Tocilizumab in giant cell arteritis: differences between the GiACTA trial and a multicentre series of patients from the clinical practice.
Monica Calderón-Goercke, Santos Castañeda, Vicente Aldasoro, Ignacio Villa, D. Prieto-Peña, Belén Atienza‐Mateo, Esther Patiño, C. Moriano, Susana Romero-Yuste, Javier Narváez, Catalina Gómez‐Arango, Eva Pérez‐Pampín, R. Melero, E. Becerra, Marcelino Revenga, Noelia Álvarez-Rivas, Carles Galisteo, Francisca Sivera, Alejandro Olivé-Marqués, María Álvarez del Buergo, Luisa Marena-Rojas, C. Fernández-López, Francisco Navarro, Enrique Raya, E. Galíndez-Agirregoikoa, Beatriz Arca, Roser Solans‐Laqué, Arantxa Conesa, Cristina Hidalgo, Carlos Vázquez, José Andrés Román-Ivorra, J. Loricera, Pau Lluch, Sara Manrique‐Arija, Paloma Vela, Eugenio de Miguel, Carmen Torres-Martín, Juan Carlos Nieto‐González, Carmen Ordás-Calvo, Eva Salgado-Pérez, Cristina Luna-Gomez, Francisco J. Toyos‐Sáenz de Miera, N. Fernández-Llanio, Antonio García, Carmen Larena, Carmen González‐Vela, Alfonso Corrales, María Varela‐García, Elena Aurrecoechea, R. Dos-Santos, Ángel García-Manzanares, N. Ortego, Sabela Fernández, F. Ortíz-Sanjuán, Montserrat Corteguera, José L. Hernández, Miguel Á. González‐Gay, Ricardo Blanco
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.