Evidence map›Paper›PMID 30602032›Full record

Trial reportRheumatology (Oxford, England)2019

Efficacy of denosumab with regard to bone destruction in prognostic subgroups of Japanese rheumatoid arthritis patients from the phase II DRIVE study.

Naoki Ishiguro, Yoshiya Tanaka, Hisashi Yamanaka, Toshiyuki Yoneda, Takeshi Ohira, Naoki Okubo, Harry K Genant, Désirée van der Heijde, Tsutomu Takeuchi

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% of its field
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

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

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Update on Glucocorticoid Induced Osteoporosis.Endocrinology and metabolism (Seoul, Korea) · 2021
    Article
  8. Article
  9. Article
  10. Review
  11. 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

9 authors at 8 institutions in 4 countries.

Naoki IshiguroDepartment of Orthopaedics, Nagoya University Graduate School of Medicine, Nagoya, Aichi.
Yoshiya TanakaFirst Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu.
Hisashi YamanakaInstitute of Rheumatology, Tokyo Women's Medical University, Tokyo.
Toshiyuki YonedaDepartment of Biochemistry, Osaka University Graduate School of Dentistry, Osaka.
Takeshi OhiraDaiichi-Sankyo Co., Ltd, Tokyo, Japan.
Naoki OkuboDaiichi-Sankyo Co., Ltd, Tokyo, Japan.
Harry K GenantDepartments of Radiology, Medicine and Orthopaedic Surgery, University of California, San Francisco, CA, USA.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.
Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Daiichi-Sankyo (Japan) · JPInstitute of Rheumatology · CZKeio University · JPLeiden University Medical Center · NLNagoya University · JPOsaka University · JPUniversity of California, San Francisco · USUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy of denosumab for progressive bone erosion in risk factor subgroups of Japanese RA patients.

methodsThis study included 340 RA patients on MTX from the dose-response study of Denosumab in patients with RheumatoId arthritis on methotrexate to Validate inhibitory effect on bone Erosion (DRIVE study-a 12-month, multicentre, randomized, double-blind, placebo-controlled, phase II study). The patients were randomized to receive placebo or denosumab 60 mg every 6 months, 3 months or 2 months. Subgroup analyses involved baseline RF, ACPA, swollen joint count, CRP level, RA duration, ESR and glucocorticoid use.

resultsPatients with risk factor positivity generally showed consistent results for the primary endpoint of the change in the modified Sharp erosion score at 12 months from baseline. In the placebo, every 6 months, every 3 months and every 2 months groups, the mean changes in the erosion score, according to the RF status (RF-positive vs -negative subgroups), were 1.18 vs 0.59, 0.25 (P = 0.0601 vs placebo) vs 0.31 (P = 0.0827), 0.21 (P = 0.0422) vs -0.02 (P = 0.0631) and 0.15 (P = 0.0010) vs -0.05 (P = 0.0332), respectively, while the mean changes in the erosion score, according to the ACPA status (ACPA-positive vs -negative subgroups), were 1.30 vs 0.07, 0.26 (P = 0.0142) vs 0.33 (P = 0.2748), 0.16 (P = 0.0058) vs 0.08 (P = 0.7166) and 0.09 (P < 0.0001) vs 0.08 (P = 0.8939), respectively.

conclusionDenosumab is a potentially useful treatment option for RA patients who are positive for RF, ACPA and other possible risk factors.

trial registrationJAPIC Clinical Trials Information, http://www.clinicaltrials.jp/user/cteSearch_e.jsp, JapicCTI-101263.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidBone DensityBone Density Conservation AgentsBone ResorptionDenosumabDisease ProgressionDouble-Blind MethodFemaleHumansJapanMaleMethotrexateMiddle AgedAntirheumatic AgentsBone Density Conservation AgentsDenosumabMethotrexateRheumatoid Factoranti-cyclic citrullinated peptide antibodybone erosiondenosumabrheumatoid arthritisrheumatoid factorsubgroup analysis

Identifiers

PMID30602032
PMCPMC6532444
OpenAlexW2908389029

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.