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The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

Teprotumumab for Thyroid-Associated Ophthalmopathy

Open access
Smith, Terry J., Kahaly, George J., Ezra, Daniel G., Fleming, James C., Dailey, Roger A., Tang, Rosa A., Harris, Gerald J., Antonelli, Alessandro, Salvi, Mario, Goldberg, Robert A., Gigantelli, James W., Couch, Steven M., Shriver, Erin M., Hayek, Brent R., Hink, Eric M., Woodward, Richard M., Gabriel, Kathleen, Magni, Guido, Douglas, Raymond S.·2017·New England Journal of Medicine
DOI 10.1056/nejmoa1614949
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Abstract

BACKGROUND: Thyroid-associated ophthalmopathy, a condition commonly associated with Graves' disease, remains inadequately treated. Current medical therapies, which primarily consist of glucocorticoids, have limited efficacy and present safety concerns. Inhibition of the insulin-like growth factor I receptor (IGF-IR) is a new therapeutic strategy to attenuate the underlying autoimmune pathogenesis of ophthalmopathy. METHODS: We conducted a multicenter, double-masked, randomized, placebo-controlled trial to determine the efficacy and safety of teprotumumab, a human monoclonal antibody inhibitor of IGF-IR, in patients with active, moderate-to-severe ophthalmopathy. A total of 88 patients were randomly assigned to receive placebo or active drug administered intravenously once every 3 weeks for a total of eight infusions. The primary end point was the response in the study eye. This response was defined as a reduction of 2 points or more in the Clinical Activity Score (scores range from 0 to 7, with a score of ≥3 indicating active thyroid-associated ophthalmopathy) and a reduction of 2 mm or more in proptosis at week 24. Secondary end points, measured as continuous variables, included proptosis, the Clinical Activity Score, and results on the Graves' ophthalmopathy-specific quality-of-life questionnaire. Adverse events were assessed. RESULTS: In the intention-to-treat population, 29 of 42 patients who received teprotumumab (69%), as compared with 9 of 45 patients who received placebo (20%), had a response at week 24 (P<0.001). Therapeutic effects were rapid; at week 6, a total of 18 of 42 patients in the teprotumumab group (43%) and 2 of 45 patients in the placebo group (4%) had a response (P<0.001). Differences between the groups increased at subsequent time points. The only drug-related adverse event was hyperglycemia in patients with diabetes; this event was controlled by adjusting medication for diabetes. CONCLUSIONS: In patients with active ophthalmopathy, teprotumumab was more effective than placebo in reducing proptosis and the Clinical Activity Score. (Funded by River Vision Development and others; ClinicalTrials.gov number, NCT01868997 .).

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Metadata

Authors
Smith, T. J., Kahaly, G. J., Ezra, D. G., Fleming, J. C., Dailey, R. A., Tang, R. A., Harris, G. J., Antonelli, A., Salvi, M., Goldberg, R. A., Gigantelli, J. W., Couch, S. M., Shriver, E. M., Hayek, B. R., Hink, E. M., Woodward, R. M., Gabriel, K., Magni, G., & Douglas, R. S.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2017-05-04
Volume
376
Issue
18
Pages
1748-1761
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1614949
OpenAlex
W2611131029
Cited by
756
References
33
FWCI
37.46
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Teprotumumab for Thyroid-Associated Ophthalmopathy. https://app.cochat.ai/papers/10.1056/nejmoa1614949
The paper
Smith, T. J., Kahaly, G. J., Ezra, D. G., Fleming, J. C., Dailey, R. A., Tang, R. A., Harris, G. J., Antonelli, A., Salvi, M., Goldberg, R. A., Gigantelli, J. W., Couch, S. M., Shriver, E. M., Hayek, B. R., Hink, E. M., Woodward, R. M., Gabriel, K., Magni, G., & Douglas, R. S. (2017). Teprotumumab for Thyroid-Associated Ophthalmopathy. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1614949

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.