoid arthritis

Identifiers

PMID26474192
PMCPMC4924564

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.