Prieto Peña, DianaBernabeu, PilarVela, PalomaNarváez, JavierFernández López, Jesús C.Freire González, MercedesGonzález Álvarez, BeatrizSolans Laqué, RoserCallejas Rubio, José LuisOrtego Centeno, NorbertoFernández Díaz, CarlosRubio, EstebanGarcía Morillo, SalvadorMinguez, MauricioFernández Carballido, CristinaMiguel, Eugenio deMelchor, SheilaSalgado Pérez, EvaBravo, BeatrizRomero Yuste, SusanaSalvatierra, JuanHidalgo, CristinaManrique Arija, SaraRomero Gómez, CarlosMoya, PatriciaÁlvarez Rivas, NoeliaMendizabal, JavierOrtiz Sanjuán, FranciscoPérez de Pedro, IvánAlonso Valdivielso, José L.Pérez Sánchez, LauraRoldán, RosaFernandez-Llanio, NagoreGómez de la Torre, RicardoSuarez, SilviaMontesa Cabrera, María JesúsDelgado Sánchez, MónicaLoricera, JavierAtienza Mateo, BelénCastañeda, SantosGonzález Gay, Miguel A.Blanco, Ricardo2021-09-132021-09-132021-01-011759-7218https://hdl.handle.net/2445/179984Objective: To assess the efficacy and safety of tocilizumab (TCZ) in Caucasian patients with refractory Takayasu's arteritis (TAK) in clinical practice. Methods: A multicenter study of Caucasian patients with refractory TAK who received TCZ. The outcome variables were remission, glucocorticoid-sparing effect, improvement in imaging techniques, and adverse events. A comparative study between patients who received TCZ as monotherapy (TCZMONO) and combined with conventional disease modifying anti-rheumatic drugs (cDMARDs) (TCZCOMBO) was performed. Results: The study comprised 54 patients (46 women/8 men) with a median [interquartile range (IQR)] age of 42.0 (32.5-50.5) years. TCZ was started after a median (IQR) of 12.0 (3.0-31.5) months since TAK diagnosis. Remission was achieved in 12/54 (22.2%), 19/49 (38.8%), 23/44 (52.3%), and 27/36 (75%) patients at 1, 3, 6, and 12 months, respectively. The prednisone dose was reduced from 30.0 mg/day (12.5-50.0) to 5.0 (0.0-5.6) mg/day at 12 months. An improvement in imaging findings was reported in 28 (73.7%) patients after a median (IQR) of 9.0 (6.0-14.0) months. Twenty-three (42.6%) patients were on TCZMONO and 31 (57.4%) on TCZCOMBO: MTX (n = 28), cyclosporine A (n = 2), azathioprine (n = 1). Patients on TCZCOMBO were younger [38.0 (27.0-46.0) versus 45.0 (38.0-57.0)] years; difference (diff) [95% confidence interval (CI) = -7.0 (-17.9, -0.56] with a trend to longer TAK duration [21.0 (6.0-38.0) versus 6.0 (1.0-23.0)] months; diff 95% CI = 15 (-8.9, 35.5), and higher c-reactive protein [2.4 (0.7-5.6) versus 1.3 (0.3-3.3)] mg/dl; diff 95% CI = 1.1 (-0.26, 2.99). Despite these differences, similar outcomes were observed in both groups (log rank p = 0.862). Relevant adverse events were reported in six (11.1%) patients, but only three developed severe events that required TCZ withdrawal. Conclusion: TCZ in monotherapy, or combined with cDMARDs, is effective and safe in patients with refractory TAK of Caucasian origin.12 p.application/pdfengcc by-nc (c) Prieto Peña, Diana et al, 2021http://creativecommons.org/licenses/by-nc/3.0/es/ArteritisBlancsArteritisWhitesinfo:eu-repo/semantics/article2021-09-10info:eu-repo/semantics/openAccess34211589