Tocilizumab in giant cell arteritis: differences between the GiACTA trial and a multicentre series of patients from the clinical practice

被引:0
作者
Calderon-Goercke, M. [1 ]
Castaneda, S. [2 ,3 ]
Aldasoro, V. [4 ]
Villa, I. [5 ]
Prieto-Pena, D. [1 ]
Atienza-Mateo, B. [1 ]
Patino, E. [2 ,3 ]
Moriano, C. [6 ]
Romero-Yuste, S. [7 ]
Narvaez, J. [8 ]
Gomez-Arango, C. [9 ]
Perez-Pampin, E. [10 ]
Melero, R. [11 ]
Becerra-Fernandez, E. [12 ]
Revenga, M. [13 ]
Alvarez-Rivas, N. [14 ]
Galisteo, C. [15 ]
Sivera, F. [16 ]
Olive-Marques, A. [17 ]
Buergo, M. Alvarez del [18 ]
Marena-Rojas, L. [19 ]
Fernandez-Lopez, C. [20 ]
Navarro, F. [21 ]
Raya, E. [22 ]
Galindez-Agirregoikoa, E. [23 ]
Arca, B. [24 ]
Solans-Laque, R. [25 ]
Conesa, A. [26 ]
Hidalgo, C. [27 ]
Vazquez, C. [28 ]
Roman-Ivorra, J. A. [29 ]
Loricera, J. [1 ]
Lluch, P. [30 ]
Manrique-Arija, S. [31 ]
Vela, P. [32 ]
Miguel, E. De [33 ]
Torres-Martin, C. [34 ]
Nieto, J. C. [35 ]
Ordas-Calvo, C. [36 ]
Salgado-Perez, E. [37 ]
Luna-Gomez, C. [38 ]
Miera, F. J. Toyos-Saenz de [39 ]
Fernandez-Llanio, N. [40 ]
Garcia, A. [41 ]
Larena, C. [13 ]
Gonzalez-Vela, C. [1 ]
Corrales, A. [1 ]
Varela-Garcia, M. [2 ,3 ]
Aurrecoechea, E. [5 ]
Santos, R. Dos [10 ]
机构
[1] Univ Cantabria, Hosp Univ Marques Valdecilla, Dept Rheumatol Internal Med & Pathol, IDIVAL, Santander, Spain
[2] Hosp Univ La Princesa, Dept Rheumatol, IIS Princesa, Madrid, Spain
[3] Univ Autonoma UAM, Catedra UAM Roche, END Future, Madrid, Spain
[4] Complejo Hosp Navarra, Dept Rheumatol, Pamplona, Spain
[5] Hosp Sierrallana, Dept Rheumatol, Torrelavega, Cantabria, Spain
[6] Complejo Asistencial Univ Leon, Dept Rheumatol, Leon, Spain
[7] Complejo Hosp Univ Pontevedra, Dept Rheumatol, Pontevedra, Spain
[8] Hosp Bellvitge Princeps Espanya, Dept Rheumatol, Barcelona, Spain
[9] Hosp Alto Deha, Dept Rheumatol, Arrasate Mondragon, Spain
[10] Complejo Hosp Univ Santiago, Dept Rheumatol, Santiago De Compostela, Spain
[11] Complex Hosp Univ Vigo, Dept Rheumatol, Vigo, Spain
[12] Hosp Univ Torrevieja, Dept Rheumatol, Alicante, Spain
[13] Hosp Ramon & Cajal, Dept Rheumatol, Madrid, Spain
[14] Hosp Univ Lucus Augusti, Dept Rheumatol, Lugo, Spain
[15] Hosp Parc Tauli, Dept Rheumatol, Barcelona, Spain
[16] Hosp Univ Elda, Dept Rheumatol, Alicante, Spain
[17] Hosp Trias & Pujol, Dept Rheumatol, Badalona, Spain
[18] Hosp Rio Carrion, Dept Rheumatol, Palencia, Spain
[19] Hosp La Mancha Ctr, Dept Rheumatol, Alcazar De San Juan, Spain
[20] Hosp Univ Juan Canalejo, Dept Rheumatol, La Coruna, Spain
[21] Hosp Gen Univ Elche, Dept Rheumatol, Alicante, Spain
[22] Hosp San Cecilio, Dept Rheumatol & Internal Med, Granada, Spain
[23] Hosp Basurto, Dept Rheumatol, Bilbao, Spain
[24] Hosp Univ San Agustin, Dept Rheumatol, Aviles, Spain
[25] Hosp Valle De Hebron, Dept Internal Med, Barcelona, Spain
[26] Hosp Gen Univ Castellon, Dept Rheumatol, Castellon de La Plana, Spain
[27] Complejo Asistencial Univ Salamanca, Dept Rheumatol, Salamanca, Spain
