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1. Tocilizumab in refractory Caucasian Takayasu's arteritis: a multicenter study of 54 patients and literature review

Author

Prieto-Pena D, Bernabeu P, Vela P, Narvaez J, Fernandez-Lopez J, Freire-Gonzalez M, Gonzalez-Alvarez B, Solans-Laque R, Rubio J, Ortego N, Fernandez-Diaz C, Rubio E, Garcia-Morillo S, Minguez M, Fernandez-Carballido C, de Miguel E, Melchor S, Salgado E, Bravo B, Romero-Yuste S, Salvatierra J, Hidalgo C, Manrique S, Romero-Gomez C, Moya P, Alvarez-Rivas N, Mendizabal J, Ortiz-Sanjuan F, de Pedro I, Alonso-Valdivielso J, Perez-Sanchez L, Roldan R, Fernandez-Llanio N, de la Torre R, Suarez S, Cabrera M, Sanchez M, Loricera J, Atienza-Mateo B, Castaneda S, Gonzalez-Gay M, and Blanco R

Subjects
Takayasu's arteritis, cDMARDs, biological therapy, Caucasian, Tocilizumab
Abstract

Objective: 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 (TCZ(MONO)) and combined with conventional disease modifying anti-rheumatic drugs (cDMARDs) (TCZ(COMBO)) 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 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) 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.

Published
2021

2. FACTORS AFFECTING MORTALITY OF SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS IN SPAIN IN THE 21ST CENTURY: DATA FROM THE RELESSER REGISTRY

Author

Moriano C, Calvo-Alen J, Rua-Figueroa I, Alvarez E, Bermudez C, Lopez-Longo F, Galindo-Izquierdo M, Olive-Marques A, Muriel E, Fernandez-Nebro A, Freire-Gonzalez M, Fernandez-Berrizbeitia O, Gomez A, Uriarte M, Fernandez-Cid C, Morales C, Soler G, Blanco R, Rodriguez-Gomez M, Vela P, Boteanu A, Narvaez F, Taboada V, Cruz B, Sanchez J, Hernandez-Beriain J, Exposito L, Almagro R, Ibanez-Barcelo M, Castellvi I, Galisteo C, Raya E, Quevedo-Vila V, Vazquez T, Ibanez-Ruan J, and Pego-Reigosa J

Published
2020

3. Gastrointestinal Disease in SLE: Does It Indicate a Worse Prognosis?

Author

Segura B, Gonzalez I, Rua-Figueroa I, Veiga N, Perez V, Olive-Marques A, Galindo-Izquierdo M, Calvo-Alen J, Ovalles-Bonilla J, Fernandez-Nebro A, Almagro R, Muriel E, Del-val-del-amo N, Uriarte M, Taboada V, Sanchez J, Boteanu A, Narvaez F, Morasat A, Morales C, Gallego J, Cruz B, Andres M, Perez E, Freire-Gonzalez M, Garcia S, Moriano C, Exposito L, Perez-Velasquez C, Velloso-Feijoo M, Cacheda A, Rivas N, Bonilla G, Arevalo M, Jimenez I, Quevedo-Vila V, Manero-Ruiz F, de la Pena P, Vazquez-Rodriguez T, Ibanez-Ruan J, Cobo-Ibanez T, and Pego-Reigosa J

Published
2020

4. AB0751 SAFETY AND PERSISTENCE OF USTEKINUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS IN BIOBADASER

Author

Busquets-Pérez, N., primary, Sánchez-Piedra, C., additional, Vela-Casasempere, P., additional, Freire-Gonzalez, M., additional, Bohórquez, C., additional, Expósito, L., additional, Magallon, B., additional, Manero, F., additional, Del Pino Montes, J., additional, Diaz Torne, C., additional, Martin Domenech, R., additional, Pascual, M., additional, and Sánchez-Alonso, F., additional

Published
2020
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5. The comparative responsiveness of Hospital Universitario Princesa Index and other composite indices for assessing rheumatoid arthritis activity

