ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2754

Comparison between Tocilizumab Prescribed As Monotherapy Versus Combined with Conventional Immunosuppressant Agents in Giant Cell Arteritis Patients

Monica Calderón Goercke1, Diana Prieto Peña1, Javier Loricera2, Vicente Aldasoro3, Santos Castañeda4, Ignacio Villa-Blanco5, Alicia Humbría4, Clara Moriano Morales6, Susana Romero-Yuste7, Francisco Javier Narváez8, Catalina Gómez-Arango9, Eva Perez Pampín10, Rafael Melero11, Elena Becerra-Fernández12, Marcelino Revenga Martínez13, Noelia Álvarez-Rivas14, Carlos Galisteo15, Francisca Sivera16, Alejandro Olivé-Marqués17, Maria Concepcion Alvarez de Buergo18, Luisa Marena Rojas Vargas19, Carlos Fernandez-Lopez20, Francisco Navarro21, Enrique Raya Álvarez22, Eva Galindez-Agirregoikoa23, Beatriz Arca24, Roser Solans25, Arantxa Conesa26, Cristina Hidalgo-Calleja27, Carlos Vázquez28, Pau Lluch29, Jose Andrés Román Ivorra30, Sara Manrique-Arija31, Paloma Vela32, Eugenio De Miguel33, Carmen Torres-Martín34, Juan Carlos Nieto35, Carmen Ordas-Calvo36, Eva Salgado-Pérez37, Cristina Luna Gómez38, Francisco J. Toyos Sáenz de Miera39, Nagore Fernandez-Llanio Cornella40, Antonio García41, Carmen Larena42, Belén Atienza-Mateo43, José Luis Martín-Varillas43, Natalia Palmou-Fontana43, Vanesa Calvo-Río43, Carmen González-Vela44, Alfonso Corrales43, María Varela-García45, Elena Aurrecoechea46, Raquel Dos Santos47, Angel García-Manzanares12, Norberto Ortego Centeno48, Sabela Fernández49, Francisco Ortiz-Sanjuán50, Montserrat Corteguera34, Miguel Angel González-Gay43, José Luis Hernández2 and Ricardo Blanco43, 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, Hospital La Princesa. Madrid. Spain, Madrid, Spain, 5Hospital de Sierrallana. Torrelavega. Spain, Torrelavega, Spain, 6Rheumatology, Complejo Asistencial Universitario de León. León. Spain, León, Spain, 7Hospital de Pontevedra. Spain, Pontevedra, Spain, 8Rheumatology Department, Hospital de Bellvitge. Barcelona. Spain, L’Hospitalet de Llobregat, Spain, 9Hospital Alto Deba, Mondragón. Spain, Mondragón, Spain, 10Rheumatology Division. Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain, 11Rheumatology, Complexo Hospitalario Universitario de Vigo, Vigo. Spain, Vigo, Spain, 12Hospital Universitario de Torrevieja, Alicante. Spain, Alicante, Spain, 13Hospital Universitario Ramón y Cajal. Madrid. Spain, Madrid, Spain, 14Hospital Universitario Lucus Augusti, Lugo. Spain, Lugo, Spain, 15Rheumatology, Hospital Parc-Taulí, Sabadell, Spain, 16Rheumatology, Hospital General Universitario de Elda. Comunidad Valenciana. Spain, Elda, Spain, 17Rheumatology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, 18Rheumatology, Hospital Río Carrión. Palencia. Spain, Palencia, Spain, 19Rheumatology Department, Hospital General La Mancha Centro, Alcázar de San Juan, Spain, 20Servicio de Reumatología, Complexo Hospitalario Universitario de A Coruña (CHUAC), A Coruña. España, A Coruña, Spain, 21Hospital General Universitario de Elche, Alicante. Spain, Alicante, Spain, 22Rheumatology, Hospital Universitario San Cecilio. Granada. Spain, Granada, Spain, 23Rheumatology, University Hospital of Basurto, Bilbao, Spain, 24Hospital Universitario San Agustín, Avilés. Spain, Avilés, Spain, 25Autoimmune Systemic Diseases Unit, Department of Internal Medicine, Hospital Vall d'Hebron, Autonomous University of Barcelona, Spain, Barcelona, Spain, 26Rheumatology, Hospital Clínico Universitario de Valencia. Spain, Valencia, Spain, 27Rheumatology, Hospital Clínico Universitario de Salamanca, Salamanca. Spain, Salamanca, Spain, 28Hospital Miguel Servet, Zaragoza. Spain, Zaragoza, Spain, 29Rheumatology, Hospital Mateu Orfila. Menorca. Spain, Menorca, Spain, 30Hospital La Fe. Valencia. Spain, Valencia, Spain, 31Medicine, University of Málaga, MÁLAGA, Spain, 32Reumatología, Hospital General Universitario Alicante, Alicante, Spain, 33Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, 34Complejo Asistencial de Ávila, Ávila. Spain, Ávila, Spain, 35Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain, 36Hospital Cabueñes, Gijón. Spain, Gijón, Spain, 37Rheumatology, Complejo Hospitalario Universitario de Ourense, Ourense. Spain, Ourense, Spain, 38Rheumatology, University Hospital Ntra. Sra. de La Candelaria, Santa Cruz de Tenerife, Spain, 39Hospital Virgen de La Macarena. Sevilla. Spain, Sevilla, Spain, 40Rheumatology Section. Hospital Arnau de Vilanova, Valencia, Spain, 41Hospital Unviersitario Virgen de las Nieves, Granada. Spain, Granada, Spain, 42Hospital General Universitario Gregorio Marañón, Madrid, Spain, 43Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, 44Pathology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, 45Complejo Hospitalario de Navarra, Navarra, Spain, 46Rheumatology, Hospital de Sierrallana. Torrelavega. Spain, Torrelavega, Spain, 47Complejo Hospitalario Universitario de Santiago. Spain, Santiago de Compostela, Spain, 48Medicine Department, Hospital Universitario San Cecilio. Granada. Spain, Granada, Spain, 49Rheumatology, Hospital Universitario San Agustín, Avilés. Spain, Avilés, Spain, 50Rheumatology, Hospital La Fe. Valencia. Spain, Valencia, Spain

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: ,

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: Giant cell arteritis (GCA) can be refractory to corticosteroid therapy (1-3). Tocilizumab (TCZ) has been approved in the treatment of GCA. There are no studies comparing the efficacy and safety when using TCZ as monotherapy or in combination with conventional immunosuppressive drugs in GCA. Our aim was to compare efficacy and safety of TCZ combined or in monotherapy in GCA.

 

Methods: Multicenter study on 134 patients with refractory GCA who received TCZ therapy as monotherapy or combined with conventional immunosuppressants. Large vessel involvement was considered when the aorta and/or its major branches were involved and when disclosed by imaging techniques such as 18F-FDG PET-CT scan, MRI-A, CT-A, or helical CT-scan. Prolonged remission was defined by the absence of clinical symptoms and signs and normalization of the acute phase reactants for at least 6 months. Relapse was defined as the recurrence of signs or symptoms of GCA and/or ESR >20 mm/h in men or >25 mm/h in women, and/or serum CRP >0.5 mg/dL related to GCA, both before and after starting TCZ therapy. A serious infection was considered to be present when a life-threatening, fatal, or required hospitalization infection occurred, intravenous antibiotics were necessary, or the process lead to persistent or significant disability. We also compared a subgroup of 36 patients, that had a baseline and follow-up PET/CT, to evaluate evolution of the vascular involvement.

 

Results: We evaluated 134 patients (101 w/33 m); mean age, 73.0±8.8 years. TCZ was prescribed as monotherapy in 82 (62.2%) and combined with conventional immunosuppressants in 52 (38.8%) patients: MTX (n=48), AZA (n=3), and LFN (n=1). A comparative study between both groups is summarized in TABLE. Patients who received combined TCZ were younger and had a higher C-reactive protein (CRP) and a higher presence of aortitis in imaging techniques. When TCZ was started, prolonged remission was reached with combined therapy (statistical significance at 12 and 24 months). The corticosteroids sparing effect was similar in both groups. Side effects were similar in both groups too. There were no statistical significance regarding aortitis evolution.

