Evidence map›Paper›PMID 25343233›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2015

Randomized controlled trial of rituximab in patients with Graves' orbitopathy.

Marius N Stan, James A Garrity, Barbara G Carranza Leon, Thapa Prabin, Elizabeth A Bradley, Rebecca S Bahn

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

Trial report in The Journal of clinical endocrinology and metabolism, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 149 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
149citing papers in PubMed, 9 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

149 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Pooled it
  5. Pooled it
  6. Rituximab for thyroid-associated ophthalmopathy.The Cochrane database of systematic reviews · 2022
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Teprotumumab for Thyroid-Associated Ophthalmopathy.The New England journal of medicine · 2017
    Trial
  11. Trial
  12. Article
  13. Review
  14. Review
  15. Bibliometrics in thyroid eye disease.Journal of endocrinological investigation · 2026
    Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article

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

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

6 authors.

Marius N StanDivision of Endocrinology and Metabolism (M.N.S., B.G.C.L., R.S.B.), Department of Ophthalmology (J.A.G., E.A.B.), and Department of Health Sciences Research (T.P.), Mayo Clinic, 200 First St SW, Rochester, Minnesota 55905.
James A Garrity
Barbara G Carranza Leon
Thapa Prabin
Elizabeth A Bradley
Rebecca S Bahn

Funding

Thyrotropin Receptor Auto Antibodies in Graves' OphthalmopathyR01DK077814 · NIDDK · MAYO CLINIC ROCHESTER · PI BAHN, REBECCA S · 2007 to 2010
$1.6M
NIDDK NIH HHS R01 DK077814NIDDK NIH HHS R01DK077814
6 · The paper itself

Abstract

contextGraves' orbitopathy (GO) is a potentially sight-threatening disease for which available medical therapy is not uniformly successful. Multiple case series suggest that rituximab (RTX) may be effective therapy for GO patients.

objectiveTo determine the efficacy of RTX in GO.

designIt is a prospective, randomized, double-masked, placebo-controlled trial.

settingThe study was conducted at a large academic private practice. PATIENTS: Twenty five patients with active moderate to severe GO were enrolled, and 21 completed the study to the primary endpoint.

interventionsTwo RTX infusions (1000 mg each) or two saline infusions were given 2 weeks apart.

main outcome measuresThe primary endpoint was a reduction in clinical activity score (CAS) assessed as a continuum and separately as improvement by ≥ 2 points at 24 weeks. Secondary endpoints included success and failure rates, proportions showing clinically significant improvement in proptosis, lid fissure width, diplopia score, lagophthalmos and disease severity, and changes in those parameters, orbital fat/ muscle volume and quality-of-life.

resultsThe treatment groups were similar in all parameters at baseline. The last observation was carried forward if the patient discontinued prematurely. No differences were found in the proportions of patients showing CAS improvement at 24 weeks (25% placebo; 31% RTX, P = .75) or in CAS decrease from baseline to 24 or 52 weeks [mean 1.5 points (1.8 SD) placebo; 1.2 (2 SD) RTX at 24 weeks, P = .73]. Similarly, there were no differences between groups in any of the secondary endpoints at either 24 or 52 weeks. There were four adverse events (AE) in 3/12 placebo patients and 11 AE in 8/13 RTX-treated patients; 5/6 moderate or severe AE occurred in the RTX group.

conclusionRTX offered no additional benefit over placebo to our patients with active and moderate to severe GO and carried with it non-negligible adverse effects.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedDouble-Blind MethodFemaleGraves OphthalmopathyHumansImmunologic FactorsMaleMiddle AgedProspective StudiesRituximabTreatment OutcomeYoung AdultAntibodies, Monoclonal, Murine-DerivedImmunologic FactorsRituximab

Identifiers

PMID25343233
PMCPMC4318907

What OpenQuestion holds

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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.