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1. High-Titer Rheumatoid Factor is Associated with Worse Clinical Outcomes and Higher Needs for Advanced Therapies in Rheumatoid Arthritis Under Real-Life Conditions

Author

Oliveira, Victor Davi R. S., Reis, Ana Paula M. G., Brenol, Claiton V., Pereira, Ivânio A., Bonfiglioli, Karina R., Pereira, Letícia R., Bértolo, Manoel B., de Fátima L. C. Sauma, Maria, Guimarães, Maria Fernanda B. R., Louzada-Júnior, Paulo, Giorgi, Rina D. N., Radominski, Sebastião C., Mota, Licia Maria H., Albuquerque, Cleandro P., and Castelar-Pinheiro, Geraldo R.

Published
2025
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2. Clinical predictors of remission and low disease activity in Latin American early rheumatoid arthritis: data from the GLADAR cohort

Author

Gamboa-Cárdenas, Rocio V, Ugarte-Gil, Manuel F., Loreto, Massardo, Sacnun, Mónica P., Saurit, Verónica, Cardiel, Mario H., Soriano, Enrique R., Pisoni, Cecilia, Galarza-Maldonado, Claudio M., Rios, Carlos, Radominski, Sebastião C., Castelar-Pinheiro, Geraldo da R., Bianchi, Washington Alves, Appenzeller, Simone, da Silveira, Inés Guimarães, de Freitas Zerbini, Cristiano A., Caballero-Uribe, Carlo V., Rojas-Villarraga, Adriana, Guibert-Toledano, Marlene, Ballesteros, Francisco, Montufar, Rubén, Vázquez-Mellado, Janitzia, Esquivel-Valerio, Jorge, De La Torre, Ignacio García, Barile-Fabris, Leonor A., Palezuelos, Fedra Irazoque, Andrade-Ortega, Lilia, Monge, Pablo, Teijeiro, Raquel, Achurra-Castillo, Ángel F., Esteva Spinetti, María H., Alarcón, Graciela S., and Pons-Estel, Bernardo A.

Published
2019
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4. Correction to: Clinical predictors of remission and low disease activity in Latin American early rheumatoid arthritis: data from the GLADAR cohort

Author

Gamboa-Cárdenas, Rocio V, Ugarte-Gil, Manuel F., Massardo, Loreto, Sacnun, Mónica P., Saurit, Verónica, Cardiel, Mario H., Soriano, Enrique R., Pisoni, Cecilia, Galarza-Maldonado, Claudio M., Rios, Carlos, Radominski, Sebastião C., Castelar-Pinheiro, Geraldo da R., Bianchi, Washington Alves, Appenzeller, Simone, da Silveira, Inés Guimarães, de Freitas Zerbini, Cristiano A., Caballero-Uribe, Carlo V., Rojas-Villarraga, Adriana, Guibert-Toledano, Marlene, Ballesteros, Francisco, Montufar, Rubén, Vázquez-Mellado, Janitzia, Esquivel-Valerio, Jorge, De La Torre, Ignacio García, Barile-Fabris, Leonor A., Palezuelos, Fedra Irazoque, Andrade-Ortega, Lilia, Monge, Pablo, Teijeiro, Raquel, Achurra-Castillo, Ángel F., Esteva Spinetti, María H., Alarcón, Graciela S., and Pons-Estel, Bernardo A.

Published
2019
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5. High-Titer Rheumatoid Factor is Associated with Worse Clinical Outcomes and Higher Needs for Advanced Therapies in Rheumatoid Arthritis Under Real-Life Conditions

Author

Oliveira, Victor Davi R. S., Reis, Ana Paula M. G., Brenol, Claiton V., Pereira, Ivânio A., Bonfiglioli, Karina R., Pereira, Letícia R., Bértolo, Manoel B., de Fátima L. C. Sauma, Maria, Guimarães, Maria Fernanda B. R., Louzada-Júnior, Paulo, Giorgi, Rina D. N., Radominski, Sebastião C., Mota, Licia Maria H., Albuquerque, Cleandro P., and Castelar-Pinheiro, Geraldo R.

