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Optimisation of tocilizumab therapy in giant cell arteritis. A multicentre real-life study of 471 patients
M. Calderón-Goercke1, J. Loricera2, C. Moriano3, S. Castañeda4, J. Narváez5, V. Aldasoro6, O. Maiz7, R. Melero8, J.I. Villa9, P. Vela10, S. Romero-Yuste11, J.L. Callejas12, E. De Miguel13, E. Galíndez-Agirregoikoa14, F. Sivera15, J.C. Fernández-López16, C. Galisteo17, I. Ferraz-Amaro18, J. Sanchéz-Martín19, L. Sánchez-Bilbao20, M.A. González-Gay21, J.L. Hernández22, R. Blanco23
Collaborator/s: J.C. Nieto1, J.R. De Dios2, E. Fernández3, I. De La Morena4, P. Moya5, R. Solans-Laqué6, E. Pérez Pampín7, J.L. Andreu8, M. Revenga9, E. Labrador10, A. García-Valle11, A. Gallego12, C. Iñíguez13, C. Hidalgo14, N. Garrido-Puñal15, R. López-González16, J.A. Román-Ivorra17, F.M. Ortiz-Sanjuán18, J.P. Baldivieso-Achá19, S. Manrique20, P. Collado21, E. Raya22, V. Pinillos23, F. Navarro24, A. Olivé-Marqués25, F.J. Toyos26, M.L. Marena Rojas27, A.J. Más28, B. Arca29, C. Ordas-Calvo30, M.D. Boquet31, N. Álvarez-Rivas32, M.L. Velloso-Feijoo33, C. Campos34, Í. Rúa-Figueroa35, A. García36, C. Vázquez37, P. Lluch38, C. Torres39, C. Luna40, E. Becerra41, N. Fernández-Llanio42, A. Conesa43, E. Salgado44
- Department of Rheumatology, Hospital José Molina Orosa, Lanzarote, Spain.
- Department of Rheumatology and Internal Medicine, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Valdecilla (IDIVAL), Dpto. de Medicina y Psiquiatria, Universidad de Cantabria, Santander, Spain.
- Department of Rheumatology, Complejo Asistencial Universitario de León, Spain.
- Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Cátedra UAM-Roche, EPID-Future, Autonomous University of Madrid, Spain.
- Department of Rheumatology, Hospital de Bellvitge, Barcelona, Spain.
- Department of Rheumatology, Complejo Hospitalario de Navarra, Pamplona, Spain.
- Department of Rheumatology, Hospital Universitario de Donosti, San Sebastián, Spain.
- Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Spain.
- Department of Rheumatology, Hospital Sierrallana, Torrelavega, Spain.
- Department of Rheumatology, Hospital General Universitario de Alicante, Spain.
- Department of Rheumatology, Complejo Hospitalario Universitario de Pontevedra, Spain.
- Department of Rheumatology, Hospital San Cecilio, Granada, Spain.
- Department of Rheumatology, Hospital La Paz, Madrid, Spain.
- Department of Rheumatology, Hospital de Basurto, Bilbao, Spain.
- Department of Rheumatology, Hospital Universitario de Elda, Alicante, Spain.
- Department of Rheumatology, Hospital Universitario Juan Canalejo, A Coruña, Spain.
- Department of Rheumatology, Hospital Parc Taulí, Barcelona, Spain.
- Department of Rheumatology, Complejo Hospitalario Universitario de Canarias, Tenerife, Spain.
- Department of Rheumatology, Hospital Universitario 12 de Octubre, Madrid, Spain.
- Department of Rheumatology and Internal Medicine, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Valdecilla (IDIVAL), Dpto. de Medicina y Psiquiatria, Universidad de Cantabria, Santander, Spain.
