Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice

Calderón-Goercke, Mónica; Loricera, Javier; Aldasoro, Vicente; Castañeda, Santos; Villa, Ignacio; Humbría, Alicia; Moriano, Clara; Romero-Yuste, Susana; Narváez, Javier; Gómez-Arango, Catalina; Pérez-Pampín, Eva; Melero, Rafael; Becerra-Fernández, Elena; Revenga, Marcelino; Álvarez-Rivas, Noelia; Galisteo, Carles; Sivera, Francisca; Olivé-Marqués, Alejandro; Álvarez del Buergo, María; Marena-Rojas, Luisa; Román Ivorra, José Andrés; Blanco, Ricardo

Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice

Objective: Tocilizumab (TCZ) has shown efficacy in clinical trials on giant cell arteritis (GCA). Real-world data are scarce. Our objective was to assess efficacy and safety of TCZ in unselected patients with GCA in clinical practice Methods: Observational, open-label multicenter study from 40 natio...

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Autores:	Calderón-Goercke, Mónica, Loricera, Javier, Aldasoro, Vicente, Castañeda, Santos, Villa, Ignacio, Humbría, Alicia, Moriano, Clara, Romero-Yuste, Susana, Narváez, Javier, Gómez-Arango, Catalina, Pérez-Pampín, Eva, Melero, Rafael, Becerra-Fernández, Elena, Revenga, Marcelino, Álvarez-Rivas, Noelia, Galisteo, Carles, Sivera, Francisca, Olivé-Marqués, Alejandro, Álvarez del Buergo, María, Marena-Rojas, Luisa, Román Ivorra, José Andrés, Blanco, Ricardo
Tipo de recurso:	artículo
Fecha de publicación:	2019
País:	España
Institución:	Universidad Católica de Valencia San Vicente Mártir
Repositorio:	RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir
Idioma:	inglés
OAI Identifier:	oai:riucv.ucv.es:20.500.12466/5127
Acceso en línea:	http://hdl.handle.net/20.500.12466/5127
Access Level:	acceso abierto
Palabra clave:	Biological Therapy Giant Cell Arteritis Large-Vessel Vasculitis Tocilizumab 3205.09 Reumatología

