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Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients

Graves’ orbitopathy (GO) is the most common extrathyroidal manifestation of Graves’ disease (GD). Our aim was to assess the efficacy and safety of Tocilizumab (TCZ) in GO refractory to conventional therapy. This was an open-label multicenter study of glucocorticoid-resistant GO treated with TCZ. The...

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Autores principales: Sánchez-Bilbao, Lara, Martínez-López, David, Revenga, Marcelino, López-Vázquez, Ángel, Valls-Pascual, Elia, Atienza-Mateo, Belén, Valls-Espinosa, Beatriz, Maiz-Alonso, Olga, Blanco, Ana, Torre-Salaberri, Ignacio, Rodríguez-Méndez, Verónica, García-Aparicio, Ángel, Veroz-González, Raúl, Jovaní, Vega, Peiteado, Diana, Sánchez-Orgaz, Margarita, Tomero, Eva, Toyos-Sáenz de Miera, Francisco J., Pinillos, Valvanera, Aurrecoechea, Elena, Mora, Ángel, Conesa, Arantxa, Fernández-Prada, Manuel, Troyano, Juan A., Calvo-Río, Vanesa, Demetrio-Pablo, Rosalía, González-Mazón, Íñigo, Hernández, José L., Castañeda, Santos, González-Gay, Miguel Á., Blanco, Ricardo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7563792/
https://www.ncbi.nlm.nih.gov/pubmed/32878150
http://dx.doi.org/10.3390/jcm9092816
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author Sánchez-Bilbao, Lara
Martínez-López, David
Revenga, Marcelino
López-Vázquez, Ángel
Valls-Pascual, Elia
Atienza-Mateo, Belén
Valls-Espinosa, Beatriz
Maiz-Alonso, Olga
Blanco, Ana
Torre-Salaberri, Ignacio
Rodríguez-Méndez, Verónica
García-Aparicio, Ángel
Veroz-González, Raúl
Jovaní, Vega
Peiteado, Diana
Sánchez-Orgaz, Margarita
Tomero, Eva
Toyos-Sáenz de Miera, Francisco J.
Pinillos, Valvanera
Aurrecoechea, Elena
Mora, Ángel
Conesa, Arantxa
Fernández-Prada, Manuel
Troyano, Juan A.
Calvo-Río, Vanesa
Demetrio-Pablo, Rosalía
González-Mazón, Íñigo
Hernández, José L.
Castañeda, Santos
González-Gay, Miguel Á.
Blanco, Ricardo
author_facet Sánchez-Bilbao, Lara
Martínez-López, David
Revenga, Marcelino
López-Vázquez, Ángel
Valls-Pascual, Elia
Atienza-Mateo, Belén
Valls-Espinosa, Beatriz
Maiz-Alonso, Olga
Blanco, Ana
Torre-Salaberri, Ignacio
Rodríguez-Méndez, Verónica
García-Aparicio, Ángel
Veroz-González, Raúl
Jovaní, Vega
Peiteado, Diana
Sánchez-Orgaz, Margarita
Tomero, Eva
Toyos-Sáenz de Miera, Francisco J.
Pinillos, Valvanera
Aurrecoechea, Elena
Mora, Ángel
Conesa, Arantxa
Fernández-Prada, Manuel
Troyano, Juan A.
Calvo-Río, Vanesa
Demetrio-Pablo, Rosalía
González-Mazón, Íñigo
Hernández, José L.
Castañeda, Santos
González-Gay, Miguel Á.
Blanco, Ricardo
author_sort Sánchez-Bilbao, Lara
collection PubMed
description Graves’ orbitopathy (GO) is the most common extrathyroidal manifestation of Graves’ disease (GD). Our aim was to assess the efficacy and safety of Tocilizumab (TCZ) in GO refractory to conventional therapy. This was an open-label multicenter study of glucocorticoid-resistant GO treated with TCZ. The main outcomes were the best-corrected visual acuity (BVCA), Clinical Activity Score (CAS) and intraocular pressure (IOP). These outcome variables were assessed at baseline, 1st, 3rd, 6th and 12th month after TCZ therapy onset. The severity of GO was assessed according to the European Group on Graves’ Orbitopathy (EUGOGO). We studied 48 (38 women and 10 men) patients (95 eyes); mean age ± standard deviation 51 ± 11.8 years. Before TCZ and besides oral glucocorticoids, they had received IV methylprednisolone (n = 43), or selenium (n = 11). GO disease was moderate (n =29) or severe (n = 19) and dysthyroid optic neuropathy (DON) (n = 7). TCZ was used in monotherapy (n = 45) or combined (n = 3) at a dose of 8 mg/kg IV every four weeks (n = 43) or 162 mg/s.c. every week (n = 5). TCZ yielded a significant improvement in all of the main outcomes at the 1st month that was maintained at one year. Comparing the baseline with data at 1 year all of the variables improved; BCVA (0.78 ± 0.25 vs. 0.9 ± 0.16; p = 0.0001), CAS (4.64 ± 1.5 vs. 1.05 ± 1.27; p = 0.0001) and intraocular pressure (IOP) (19.05 ± 4.1 vs. 16.73 ± 3.4 mmHg; p = 0.007). After a mean follow-up of 16.1 ± 2.1 months, low disease activity (CAS ≤ 3), was achieved in 88 eyes (92.6%) and TCZ was withdrawn in 29 cases due to low disease activity (n = 25) or inefficacy (n = 4). No serious adverse events were observed. In conclusion, TCZ is a useful and safe therapeutic option in refractory GO treatment.
