A Multicenter Series of Giant Cell Arteritis Patients from Clinical Practice in Treatmet with Tocilizumab Compared with Giacta Trial

Monica Calderón Goercke¹, Javier Loricera², Diana Prieto Peña¹, Vicente Aldasoro³, Santos Castañeda⁴, Ignacio Villa-Blanco⁵, Alicia Humbría⁶, Clara Moriano Morales⁷, Susana Romero-Yuste⁸, Francisco Javier Narváez⁹, Catalina Gómez-Arango¹⁰, Eva Perez Pampín¹¹, Rafael Melero¹², Elena Becerra-Fernández¹³, Marcelino Revenga Martínez¹⁴, Noelia Álvarez-Rivas¹⁵, Carlos Galisteo¹⁶, Francisca Sivera¹⁷, Alejandro Olivé-Marqués¹⁸, Maria Concepcion Alvarez de Buergo¹⁹, Luisa Marena Rojas Vargas²⁰, Carlos Fernandez-Lopez²¹, Francisco Navarro²², Enrique Raya Álvarez²³, Eva Galindez-Agirregoikoa²⁴, Beatriz Arca²⁵, Roser Solans²⁶, Arantxa Conesa²⁷, Cristina Hidalgo-Calleja²⁸, Carlos Vázquez²⁹, Jose Andrés Román Ivorra³⁰, Pau Lluch³¹, Sara Manrique-Arija³², Paloma Vela³³, Eugenio De Miguel³⁴, Carmen Torres-Martín³⁵, Juan Carlos Nieto³⁶, Carmen Ordas-Calvo³⁷, Eva Salgado-Pérez³⁸, Cristina Luna Gómez³⁹, Francisco J. Toyos Sáenz de Miera⁴⁰, Nagore Fernandez-Llanio Cornella⁴¹, Antonio García⁴², Carmen Larena⁴³, Belén Atienza-Mateo⁴⁴, José Luis Martín-Varillas⁴⁴, Natalia Palmou-Fontana², Vanesa Calvo-Río⁴⁴, Carmen González-Vela⁴⁵, Alfonso Corrales⁴⁴, María Varela-García⁴⁶, Elena Aurrecoechea⁴⁷, Raquel Dos Santos⁴⁸, Angel García-Manzanares¹³, Norberto Ortego Centeno⁴⁹, Sabela Fernández⁵⁰, Francisco Ortiz-Sanjuán⁵¹, Montserrat Corteguera³⁵, Miguel Angel González-Gay², José Luis Hernández² and Ricardo Blanco⁴⁴, ¹Rheumatology, Rheumatology. Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ²Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ³Hospital Alto Deba. Mondragón. Spain, Mondragon, Spain, ⁴Hospital Universitario La Princesa, IIS-Princesa, Madrid, Spain, ⁵Hospital de Sierrallana. Torrelavega. Spain, Torrelavega, Spain, ⁶Rheumatology, Hospital La Princesa. Madrid. Spain, Madrid, Spain, ⁷Rheumatology, Complejo Asistencial Universitario de León. León. Spain, León, Spain, ⁸Hospital Pontevedra. Pontevedra. Spain., Pontevedra, Spain, ⁹Rheumatology Department, Hospital Universitario de Bellvitge, Idibell, Barcelona, Spain, ¹⁰Hospital Alto Deba, Mondragón. Spain, Mondragón, Spain, ¹¹Rheumatology Division. Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain, ¹²Rheumatology, Complexo Hospitalario Universitario de Vigo, Vigo. Spain, Vigo, Spain, ¹³Hospital Universitario de Torrevieja, Alicante. Spain, Alicante, Spain, ¹⁴Hospital Universitario Ramón y Cajal. Madrid. Spain, Madrid, Spain, ¹⁵Hospital Universitario Lucus Augusti, Lugo. Spain, Lugo, Spain, ¹⁶Rheumatology, Hospital Parc-Taulí, Sabadell, Spain, ¹⁷Rheumatology, Hospital