Evidence map›Paper›PMID 25494967›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2015

Efficacy of B-cell targeted therapy with rituximab in patients with active moderate to severe Graves' orbitopathy: a randomized controlled study.

Mario Salvi, Guia Vannucchi, Nicola Currò, Irene Campi, Danila Covelli, Davide Dazzi, Simona Simonetta, Claudio Guastella, Lorenzo Pignataro, Sabrina Avignone and 1 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized 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. It is linked to trial NCT04876534 (Multicenter, Randomized, Observer-blind, Controlled Study of the Anti-IL-6 Receptor Antibody Tocilizumab), which is not on this map. Cited by 168 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
168citing papers in PubMed, 13 pooled it
13.9field-weighted citation impact, top 1% 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.

NCT04876534 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Multicenter, Randomized, Observer-blind, Controlled Study of the Anti-IL-6 Receptor Antibody Tocilizumab (TCZ) or Methylprednisolone (MP) Treatment in Patients With Active Moderate-severe Graves' Orbitopathy

TypeinterventionalSponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoRan2019 to 2023Enrolled64ConditionsGraves OphthalmopathyArmsTocilizumab 20 Mg/mL Intravenous Solution, MethylPREDNISolone Injectable Solution
3 · Its place in the literature

Who cites it

168 citing papers in PubMed, 13 syntheses or guidelines pooled it, 392 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Rituximab for thyroid-associated ophthalmopathy.The Cochrane database of systematic reviews · 2022
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Adjuvant Rituximab-Exploratory Trial in Young People With Graves Disease.The Journal of clinical endocrinology and metabolism · 2022
    Trial
  15. Teprotumumab for Thyroid-Associated Ophthalmopathy.The New England journal of medicine · 2017
    Trial
  16. Article
  17. Review
  18. Article
  19. Review
  20. Review

108 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

11 authors at 3 institutions in 2 countries.

Mario SalviGraves' Orbitopathy Center, Endocrinology Unit, Departments of Clinical Sciences and Community Health (M.S., G.V., I.C., D.C., P.B.-P.), Ophthalmology (N.C., S.S.), Otolaryngology (C.G., L.P.), and Neuroradiology (S.A.), Fondazione Cà Granda Istituto di Ricovero e Cura a Carattere Scientifico and University of Milan, I-20122 Milan, Italy; and Division of Internal Medicine (D.D.), Ospedale di Fidenza, I-43036 Fidenza, Italy.
Guia Vannucchi
Nicola Currò
Irene Campi
Danila Covelli
Davide Dazzi
Simona Simonetta
Claudio Guastella
Lorenzo Pignataro
Sabrina Avignone
Paolo Beck-Peccoz
Ophthalmology Associates (United States) · USFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreliminary studies have shown that rituximab (RTX) is effective in the treatment of active Graves' orbitopathy (GO).

methodsWe conducted a double-blind, randomized trial (European Clinical Trials Database [EudraCT] 2007-003910-33) to compare RTX with iv methylprednisolone (ivMP) in patients with active moderate to severe GO. Thirty-two patients were randomized to receive either ivMP (7.5 g) or RTX (2000 or 500 mg). The primary end point was the decrease of the clinical activity score of 2 points or to less than 3 at week 24. Changes of proptosis, lid fissure, diplopia and eye muscle motility, and quality of life score were secondary end points. The number of therapeutic responses, disease reactivation, and surgical procedures required during follow-up and the patients' quality of life were also assessed.

resultsThe clinical activity score decreased with both treatments but more after RTX at 16, 20, and 24 weeks (P < .04, P < .02, P < .006, respectively), whether 1000 mg RTX twice or 500 mg RTX once was used (P = NS). At 24 weeks 100% of RTX patients improved compared with 69% after ivMP (P < .001). Disease reactivation was never observed in RTX patients but was observed in five after ivMP. Patients treated with RTX scored better motility at 52 weeks in both the right (P = .014) and the left eye (P = .026). Overall rehabilitative surgical procedures carried out during follow-up (at 76 wk) were 12 in 16 ivMP patients and 5 in 15 RTX patients (P = .049).

conclusionsThe results of this trial confirm preliminary reports on a better therapeutic outcome of RTX in active moderate to severe GO, when compared with ivMP, even after a lower RTX dose. The better eye motility outcome, visual functioning of the quality of life assessment, and the reduced number of surgical procedures in patients after RTX seem to suggest a disease-modifying effect of the drug.

Indexed as

AdultAntibodies, Monoclonal, Murine-DerivedDouble-Blind MethodFemaleGlucocorticoidsGraves OphthalmopathyHumansImmunologic FactorsMaleMethylprednisoloneMiddle AgedRituximabSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Murine-DerivedGlucocorticoidsImmunologic FactorsMethylprednisoloneRituximab

Identifiers

PMID25494967
PMCPMC4318899
OpenAlexW2099402970

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.