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

被引：108

作者：

Calderon-Goercke, Monica ^{[1
,2
,3
]}

Loricera, Javier ^{[1
,2
,3
]}

Aldasoro, Vicente ^{[4
]}

Castaneda, Santos ^{[5
]}

Villa, Ignacio ^{[6
]}

Humbria, Alicia ^{[5
]}

Moriano, Clara ^{[7
]}

Romero-Yuste, Susana ^{[8
]}

Narvaez, Javier ^{[9
]}

Gomez-Arango, Catalina ^{[10
]}

Perez-Pampin, Eva ^{[11
]}

Melero, Rafael ^{[12
]}

Becerra-Fernandez, Elena ^{[13
]}

Revenga, Marcelino ^{[14
]}

Alvarez-Rivas, Noelia ^{[15
]}

Galisteo, Caries ^{[16
]}

Sivera, Francisca ^{[17
]}

Olive-Marques, Alejandro ^{[18
]}

Alvarez del Buergo, Maria ^{[19
]}

Marena-Rojas, Luisa ^{[20
]}

Fernandez-Lopez, Carlos ^{[21
]}

Navarro, Francisco ^{[22
]}

Raya, Enrique ^{[23
]}

Galindez-Agirregoikoa, Eva ^{[24
]}

Arca, Beatriz ^{[25
]}

Solans-Laque, Roser ^{[26
]}

Conesa, Arantxa ^{[27
]}

Hidalgo, Cristina ^{[28
]}

Vazquez, Carlos ^{[29
]}

Andres Roman-Ivorra, Jose ^{[30
]}

Lluch, Pau ^{[31
]}

Manrique-Arija, Sara ^{[32
]}

Vela, Paloma ^{[33
]}

De Miguel, Eugenio ^{[34
]}

Torres-Martin, Carmen ^{[35
]}

Carlos Nieto, Juan ^{[36
]}

Ordas-Calvo, Carmen ^{[37
]}

Salgado-Perez, Eva ^{[38
]}

Luna-Gomez, Cristina ^{[39
]}

Toyos-Saenz de Miera, F. Javier ^{[40
]}

Fernandez-Llanio, Nagore ^{[41
]}

Garcia, Antonio ^{[42
]}

Larena, Carmen ^{[14
]}

Palmou-Fontana, Natalia ^{[1
,2
,3
]}

Calvo-Rio, Vanesa ^{[1
,2
,3
]}

Prieto-Pena, Diana ^{[1
,2
,3
]}

Gonzalez-Vela, Carmen ^{[1
,2
,3
]}

Corrales, Alfonso ^{[1
,2
,3
]}

Varela-Garcia, Maria ^{[4
]}

Aurrecoechea, Elena ^{[6
]}

机构：

[1] Univ Cantabria, Hosp Univ Marques Valdecilla, IDIVAL, Dept Rheumatol, Santander, Spain

[2] Univ Cantabria, Hosp Univ Marques Valdecilla, IDIVAL, Dept Internal Med, Santander, Spain

[3] Univ Cantabria, Hosp Univ Marques Valdecilla, IDIVAL, Dept Pathol, Santander, Spain

[4] Complejo Hosp Navarra, Dept Rheumatol, Navarra, Spain

[5] Hosp Univ La Princesa, IIS Princesa, Dept Rheumatol, Madrid, Spain

[6] Hosp Sierrallana, Dept Rheumatol, Torrelavega, Spain

[7] Complejo Asistencial Univ Leon, Dept Rheumatol, Leon, Spain

[8] Complejo Hosp Univ Pontevedra, Dept Rheumatol, Pontevedra, Spain

[9] Hosp Bellvitge Princeps Espanya, Dept Rheumatol, Barcelona, Spain

[10] Hosp Alto Deba, Dept Rheumatol, Arrasate Mondragon, Spain

[11] Complejo Hosp Univ Santiago, Dept Rheumatol, Santiago De Compostela, Spain

[12] Complexo Hosp Univ Vigo, Dept Rheumatol, Vigo, Spain

[13] Hosp Univ Torrevieja, Dept Rheumatol, Alicante, Spain

[14] Hosp Ramon & Cajal, Dept Rheumatol, Madrid, Spain

[15] Hosp Univ Lucus Augusti, Dept Rheumatol, Lugo, Spain

[16] Hosp Parc Taull, Dept Rheumatol, Barcelona, Spain

[17] Hosp Univ Elda, Dept Rheumatol, Alicante, Spain

[18] Hosp Trias & Pujol, Dept Rheumatol, Badalona, Spain

[19] Hosp Rio Carr, Dept Rheumatol, Palencia, Spain

[20] Hosp Mancha Ctr, Dept Rheumatol, Alcazar De San Juan, Spain

[21] Hosp Univ Juan Canalejo, Dept Rheumatol, La Coruna, Spain

[22] Hosp Gen Univ Elche, Dept Rheumatol, Alicante, Spain

[23] Hosp San Cecilio, Dept Rheumatol & Internal Med, Granada, Spain

[24] Hosp Basurto, Dept Rheumatol, Bilbao, Spain

[25] Hosp Univ San Agustin, Dept Rheumatol, Aviles, Spain

[26] Hosp Valle De Hebron, Dept Internal Med, Barcelona, Spain

[27] Hosp Gen Univ Castellon, Dept Rheumatol, Castellon De La Plana, Spain

[28] Complejo Asistencial Univ Salamanca, Dept Rheumatol, Salamanca, Spain

[29] Hosp Miguel Servet, Dept Rheumatol, Zaragoza, Spain

[30] Hosp Univ & Politecn La Fe, Dept Rheumatol, Valencia, Spain

[31] Hosp Mateu Orfila, Dept Rheumatol, Menorca, Spain

[32] Hosp Reg Malaga, Dept Rheumatol, Malaga, Spain

[33] Hosp Gen Univ Alicante, Dept Rheumatol, Alicante, Spain

[34] Hosp La Paz, Dept Rheumatol, Madrid, Spain

[35] Complejo Asistencial Avila, Dept Rheumatol, Avila, Spain

[36] Hosp Gregorio Maranon, Dept Rheumatol, Madrid, Spain

[37] Hosp Cabuenes, Dept Rheumatol, Gijon, Spain

[38] Complejo Hosp Univ Ourense, Dept Rheumatol, Orense, Spain

[39] Hosp Univ Nuestra Senora Candelaria, Dept Rheumatol, Tenerife, Spain

[40] Hosp Univ Virgen Macarena, Dept Rheumatol, Seville, Spain

[41] Hosp Arnau Vilanova, Dept Rheumatol, Lerida, Spain

[42] Hosp Virgen Nieves, Dept Rheumatol, Granada, Spain

来源：

SEMINARS IN ARTHRITIS AND RHEUMATISM | 2019年 / 49卷 / 01期

关键词：

Tocilizumab; Giant cell arteritis; Biological therapy; Large-vessel vasculitis; POLYMYALGIA-RHEUMATICA; RECEPTOR TOCILIZUMAB; REFRACTORY UVEITIS; BEHCETS-DISEASE; THERAPY; EFFICACY; CLASSIFICATION; MAINTENANCE; INDUCTION; REMISSION;

D O I：

10.1016/j.semarthrit.2019.01.003

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：126 / 135

页数：10

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