Abstract

Introduction: Rheumatoid factor (RF) plays an important role in rheumatoid arthritis (RA) pathophysiology, yet the differential effects of varying RF titers remain understudied. We evaluated associations between different RF titers and clinical outcomes in long-standing RA. Methods: This multicenter, cross-sectional study included adults meeting ACR/EULAR (2010) criteria for RA. Circulating RF titers and clinical-epidemiological characteristics were evaluated. Bivariate (Student’s tand chi-squared tests) tests and multiple logistic and linear regression analyses were conducted. Results: We included 1097 participants; 78.7% had positive RF, with high titers (≥ 3 × the upper limit of normality) in 56.2%. Negative vs. low-positive RF groups performed similarly concerning all clinical outcomes, being subsequently aggregated as "non-high" RF group. High RF titers (compared to "non-high") were associated with tobacco use (odds ratio, OR [95% confidence interval, CI]: 2.04 [1.35, 3.08]; p< 0.001), multiraciality (OR [95% CI] 1.31 [1.03, 1.67]; p= 0.028, compared to White race), and higher body mass index (mean difference [95% CI] 0.69 [0.05, 1.33] kg/m2; p= 0.033). In multivariate analyses, high-titer RF was independently associated with higher disease activity (Clinical Disease Activity Index, CDAI: β= 2.44 [0.89, 3.99], p= 0.002), worse functional capacity (Health Assessment Questionnaire Disability Index, HAQ-DI: β= 0.112 [0.018, 0.205], p= 0.020); extra-articular manifestations (OR 1.48 [1.09, 2.00], p= 0.011); increased corticosteroid (OR 1.53 [1.19, 1.96], p= 0.001) and biological disease-modifying antirheumatic drugs (bDMARD) use (OR 1.41 [1.08, 1.84], p= 0.011). Conclusions: High RF titers in long-standing RA were associated with worse disease activity, lower physical functionality, increased extra-articular manifestations, and higher usage of corticosteroids and bDMARDs. Comparing high vs. non-high RF titers (rather than positive vs. negative RF) seems more useful for evaluating the clinical effects of RF in RA. This approach should be considered in future studies of RF.

Published
2024
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6. Prediction of improvement in skin fibrosis in diffuse cutaneous systemic sclerosis: a EUSTAR analysis