[28] Hosp Miguel Servet, Dept Rheumatol, Zaragoza, Spain
[29] Hosp Univ Politecn La Fe, Dept Rheumatol, Valencia, Spain
[30] Hosp Mateu Orfila, Dept Rheumatol, Menorca, Spain
[31] Hosp Reg Malaga, Dept Rheumatol, Malaga, Spain
[32] Hosp Gen Univ Alicante, Dept Rheumatol, Alicante, Spain
[33] Hosp La Paz, Dept Rheumatol, Madrid, Spain
[34] Complejo Asistencial Avila, Dept Rheumatol, Avila, Spain
[35] Hosp Gregorio Maranon, Dept Rheumatol, Madrid, Spain
[36] Hosp Cahuelies, Dept Rheumatol, Gijon, Spain
[37] Complejo Hosp Univ Ourense, Dept Rheumatol, Orense, Spain
[38] Hosp Univ Nuestra Senora Candelaria, Dept Rheumatol, Tenerife, Spain
[39] Hosp Univ Virgen Macarena, Dept Rheumatol, Seville, Spain
[40] Hosp Arnau Vilanova, Dept Rheumatol, Lerida, Spain
[41] Hosp Virgen Las Nieves, Dept Rheumatol, Granada, Spain
关键词
giant cell arteritis; tocilizumab; clinical practice; real-world; GiACTA trial; POLYMYALGIA-RHEUMATICA; RANDOMIZED-TRIALS; DOUBLE-BLIND; THERAPY; EFFICACY; RELAPSES;
D O I
暂无
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective. A potential point of concern among clinicians is whether results derived from the clinical trials can be reasonably applied or generalised to a definable group of patients seen in real world. It can be the case of the GiACTA study that is a phase III randomised controlled trial of tocilizumab (TCZ) in giant cell arteritis (GCA). To address this question, we compared the clinical features and the response to TCZ from the GiACTA trial patients with those from a series of GCA. seen in the daily clinical practice. Methods. Comparative study of clinical features between patients from the GiACTA trial (overall n=251) and those from a multicentre series of real-world GCA patients undergoing TCZ, therapy (n=134). The diagnosis of GCA in the GiACTA trial was established by the ACR modified criteria whereas in the series of real-world patients it was made by using the ACR criteria, a positive biopsy of temporal artery or the presence of imaging techniques consistent with large-vessel vasculitis in individuals who presented cranial symptoms of GCA. GiACTA trial patients received subcutaneous TCZ (162 mg every 1 or 2 weeks) whereas those from the clinical practice series were treated using standard IV dose (8 mg/kg/month) or subcutaneously (162 mg/week). Results. Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial. Despite clinical differences, TCZ, was equally effective in both GiACTA trial and clinical practice patients. However, serious infections were more commonly observed in GCA patients recruited from the clinical practice. Conclusion. Despite clinical differences with patients recruited in clinical trials, data from real-life patients confirm the efficacy of TCZ, in GCA.
引用
收藏
页码:S112 / S119
页数:8
相关论文
共 55 条
[1]   Efficacy and tolerability of leflunomide in difficult-to-treat polymyalgia rheumatica and giant cell arteritis: a case series [J].
Adizie, T. ;
Christidis, D. ;
Dharmapaliah, C. ;
Borg, F. ;
Dasgupta, B. .
INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, 2012, 66 (09) :906-909
[2]   A Tutorial and Case Study in Propensity Score Analysis: An Application to Estimating the Effect of In-Hospital Smoking Cessation Counseling on Mortality [J].
Austin, Peter C. .
MULTIVARIATE BEHAVIORAL RESEARCH, 2011, 46 (01) :119-151
[3]   Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making [J].
Berger, Marc L. ;
Sox, Harold ;
Willke, Richard J. ;
Brixner, Diana L. ;
Eichler, Hans-Georg ;
Goettsch, Wim ;
Madigan, David ;
Makady, Amr ;
Schneeweiss, Sebastian ;
Tarricone, Rosanna ;
Wang, Shirley V. ;
Watkins, John ;
Daniel Mullins, C. .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2017, 26 (09) :1033-1039
[4]   Anti-interleukin 6 receptor therapy as rescue treatment for giant cell arteritis [J].
Beyer, Christian ;
Axmann, Roland ;
Sahinbegovic, Enijad ;
Distler, Joerg H. ;
Manger, Bernhard ;
Schett, Georg ;
Zwerina, Jochen .
ANNALS OF THE RHEUMATIC DISEASES, 2011, 70 (10) :1874-1875
[5]  
Black N, 1996, BRIT MED J, V312, P1215
[6]   Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice [J].
Calderon-Goercke, Monica ;
Loricera, Javier ;
Aldasoro, Vicente ;
Castaneda, Santos ;
Villa, Ignacio ;
Humbria, Alicia ;
Moriano, Clara ;
Romero-Yuste, Susana ;
Narvaez, Javier ;
Gomez-Arango, Catalina ;
Perez-Pampin, Eva ;
Melero, Rafael ;
Becerra-Fernandez, Elena ;
Revenga, Marcelino ;
Alvarez-Rivas, Noelia ;
Galisteo, Caries ;
Sivera, Francisca ;
Olive-Marques, Alejandro ;
Alvarez del Buergo, Maria ;
Marena-Rojas, Luisa ;
Fernandez-Lopez, Carlos ;
Navarro, Francisco ;
Raya, Enrique ;
Galindez-Agirregoikoa, Eva ;
Arca, Beatriz ;
Solans-Laque, Roser ;
Conesa, Arantxa ;
Hidalgo, Cristina ;
Vazquez, Carlos ;
Andres Roman-Ivorra, Jose ;
Lluch, Pau ;
Manrique-Arija, Sara ;
Vela, Paloma ;
De Miguel, Eugenio ;
Torres-Martin, Carmen ;
Carlos Nieto, Juan ;
Ordas-Calvo, Carmen ;
Salgado-Perez, Eva ;
Luna-Gomez, Cristina ;
Toyos-Saenz de Miera, F. Javier ;
Fernandez-Llanio, Nagore ;
Garcia, Antonio ;
Larena, Carmen ;
Palmou-Fontana, Natalia ;
Calvo-Rio, Vanesa ;
Prieto-Pena, Diana ;
Gonzalez-Vela, Carmen ;
Corrales, Alfonso ;
Varela-Garcia, Maria ;
Aurrecoechea, Elena .
SEMINARS IN ARTHRITIS AND RHEUMATISM, 2019, 49 (01) :126-135
[7]   Treatment of polymyalgia rheumatica [J].
Castaneda, Santos ;
Garcia-Castaneda, Noelia ;
Prieto-Pena, Diana ;
Martinez-Quintanilla, Dolores ;
Vicente, Esther F. ;
Blanco, Ricardo ;
Gonzalez-Gay, Miguel A. .
BIOCHEMICAL PHARMACOLOGY, 2019, 165 :221-229
[8]  
Christidis Dimitrios, 2011, BMJ Case Rep, V2011, DOI 10.1136/bcr.04.2011.4135
[9]   Generalizing Evidence From Randomized Clinical Trials to Target Populations [J].
Cole, Stephen R. ;
Stuart, Elizabeth A. .
AMERICAN JOURNAL OF EPIDEMIOLOGY, 2010, 172 (01) :107-115
[10]  
de Boysson H, 2019, CLIN EXP RHEUMATOL, V37, pS57