Short and Long-Term Follow-up with Tocilizumab in Giant Cell Arteritis. National Multicenter Study of 49 Patients of Clinical Practice

Lucia C. Domínguez-Casas¹, Javier Loricera¹, Jose L. Hernández², Santos Castañeda³, Vicente Aldasoro⁴, María Varela-García⁵, Rosario Ibañez-Bosch⁵, Antonio Mera⁶, Eva Pérez-Pampin⁶, Alicia Humbría⁷, Jaime Calvo-Alén⁸, Elena Aurrecoechea⁹, Javier Narváez¹⁰, Amalia Sánchez-Andrade¹¹, Paloma Vela¹², Elvira Diez Alvarez¹³, Clara Moriano¹⁴, Cristina Mata¹⁵, Pau Lluch¹⁶, Concepción Moll¹⁷, Íñigo Hernández-Rodríguez¹⁸, Vanesa Calvo-Río¹, José Andrés Román-Ivorra¹⁹, Carlos Vazquez²⁰, Alfonso Corrales¹, MC Gonzalez-Vela²¹, Francisco Ortiz-Sanjuán²², Belén Atienza-Mateo¹, José Luis Martín-Varillas¹, Miguel Angel González-Gay²³ and Ricardo Blanco¹, ¹Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ²Internal Medicine, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ³Hospital Universitario La Princesa. IIS-IP. Madrid. Spain, Madrid, Spain, ⁴Hospital Alto Deba. Mondragón. Spain, Mondragon, Spain, ⁵Rheumatology, Complejo Hospitalario de Navarra. Navarra. Spain, Navarra, Spain, ⁶Rheumatology, Complejo Hospitalario Universitario de Santiago. Galicia. Spain, Santiago de Compostela, Spain, ⁷Rheumatology, Hospital Universitario La Princesa. IIS-IP. Madrid. Spain, Madrid, Spain, ⁸Rheumatology, Hospital de Sierrallana. Torrelavega. Cantabria. Spain, Alava, Spain, ⁹Rheumatology, Hospital de Sierrallana, Torrelavega. Cantabria. Spain, Torrelavega, Spain, ¹⁰Rheumatology Department, Hospital de Bellvitge. Barcelona. Spain, L’Hospitalet de Llobregat, Spain, ¹¹Hospital Universitario Lucus Augusti. Lugo. Spain, Lugo, Spain, ¹²Reumatología, Hospital General Universitario de Alicante. Alicante. Spain, Alicante, Spain, ¹³Complejo Asistencial Universitario de León. León. Spain, León, Spain, ¹⁴Rheumatology, Complejo Asistencial Universitario de León. León. Spain, Leon, Spain, ¹⁵Rheumatology, Hospital de Laredo. Laredo. Spain, Laredo, Spain, ¹⁶Rheumatology, Hospital Mateu Orfila. Menorca. Spain, Menorca, Spain, ¹⁷Rheumatology., Hospital Mateu Orfila. Menorca. Spain, Menorca, Spain, ¹⁸Rheumatology, CHUVI Vigo. Galicia. Spain, Vigo, Spain, ¹⁹Rheumatology, Hospital Universitario La Fe. Valencia. Spain, Valencia, Spain, ²⁰Rheumatology, Hospital Miguel Servet. Zaragoza. Spain, Zaragoza, Spain, ²¹Pathology Anatomy, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ²²Rheumatology., Hospital Universitario La Fe. Valencia. Spain, Valencia, Spain, ²³Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Johannesburg, South Africa

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: giant cell arteritis, tocilizumab and vasculitis

Session Information

Date: Sunday, November 5, 2017

Session Title: Vasculitis Poster I: Large Vessel Vasculitis

Session Type: ACR Poster Session A

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

Background/Purpose: Randomized clinical trial has shown the efficacy of tocilizumab (TCZ) in Giant cell arteritis (GCA). However this data are of selected cases of clinical trial and only a short follow-up have been published. Our aim was to assess the short and long-term efficacy/side effects in clinical practice

Methods: Multicenter open-label study on 49 GCA patients treated with TCZ [iv; 8 mg/kg/monthly (n=45), and subcutaneously; 162 mg/week (n=4)]. We assessed the short and long-term efficacy/safety and the optimization of TCZ dose.

