Large-vessel vasculitis
Tocilizumab in giant cell arteritis: differences between the GiACTA trial and a multicentre series of patients from the clinical practice
M. Calderón-Goercke1, S. Castañeda2, V. Aldasoro3, I. Villa4, D. Prieto-Peña5, B. Atienza-Mateo6, E. Patiño7, C. Moriano8, S. Romero-Yuste9, J. Narváez10, C. Gómez-Arango11, E. Pérez-Pampín12, R. Melero13, E. Becerra-Fernández14, M. Revenga15, N. Álvarez-Rivas16, C. Galisteo17, F. Sivera18, A. Olivé-Marqués19, M. Álvarez Del Buergo20, L. Marena-Rojas21, C. Fernández-López22, F. Navarro23, E. Raya24, E. Galindez-Agirregoikoa25, B. Arca26, R. Solans-Laqué27, A. Conesa28, C. Hidalgo29, C. Vázquez30, J.A. Román-Ivorra31, J. Loricera32, P. Lluch33, S. Manrique-Arija34, P. Vela35, E. De Miguel36, C. Torres-Martín37, J.C. Nieto38, C. Ordas-Calvo39, E. Salgado-Pérez40, C. Luna-Gomez41, F.J. Toyos-Sáenz de miera42, N. Fernández-Llanio43, A. García44, C. Larena45, C. González-Vela46, A. Corrales47, M. Varela-García48, E. Aurrecoechea49, R. Dos Santos50, Á. García-Manzanares51, N. Ortego52, S. Fernández53, F. Ortiz-Sanjuán54, M. Corteguera55, J.L. Hernández56, M.Á. González-Gay57, R. Blanco58
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.
- Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.
- Department of Rheumatology, Complejo Hospitalario de Navarra, Spain.
- Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Cantabria, Spain.
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.
- Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.
- Department of Rheumatology, Complejo Asistencial Universitario de León, Spain.
- Department of Rheumatology, Complejo Hospitalario Universitario Pontevedra, Spain.
- Department of Rheumatology, Hospital de Bellvitge, Barcelona, Spain.
- Department of Rheumatology, Hospital Alto Deba, Mondragón, Spain.
- Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
- Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Spain.
- Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.
- Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain.
- Department of Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain.
- Department of Rheumatology, Hospital Parc Taulí, Barcelona, Spain.
- Department of Rheumatology, Hospital Universitario de Elda, Alicante, Spain.
- Department of Rheumatology, Hospital Trías i Pujol, Badalona, Spain.
- Department of Rheumatology, Hospital Río Carrión, Palencia, Spain.
- Department of Rheumatology, Hospital La Mancha Centro, Alcázar de San Juan, Spain.
- Department of Rheumatology, Hospital Universitario Juan Canalejo, A Coruña, Spain.
- Department of Rheumatology, Hospital General Universitario de Elche, Alicante, Spain.
- Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain.
- Department of Rheumatology, Hospital de Basurto, Bilbao, Spain.
- Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain.
- Department of Internal Medicine, Hospital Valle de Hebrón, Barcelona, Spain.
- Department of Rheumatology, Hospital General Universitario de Castellón, Spain.
- Department of Rheumatology, Complejo Asistencial Universitario de Salamanca, Spain.
- Department of Rheumatology, Hospital Miguel Servet, Zaragoza, Spain.
- Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.
- Department of Rheumatology, Hospital Mateu Orfila, Menorca, Spain.
- Department of Rheumatology, Hospital Regional de Málaga, Spain.
- Department of Rheumatology, Hospital General Universitario de Alicante, Spain.
- Department of Rheumatology, Hospital La Paz, Madrid, Spain.
- Department of Rheumatology, Complejo Asistencial de Ávila, Spain.
- Department of Rheumatology, Hospital Gregorio Marañón, Madrid, Spain.
- Department of Rheumatology, Hospital Cabueñes, Gijón, Spain.
- Department of Rheumatology, Complejo Hospitalario Universitario de Ourense, Spain.
- Department of Rheumatology, Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Spain.
- Department of Rheumatology, Hospital Universitario Virgen Macarena, Sevilla, Spain.
- Department of Rheumatology, Hospital Arnau de Vilanova, Lérida, Spain.
- Department of Rheumatology, Hospital Virgen de las Nieves, Granada, Spain.
- Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain.
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.
- Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.
- Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Cantabria, Spain.
- Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
- Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.
- Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain.
- Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain.
- Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
- Department of Rheumatology, Complejo Asistencial de Ávila, Spain.
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. miguelaggay@hotmail.com
- Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. rblanco@humv.es
CER13117
2020 Vol.38, N°2 ,Suppl.124
PI 0112, PF 0119
Large-vessel vasculitis
Free to view
(click on article PDF icon to read the article)
PMID: 32441643 [PubMed]
Received: 17/01/2020
Accepted : 06/04/2020
In Press: 21/05/2020
Published: 21/05/2020
Abstract
OBJECTIVES:
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 responses 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 subcutaneous (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.
CONCLUSIONS:
Despite clinical differences with patients recruited in clinical trials, data from real-life patients confirm the efficacy of TCZ in GCA.
