Tocilizumab in Giant Cell Arteritis. National Multicenter Study of 134 Patients of Clinical Practice

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, Francisco Ortiz-Sanjuán³⁰, Pau Lluch³¹, Sara Manrique-Arija³², Paloma Vela³³, Eugenio De Miguel³⁴, Carmen Torres-Martín³⁵, Juan Carlos Nieto³⁶, Carmen Ordas-Calvo³⁷, Eva Salgado-Pérez³⁸, María Varela-García³⁹, Cristina Luna Gómez⁴⁰, Francisco J. Toyos Sáenz de Miera⁴¹, Nagore Fernandez-Llanio Cornella⁴², Jose Andrés Román Ivorra⁴³, Antonio García⁴⁴, Natalia Palmou-Fontana⁴⁵, Vanesa Calvo-Río⁴⁵, José Luis Martín-Varillas⁴⁵, Belén Atienza-Mateo⁴⁵, Carmen González-Vela⁴⁶, Alfonso Corrales⁴⁵, Elena Aurrecoechea⁴⁷, Raquel Dos Santos⁴⁸, Angel García-Manzanares¹³, Norberto Ortego Centeno⁴⁹, Sabela Fernández⁵⁰, Montserrat Corteguera³⁵, Miguel Angel González-Gay², José Luis Hernández² and Ricardo Blanco⁴⁵, 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, ⁴Rheumatology, Rheumatology Department, Hospital 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 de Pontevedra. Spain, Pontevedra, Spain, ⁹Rheumatology Department, Hospital de Bellvitge. Barcelona. Spain, L’Hospitalet de Llobregat, 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, ¹⁸Rheumatology, Hospital Universitari Germans Trias i Pujol, Badalona, 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 Division, Hospital Universitario de Basurto, Bilbao, Spain, ²⁵Hospital Universitario San Agustín, Avilés. Spain, Avilés, Spain, ²⁶Autoimmune Systemic Diseases Unit, Department of Internal Medicine, Hospital Vall d'Hebron, Autonomous University of Barcelona, Spain, 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, ³⁰Rheumatology, Hospital La Fe. Valencia. Spain, Valencia, Spain, ³¹Rheumatology, Hospital Mateu Orfila. Menorca. Spain, Menorca, Spain, ³²Medicine, University of Málaga, 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, ³⁹Complejo Hospitalario de Navarra, Navarra, Spain, ⁴⁰Rheumatology, University Hospital Ntra. Sra. de La Candelaria, Santa Cruz de Tenerife, Spain, ⁴¹Hospital Virgen de La Macarena. Sevilla. Spain, Sevilla, Spain, ⁴²Rheumatology Section. Hospital Arnau de Vilanova, Valencia, Spain, ⁴³Hospital La Fe. Valencia. Spain, Valencia, Spain, ⁴⁴Hospital Unviersitario Virgen de las Nieves, Granada. Spain, Granada, Spain, ⁴⁵Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ⁴⁶Pathology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, 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

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: Tocilizumab (TCZ) has showed efficacy in randomized clinical trials in Giant cell arteritis (GCA). Data were of selected patients including many GCA of recent onset. In addition, TCZ route (IV or SC) and concomitant corticosteroid dose were not established. To assess the efficacy and safety of TCZ in an unselected largest series of GCA in clinical practice.

Methods: Retrospective, open label multicenter study on 134 patients from 40 national referral centers with GCA in treatment with TCZ due to lack of efficacy and/or unacceptable adverse events of previous therapy.

Results: 134 (101 women) patients; mean age, 73.0±8.8 years. Before TCZ and besides steroids, 98 (73.1%) patients also received immunosuppressive agents. The median [IQR] time from GCA diagnosis was 13.5 [5.0-33.5] months. After 1 month of TCZ, 93.9% showed clinical improvement. It was observed a decrease in: a) CRP from 1.7 [0.4-3.2] to 0.11 [0.05-0.5] mg/dL (p<0.0001), b) ESR from 33 [14.5-61] to 6 [2-12] mm/1st hour (p<0.0001), c) anemia from 16.4% to 3.8% (p<0.0001). This improvement was maintained reaching prolonged remission at 55.5%, 70.4%, 69.2% and 90% at 6, 12, 18 and 24 months respectively. Improvement in ¹⁸F-FDG uptake in PET-TAC occurred slower, and complete resolution was observed in 0%, 14.3%, 18.7% and 19.5% cases at 6, 12, 18 and 24 months respectively. The most relevant side-effects were serious infections (10.6/100 patients-year), associated to higher doses of prednisone during the first three months of TCZ.