Results: We included 49 patients (39 women/10 men), mean age 73±9 years. The main clinical features at TCZ onset were: polymyalgia rheumatica (n=31), headache (25), asthenia (17), constitutional syndrome (15), jaw claudication (5), and visual loss (6). Besides corticosteroids and before TCZ, 43 patients had also received several conventional immunosuppressive and/or biologic drugs. 45 of 49 patients achieved a rapid and maintained clinical improvement after TCZ (Table). After a median follow-up of 18 [IQR, 7-28] months we observe a reduction of the median of: a) C-reactive protein; b) ESR; and c) prednisone dose. In this follow-up period, the outcome of patients was as follows: a) discontinuation of TCZ due to sustained remission(n=8); b) dose reduction due to improvement (8) or side effects (4); c) withdrawal of TCZ because of side effects (9); and d) the same dose that at onset (19). TCZ was discontinued due to: severe neutropenia; recurrent pneumonia; colon adenocarcinoma; cytomegalovirus infection; Alzheimer´s disease and atrioventricular blockade; hypertensive crisis during infusion; myelodysplastic syndrome; colon neoplasm and overall health deterioration. The latter patient died because of stroke. Another patient also died after the second TCZ infusion due to stroke in the context of an infective endocarditis. In another one, the dose had to be reduced by recurrent urinary tract infection. In other two patients TCZ was reduced because of moderate neutropenia (one of them also developed cellulitis) and another patient developed diverticulitis.

Conclusion: TCZ therapy leads to a rapid and maintained improvement in patients with refractory GCA and/or with unacceptable side effects related to corticosteroids. However, the risk of neutropenia and infection should be kept in mind when using this biologic agent in patients with GCA

TABLE

	Baseline	Month 6	Month 12	Month 18	Month 24
Clinical improvement, % (n)		100 (43/43)**	97 (32/33)**	91 (20/22)**	100 (16/16)*
Laboratory markers, median [IQR]
ESR (mm/1^st/h)	43 [18-66] (46)	16 [2-5]** (38)	5 [2-8.5]** (28)	2 [2-15.5]** (20)	6 [2-12.5]** (16)
CRP (mg/dl)	1.9 [1.1-3.2] (49)	0.1 [0.1-0.2]** (41)	0.1 [0.1-0.3]** (29)	0.1 [0.1-0.6]* (18)	0.2 [0.1-0.3]** (16)
Dose of corticosteroids, median [IQR]	15 [10-30] (49)	5 [2.5-7.5] (47)	2.5 [0-5] (33)	2.5 [0-5] (23)	2.5 [0-5.6] (17)

The number of patients with available data is shown in parentheses

* p <0.05 ** p < 0.01 vs. baseline (Wilcoxon test)The number of patients with available data is shown in parentheses

Disclosure: L. C. Domínguez-Casas, None; J. Loricera, None; J. L. Hernández, None; S. Castañeda, None; V. Aldasoro, None; M. Varela-García, None; R. Ibañez-Bosch, None; A. Mera, None; E. Pérez-Pampin, None; A. Humbría, None; J. Calvo-Alén, None; E. Aurrecoechea, None; J. Narváez, None; A. Sánchez-Andrade, None; P. Vela, None; E. Diez Alvarez, None; C. Moriano, None; C. Mata, None; P. Lluch, None; C. Moll, None; Í. Hernández-Rodríguez, None; V. Calvo-Río, None; J. A. Román-Ivorra, None; C. Vazquez, None; A. Corrales, None; M. Gonzalez-Vela, None; F. Ortiz-Sanjuán, None; B. Atienza-Mateo, None; J. L. Martín-Varillas, None; M. A. González-Gay, None; R. Blanco, None.

To cite this abstract in AMA style:

Domínguez-Casas LC, Loricera J, Hernández JL, Castañeda S, Aldasoro V, Varela-García M, Ibañez-Bosch R, Mera A, Pérez-Pampin E, Humbría A, Calvo-Alén J, Aurrecoechea E, Narváez J, Sánchez-Andrade A, Vela P, Diez Alvarez E, Moriano C, Mata C, Lluch P, Moll C, Hernández-Rodríguez Í, Calvo-Río V, Román-Ivorra JA, Vazquez C, Corrales A, Gonzalez-Vela M, Ortiz-Sanjuán F, Atienza-Mateo B, Martín-Varillas JL, González-Gay MA, Blanco R. Short and Long-Term Follow-up with Tocilizumab in Giant Cell Arteritis. National Multicenter Study of 49 Patients of Clinical Practice [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/short-and-long-term-follow-up-with-tocilizumab-in-giant-cell-arteritis-national-multicenter-study-of-49-patients-of-clinical-practice/. Accessed April 17, 2021.

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