Author

Gonzalez-Alvaro, Isidoro, Castrejon, Isabel, Carmona, Loreto, Dougados, M., Huizinga, T., Abu Shakra, M., Alberts, A., Alperi Lopez, M., Amital, H., Aringer, M., Aslanidis, S., Berenbaum, F., Bijlsma, H., Blanco Garcia, F. J., Bliddal, H., Borofsky, M., Brocq, O., Buldakov, S., Cantini, F., Carreno Perez, L., Chahade, W., Ciconelli, R., Codreanu, C., Dahlqvist, S. R., Damjanov, N., Diamantopoulos, A., Dimdina, L., Dimic, A., Dorokhov, A., Dubikov, A., Fadienko, G., Fano, N., Ferreira, G., Gabrielli, A., Gaffney, K., Gaudin, P., Gerlag, D. M., Gerli, R., Goncalves, C. R., Hansen, M. S., Hanvivadhanakul, P., Hoili, C., Hou, A., Hunter, J., Ilic, T., Ionescu, R., Kaine, J., Kakurina, N., Kamalova, R., Kelly, T., Knyazeva, L., Krumina, L., Kurthen, R., Lagrone, R. P., Lapadula, G., Lavrentjevs, V, Lawson, J. G., Lazic, Z., Lejnieks, A., Levy, Y., Lexberg, A., Mader, R., Mariette, X., Markovits, D., Mola, Martin E., Maugars, Y., Guarch, Maymo J., Mazurov, V., I, Mikkelsen, K., Vergles, Morovic J., Nabizadeh, S., Nanagara, R., Nasonov, E. L., Sarabia, Navarro F., Neumann, T., Novak, S., Olech, E., Oza, M., Paran, D., Parsik, E., Pegram, S., Suarez, Pombo M., Popova, T., Puechal, X., Raja, N., Ridley, D., Rosner, I, Rubbert-Roth, A., Rudin, A., Saraux, A., Saulite-Kandevica, D., Settas, L., Sfikakis, P., Sheeran, T., Sizikov, A., Stamenkovic, D., Stefanovic, D., Stolow, J. B., Tan, A. L., Tebib, J., Tishler, M., Tony, H. P., Troum, O. M., Uaratanawong, S., Ucar Angulo, E., Valenzuela, G., van der Laken, K., Van Laar, J., van Riel, P. L. C. M., Vasilopoulos, D., Veldi, T., Vinogradova, I, Vosse, D., Wassenberg, S., Weidmann, C., Weitz, M., Wollenhaupt, J., Xavier, R., Yakupova, S., Zagar, I, Zavgorodnaja, T., Zemerova, E., Zisman, D., Zonova, E., Camona, Loreto, Abasolo Alcazar, L., Alegre de Miguel, C., Andreu Sanchez, J. L., Aragon Diez, A., Balsa Criado, A., Batlle Gualda, E., Belmonte Serrano, M. A., Beltran Audera, J., Beltran Fabregat, J., Bonilla Hernan, G., Caro Fernandez, N., Casado, E., Cebrian Mendez, L., Corteguera Coro, M., Cuadra Diaz, J. L., Cuesta, E., Fiter Areste, J., Freire Gonzalez, M., Galindo Izquierdo, M., Garcia Meijide, J. A., Garcia Gomez, M. C., Gimenez Ubeda, E., Gomez Centeno, E., Gomez Vaquero, C., Gonzalez Fernandez, M. J., Gonzalez Gomez, M. L., Gonzalez Hernandez, T., Gonzalez-Alvaro, I, Gonzalez-Montagut Gomez, C., Grandal Delgado, Y., Gratacos Masmitja, J., Hernandez del Rio, A., Instxaurbe, A. R., Irigoyen Oyarzabal, M., V, Jimenez Palop, M., Juan Mas, A., Judez Navarro, E., Larrosa Padro, M., Lopez Longo, F. J., Loza Santamaria, E., Maese Manzano, J., Manero Ruiz, F. J., Mateo Bernardo, I, Mayordomo Gonzalez, L., Mazzucheli, R., Medrano San Idelfonso, M., Naranjo Hernandez, A., Pecondon Espanol, A., Peiro Callizo, E., Quiros Donate, J., Ramos Lopez, P., Rivera Redondo, J., Rodriguez Gomez, M., Rodriguez Lopez, M., Rosello Pardo, R., Sampedro Alvarez, J., Sanmarti Sala, R., Rey Rey, Santos J., Tena Marsa, X., Tenorio Martin, M., Torres Martin, M. C., Urena Garnica, I, Valdazo de Diego, J. P., Valls, M., Villaverde Garcia, V., Zarco Montejo, P., Zubieta Tabernero, J., Balsa, Alejandro, Sanmarti, Raimon, Cabezas, J. A., Cantalejo, M., Chamizo, E., Ciruelo, E., Corrales, A., Cruz, A., Diaz, C., Fiter, J., Freire, M. M., Galindo, M., Garcia de Vicuna, M. R., Gelman, S. M., Gonzalez Crespo, R., Gonzalez Fernandez, C., Gracia, A., Granados, J., Guzman, M. A., Irigoyen, M., V, Juan, A., Juanola, X., Laiz, A., Manero, F. J., Martinez, A., Martinez, F., Mata, C., Maymo, J., Navarro, F. J., Peiro, E., Perez, F., Perez, G., Perez, M., Pujol, M., Quiros, J., Ribas, B., Riera, M., Rivera, J., Rodriguez, J. M., Rosello, R., Tenorio, M., Toyos, F. J., ACT-RAY Study Grp, PROAR Study Grp, EMECAR Study Grp, Interne Geneeskunde, MUMC+: MA Reumatologie (9), and RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation

Subjects
Male, medicine.medical_specialty, Science, humanos, Severity of Illness Index, RECOMMENDATIONS, VALIDATION, VARIABLES, ensayos clínicos como asunto, Arthritis, Rheumatoid, Cohort Studies, Internal medicine, Linear regression, Severity of illness, medicine, Humans, índice de gravedad de la enfermedad, estudios de cohortes, mediana edad, Clinical Trials as Topic, DISEASE-ACTIVITY MEASURES, Multidisciplinary, SCORES, business.industry, Arthritis, resultado del tratamiento, modelos lineales, Secondary data, Gold standard (test), Middle Aged, medicine.disease, Clinical trial, Treatment Outcome, Rheumatoid arthritis, Antirheumatic Agents, Cohort, Linear Models, Medicine, Female, GENDER, business, antirreumáticos, artritis, Cohort study
Abstract

Objective To evaluate the responsiveness in terms of correlation of the Hospital Universitario La Princesa Index (HUPI) comparatively to the traditional composite indices used to assess disease activity in rheumatoid arthritis (RA), and to compare the performance of HUPI-based response criteria with that of the EULAR response criteria. Methods Secondary data analysis from the following studies: ACT-RAY (clinical trial), PROAR (early RA cohort) and EMECAR (pre-biologic era long term RA cohort). Responsiveness was evaluated by: 1) comparing change from baseline (Delta) of HUPI with Delta in other scores by calculating correlation coefficients; 2) calculating standardised effect sizes. The accuracy of response by HUPI and by EULAR criteria was analyzed using linear regressions in which the dependent variable was change in global assessment by physician (Delta GDA-Phy). Results Delta HUPI correlation with change in all other indices ranged from 0.387 to 0.791); HUPI's standardized effect size was larger than those from the other indices in each database used. In ACT-RAY, depending on visit, between 65 and 80% of patients were equally classified by HUPI and EULAR response criteria. However, HUPI criteria were slightly more stringent, with higher percentage of patients classified as non-responder, especially at early visits. HUPI response criteria showed a slightly higher accuracy than EULAR response criteria when using Delta GDA-Phy as gold standard. Conclusion HUPI shows good responsiveness in terms of correlation in each studied scenario (clinical trial, early RA cohort, and established RA cohort). Response criteria by HUPI seem more stringent than EULAR's., Our study was supported by grants RD16/0012/0011 and PI14/00442 from the Ministerio de Economia y Competitividad (Instituto de Salud Carlos III; Spain) and cofunded by the Fondo Europeo de Desarrollo Regional (FEDER). Data from ACT-RAY clinical trial were kindly provided by Hoffmann-La Roche Ltd. No financial support was received from Hoffmann-La Roche Ltd Data from EMECAR and PROAR cohorts were provided by the Spanish Society of Rheumatology. No financial support was received from the Spanish Society of Rheumatology. None of these institutions played any role in the analysis or interpretation of data, nor were they involved in the writing of the manuscript. Roche and Sociedad Espanola de Reumatologia were involved in the collection of data from ACT-RAY, and EMECAR and PROAR, respectively. However, these funders had no role in study design, analysis, decision to publish, or preparation of the manuscript.