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spelling	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practiceCalderón-Goercke, MónicaLoricera, JavierAldasoro, VicenteCastañeda, SantosVilla, IgnacioHumbría, AliciaMoriano, ClaraRomero-Yuste, SusanaNarváez, JavierGómez-Arango, CatalinaPérez-Pampín, EvaMelero, RafaelBecerra-Fernández, ElenaRevenga, MarcelinoÁlvarez-Rivas, NoeliaGalisteo, CarlesSivera, FranciscaOlivé-Marqués, AlejandroÁlvarez del Buergo, MaríaMarena-Rojas, LuisaRomán Ivorra, José AndrésBlanco, RicardoBiological TherapyGiant Cell ArteritisLarge-Vessel VasculitisTocilizumab3205.09 ReumatologíaObjective: Tocilizumab (TCZ) has shown efficacy in clinical trials on giant cell arteritis (GCA). Real-world data are scarce. Our objective was to assess efficacy and safety of TCZ in unselected patients with GCA in clinical practice Methods: Observational, open-label multicenter study from 40 national referral centers of GCA patients treated with TCZ due to inefficacy or adverse events of previous therapy. Outcomes variables were improvement of clinical features, acute phase reactants, glucocorticoid-sparing effect, prolonged remission and relapses. A comparative study was performed: (a) TCZ route (SC vs. IV); (b) GCA duration (≤6 vs. >6 months); (c) serious infections (with or without); (d) ≤15 vs. >15 mg/day at TCZ onset. Results: 134 patients; mean age, 73.0 ± 8.8 years. TCZ was started after a median [IQR] time from GCA diagnosis of 13.5 [5.0–33.5] months. Ninety-eight (73.1%) patients had received immunosuppressive agents. After 1 month of TCZ 93.9% experienced clinical improvement. Reduction of CRP from 1.7 [0.4–3.2] to 0.11 [0.05–0.5] mg/dL (p < 0.0001), ESR from 33 [14.5–61] to 6 [2–12] mm/1st hour (p < 0.0001) and decrease in patients with anemia from 16.4% to 3.8% (p < 0.0001) were observed. Regardless of administration route or disease duration, clinical improvement leading to remission at 6, 12, 18, 24 months was observed in 55.5%, 70.4%, 69.2% and 90% of patients. Most relevant adverse side-effect was serious infections (10.6/100 patients-year), associated with higher doses of prednisone during the first three months of therapy. Conclusion: In clinical practice, TCZ yields a rapid and maintained improvement of refractory GCA. Serious infections appear to be higher than in clinical trials.20252025-01-1420192019-08-0120192019-08-01journal articlehttp://purl.org/coar/resource_type/c_6501AMhttp://purl.org/coar/version/c_ab4af688f83e57aainfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/20.500.12466/5127reponame:RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártirinstname:Universidad Católica de Valencia San Vicente MártirInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:riucv.ucv.es:20.500.12466/51272026-06-19T08:32:07Z
dc.title.none.fl_str_mv	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice
title	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice
spellingShingle	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice Calderón-Goercke, Mónica Biological Therapy Giant Cell Arteritis Large-Vessel Vasculitis Tocilizumab 3205.09 Reumatología
title_short	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice
title_full	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice
title_fullStr	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice
title_full_unstemmed	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice
title_sort	Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice
dc.creator.none.fl_str_mv	Calderón-Goercke, Mónica Loricera, Javier Aldasoro, Vicente Castañeda, Santos Villa, Ignacio Humbría, Alicia Moriano, Clara Romero-Yuste, Susana Narváez, Javier Gómez-Arango, Catalina Pérez-Pampín, Eva Melero, Rafael Becerra-Fernández, Elena Revenga, Marcelino Álvarez-Rivas, Noelia Galisteo, Carles Sivera, Francisca Olivé-Marqués, Alejandro Álvarez del Buergo, María Marena-Rojas, Luisa Román Ivorra, José Andrés Blanco, Ricardo
author	Calderón-Goercke, Mónica
author_facet	Calderón-Goercke, Mónica Loricera, Javier Aldasoro, Vicente Castañeda, Santos Villa, Ignacio Humbría, Alicia Moriano, Clara Romero-Yuste, Susana Narváez, Javier Gómez-Arango, Catalina Pérez-Pampín, Eva Melero, Rafael Becerra-Fernández, Elena Revenga, Marcelino Álvarez-Rivas, Noelia Galisteo, Carles Sivera, Francisca Olivé-Marqués, Alejandro Álvarez del Buergo, María Marena-Rojas, Luisa Román Ivorra, José Andrés Blanco, Ricardo
author_role	author
author2	Loricera, Javier Aldasoro, Vicente Castañeda, Santos Villa, Ignacio Humbría, Alicia Moriano, Clara Romero-Yuste, Susana Narváez, Javier Gómez-Arango, Catalina Pérez-Pampín, Eva Melero, Rafael Becerra-Fernández, Elena Revenga, Marcelino Álvarez-Rivas, Noelia Galisteo, Carles Sivera, Francisca Olivé-Marqués, Alejandro Álvarez del Buergo, María Marena-Rojas, Luisa Román Ivorra, José Andrés Blanco, Ricardo
author2_role	author author author author author author author author author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv	Biological Therapy Giant Cell Arteritis Large-Vessel Vasculitis Tocilizumab 3205.09 Reumatología
topic	Biological Therapy Giant Cell Arteritis Large-Vessel Vasculitis Tocilizumab 3205.09 Reumatología
description	Objective: Tocilizumab (TCZ) has shown efficacy in clinical trials on giant cell arteritis (GCA). Real-world data are scarce. Our objective was to assess efficacy and safety of TCZ in unselected patients with GCA in clinical practice Methods: Observational, open-label multicenter study from 40 national referral centers of GCA patients treated with TCZ due to inefficacy or adverse events of previous therapy. Outcomes variables were improvement of clinical features, acute phase reactants, glucocorticoid-sparing effect, prolonged remission and relapses. A comparative study was performed: (a) TCZ route (SC vs. IV); (b) GCA duration (≤6 vs. >6 months); (c) serious infections (with or without); (d) ≤15 vs. >15 mg/day at TCZ onset. Results: 134 patients; mean age, 73.0 ± 8.8 years. TCZ was started after a median [IQR] time from GCA diagnosis of 13.5 [5.0–33.5] months. Ninety-eight (73.1%) patients had received immunosuppressive agents. After 1 month of TCZ 93.9% experienced clinical improvement. Reduction of CRP from 1.7 [0.4–3.2] to 0.11 [0.05–0.5] mg/dL (p < 0.0001), ESR from 33 [14.5–61] to 6 [2–12] mm/1st hour (p < 0.0001) and decrease in patients with anemia from 16.4% to 3.8% (p < 0.0001) were observed. Regardless of administration route or disease duration, clinical improvement leading to remission at 6, 12, 18, 24 months was observed in 55.5%, 70.4%, 69.2% and 90% of patients. Most relevant adverse side-effect was serious infections (10.6/100 patients-year), associated with higher doses of prednisone during the first three months of therapy. Conclusion: In clinical practice, TCZ yields a rapid and maintained improvement of refractory GCA. Serious infections appear to be higher than in clinical trials.
publishDate	2019
dc.date.none.fl_str_mv	2019 2019-08-01 2019 2019-08-01 2025 2025-01-14
dc.type.none.fl_str_mv	journal article http://purl.org/coar/resource_type/c_6501 AM http://purl.org/coar/version/c_ab4af688f83e57aa
dc.type.openaire.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	http://hdl.handle.net/20.500.12466/5127
url	http://hdl.handle.net/20.500.12466/5127
dc.language.none.fl_str_mv	Inglés eng
language_invalid_str_mv	Inglés
language	eng
dc.rights.none.fl_str_mv	open access http://purl.org/coar/access_right/c_abf2 Attribution-NonCommercial-NoDerivatives 4.0 Internacional http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv	info:eu-repo/semantics/openAccess
rights_invalid_str_mv	open access http://purl.org/coar/access_right/c_abf2 Attribution-NonCommercial-NoDerivatives 4.0 Internacional http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.source.none.fl_str_mv	reponame:RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir instname:Universidad Católica de Valencia San Vicente Mártir
instname_str	Universidad Católica de Valencia San Vicente Mártir
reponame_str	RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir
collection	RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir
repository.name.fl_str_mv
repository.mail.fl_str_mv
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Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice

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