General Universitario de Elda. Comunidad Valenciana. Spain, Elda, Spain, ¹⁸Hospital Trías i Pujol, Badalona, Barcelona, Spain, ¹⁹Rheumatology, Hospital Río Carrión. Palencia. Spain, Palencia, Spain, ²⁰Rheumatology Department, Hospital General La Mancha Centro, Alcázar de San Juan, Spain, ²¹Servicio de Reumatología, Complexo Hospitalario Universitario de A Coruña (CHUAC), A Coruña. España, A Coruña, Spain, ²²Hospital General Universitario de Elche, Alicante. Spain, Alicante, Spain, ²³Rheumatology, Hospital Universitario San Cecilio. Granada. Spain, Granada, Spain, ²⁴Rheumatology, University Hospital of Basurto, Bilbao, Spain, ²⁵Hospital Universitario San Agustín, Avilés. Spain, Avilés, Spain, ²⁶Systemic Autoimmune Diseases Unit, Hospital Vall d’Hebron, Barcelona, Barcelona, Spain, ²⁷Rheumatology, Hospital Clínico Universitario de Valencia. Spain, Valencia, Spain, ²⁸Rheumatology, Hospital Clínico Universitario de Salamanca, Salamanca. Spain, Salamanca, Spain, ²⁹Hospital Miguel Servet, Zaragoza. Spain, Zaragoza, Spain, ³⁰Hospital La Fe. Valencia. Spain, Valencia, Spain, ³¹Rheumatology, Hospital Mateu Orfila. Menorca. Spain, Menorca, Spain, ³²UGC de Reumatología, Instituto de Investigación Biomédica de Málaga (IBIMA) Hospital Regional Universitario de Málaga, Universidad de Málaga, Málaga, Spain., Málaga, Spain, ³³Reumatología, Hospital General Universitario Alicante, Alicante, Spain, ³⁴Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, ³⁵Complejo Asistencial de Ávila, Ávila. Spain, Ávila, Spain, ³⁶Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain, ³⁷Hospital Cabueñes, Gijón. Spain, Gijón, Spain, ³⁸Rheumatology, Complejo Hospitalario Universitario de Ourense, Ourense. Spain, Ourense, Spain, ³⁹Rheumatology, University Hospital Ntra. Sra. de La Candelaria, Santa Cruz de Tenerife, Spain, ⁴⁰Hospital Virgen de La Macarena. Sevilla. Spain, Sevilla, Spain, ⁴¹Rheumatology Section. Hospital Arnau de Vilanova, Valencia, Spain, ⁴²Hospital Unviersitario Virgen de las Nieves, Granada. Spain, Granada, Spain, ⁴³Hospital General Universitario Gregorio Marañón, Madrid, Spain, ⁴⁴Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ⁴⁵Pathology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ⁴⁶Complejo Hospitalario de Navarra, Navarra, Spain, ⁴⁷Rheumatology, Hospital de Sierrallana. Torrelavega. Spain, Torrelavega, Spain, ⁴⁸Complejo Hospitalario Universitario de Santiago. Spain, Santiago de Compostela, Spain, ⁴⁹Medicine Department, Hospital Universitario San Cecilio. Granada. Spain, Granada, Spain, ⁵⁰Rheumatology, Hospital Universitario San Agustín, Avilés. Spain, Avilés, Spain, ⁵¹Rheumatology, Hospital La Fe. Valencia. Spain, Valencia, Spain