- Department of Rheumatology and Internal Medicine, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Valdecilla (IDIVAL), Dpto. de Medicina y Psiquiatria, Universidad de Cantabria, Santander, Spain. miguelaggay@hotmail.com
- Department of Rheumatology and Internal Medicine, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Valdecilla (IDIVAL), Dpto. de Medicina y Psiquiatria, Universidad de Cantabria, Santander, Spain. hernandezjluis@gmail.com
- Department of Rheumatology and Internal Medicine, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Valdecilla (IDIVAL), Dpto. de Medicina y Psiquiatria, Universidad de Cantabria, Santander, Spain. rblancovela@gmail.com
- H. Gregorio Marañón
- H.U. Araba
- H. Clínico Universitario Virgen de la Arrixaca
- H. Clínico Universitario de Valencia
- H. Sant Pau
- H. Valle de Hebrón
- H.U. de Santiago
- H.U. Puerta de Hierro
- H. Ramón y Cajal
- H. San Pedro
- Complejo Asistencial Universitario de Palencia
- Complejo Hospitalario Universitario de Badajoz
- H.U. Lucus Augusti
- Complejo Asistencial Universitario de Salamanca
- H. Virgen del Rocío
- Complejo Hospitalario de Zamora
- H.U. y Politécnico La Fe
- H.U. y Politécnico La Fe
- Hospital Universitario de La Princesa, Madrid
- H. Regional de Málaga
- H.U. Severo Ochoa
- H. San Cecilio
- H. San Pedro
- H. General Universitario de Elche
- H. Trías i Pujol
- H.U. Virgen Macarena
- H. La Mancha Centro
- H.U. Son Llàtzer
- H.U. San Agustín
- H. Cabueñes
- H. Arnau de Vilanova
- H.U. Lucus Augusti
- H.U. de Valme
- H. General Universitario de Valencia
- H. Doctor Negrín
- H. Virgen de las Nieves
- H. Miguel Servet
- H. Mateu Orfila
- Complejo Asistencial de Ávila
- H.U. Nuestra Señora de la Candelaria
- H.U. de Torrevieja
- H. Arnáu de Vilanova
- H.U. de Castellón
- Complejo Hospitalario Universitario de Ourense
on behalf of the Tocilizumab in Giant Cell Arteritis Spanish Collaborative Group
CER15942
2023 Vol.41, N°4
PI 0829, PF 0836
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PMID: 36377586 [PubMed]
Received: 12/06/2022
Accepted : 12/09/2022
In Press: 02/11/2022
Published: 18/04/2023
Abstract
OBJECTIVES:
Tocilizumab (TCZ) is the only biologic therapy approved for giant cell arteritis (GCA). There is general agreement on the initial/maintenance dose, duration of TCZ therapy is not well established. In GiACTA trial, after one year on TCZ, most patients had GCA relapse after withdrawal. The aim of this study is to assess the effectiveness and safety of TCZ therapy optimisation in a large unselected series of patients with GCA in a clinical practice scenario.
METHODS:
We carried out a multicentre study on 471 GCA patients treated with TCZ. Once prolonged remission was achieved (n=231) and based on a decision between patient and physician, TCZ was optimised (n=125). We compared optimised (TCZOPT) and not optimised (TCZNON-OPT) groups. Prolonged remission defined as normalisation of clinical and laboratory data for 6 months. Optimisation was carried out by decreasing TCZ dose and/or increasing dosing interval.
RESULTS:
We evaluated 231 GCA patients on TCZ in prolonged remission. At TCZ onset, no differences in demographic, clinical, or laboratory data were observed. First TCZ optimisation was performed after a median follow-up of 12[6-17] months. Intravenous TCZ was optimised from 8 to 4mg/kg/4weeks in 44% patients, while subcutaneous TCZ was optimised from 162mg/w to 162mg/every-other-week in 65% cases. At the end of follow-up, prolonged remission (78.2% vs. 84.2%; p=0.29) and relapses (5.6% vs. 10.4%, p=0.177) were similar in TCZOPT vs. TCZNON-OPT. Severe infections were more frequent in TCZNON-OPT (12.9% vs. 6.6%; p=0.009).
CONCLUSIONS:
TCZ optimisation may be done once complete remission is achieved by reducing dose or increasing dosing interval. This seems to be effective, safe and cost-effective therapeutic scheme.