Conclusion: TCZ leads to a rapid and maintained improvement in refractory GCA, regardless TCZ route, GCA duration and prednisone dose. Serious infections were higher than in clinical trials. With TCZ a maximum dose of prednisone of 15 mg with rapid reduction is advisable.

Baseline

n= 134

Month 1

n= 132

Month 3

n= 122

Month 6

n= 99

Month 12

n= 71

Month 24

n= 39

Month 48

n= 10

Clinical improvement, %

(n/n available cases)

93.9%

(124/132)

94.2%

(119/122)

90.9%

(97/99)

92.9%

(66/71)

100%

(39/39)

100%

(10/10)

Laboratory improvement

CRP (mg/dL), median [IQR]

(n/n available cases)

1.7 [0.4-3.2]

(131/134)

0.11 [0.05-0.5]*

(98/132)

0.09 [0.02-0.3]*

(110/122)

0.09 [0.03-0.2]*

(92/99)

0.09 [0.02-0.19]*

(67/71)

0.1 [0.02-0.34]*

(39/39)

0.13 [0.09-0.47]*

(10/10)

ESR (mm/1^st/h), median [IQR]

(n/n available cases)

33 [14.5-61]

(129/134)

6 [2-12]*

(102/132)

4 [2-7.5]*

(116/122)

4 [2-8]*

(93/99)

4 [2-8]*

(71/71)

6 [2-16]*

(39/39)

9 [3-22]*

(10/10)

Hemoglobin (g/dL), mean (SD)

(n/n available cases)

12.31.5

(125/134)

13.11.3*

(104/132)

13.31.3*

(107/122)

13.41.4*

(88/99)

13.31.4 *

(64/71)

13.11.3*

(36/39)

13.31.1*

(9/10)

Anemia (<11.0 g/dL), %

(n/n available cases)

16.4%

(22/134)

3.8%

(5/132)

4.9%

(6/122)

3.0%

(3/99)

4.2%

(3/71)

5.1%

(2/39)

(0/10)

Prolonged remission † %,

(n/n available cases)

–

55.5%

(55/99)

70.4%

(50/71)

69.2%

(27/39)

90%

(9/10)

Relapses ‡ %,

(n/n available cases)

–

3.0%

(4/132)

5.8%

(7/122)

5.1%

(5/99)

14.1%

(10/71)

17.9%

(7/39)

10%

(1/10)

Prednisone dose, median [IQR]

(n/n available cases)

15 [10-30]

(134/134)

13.75 [7.5-20]*

(115/132)

8.1 [5-12.5]*

(120/122)

5 [2.5-7.5]*

(97/99)

2.5 [0.0-5]*

(71/71)

0.0 [0.0-5]*

(39/39)

2.5 [1.3-7.5]*

(10/10)

*p <0.01 vs. baseline (Wilcoxon test).

† Prolonged remission: absence of clinical symptoms and signs and normalization of the acute phase reactants (CRP and ESR) for at least 6 months. ESR <20 or 25 mm/h (in men and women, respectively) and/or CRP <0.5 mg/dL were considered normal.

‡ At least one relapse during follow-up.

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; F. Ortiz-Sanjuán, 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; M. Varela-García, None; C. Luna Gómez, None; F. J. Toyos Sáenz de Miera, None; N. Fernandez-Llanio Cornella, None; J. A. Román Ivorra, None; A. García, None; N. Palmou-Fontana, None; V. Calvo-Río, None; J. L. Martín-Varillas, None; B. Atienza-Mateo, None; C. González-Vela, None; A. Corrales, None; E. Aurrecoechea, None; R. Dos Santos, None; A. García-Manzanares, None; N. Ortego Centeno, None; S. Fernández, 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, Ortiz-Sanjuán F, Lluch P, Manrique-Arija S, Vela P, De Miguel E, Torres-Martín C, Nieto JC, Ordas-Calvo C, Salgado-Pérez E, Varela-García M, Luna Gómez C, Toyos Sáenz de Miera FJ, Fernandez-Llanio Cornella N, Román Ivorra JA, García A, Palmou-Fontana N, Calvo-Río V, Martín-Varillas JL, Atienza-Mateo B, González-Vela C, Corrales A, Aurrecoechea E, Dos Santos R, García-Manzanares A, Ortego Centeno N, Fernández S, Corteguera M, González-Gay MA, Hernández JL, Blanco R. Tocilizumab in Giant Cell Arteritis. National Multicenter Study of 134 Patients of Clinical Practice [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/tocilizumab-in-giant-cell-arteritis-national-multicenter-study-of-134-patients-of-clinical-practice/. Accessed .

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