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Clinical practice, giant cell arteritis and tocilizumab

Session Information

Date: Tuesday, October 23, 2018

Title: Vasculitis Poster III: Immunosuppressive Therapy in Giant Cell Arteritis and Polymyalgia Rheumatica

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: GiACTA study is a randomized, phase III controlled clinical trial of tocilizumab (TCZ) in giant cell arteritis (GCA) (1,2). Our aim was to compare GiACTA trial data from those of a national multicenter series of 134 patients with GCA from the clinical practice.

Methods: In the GiACTA study the diagnosis of GCA was established by the ACR modified criteria, in our clinical practice series it was established by ACR criteria, positive biopsy of temporal artery and/or presence of imaging techniques consistent with LVV in patients with cranial symptoms of GCA. In the GiACTA trial TCZ was given subcutaneously (162 mg every 1 or 2 weeks) while in the clinical practice study TCZ was used at standard IV dose (8 mg/kg/month) and subcutaneously (162 mg/week). Quantitative variables were expressed as mean±SD and they were compared by the Student’s t-test. Dichotomous variables were expressed as percentages and compared using the chi-square test.

Results: We did a comparative study between GiACTA trial (overall n=251 and only relapsing n=132) and our clinical practice series (overall n=134). At TCZ onset, in the clinical practice series (n=134) there were a significantly greater (TABLE): a) mean age at ACG diagnosis, b) polymyalgia rheumatica and visual affection frequency, c) ESR and CRP, and d) previous conventional immunosuppressants (mainly MTX). There was also a non-statistically significant difference, in terms of achieving sustained remission and developing severe infections. The mean dose of prednisone at the TCZ onset was lower in patients from the clinical practice.

Conclusion: Patients receiving TCZ in the clinical practice study have several baseline clinical and laboratory differences when compared to those included in the GiACTA trial. Patients of clinical practice were older, with a longer evolution time of disease. At TCZ onset were more symptomatic and had elevated levels of ESR and CRP, as well as, they had received more previous immunosuppressant agents.

TABLE

	GiACTA overall (n=251)	GiACTA (only relapsing; n=132)	Clinical Practice Overall (n=134)	GiACTA overall vs Clinical Practice overall	GiACTA relapsing vs Clinical Practice overall
Inclusion criteria	ACR 1990 modified	ACR 1990 modified	ACR 1990, biopsy proven GCA, cranial symptoms plus LVV*
Women / men, n (%)	188 (74.9)/63 (25.1)	99 (75)/33 (25)	101 (75.4)/ 33 (24.6)	0.98	0.94
Age, mean (SD)	69 (8.2)	69.1 (8)	73 (8.8)	<0.0001	0.0002
Newly diagnosed GCA/ recurrent GCA	119/132	0/132	0/134	–	–
Time (months) from GCA diagnosis, mean (SD)	9.1 (16.8)	16.9 (20.3)	13.5 [5.0-33.5]	–	–
Signs/symptoms of GCA at TCZ onset	98 (39)	59 (44.7)	74 (55.2)	0.003	0.11
PMR, n (%)	49 (19.5)	40 (30.3)	73 (54)	<0.0001	0.0001
Visual affection, n (%)	4 (1.6)	4 (3)	28 (20.9)	<0.0001	<0.0001
ESR, mean (SD)	24 (19.4)	26.8 (19.6)	40.5 (31.2)	<0.0001	<0.0001
CRP, mean (SD)	7.5 (13.4)	8.4 (15.4)	3 (5.3)	<0.0001	0.0002
Positive TAB, n (%)	156 (62.1)	82 (62.1)	72 (53.7)	0.14	0.21
Imaging techniques, n (%)	138 (55)	70 (53)	75 (56)	0.93	0.72
Positive MRA, n (%)	8 (3.2)	4 (3)	16 (11.9)	0.002	0.01
Positive CT scan, n (%)	13 (5.2)	7 (5.3)	4 (44.4)	0.46	0.52
Positive PET/CT scan, n (%)	97 (38.7)	42 (31.8)	52 (38.8)	0.93	0.29
Patients on corticosteroids at study onset, n (%)	251 (100)	132 (100)	134 (100)	–	–
Prednisone at TCZ onset, mean (SD)	40 (13.1)	30.2 (12)	21.7(16.1)	<0.0001	<0.0001
Previous immunosuppressant agents, n (%)	27 (10.8)	23 (17)	98 (73.1)	<0.0001	<0.0001
Previous biologic therapy, n (%)	–	–	3 (2.2)	–	–
TCZ route	SC	SC	IV (106) SC (28)	–	–
Sustained remission, n (%) §	82 (54.6)	–	50 (70.4)	0.42	–
Severe infection, n (%)§	9/150 (6)	–	16 (11.9)	0.12	–

* Large vessel vasculitis (LVV) by imaging techniques.

