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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creator | 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 |
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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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.</description><identifier>ISSN: 2077-0383</identifier><identifier>EISSN: 2077-0383</identifier><identifier>DOI: 10.3390/jcm9092816</identifier><identifier>PMID: 32878150</identifier><language>eng</language><publisher>Basel: MDPI AG</publisher><subject>Clinical medicine ; Drug dosages ; Edema ; Eye movements ; Graves disease ; Hepatitis ; Immunosuppressive agents ; Infections ; Monoclonal antibodies ; Neutropenia ; Observational studies ; Pain ; Patients ; Strabismus ; Thyroid gland ; Tuberculosis ; Ulcers</subject><ispartof>Journal of clinical medicine, 2020-08, Vol.9 (9), p.2816</ispartof><rights>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/). 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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.</description><subject>Clinical medicine</subject><subject>Drug dosages</subject><subject>Edema</subject><subject>Eye movements</subject><subject>Graves disease</subject><subject>Hepatitis</subject><subject>Immunosuppressive agents</subject><subject>Infections</subject><subject>Monoclonal antibodies</subject><subject>Neutropenia</subject><subject>Observational studies</subject><subject>Pain</subject><subject>Patients</subject><subject>Strabismus</subject><subject>Thyroid 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sánchez-Bilbao, Lara</au><au>Martínez-López, David</au><au>Revenga, Marcelino</au><au>López-Vázquez, Ángel</au><au>Valls-Pascual, Elia</au><au>Atienza-Mateo, Belén</au><au>Valls-Espinosa, Beatriz</au><au>Maiz-Alonso, Olga</au><au>Blanco, Ana</au><au>Torre-Salaberri, Ignacio</au><au>Rodríguez-Méndez, Verónica</au><au>García-Aparicio, Ángel</au><au>Veroz-González, Raúl</au><au>Jovaní, Vega</au><au>Peiteado, Diana</au><au>Sánchez-Orgaz, Margarita</au><au>Tomero, Eva</au><au>Toyos-Sáenz de Miera, Francisco J.</au><au>Pinillos, Valvanera</au><au>Aurrecoechea, Elena</au><au>Mora, Ángel</au><au>Conesa, Arantxa</au><au>Fernández-Prada, Manuel</au><au>Troyano, Juan A.</au><au>Calvo-Río, Vanesa</au><au>Demetrio-Pablo, Rosalía</au><au>González-Mazón, Íñigo</au><au>Hernández, José L.</au><au>Castañeda, Santos</au><au>González-Gay, Miguel Á.</au><au>Blanco, Ricardo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients</atitle><jtitle>Journal of clinical medicine</jtitle><date>2020-08-31</date><risdate>2020</risdate><volume>9</volume><issue>9</issue><spage>2816</spage><pages>2816-</pages><issn>2077-0383</issn><eissn>2077-0383</eissn><abstract>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.</abstract><cop>Basel</cop><pub>MDPI AG</pub><pmid>32878150</pmid><doi>10.3390/jcm9092816</doi><orcidid>https://orcid.org/0000-0003-2344-2285</orcidid><orcidid>https://orcid.org/0000-0002-7924-7406</orcidid><orcidid>https://orcid.org/0000-0001-8529-4551</orcidid><orcidid>https://orcid.org/0000-0003-1184-843X</orcidid><orcidid>https://orcid.org/0000-0002-7350-8214</orcidid><orcidid>https://orcid.org/0000-0001-7119-0786</orcidid><orcidid>https://orcid.org/0000-0002-6585-8847</orcidid><orcidid>https://orcid.org/0000-0002-6875-4090</orcidid><orcidid>https://orcid.org/0000-0001-6789-7236</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 2077-0383 |
ispartof | Journal of clinical medicine, 2020-08, Vol.9 (9), p.2816 |
issn | 2077-0383 2077-0383 |
language | eng |
recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7563792 |
source | Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; MDPI - Multidisciplinary Digital Publishing Institute; PubMed Central |
subjects | Clinical medicine Drug dosages Edema Eye movements Graves disease Hepatitis Immunosuppressive agents Infections Monoclonal antibodies Neutropenia Observational studies Pain Patients Strabismus Thyroid gland Tuberculosis Ulcers |
title | Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients |
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