AB0366 TOCILIZUMAB FOR TAKAYASU ARTERITIS: MULTICENTER STUDY OF 54 WHITE PATIENTS
Authors: D. Prieto-Peña, P. Bernabéu, P. Vela-Casasempere, J. Narváez, C. Fernández-López, M. Freire González, B. González-Alvarez, R. Solans-Laqué, J. L. Callejas-Rubio, N. Ortego, C. Fernández-Díaz, E. Rubio Romero, S. García Morillo, M. Minguez, C. Fernández-Carballido, E. De Miguel, S. Melchor, E. Salgado-Pérez, B. Bravo, S. Romero-Yuste, J. Salvatierra, C. Hidalgo, S. Manrique Arija, C. Romero-Gómez, P. Moya, N. Alvarez-Rivas, J. Mendizabal, F. M. Ortiz Sanjuan, I. Pérez de Pedro, J. L. Alonso Valdivieso, P. S. Laura, R. M. Rosa, N. Fernández-Llanio, R. Gómez de la Torre, S. Suarez, M. J. Montesa, M. Delgado Sanchez, J. Loricera, B. Atienza-Mateo, S. Castañeda, M. A. González-Gay, R. Blanco
Journal: Annals of the Rheumatic Diseases (2021)

Background: Tocilizumab (TCZ) has shown to be effective for large vessel vasculitis including Takayasu arteritis (TAK) (1-3). Most evidence in TAK comes from Asian patients. However, white patients seem to have different clinical and prognostic features. Objectives: Our aims were to: a ) assess the efficacy and safety of TCZ in white patients with refractory TAK, b ) determine if clinical improvement correlates with imaging outcomes, c ) compare TCZ in monotherapy (TCZ MONO ) vs combined with conventional immunosuppressive drugs (TCZ COMBO ) Methods: Multicenter study of white patients with refractory TAK who received TCZ.Outcomes variables were remission, glucocorticoid-sparing effect, improvement in imaging techniques, and adverse events. A comparative study between patients who received TCZ MONO and TCZ COMBO was performed. Results: 54 patients (46 women/8 men; median age 42.0 [32.5-50.5] years). TCZ was started after 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%) at 1, 3, 6 and 12 months, respectively. Prednisone dose was reduced from 30.0 [12.5-50.0] to 5.0 [0.0-5.6] mg/day at 12 months (Table 1). 10 (26.3%) of the 38 patients in whom an imaging follow-up test was performed showed no radiographic improvement after a median of 9.0 [6.0-14.0] months. 4 of them were in clinical remission.23 (42.6%) patients were on TCZ MONO and 31 (57.4%) on TCZ COMBO : MTX (n=28), cyclosporine A (n=2), azathioprine (n=1). Patients on TCZ COMBO were younger (38.0 [27.0-46.0] vs 45 [38.0-57.0] years; p= 0.048), with a trend to longer TAK duration (21.0 [6.0-38.0] vs 6.0 [1.0-23.0] months; p= 0.08) and higher C-reactive protein (2.4 [0.7-5.6] vs 1.3 [0.3-3.3] mg/dL; p=0.16). Despite these differences, similar outcomes were observed in both groups (log rank p=0.862) (Figure 1). Relevant adverse events were reported in 6 (11.1%) patients, but only 3 developed severe events that required TCZ withdrawal. Table 1. Baseline n=54 Month 1 N=54 Month 3 N=49 Month 6 N=44 Month 12 N=36 Clinical remission , n (%) 12 (22.2) 19 (38.8) 23 (52.3) 27 (75.0) Laboratory improvemen t CRP ( mg/dL ), median [IQR] 1.5 [0.5-3.5] 0.2 [0.1-0.7]* 0.2 [0.5-0.5]* 0.2 [0.1-0.5]* 0.1 [0.0-0.4]* ESR ( mm/1 st hour ), median [IQR] 30.5 [8.7-52.7] 7.0 [3.0-14.0]* 4.5 [2.0-8.0]* 5.0[2.0-6.0]* 4.0 [2.0-9.5]* Hemoglobin ( g/dL ), mean ± SD 12.4 ±1.5 13.0 ±1.2* 13.0 ±1.4* 13.2 ±1.5* 12.9 ±1.6* Prednisone dose , median [IQR] 30.0 [12.5-50.0] 20.0 [10.0-30.0]* 10.0 [5.0-20.0]* 5.0 [5.0-10.5]* 5.0 [0.0-5.6]* CRP: C-Reactive Protein; ESR : Erythrocyte Sedimentation Rate; IQR: interquartile range; n: number. *p&lt;0.01 vs baseline (Wilcoxon test). Conclusion: TCZ is effective and safe in white patients with refractory TAK. A discordance between clinical and imaging activity assessment may exist. References: [1]Prieto Peña D et al. Clin Exp Rheumatol 2020 Nov 27. PMID: 33253103. [2]Loricera J, et al. Clin Exp Rheumatol 2016; 34:S44-53. PMID: 27050507. [3]Calderón-Goercke M, et al. Semin Arthritis Rheum 2019; 49:126-35. PMID: 30655091 Disclosure of Interests: Diana Prieto-Peña Grant/research support from: DP-P has received research support from UCB Pharma, Roche, Sanofi, Pfizer, AbbVie and Lilly., Pilar Bernabéu: None declared, Paloma Vela-Casasempere: None declared, J. Narváez: None declared, Carlos Fernández-López: None declared, Mercedes Freire González: None declared, Beatriz González-Alvarez: None declared, Roser Solans-Laqué: None declared, Jose Luis Callejas-Rubio: None declared, Norberto Ortego: None declared, Carlos Fernández-Díaz: None declared, Esteban Rubio Romero: None declared, SALVADOR GARCÍA MORILLO: None declared, Mauricio Minguez: None declared, Cristina Fernández-Carballido: None declared, Eugenio de Miguel: None declared, Sheila Melchor: None declared, Eva Salgado-Pérez: None declared, Beatriz Bravo: None declared, Susana Romero-Yuste: None declared, Juan Salvatierra: None declared, Cristina Hidalgo: None declared, Sara Manrique Arija: None declared, C. Romero-Gómez: None declared, Patricia Moya: None declared, Noelia Alvarez-Rivas: None declared, Javier Mendizabal: None declared, Francisco Miguel Ortiz Sanjuan: None declared, I. Pérez de Pedro: None declared, JOSE LUIS ALONSO VALDIVIESO: None declared, Pérez Sánchez Laura: None declared, Roldán Molina Rosa: None declared, Nagore Fernández-Llanio: None declared, Ricardo Gómez de la Torre: None declared, Silvia Suarez: None declared, María Jesús Montesa: None declared, Monica Delgado Sanchez: None declared, J. Loricera: None declared, Belén Atienza-Mateo: None declared, Santos Castañeda: None declared, Miguel A González-Gay Grant/research support from: MAG-G received grants/research supports from Abbvie, MSD, Jansen and Roche and had consultation fees/participation in company sponsored speaker´s bureau from Abbvie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Ricardo Blanco Grant/research support from: RB received grants/research supports from Abbvie, MSD and Roche, and had consultation fees/participation in company sponsored speaker´s bureau from Abbvie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD.