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...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2019 |
| País: | España |
| Institución: | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
| Repositorio: | r-FISABIO. Repositorio Institucional de Producción Científica |
| OAI Identifier: | oai:fisabio.fundanetsuite.com:p7994 |
| Acceso en línea: | https://fisabio.portalinvestigacion.com/publicaciones/7994 |
| Access Level: | acceso abierto |
| Palabra clave: | Tocilizumab Giant cell arteritis Biological therapy Large-vessel vasculitis |
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Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practiceCalderón-Goercke MLoricera JAldasoro VCastañeda SVilla IHumbría AMoriano CRomero-Yuste SNarváez JGómez-Arango CPérez-Pampín EMelero RBecerra-Fernández ERevenga MÁlvarez-Rivas NGalisteo CSivera FOlivé-Marqués AÁlvarez Del Buergo MMarena-Rojas LFernández-López CNavarro FRaya EGalindez-Agirregoikoa EArca BSolans-Laqué RConesa AHidalgo CVázquez CRomán-Ivorra JALluch PManrique-Arija SDe Miguel ETorres-Martín CNieto JCOrdas-Calvo CSalgado-Pérez ELuna-Gomez CToyos-Sáenz de Miera FJFernández-Llanio NGarcía ALarena CPalmou-Fontana NCalvo-Río VPrieto-Peña DGonzález-Vela CCorrales AVarela-García MAurrecoechea EDos Santos RGarcía-Manzanares ÁOrtego NFernández SOrtiz-Sanjuán FCorteguera MHernández JLGonzález-Gay MÁBlanco RTocilizumabGiant cell arteritisBiological therapyLarge-vessel vasculitisObjective: 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. (C) 2019 Elsevier Inc. All rights reserved.W B SAUNDERS CO-ELSEVIER INC2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/7994SEMINARS IN ARTHRITIS AND RHEUMATISMISSN: 00490172ISSNe: 1532866Xreponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p79942026-06-11T12:45:17Z |
| 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 M Tocilizumab Giant cell arteritis Biological therapy Large-vessel vasculitis |
| 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 M Loricera J Aldasoro V Castañeda S Villa I Humbría A Moriano C Romero-Yuste S Narváez J Gómez-Arango C Pérez-Pampín E Melero R Becerra-Fernández E Revenga M Álvarez-Rivas N Galisteo C Sivera F Olivé-Marqués A Álvarez Del Buergo M Marena-Rojas L Fernández-López C Navarro F Raya E Galindez-Agirregoikoa E Arca B Solans-Laqué R Conesa A Hidalgo C Vázquez C Román-Ivorra JA Lluch P Manrique-Arija S De Miguel E Torres-Martín C Nieto JC Ordas-Calvo C Salgado-Pérez E Luna-Gomez C Toyos-Sáenz de Miera FJ Fernández-Llanio N García A Larena C Palmou-Fontana N Calvo-Río V Prieto-Peña D González-Vela C Corrales A Varela-García M Aurrecoechea E Dos Santos R García-Manzanares Á Ortego N Fernández S Ortiz-Sanjuán F Corteguera M Hernández JL González-Gay MÁ Blanco R |
| author |
Calderón-Goercke M |
| author_facet |
Calderón-Goercke M Loricera J Aldasoro V Castañeda S Villa I Humbría A Moriano C Romero-Yuste S Narváez J Gómez-Arango C Pérez-Pampín E Melero R Becerra-Fernández E Revenga M Álvarez-Rivas N Galisteo C Sivera F Olivé-Marqués A Álvarez Del Buergo M Marena-Rojas L Fernández-López C Navarro F Raya E Galindez-Agirregoikoa E Arca B Solans-Laqué R Conesa A Hidalgo C Vázquez C Román-Ivorra JA Lluch P Manrique-Arija S De Miguel E Torres-Martín C Nieto JC Ordas-Calvo C Salgado-Pérez E Luna-Gomez C Toyos-Sáenz de Miera FJ Fernández-Llanio N García A Larena C Palmou-Fontana N Calvo-Río V Prieto-Peña D González-Vela C Corrales A Varela-García M Aurrecoechea E Dos Santos R García-Manzanares Á Ortego N Fernández S Ortiz-Sanjuán F Corteguera M Hernández JL González-Gay MÁ Blanco R |
| author_role |
author |
| author2 |
Loricera J Aldasoro V Castañeda S Villa I Humbría A Moriano C Romero-Yuste S Narváez J Gómez-Arango C Pérez-Pampín E Melero R Becerra-Fernández E Revenga M Álvarez-Rivas N Galisteo C Sivera F Olivé-Marqués A Álvarez Del Buergo M Marena-Rojas L Fernández-López C Navarro F Raya E Galindez-Agirregoikoa E Arca B Solans-Laqué R Conesa A Hidalgo C Vázquez C Román-Ivorra JA Lluch P Manrique-Arija S De Miguel E Torres-Martín C Nieto JC Ordas-Calvo C Salgado-Pérez E Luna-Gomez C Toyos-Sáenz de Miera FJ Fernández-Llanio N García A Larena C Palmou-Fontana N Calvo-Río V Prieto-Peña D González-Vela C Corrales A Varela-García M Aurrecoechea E Dos Santos R García-Manzanares Á Ortego N Fernández S Ortiz-Sanjuán F Corteguera M Hernández JL González-Gay MÁ Blanco R |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Tocilizumab Giant cell arteritis Biological therapy Large-vessel vasculitis |
| topic |
Tocilizumab Giant cell arteritis Biological therapy Large-vessel vasculitis |
| 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. (C) 2019 Elsevier Inc. All rights reserved. |
| publishDate |
2019 |
| dc.date.none.fl_str_mv |
2019 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
https://fisabio.portalinvestigacion.com/publicaciones/7994 |
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https://fisabio.portalinvestigacion.com/publicaciones/7994 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess |
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openAccess |
| dc.publisher.none.fl_str_mv |
W B SAUNDERS CO-ELSEVIER INC |
| publisher.none.fl_str_mv |
W B SAUNDERS CO-ELSEVIER INC |
| dc.source.none.fl_str_mv |
SEMINARS IN ARTHRITIS AND RHEUMATISM ISSN: 00490172 ISSNe: 1532866X reponame:r-FISABIO. Repositorio Institucional de Producción Científica instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
| reponame_str |
r-FISABIO. Repositorio Institucional de Producción Científica |
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r-FISABIO. Repositorio Institucional de Producción Científica |
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1869403086031683584 |
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15,81155 |