Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice
Por:
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, Vela C, 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 and Blanco R
Publicada:
1 ago 2019
Ahead of Print:
5 ene 2019
Resumen:
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.
Filiaciones:
Calderón-Goercke M:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
Loricera J:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
Aldasoro V:
Department of Rheumatology, Complejo Hospitalario de Navarra, Navarra, Spain
Castañeda S:
Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Spain
Villa I:
Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Spain
Humbría A:
Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Spain
Moriano C:
Department of Rheumatology, Complejo Asistencial Universitario de León, León, Spain
Romero-Yuste S:
Department of Rheumatology, Complejo Hospitalario Universitario Pontevedra, Spain
Narváez J:
Department of Rheumatology, Hospital de Bellvitge, Barcelona, Spain
Gómez-Arango C:
Department of Rheumatology, Hospital Alto Deba, Mondragón, Spain
Pérez-Pampín E:
Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
Melero R:
Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain
Becerra-Fernández E:
Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain
Revenga M:
Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain
Álvarez-Rivas N:
Department of Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain
Galisteo C:
Department of Rheumatology, Hospital Parc Taulí, Barcelona, Spain
:
Department of Rheumatology, Hospital Universitario de Elda, Alicante, Spain
Olivé-Marqués A:
Department of Rheumatology, Hospital Trías i Pujol, Badalona, Spain
Álvarez Del Buergo M:
Department of Rheumatology, Hospital Río Carrión, Palencia, Spain
Marena-Rojas L:
Department of Rheumatology, Hospital La Mancha Centro, Alcázar de San Juan, Spain
Fernández-López C:
Department of Rheumatology, Hospital Universitario Juan Canalejo, A Coruña, Spain
:
Department of Rheumatology, Hospital General Universitario de Elche, Alicante, Spain
Raya E:
Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain
Galindez-Agirregoikoa E:
Department of Rheumatology, Hospital de Basurto, Bilbao, Spain
Arca B:
Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain
Solans-Laqué R:
Department of Internal Medicine, Hospital Valle de Hebrón, Barcelona, Spain
:
Department of Rheumatology, Hospital General Universitario de Castellón, Spain
Hidalgo C:
Department of Rheumatology, Complejo Asistencial Universitario de Salamanca, Spain
Vázquez C:
Department of Rheumatology, Hospital Miguel Servet, Zaragoza, Spain
Román-Ivorra JA:
Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Lluch P:
Department of Rheumatology, Hospital Mateu Orfila, Menorca, Spain
Manrique-Arija S:
Department of Rheumatology, Hospital Regional de Málaga, Málaga, Spain
Vela C:
Department of Rheumatology, Hospital General Universitario de Alicante, Alicante, Spain
De Miguel E:
Department of Rheumatology, Hospital La Paz, Madrid, Spain
Torres-Martín C:
Department of Rheumatology, Complejo Asistencial de Ávila, Ávila, Spain
Nieto JC:
Department of Rheumatology, Hospital Gregorio Marañón, Madrid, Spain
Ordas-Calvo C:
Department of Rheumatology, Hospital Cabueñes, Gijón, Spain
Salgado-Pérez E:
Department of Rheumatology, Complejo Hospitalario Universitario de Ourense, Ourense, Spain
Luna-Gomez C:
Department of Rheumatology, Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Spain
Toyos-Sáenz de Miera FJ:
Department of Rheumatology, Hospital Universitario Virgen Macarena, Sevilla, Spain
Fernández-Llanio N:
Department of Rheumatology, Hospital Arnau de Vilanova, Lérida, Spain
García A:
Department of Rheumatology, Hospital Virgen de las Nieves, Granada, Spain
Larena C:
Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain
Palmou-Fontana N:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
Calvo-Río V:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
Prieto-Peña D:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
González-Vela C:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
Corrales A:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
Varela-García M:
Department of Rheumatology, Complejo Hospitalario de Navarra, Navarra, Spain
Aurrecoechea E:
Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Spain
Dos Santos R:
Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
:
Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain
Ortego N:
Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain
Fernández S:
Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain
Ortiz-Sanjuán F:
Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Corteguera M:
Department of Rheumatology, Complejo Asistencial de Ávila, Ávila, Spain
Hernández JL:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
González-Gay MÁ:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
Blanco R:
Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain
Green Accepted
|