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spelling pubmed-75637922020-10-27 Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients Sánchez-Bilbao, Lara Martínez-López, David Revenga, Marcelino López-Vázquez, Ángel Valls-Pascual, Elia Atienza-Mateo, Belén Valls-Espinosa, Beatriz Maiz-Alonso, Olga Blanco, Ana Torre-Salaberri, Ignacio Rodríguez-Méndez, Verónica García-Aparicio, Ángel Veroz-González, Raúl Jovaní, Vega Peiteado, Diana Sánchez-Orgaz, Margarita Tomero, Eva Toyos-Sáenz de Miera, Francisco J. Pinillos, Valvanera Aurrecoechea, Elena Mora, Ángel Conesa, Arantxa Fernández-Prada, Manuel Troyano, Juan A. Calvo-Río, Vanesa Demetrio-Pablo, Rosalía González-Mazón, Íñigo Hernández, José L. Castañeda, Santos González-Gay, Miguel Á. Blanco, Ricardo J Clin Med Article Graves’ orbitopathy (GO) is the most common extrathyroidal manifestation of Graves’ disease (GD). Our aim was to assess the efficacy and safety of Tocilizumab (TCZ) in GO refractory to conventional therapy. This was an open-label multicenter study of glucocorticoid-resistant GO treated with TCZ. The main outcomes were the best-corrected visual acuity (BVCA), Clinical Activity Score (CAS) and intraocular pressure (IOP). These outcome variables were assessed at baseline, 1st, 3rd, 6th and 12th month after TCZ therapy onset. The severity of GO was assessed according to the European Group on Graves’ Orbitopathy (EUGOGO). We studied 48 (38 women and 10 men) patients (95 eyes); mean age ± standard deviation 51 ± 11.8 years. Before TCZ and besides oral glucocorticoids, they had received IV methylprednisolone (n = 43), or selenium (n = 11). GO disease was moderate (n =29) or severe (n = 19) and dysthyroid optic neuropathy (DON) (n = 7). TCZ was used in monotherapy (n = 45) or combined (n = 3) at a dose of 8 mg/kg IV every four weeks (n = 43) or 162 mg/s.c. every week (n = 5). TCZ yielded a significant improvement in all of the main outcomes at the 1st month that was maintained at one year. Comparing the baseline with data at 1 year all of the variables improved; BCVA (0.78 ± 0.25 vs. 0.9 ± 0.16; p = 0.0001), CAS (4.64 ± 1.5 vs. 1.05 ± 1.27; p = 0.0001) and intraocular pressure (IOP) (19.05 ± 4.1 vs. 16.73 ± 3.4 mmHg; p = 0.007). After a mean follow-up of 16.1 ± 2.1 months, low disease activity (CAS ≤ 3), was achieved in 88 eyes (92.6%) and TCZ was withdrawn in 29 cases due to low disease activity (n = 25) or inefficacy (n = 4). No serious adverse events were observed. In conclusion, TCZ is a useful and safe therapeutic option in refractory GO treatment. MDPI 2020-08-31 /pmc/articles/PMC7563792/ /pubmed/32878150 http://dx.doi.org/10.3390/jcm9092816 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sánchez-Bilbao, Lara
Martínez-López, David
Revenga, Marcelino
López-Vázquez, Ángel
Valls-Pascual, Elia
Atienza-Mateo, Belén
Valls-Espinosa, Beatriz
Maiz-Alonso, Olga
Blanco, Ana
Torre-Salaberri, Ignacio
Rodríguez-Méndez, Verónica
García-Aparicio, Ángel
Veroz-González, Raúl
Jovaní, Vega
Peiteado, Diana
Sánchez-Orgaz, Margarita
Tomero, Eva
Toyos-Sáenz de Miera, Francisco J.
Pinillos, Valvanera
Aurrecoechea, Elena
Mora, Ángel
Conesa, Arantxa
Fernández-Prada, Manuel
Troyano, Juan A.
Calvo-Río, Vanesa
Demetrio-Pablo, Rosalía
González-Mazón, Íñigo
Hernández, José L.
Castañeda, Santos
González-Gay, Miguel Á.
Blanco, Ricardo
Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients
title Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients
title_full Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients
title_fullStr Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients
title_full_unstemmed Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients
title_short Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients
title_sort anti-il-6 receptor tocilizumab in refractory graves’ orbitopathy: national multicenter observational study of 48 patients
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7563792/
https://www.ncbi.nlm.nih.gov/pubmed/32878150
http://dx.doi.org/10.3390/jcm9092816
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