Evidence map›Paper›PMID 23712302›Full record

Trial reportCanadian journal of gastroenterology = Journal canadien de gastroenterologie2013

Rituximab for the treatment of patients with autoimmune hepatitis who are refractory or intolerant to standard therapy.

Kelly W Burak, Mark G Swain, Tania Santodomingo-Garzon, Tania Santodomino-Garzon, Samuel S Lee, Stefan J Urbanski, Alexander I Aspinall, Carla S Coffin, Robert P Myers

Erratum issuedOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 69 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 6 pooled it
5.2field-weighted citation impact, top 4% 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

69 citing papers in PubMed, 6 syntheses or guidelines pooled it, 168 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Guideline
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Article
  8. Review
  9. Article
  10. Review
  11. The Role of Novel Immunomodulators in the Treatment of Autoimmune Hepatitis.Journal of clinical and translational hepatology · 2025
    Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Seronegative Autoimmune Hepatitis.Journal of clinical and translational hepatology · 2023
    Review
  20. [Treatment of Autoimmune Hepatitis].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2023
    Review

9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
    Santodomino-Garzon, Tania [corrected to Santodomingo-Garzon, Tania]
5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Kelly W BurakLiver Unit, Division of Gastroenterologyand Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada. kwburak@ucalgary.ca
Mark G Swain
Tania Santodomingo-Garzon
Tania Santodomino-Garzon
Samuel S Lee
Stefan J Urbanski
Alexander I Aspinall
Carla S Coffin
Robert P Myers
University of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough most patients with autoimmune hepatitis (AIH) respond to treatment with prednisone and⁄or azathioprine, some patients are intolerant or refractory to standard therapy. Rituximab is an anti-CD20 monoclonal antibody that depletes B cells and has demonstrated efficacy in other autoimmune conditions.

aimsTo evaluate the safety and efficacy of rituximab in patients with refractory AIH in an open-label, single-centre pilot study.

methodsSix patients with definite, biopsy-proven AIH who failed prednisone and azathioprine treatment received two infusions of rituximab 1000 mg two weeks apart and were followed for 72 weeks.

resultsRituximab was well tolerated with no serious adverse events. By week 24, mean (± SD) aspartate aminotransferase (AST) levels had significantly improved (90.0±23.3 U⁄L versus 31.3±4.2 U⁄L; P=0.03) and mean immunoglobulin G levels had fallen (16.4±2.0 g⁄L versus 11.5±1.1 g⁄L; P=0.056). The prednisone dose was weaned in three of four subjects, with one subject flaring after steroid withdrawal. Inflammation grade improved in all four subjects who underwent repeat liver biopsy at week 48. Regulatory T cell levels examined by FoxP3 immunohistochemistry paralleled inflammatory activity and did not increase on follow-up biopsies. There was no significant change in serum chemokine or cytokine levels from baseline to week 24 (n=5), although interferon-gamma-induced protein 10 levels improved in three of five subjects.

conclusionsRituximab was safe, well tolerated and resulted in biochemical improvement in subjects with refractory AIH. These results support further investigation of rituximab as a treatment for AIH.

Indexed as

AdultAgedAntibodies, Monoclonal, Murine-DerivedAspartate AminotransferasesAzathioprineChemokinesCytokinesDose-Response Relationship, DrugFemaleFollow-Up StudiesHepatitis, AutoimmuneHumansImmunoglobulin GImmunologic FactorsInfusions, IntravenousMaleAntibodies, Monoclonal, Murine-DerivedAspartate AminotransferasesAzathioprineChemokinesCytokinesImmunoglobulin GImmunologic FactorsPrednisoneRituximab

Identifiers

PMID23712302
PMCPMC3735730
OpenAlexW116289366

What OpenQuestion holds

Textmetadata
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.