Published
2019

6. Cut-offs and response criteria for the Hospital Universitario la Princesa Index (HUPI) and their comparison to widely-used indices of disease activity in rheumatoid arthritis

Author

González-Álvaro, I., Castrejón, I., Ortiz, A.M., Toledano, E., Castañeda, S., García-Vadillo, A., Carmona, L., Abasolo Alcazar, L., Miguel, Alegre De, Andreu Sánchez, J.L., Aragón Díez, A., Balsa Criado, A., Batlle Gualda, E., Belmonte Serrano, M.A., Beltrán Audera, J., Beltrán Fabregat, J., Bonilla Hernan, G., Carmona Ortells, L., Caro Fernández, N., Casado, E., Cebrian Mendez, L., Corteguera Coro, M., Cuadra Díaz, J.L., Cuesta, E., Fiter Aresté, J., Freire Gonzalez, M., Galindo Izquierdo, M., García Meijide, J.A., García Gómez, M.C., Giménez Ubeda, E., Gómez Centeno, E., Gómez Vaquero, C., González Fernández, M.J., González Gómez, M.L., González Hernández, T., González-Alvaro, I., González-Montagut Gómez, C., Grandal Delgado, Y., Gratacos Masmitja, J., Hernández, Del R., Instxaurbe, A.R., Irigoyen Oyarzabal, M.V., Jiménez Palop, M., Juan Mas, A., Júdez Navarro, E., Larrosa Padro, M., López Longo, F.J., Loza Santamaria, E., Maese Manzano, J., Manero Ruiz, F.J., Mateo Bernardo, I., Mayordomo González, L., Mazzucheli, R., Medrano, San Idelfonso, Naranjo Hernández, A., Pecondón Español, A., Peiró Callizo, E., Quirós Donate, J., Ramos López, P., Rivera Redondo, J., Rodríguez Gómez, M., Rodríguez López, M., Roselló Pardo, R., Sampedro Alvarez, J., Sanmartí Sala, R., Santos, Rey Rey, Tena Marsá, X., Tenorio Martín, M., Torres Martín, Mc, Ureña Garnica, I., Diego, Valdazo De, Valls, M., Villaverde García, V., Zarco Montejo, P., and Zubieta Tabernero, J.

Abstract

Objective To estimate cut-off points and to establish response criteria for the Hospital Universitario La Princesa Index (HUPI) in patients with chronic polyarthritis. Methods Two cohorts, one of early arthritis (Princesa Early Arthritis Register Longitudinal PEARL] study) and other of long-term rheumatoid arthritis (Estudio de la Morbilidad y Expresión Clínica de la Artritis Reumatoide EMECAR]) including altogether 1200 patients were used to determine cut-off values for remission, and for low, moderate and high activity through receiver operating curve (ROC) analysis. The areas under ROC (AUC) were compared to those of validated indexes (SDAI, CDAI, DAS28). ROC analysis was also applied to establish minimal and relevant clinical improvement for HUPI. Results The best cut-off points for HUPI are 2, 5 and 9, classifying RA activity as remission if =2, low disease activity if >2 and =5), moderate if >5 and

Published
2016

9. Vascular involvement in Behçet's disease.

Author

Graña Gil J, Sanchez Meizoso MO, Freire Gonzalez M, and Galdo Fernandez B

Subjects
Adult, Humans, Male, Behcet Syndrome complications, Thrombophlebitis complications
Published
1993

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