Disclosure: M. Calderón Goercke, None; J. Loricera, None; D. Prieto Peña, None; V. Aldasoro, None; S. Castañeda, None; I. Villa-Blanco, None; A. Humbría, None; C. Moriano Morales, None; S. Romero-Yuste, None; F. J. Narváez, None; C. Gómez-Arango, None; E. Perez Pampín, None; R. Melero, None; E. Becerra-Fernández, None; M. Revenga Martínez, None; N. Álvarez-Rivas, None; C. Galisteo, None; F. Sivera, None; A. Olivé-Marqués, None; M. C. Alvarez de Buergo, None; L. M. Rojas Vargas, None; C. Fernandez-Lopez, None; F. Navarro, None; E. Raya Álvarez, None; E. Galindez-Agirregoikoa, None; B. Arca, None; R. Solans, None; A. Conesa, None; C. Hidalgo-Calleja, None; C. Vázquez, None; J. A. Román Ivorra, None; P. Lluch, None; S. Manrique-Arija, None; P. Vela, None; E. De Miguel, None; C. Torres-Martín, None; J. C. Nieto, None; C. Ordas-Calvo, None; E. Salgado-Pérez, None; C. Luna Gómez, None; F. J. Toyos Sáenz de Miera, None; N. Fernandez-Llanio Cornella, None; A. García, None; C. Larena, None; B. Atienza-Mateo, None; J. L. Martín-Varillas, None; N. Palmou-Fontana, None; V. Calvo-Río, None; C. González-Vela, None; A. Corrales, None; M. Varela-García, None; E. Aurrecoechea, None; R. Dos Santos, None; A. García-Manzanares, None; N. Ortego Centeno, None; S. Fernández, None; F. Ortiz-Sanjuán, None; M. Corteguera, None; M. A. González-Gay, None; J. L. Hernández, None; R. Blanco, None.

To cite this abstract in AMA style:

Calderón Goercke M, Loricera J, Prieto Peña D, Aldasoro V, Castañeda S, Villa-Blanco I, Humbría A, Moriano Morales C, Romero-Yuste S, Narváez FJ, Gómez-Arango C, Perez Pampín E, Melero R, Becerra-Fernández E, Revenga Martínez M, Álvarez-Rivas N, Galisteo C, Sivera F, Olivé-Marqués A, Alvarez de Buergo MC, Rojas Vargas LM, Fernandez-Lopez C, Navarro F, Raya Álvarez E, Galindez-Agirregoikoa E, Arca B, Solans R, Conesa A, Hidalgo-Calleja C, Vázquez C, Román Ivorra JA, Lluch P, Manrique-Arija S, Vela P, De Miguel E, Torres-Martín C, Nieto JC, Ordas-Calvo C, Salgado-Pérez E, Luna Gómez C, Toyos Sáenz de Miera FJ, Fernandez-Llanio Cornella N, García A, Larena C, Atienza-Mateo B, Martín-Varillas JL, Palmou-Fontana N, Calvo-Río V, González-Vela C, Corrales A, Varela-García M, Aurrecoechea E, Dos Santos R, García-Manzanares A, Ortego Centeno N, Fernández S, Ortiz-Sanjuán F, Corteguera M, González-Gay MA, Hernández JL, Blanco R. A Multicenter Series of Giant Cell Arteritis Patients from Clinical Practice in Treatmet with Tocilizumab Compared with Giacta Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/a-multicenter-series-of-giant-cell-arteritis-patients-from-clinical-practice-in-treatmet-with-tocilizumab-compared-with-giacta-trial/. Accessed .

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