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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Veröffentlicht in:Journal of clinical medicine 2020-08, Vol.9 (9), p.2816
Hauptverfasser: 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
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container_end_page
container_issue 9
container_start_page 2816
container_title Journal of clinical medicine
container_volume 9
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.
doi_str_mv 10.3390/jcm9092816
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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. 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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 gland</subject><subject>Tuberculosis</subject><subject>Ulcers</subject><issn>2077-0383</issn><issn>2077-0383</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNpdUV1LHDEUDcVSZetLf0GgLyKMzSTZSeJDQcSqsO2Wdt9DkrlTs8xMtklmYeuLf8O_5y9pRPt5X-7lnMO5Xwi9qckJY4q8W7tBEUVl3bxAB5QIUREm2d5f9T46TGlNSkjJaS1eoX1GpZD1nByg27Mx--p6UTX4CzjY5BDxKjjf-x_TYCz2Y8G7aFwhdvgymi2kh7t7vIzW57Ax-WZ3ij-Z7MNoevxx6rN3MGaIeGkTxO0v5mue2h0OHeYSfy5g0aTX6GVn-gSHz3mGVh8uVudX1WJ5eX1-tqgcpzxXczaXvGzIJLWcONUQIG1jy2YWVAudEGDbliknnSgQMdIY0wGXjFtDazZD759sN5MdoH0cL5peb6IfTNzpYLz-lxn9jf4WtlrMGyYULQZHzwYxfJ8gZT345KDvzQhhSppyppRQrHScobf_SddhiuUARdXwmjSUFdMZOn5SuRhSitD9HqYm-vGr-s9X2U-aHpYC</recordid><startdate>20200831</startdate><enddate>20200831</enddate><creator>Sánchez-Bilbao, Lara</creator><creator>Martínez-López, David</creator><creator>Revenga, Marcelino</creator><creator>López-Vázquez, Ángel</creator><creator>Valls-Pascual, Elia</creator><creator>Atienza-Mateo, Belén</creator><creator>Valls-Espinosa, Beatriz</creator><creator>Maiz-Alonso, Olga</creator><creator>Blanco, Ana</creator><creator>Torre-Salaberri, Ignacio</creator><creator>Rodríguez-Méndez, Verónica</creator><creator>García-Aparicio, Ángel</creator><creator>Veroz-González, Raúl</creator><creator>Jovaní, Vega</creator><creator>Peiteado, Diana</creator><creator>Sánchez-Orgaz, Margarita</creator><creator>Tomero, Eva</creator><creator>Toyos-Sáenz de Miera, Francisco J.</creator><creator>Pinillos, Valvanera</creator><creator>Aurrecoechea, Elena</creator><creator>Mora, Ángel</creator><creator>Conesa, Arantxa</creator><creator>Fernández-Prada, Manuel</creator><creator>Troyano, Juan A.</creator><creator>Calvo-Río, Vanesa</creator><creator>Demetrio-Pablo, Rosalía</creator><creator>González-Mazón, Íñigo</creator><creator>Hernández, José L.</creator><creator>Castañeda, Santos</creator><creator>González-Gay, Miguel Á.</creator><creator>Blanco, Ricardo</creator><general>MDPI AG</general><general>MDPI</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><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></search><sort><creationdate>20200831</creationdate><title>Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients</title><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></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c424t-53584928382b40c960e0d6b383be9def77ebdd39c8c73be0a8aaafe4834ba213</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Clinical medicine</topic><topic>Drug dosages</topic><topic>Edema</topic><topic>Eye movements</topic><topic>Graves disease</topic><topic>Hepatitis</topic><topic>Immunosuppressive agents</topic><topic>Infections</topic><topic>Monoclonal antibodies</topic><topic>Neutropenia</topic><topic>Observational studies</topic><topic>Pain</topic><topic>Patients</topic><topic>Strabismus</topic><topic>Thyroid gland</topic><topic>Tuberculosis</topic><topic>Ulcers</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sánchez-Bilbao, Lara</creatorcontrib><creatorcontrib>Martínez-López, David</creatorcontrib><creatorcontrib>Revenga, Marcelino</creatorcontrib><creatorcontrib>López-Vázquez, Ángel</creatorcontrib><creatorcontrib>Valls-Pascual, Elia</creatorcontrib><creatorcontrib>Atienza-Mateo, Belén</creatorcontrib><creatorcontrib>Valls-Espinosa, Beatriz</creatorcontrib><creatorcontrib>Maiz-Alonso, Olga</creatorcontrib><creatorcontrib>Blanco, Ana</creatorcontrib><creatorcontrib>Torre-Salaberri, Ignacio</creatorcontrib><creatorcontrib>Rodríguez-Méndez, Verónica</creatorcontrib><creatorcontrib>García-Aparicio, Ángel</creatorcontrib><creatorcontrib>Veroz-González, Raúl</creatorcontrib><creatorcontrib>Jovaní, Vega</creatorcontrib><creatorcontrib>Peiteado, Diana</creatorcontrib><creatorcontrib>Sánchez-Orgaz, Margarita</creatorcontrib><creatorcontrib>Tomero, Eva</creatorcontrib><creatorcontrib>Toyos-Sáenz de Miera, Francisco J.</creatorcontrib><creatorcontrib>Pinillos, Valvanera</creatorcontrib><creatorcontrib>Aurrecoechea, Elena</creatorcontrib><creatorcontrib>Mora, Ángel</creatorcontrib><creatorcontrib>Conesa, Arantxa</creatorcontrib><creatorcontrib>Fernández-Prada, Manuel</creatorcontrib><creatorcontrib>Troyano, Juan A.</creatorcontrib><creatorcontrib>Calvo-Río, Vanesa</creatorcontrib><creatorcontrib>Demetrio-Pablo, Rosalía</creatorcontrib><creatorcontrib>González-Mazón, Íñigo</creatorcontrib><creatorcontrib>Hernández, José L.</creatorcontrib><creatorcontrib>Castañeda, Santos</creatorcontrib><creatorcontrib>González-Gay, Miguel Á.</creatorcontrib><creatorcontrib>Blanco, Ricardo</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical medicine</jtitle></facets><delivery><delcategory>Remote Search 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>
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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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