Evidence map›Paper›PMID 33579690›Full record

Trial reportThe British journal of ophthalmology2022

Improvement of asymmetric thyroid eye disease with teprotumumab.

Shoaib Ugradar, Yao Wang, Tunde Mester, George J Kahaly, Raymond Douglas

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The British journal of ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 12% 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.

NCT01868997 phase2completednot on this map

A Multicenter, Double-Masked, Placebo-Controlled, Efficacy And Safety Study Of RV 001, An Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), Administered Every 3 Weeks (q3W) By Intravenous (IV) Infusion In Patients Suffering From Active Thyroid Eye Disease (TED)

TypeinterventionalSponsorAmgenRan2013 to 2017Enrolled88ConditionsThyroid Associated Ophthalmopathies, Thyroid-Associated OphthalmopathyArmsteprotumumab, normal saline
NCT03298867 phase3completednot on this map

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease

TypeinterventionalSponsorAmgenRan2017 to 2020Enrolled83ConditionsThyroid Eye Disease, Graves' OrbitopathyArmsTeprotumumab, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Time to improvement following teprotumumab treatment of thyroid eye disease: real world experience.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Article
  5. Asymmetric proptosis in thyroid eye disease.International ophthalmology · 2024
    Article
  6. Article
  7. Changing the face of thyroid eye disease.Eye (London, England) · 2023
    Article
  8. Review
  9. Teprotumumab and the Evolving Therapeutic Landscape in Thyroid Eye Disease.The Journal of clinical endocrinology and metabolism · 2022
    Review
  10. Facial and Eyelid Changes in Thyroid Eye Disease Are Reversed by Teprotumumab.Plastic and reconstructive surgery. Global open · 2021
    Article
  11. Infusion Center Guidelines for Teprotumumab Infusions: Informed Consent, Safety, and Management of Side Effects.Journal of infusion nursing : the official publication of the Infusion Nurses Society
    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

5 authors at 3 institutions in 2 countries.

Shoaib UgradarOrbital and Ophthalmic Plastic Surgery, Jules Stein Eye Institute, Los Angeles, California, USA ugradsahi@aol.com.ORCID http://orcid.org/0000-0003-4479-3033
Yao WangOculoplastics, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Tunde MesterOculoplastics, Cedars-Sinai Medical Center, Los Angeles, California, USA.
George J KahalyDepartment of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.
Raymond DouglasOphthalmology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Cedars-Sinai Medical Center · USDoheny Eye Institute · USJohannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTeprotumumab, a specific blocking antibody to the insulin like growth factor 1 receptor, significantly reduced proptosis in patients with thyroid eye disease (TED) in recent clinical trials. Given its specificity, we expect it to demonstrate greater efficacy on the worse affected orbit, in patients with asymmetric TED. Herein, we investigate the differential impact of teprotumumab on the orbits of such patients.

methodsIn this pooled analysis of patients who were enrolled in the recent phase 2 (NCT01868997) and phase 3 (NCT03298867) trials, all patients with asymmetric TED (difference in exophthalmometry of ≥3 mm) were screened for eligibility. The primary outcomes of the trials, proptosis, diplopia and Clinical Activity Score (CAS) response, were evaluated in both orbits of patients who had received treatment or placebo, to examine the differential response from baseline to week 24.

resultsFrom a pooled group of 84 patients randomised to receive teprotumumab and 87 randomised to placebo, 10 (12%) and 12 (14%), respectively, met the inclusion criteria. The teprotumumab-treated patients demonstrated significant reductions in proptosis, CAS and diplopia in both orbits of each patient and this was not seen with placebo. The reduction in proptosis and CAS was significantly greater in the worse affected orbit, improving symmetry. In the placebo arm, while the mean CAS in the study eye reduced over time, proptosis and diplopia did not change in either orbit.

conclusionThe findings in this study suggest the differential impact of teprotumumab on orbits that are clinically more affected by TED, suggesting that teprotumumab reduces asymmetry.

Indexed as

ExophthalmosGraves OphthalmopathyAntibodies, Monoclonal, HumanizedDiplopiaHumansAntibodies, Monoclonal, Humanizedteprotumumabeye (globe)eye lidsimmunologyorbitpathology

Identifiers

PMID33579690
PMCPMC9132868
OpenAlexW3129186701

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.