Evidence map›Paper›PMID 26054418›Full record

Trial reportModern rheumatology2016

Efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus and lupus nephritis who are refractory to conventional therapy.

Yoshiya Tanaka, Tsutomu Takeuchi, Nobuyuki Miyasaka, Takayuki Sumida, Tsuneyo Mimori, Takao Koike, Kazuhiro Endo, Naomi Mashino, Kazuhiko Yamamoto

Abstract readClinical Trial, Phase IIMulticenter Study
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 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

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

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

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Rituximab Dosing in Glomerular Diseases: A Scoping Review.Canadian journal of kidney health and disease · 2022
    Article
  11. Article
  12. Article
  13. Observational
  14. Review
  15. Article
  16. 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.

Yoshiya Tanakaa The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health Japan , Kitakyushu , Japan.
Tsutomu Takeuchib Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.
Nobuyuki Miyasakac Department of Medicine and Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan.
Takayuki Sumidad Division of Clinical Immunology, Doctoral Program in Clinical Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba , Ibaraki , Japan.
Tsuneyo Mimorie Department of Rheumatology and Clinical Immunology , Graduate School of Medicine, Kyoto University , Kyoto , Japan.
Takao Koikef NTT-East Sapporo Medical Center , Sapporo , Japan.
Kazuhiro Endog Zenyaku Kogyo Co., Ltd ., Tokyo Japan.
Naomi Mashinog Zenyaku Kogyo Co., Ltd ., Tokyo Japan.
Kazuhiko Yamamotoh Department of Allergy and Rheumatology , Graduate School of Medicine, The University of Tokyo , Tokyo , Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN) who are refractory to conventional immunosuppressive therapy.

methodsEligible patients received rituximab at a dose of 1,000 mg at days 1, 15, 169, and 183, and were followed for 53 weeks after the first dose of rituximab. Overall disease activity was assessed monthly using a British Isles Lupus Assessment Group activity index. Patients with LN (Upr/Ucr ≥ 1.0 at study entry) were identified and their renal responses were evaluated according to the criteria proposed by the American College of Rheumatology (ACR) and the Lupus Nephritis Assessment with Rituximab (LUNAR) study.

resultsA total of 34 patients were enrolled and received at least one dose of rituximab. Decrease in disease activity was achieved in 16 (76.5%) out of 34 patients. In 17 patients with LN, response rates of 58.8% and 52.9% by ACR and LUNAR criteria, respectively, were seen. Successful steroid tapering was achieved in association with disease remission. Rituximab was well tolerated, and most adverse drug reactions were grade 1-2 in severity.

conclusionsRituximab is effective for treatment of Japanese patients with SLE and LN refractory to conventional therapy.

Indexed as

AdultFemaleHumansImmunologic FactorsLupus Erythematosus, SystemicLupus NephritisMaleRituximabTreatment OutcomeYoung AdultImmunologic FactorsRituximabEfficacyLupus nephritisPhase II studyRituximabSafety

Identifiers

PMID26054418
PMCPMC4732415

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Registered trials

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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.