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Cited by 300

The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.

Efficacy of Tocilizumab in Patients With Moderate-to-Severe Corticosteroid-Resistant Graves Orbitopathy: A Randomized Clinical Trial

Perez-Moreiras, Jose V., Gomez-Reino, Juan J., Maneiro, Jose R., Perez-Pampin, Eva, Romo Lopez, Angel, Rodríguez Alvarez, Fernando M., Castillo Laguarta, Jesús M., del Estad Cabello, Aurora, Gessa Sorroche, María, España Gregori, Enrique, Sales-Sanz, Marco, Gomez-Reino, Juan J., Maneiro, Jose, Tome Martinez de Rituerto, Maria A., Pampin, Eva Perez, Perez-Moreiras, Jose V., Alvarez, Alejandro, Lopez, Angel Romo, Troyano, Juan, Niño, Cristina, Vico, Eva, Montañez Zorrilla, Maria C., Sanz, Marco Sales, Martín Ucero, Ana M., Revenga, Marcelino, Gregori, Enrique España, Pérez Lazaro, Antonia M., Todoli, José A., Gonzalez Alejos, Alba M., Rodríguez Alvarez, Fernando M., Díaz, César, Cubero Marcos, José M., Castillo Laguarta, Jesús M., Polo, Angel Dominguez, Lavilla, Laura, Ginés, Cilia Peralta, Cabello, Aurora del Estad, Gómez Escobar, Antonio J., Díaz, Concepción, Sarabia, Federico Navarro, Hernández, Tomás Martín, Sorroche, María Gessa, Navarro, Elena, Rubio, Esteban, Blandón, Rafael Villanueva, Maiquez, María P.·2018·American Journal of Ophthalmology
DOI 10.1016/j.ajo.2018.07.038
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Abstract

OBJECTIVE To demonstrate the efficacy of the anti-interleukin-6 receptor monoclonal antibody tocilizumab in patients with moderate-to-severe corticosteroid-resistant Graves orbitopathy (GO). DESIGN Double-masked randomized clinical trial. METHODS Setting and Participants: Thirty-two adults with moderate-to-severe corticosteroid-resistant GO from 10 medical centers in Spain were randomized (1:1). INTERVENTION Randomization to either 8 mg/kg body weight tocilizumab or placebo administered intravenously at weeks 0, 4, 8, and 12, and follow-up for an additional 28 weeks. Main Outcomes and Measures: The primary outcome was the proportion of patients with a change from baseline to week 16 of at least 2 in the clinical activity score (CAS). RESULTS The primary outcome was met by 93.3% (95% confidence interval [CI] 70.1%-98.8%) of the patients receiving tocilizumab and 58.8% (36%-78.3%) receiving placebo (P = .04; odds ratio, 9.8 [CI 1.3-73.2]). A significant difference was also observed in the proportion of patients achieving a CAS < 3 (86.7% [CI 62.1%-96.2%] vs 35.2% [CI 17.3%-58.7%], P = .005; OR 11.9 [CI 2.1-63.1]) at week 16. Additionally, a larger proportion of patients with improvement in the European Group on GO-proposed composite ophthalmic score at week 16 (73.3% [CI 48%-89.1%] vs 29.4% [CI 13.2%-53.1%]; P = .03), and exophthalmos size change from baseline to week 16 (-1.5 [-2.0 to 0.5] mm vs 0.0 [-1.0 to 0.5] mm; P = .01) were seen with tocilizumab. One patient experienced a moderate increase in transaminases at week 8; another had an acute pyelonephritis at week 32 in the tocilizumab-treated group. CONCLUSION Tocilizumab offers a meaningful improvement in activity and severity in corticosteroid-resistant GO. This trial justifies further studies to characterize the role of tocilizumab in GO.

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Authors
Perez-Moreiras, J. V., Gomez-Reino, J. J., Maneiro, J. R., Perez-Pampin, E., Romo Lopez, A., Rodríguez Alvarez, F. M., Castillo Laguarta, J. M., del Estad Cabello, A., Gessa Sorroche, M., España Gregori, E., Sales-Sanz, M., Gomez-Reino, J. J., Maneiro, J., Tome Martinez de Rituerto, M. A., Pampin, E. P., Perez-Moreiras, J. V., Alvarez, A., Lopez, A. R., Troyano, J., Niño, C., Vico, E., Montañez Zorrilla, M. C., Sanz, M. S., Martín Ucero, A. M., Revenga, M., Gregori, E. E., Pérez Lazaro, A. M., Todoli, J. A., Gonzalez Alejos, A. M., Rodríguez Alvarez, F. M., Díaz, C., Cubero Marcos, J. M., Castillo Laguarta, J. M., Polo, A. D., Lavilla, L., Ginés, C. P., Cabello, A. D. E., Gómez Escobar, A. J., Díaz, C., Sarabia, F. N., Hernández, T. M., Sorroche, M. G., Navarro, E., Rubio, E., Blandón, R. V., & Maiquez, M. P.
Venue
American Journal of Ophthalmology
Publisher
Elsevier BV
Published
2018-11
Volume
195
Pages
181-190
ISSN
0002-9394 (ISSN-L)
DOI
10.1016/j.ajo.2018.07.038
OpenAlex
W2885962121
Cited by
300
References
32
FWCI
16.87
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Efficacy of Tocilizumab in Patients With Moderate-to-Severe Corticosteroid-Resistant Graves Orbitopathy: A Randomized Clinical Trial. https://app.cochat.ai/papers/10.1016/j.ajo.2018.07.038
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Perez-Moreiras, J. V., Gomez-Reino, J. J., Maneiro, J. R., Perez-Pampin, E., Romo Lopez, A., Rodríguez Alvarez, F. M., Castillo Laguarta, J. M., del Estad Cabello, A., Gessa Sorroche, M., España Gregori, E., Sales-Sanz, M., Gomez-Reino, J. J., Maneiro, J., Tome Martinez de Rituerto, M. A., Pampin, E. P., Perez-Moreiras, J. V., Alvarez, A., Lopez, A. R., Troyano, J., . . . Maiquez, M. P. (2018). Efficacy of Tocilizumab in Patients With Moderate-to-Severe Corticosteroid-Resistant Graves Orbitopathy: A Randomized Clinical Trial. American Journal of Ophthalmology. https://doi.org/10.1016/j.ajo.2018.07.038

Data sources

Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

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.