Evidence map›Paper›PMID 26635183›Full record

ArticleModern rheumatology2016

Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis.

Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Tsuneyo Mimori, Junnosuke Ryu, Syuji Takei, Tsutomu Takeuchi, Yoshiya Tanaka, Yoshinari Takasaki, Hisashi Yamanaka and 3 more

Abstract read
In one paragraph

Article in Modern rheumatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing 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

32 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Observational
  6. Article
  7. Review
  8. Article
  9. Research Advances in Fusion Protein-Based Drugs for Diabetes Treatment.Diabetes, metabolic syndrome and obesity : targets and therapy · 2024
    Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Prevalence of adverse reactions to intravenously administered originator biologics in patients with rheumatoid arthritis: A 5-year retrospective study.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Observational
  20. Observational
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

13 authors.

Masayoshi Harigaia Graduate School of Medical and Dental Sciences , Tokyo Medical and Dental University , Tokyo , Japan .
Naoki Ishigurob Graduate School & Faculty of Medicine , Nagoya University , Nagoya , Japan .
Shigeko Inokumac Chiba Central Medical Center , Chiba , Japan .
Tsuneyo Mimorid Kyoto University Graduate School of Medicine , Kyoto , Japan .
Junnosuke Ryue Nihon University School of Medicine , Tokyo , Japan .
Syuji Takeif Faculty of Medicine, School of Health Sciences , Kagoshima University , Kagoshima , Japan .
Tsutomu Takeuchig Keio University School of Medicine , Tokyo , Japan .
Yoshiya Tanakah University of Occupational and Environmental Health , Fukuoka , Japan .
Yoshinari Takasakii Juntendo University School of Medicine , Tokyo , Japan .
Hisashi Yamanakaj Tokyo Women's Medical University , Tokyo , Japan .
Masahiko Watanabek Bristol-Myers K.K. , Tokyo , Japan .
Hiroshi Tamadak Bristol-Myers K.K. , Tokyo , Japan .
Takao Koikel NTT Sapporo Medical Center Minami , Sapporo , Japan , and.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo perform a postmarketing surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA).

methodsSafety and effectiveness data were collected for all RA patients (at 772 sites) treated with intravenous abatacept between September 2010 and June 2011. Patients were treated by the approved dosing regimen according to the package insert. Treatment effectiveness was evaluated at baseline and at weeks 4, 12, and 24 using Disease Activity Score 28 (DAS28) according to erythrocyte sedimentation rate or serum C-reactive protein concentrations.

resultsOverall, 3882 and 3016 abatacept-naïve RA patients were included in safety and effectiveness analyses, respectively. Adverse drug reactions (ADRs) were reported for 15.66% of patients and serious ADRs were detected for 2.52% of patients. The incidence of serious infections was 1.03% and these were mainly attributed to different types of bacterial pneumonia. Disease activity improved significantly over 6 months. Separate multivariate analysis identified predictors of severe ADR, and severe infections and factors predictive of clinically meaningful DAS28 improvement after 6 months of treatment with abatacept.

conclusionsAbatacept was efficacious and well tolerated in a clinical setting. No new safety concerns were detected.

Indexed as

AbataceptAgedAntirheumatic AgentsArthritis, RheumatoidBlood SedimentationC-Reactive ProteinFemaleHumansJapanMaleMiddle AgedProduct Surveillance, PostmarketingTreatment OutcomeAbataceptAntirheumatic AgentsC-Reactive ProteinAbataceptJapanPMSRheumatoid arthritisSafety

Identifiers

PMID26635183
PMCPMC4898160

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.