Efficacy of Tocilizumab in Patients With Moderate-to-Severe Corticosteroid-Resistant Graves Orbitopathy: A Randomized Clinical Trial
| Autor: | Jose V. Perez-Moreiras, Juan J. Gomez-Reino, Jose R. Maneiro, Eva Perez-Pampin, Angel Romo Lopez, Fernando M. Rodríguez Alvarez, Jesús M. Castillo Laguarta, Aurora del Estad Cabello, María Gessa Sorroche, Enrique España Gregori, Marco Sales-Sanz, Jose Maneiro, Maria A. Tome Martinez de Rituerto, Eva Perez Pampin, Alejandro Alvarez, Juan Troyano, Cristina Niño, Eva Vico, Maria C. Montañez Zorrilla, Marco Sales Sanz, Ana M. Martín Ucero, Marcelino Revenga, Antonia M. Pérez Lazaro, José A. Todoli, Alba M. Gonzalez Alejos, César Díaz, José M. Cubero Marcos, Angel Dominguez Polo, Laura Lavilla, Cilia Peralta Ginés, Antonio J. Gómez Escobar, Concepción Díaz, Federico Navarro Sarabia, Tomás Martín Hernández, Elena Navarro, Esteban Rubio, Rafael Villanueva Blandón, María P. Maiquez |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization medicine.drug_class Drug Resistance 030209 endocrinology & metabolism Placebo Antibodies Monoclonal Humanized Methylprednisolone law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Tocilizumab Randomized controlled trial Double-Blind Method law Internal medicine Medicine Humans Infusions Intravenous Glucocorticoids business.industry Odds ratio Middle Aged Receptors Interleukin-6 Confidence interval Graves Ophthalmopathy Ophthalmology Treatment Outcome chemistry Monoclonal 030221 ophthalmology & optometry Corticosteroid Female business |
| Zdroj: | American journal of ophthalmology. 195 |
| ISSN: | 1879-1891 |
| Popis: | To demonstrate the efficacy of the anti-interleukin-6 receptor monoclonal antibody tocilizumab in patients with moderate-to-severe corticosteroid-resistant Graves orbitopathy (GO).Double-masked randomized clinical trial.Setting and Participants: Thirty-two adults with moderate-to-severe corticosteroid-resistant GO from 10 medical centers in Spain were randomized (1:1).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).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 CAS3 (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.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. |
| Databáze: | OpenAIRE |
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