Conclusion: Patients receiving combined conventional immunosuppressants with TCZ in the clinical practice study showed a higher prolonged remission. The incidence of serious infections and/or relevant adverse events was not affected according to the treatment. As well as the corticoid-sparing effect was achieved in the same way in both groups.

TABLE

 

TCZ IN MONOTHERAPY (n=82)

TCZ COMBINED

(n=52)

p

BASAL FEATURES AT TCZ ONSET

 

 

 

GENERAL FEATURES

 

 

 

Age, years, mean± SD

71.2 ± 9.0

68.8 ± 8.0

0.04

Sex, female/male n (%)

62/20

39/13

0.93

Time from GCA diagnosis to TCZ onset (months), median [IQR]

13.0 [7.75-33.5]

18.5 [6.25-34.0]

0.333

SYSTEMIC MANIFESTATIONS

 

 

 

Fever, n (%)

6 (7.3%)

3 (5.8%)

0.72

Constitutional syndrome, n (%)

18 (22.0%)

13 (25.0%)

0.68

PMR, n (%)

40 (48.8%)

33 (63.5%)

0.096

ISCHEMIC MANIFESTATIONS

 

 

 

Visual involvement, n (%)

20 (24.4%)

8 (15.4%)

0.21

Headache, n (%)

42 (51.2%)

28 (53.8%)

0.76

Jaw claudication, n (%)

7 (8.5%)

7 (13.5%)

0.36

AORTITIS AND ANOTHER LVV involvement, n (%)

28 (34.1%)

30 (57.7%)

0.007

ACUTE PHASE REACTANTS

 

 

 

ESR, mm/1st hour, mean (SD)

39.4 ± 32.5

42.3 ± 29.6

0.6

CRP, mg/dL mean (SD)

2.1 ± 3.0

4.4 ± 7.5

0.014

Hemoglobin, g/dL, mean (SD)

12.2 ± 1.5

12.4 ± 1.4

0.41

CORTICOSTEROIDS AT TCZ ONSET

 

 

 

Prednisone dose, mg/d

23.9±17.3

19.4 ±14.0

0.11

EFFICACY AND SAFETY AFTER TCZ

 

 

 

Prolonged remission n (%)

Month 6

Month 12

Month 24

31 (50.8)

18 (51.4)

10 (50)

27 (69.2)

28 (82.4)

17 (85)

0.160

0.006

0.018

Relapses n (%)

Month 1

Month3

Month 6

Month 12

Month 24

3 (3.8)

4 (5.4)

3 (4.9)

6 (17.1)

6 (30)

1 (2)

3 (6.3)

2 (5.1)

3 (8.8)

1 (5)

0.579

0.845

0.962

0.305

0.037

AORTITIS AND ANOTHER LVV improvement n (%)

Month 6

Month 12

Month 24

3 (20)

6 (40)

11 (73.3)

3 (14.3)

10 (47.6)

17 (81)

0.650

0.650

0.588

CORTICOSTEROIDS SPARING EFFECTS, median [IQR]

Month 1

Month3

Month 6

Month 12

Month 24

15 [7.5-21.25]

10 [5-15]

5 [2.5-10]

5 [0-5]

1.3 [0-5]

10 [7.5-20]

7.5 [5-10]

5 [2.5-7.5]

2.5 [0-5]

0 [0-1.25]

0.457

0.179

0.146

0.064

0.095

SIDE EFFECTS, n (%)

 

 

 

Relevant adverse events

23 (28)

9 (17.3)

0.155

Serious infections

12 (14.6)

4 (7.7)

0.227 

 
Disclosure: M. Calderón Goercke, None; D. Prieto Peña, None; J. Loricera, 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; P. Lluch, None; J. A. Román Ivorra, 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, Prieto Peña D, Loricera J, 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, Lluch P, Román Ivorra JA, 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. Comparison between Tocilizumab Prescribed As Monotherapy Versus Combined with Conventional Immunosuppressant Agents in Giant Cell Arteritis Patients [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/comparison-between-tocilizumab-prescribed-as-monotherapy-versus-combined-with-conventional-immunosuppressant-agents-in-giant-cell-arteritis-patients/. Accessed .

« Back to 2018 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-between-tocilizumab-prescribed-as-monotherapy-versus-combined-with-conventional-immunosuppressant-agents-in-giant-cell-arteritis-patients/