Evidence map›Paper›PMID 35831587›Full record

Observational studyJournal of endocrinological investigation2022

Sirolimus as a second-line treatment for Graves' orbitopathy.

G Lanzolla, M N Maglionico, S Comi, F Menconi, P Piaggi, C Posarelli, M Figus, C Marcocci, M Marinò

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Journal of endocrinological investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
5.6field-weighted citation impact, top 3% 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

27 citing papers in PubMed, 40 citations in OpenAlex.

  1. Serum mTOR: an associative marker of Graves' orbitopathy.Journal of endocrinological investigation · 2026
    Article
  2. Review
  3. Pharmacologic Therapies for Active Moderate-to-Severe TED: A Comprehensive Systematic Review.Clinical medicine insights. Endocrinology and diabetes · 2026
    Review
  4. Review
  5. Review
  6. Review
  7. PDGFRαAdvanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Article
  8. Review
  9. Review
  10. Article
  11. The Use of Biologics for Thyroid Eye Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. A Review of Novel Medical Treatments for Thyroid Eye Disease.Korean journal of ophthalmology : KJO · 2024
    Review
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 at 1 institution in 2 countries.

G LanzollaEndocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
M N MaglionicoOphthalmopathy Unit I, Department of Surgical, Medical and Molecular Pathology, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
S ComiEndocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
F MenconiEndocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
P PiaggiDepartment of Information Engineering, University of Pisa and University Hospital of Pisa, Via G. Caruso 16, 56122, Pisa, Italy.
C PosarelliOphthalmopathy Unit I, Department of Surgical, Medical and Molecular Pathology, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
M FigusOphthalmopathy Unit I, Department of Surgical, Medical and Molecular Pathology, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
C MarcocciEndocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
M MarinòEndocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy. michele.marino@med.unipi.it.ORCID http://orcid.org/0000-0003-0365-116X
University of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesA beneficial effect of sirolimus in Graves' orbitopathy (GO) was reported, suggesting a possible use in clinical practice. We conducted an observational, single-centre, no-profit, clinical study to investigate the efficacy of sirolimus as a second-line treatment for moderate-to-severe, active GO compared with methylprednisolone.

methodsData from consecutive patients given sirolimus (2 mg orally on first day, followed by 0.5 mg/day for 12 weeks) or methylprednisolone [500 mg iv/weekly (6 weeks), 250 mg/weekly (6 weeks)] as a second-line treatment were collected and compared. PRIMARY

objectiveoverall GO outcome at 24 weeks, based on a composite evaluation. Secondary objectives at 24 weeks: (1) improvement in quality of life, evaluated using a specific uestionnaire (GO-QoL); (2) reduction in proptosis; (3) reduction in the clinical activity score (CAS); (4) improvement of eye ductions; and (5) reduction in eyelid aperture.

resultsData from 30 patients (15 per group) treated between January 15, 2020, and June 15, 2021, were analysed. Proportion of GO responders (primary outcome) at 24 weeks was significantly greater in sirolimus group compared with methylprednisolone group (86.6% vs 26.6%; OR: 17.8; 95% CI from 2.7 to 116.8; P = 0.0026). GO-quality of life (GO-QoL) score was greater in sirolimus group. Proportion of proptosis responders was greater in sirolimus group, as well as proportion of clinical activity score (CAS) responders. No serious adverse events were observed, with no differences between groups.

conclusionsSirolimus seems to be an effective second-line treatment for GO. Further randomized clinical trials are needed to confirm our observations.

Indexed as

ExophthalmosGraves OphthalmopathyHumansMethylprednisoloneQuality of LifeSirolimusTreatment OutcomeMethylprednisoloneSirolimusGraves’ diseaseGraves’ orbitopathyRapamycinSirolimusThyroid autoimmunityThyroid disease

Identifiers

PMID35831587
PMCPMC9525329
OpenAlexW4285395223

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.