Author

Dobrota, Rucsandra, Maurer, Britta, Graf, Nicole, Jordan, Suzana, Mihai, Carina, Kowal-Bielecka, Otylia, Allanore, Yannick, Distler, Oliver, Cerinic, Marco Matucci, Guiducci, Serena, Walker, Ulrich, Lapadula, Giovanni, Iannone, Florenzo, Becvar, Radim, Sierakowsky, Stanislaw, Cutolo, Maurizio, Sulli, Alberto, Valentini, Gabriele, Cuomo, Giovanna, Vettori, Serena, Riemekasten, Gabriela, Siegert, Elise, Rednic, Simona, Nicoara, Ileana, Kahan, André, Vlachoyiannopoulos, P., Montecucco, C., Caporali, Roberto, Carreira, Patricia E., Novak, Srdan, Czirják, László, Varju, Cecilia, Chizzolini, Carlo, Kucharz, Eugene J., Kotulska, Anna, Kopec-Medrek, Magdalena, Widuchowska, Malgorzata, Cozzi, Franco, Rozman, Blaz, Mallia, Carmel, Coleiro, Bernard, Gabrielli, Armando, Farge, Dominique, Wu, Chen, Marjanovic, Zora, Faivre, Helene, Hij, Darin, Dhamadi, Roza, Airò, Paolo, Hesselstrand, Roger, Wollheim, Frank, Wuttge, Dirk M, Andréasson, Kristofer, Martinovic, Duska, Balbir-Gurman, Alexandra, Braun-Moscovici, Yolanda, Trotta, F., Lo Monaco, Andrea, Hunzelmann, Nicolas, Pellerito, Raffaele, Mauriziano, Ospedale, Bambara, Lisa Maria, Caramaschi, Paola, Black, Carol, Denton, Christopher, Damjanov, Nemanja, Henes, Jörg, Ortiz Santamaria, Vera, Heitmann, Stefan, Krasowska, Dorota, Seidel, Matthias, Burkhardt, Harald, Himsel, Andrea, Salvador, Maria J., Silva, José Antonio Pereira Da, Stamenkovic, Bojana, Stankovic, Aleksandra, Banja, Niska, Tikly, Mohammed, Ananieva, Lidia P., Denisov, Lev N., Müller-Ladner, Ulf, Frerix, Marc, Tarner, Ingo, Scorza, Raffaella, Clinica, U.O. Immunologia, Engelhart, Merete, Strauss, Gitte, Nielsen, Henrik, Damgaard, Kirsten, Mendoza, Antonio Zea, de la Puente, Carlos, Giraldo, Walter A. Sifuentes, Midtvedt, Øyvind, Reiseter, Silje, Hachulla, Eric, Launay, David, Valesini, Guido, Riccieri, Valeria, Ionescu, Ruxandra Maria, Opris, Daniela, Groseanu, Laura, Cornateanu, Roxana Sfrent, Ionitescu, Razvan, Gherghe, Ana Maria, Soare, Alina, Gorga, Marilena, Bojinca, Mihai, Schett, Georg, Distler, Jörg HW, Beyer, Christian, Meroni, Pierluigi, Ingegnoli, Francesca, Mouthon, Luc, De Keyser, Filip, Smith, Vanessa, Cantatore, Francesco P., Corrado, Ada, Pozzi, Maria R., Eyerich, Kilian, Hein, Rüdiger, Knott, Elisabeth, Wiland, Piotr, Szmyrka-Kaczmarek, Magdalena, Sokolik, Renata, Morgiel, Ewa, Madej, Marta, Krummel-Lorenz, Brigitte, Aringer, Martin, Günther, Claudia, Westhovens, Rene, de Langhe, Ellen, Lenaerts, Jan, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Radominski, Sebastião C., de Souza Müller, Carolina, Azevedo, Valderílio F., Agachi, Svetlana, Groppa, Liliana, Chiaburu, Lealea, Russu, Eugen, Popa, Sergei, Zenone, Thierry, Highton, John, Stamp, Lisa, Chapman, Peter, O’Donnell, John, Solanki, Kamal, Veale, Douglas, OʼRourke, Marie, Loyo, Esthela, Li, Mengtao, Rosato, Edoardo, Amoroso, Antonio, Tanaseanu, Cristina-Mihaela, Popescu, Monica, Dumitrascu, Alina, Tiglea, Isabela, Foti, Rosario, Chirieac, Rodica, Ancuta, Codrina, Villiger, Peter, Adler, Sabine, Sibilia, Jean, Chatelus, Emmanuel, Gottenberg, Jacques Eric, Chifflot, Hélène, Litinsky, Ira, Venalis, Algirdas, Butrimiene, Irena, Venalis, Paulius, Rugiene, Rita, Karpec, Diana, Saketkoo, Lesley Ann, Lasky, Joseph A., Kerzberg, Eduardo, Montoya, Fabiana, Cosentino, Vanesa, Limonta, Massimiliano, Brucato, Antonio Luca, Lupi, Elide, Spertini, François, Ribi, Camillo, Buss, Guillaume, Pasquali, Jean Louis, Martin, Thierry, and Gorse, Audrey

Published
2016
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7. A gender gap in primary and secondary heart dysfunctions in systemic sclerosis: a EUSTAR prospective study

Author

Elhai, Muriel, Avouac, Jérôme, Walker, Ulrich A, Matucci-Cerinic, Marco, Riemekasten, Gabriela, Airò, Paolo, Hachulla, Eric, Valentini, Gabriele, Carreira, Patricia E, Cozzi, Franco, Balbir Gurman, Alexandra, Braun-Moscovici, Yolanda, Damjanov, Nemanja, Ananieva, Lidia P, Scorza, Raffaella, Jimenez, Sergio, Busquets, Joanna, Li, Mengtao, Müller-Ladner, Ulf, Kahan, André, Distler, Oliver, Allanore, Yannick, Guiducci, Serena, Tyndall, Alan, Lapadula, Giovanni, Iannone, Florenzo, Becvar, Radim, Sierakowsky, Stanislaw, Bielecka, Otylia Kowal, Cutolo, Maurizio, Sulli, Alberto, Cuomo, Giovanna, Vettori, Serena, Rednic, Simona, Nicoara, Ileana, Vlachoyiannopoulos, P., Montecucco, C., Caporali, Roberto, Novak, Srdan, Czirják, László, Varju, Cecilia, Chizzolini, Carlo, Kucharz, Eugene J., Kotulska, Anna, Kopec-Medrek, Magdalena, Widuchowska, Malgorzata, Rozman, Blaz, Mallia, Carmel, Coleiro, Bernard, Gabrielli, Armando, Farge, Dominique, Hij, Adrian, Hesselstrand, Roger, Scheja, Agneta, Wollheim, Frank, Martinovic, Duska, Govoni, M., Monaco, Andrea Lo, Hunzelmann, Nicolas, Pellerito, Raffaele, Bambara, Lisa Maria, Caramaschi, Paola, Black, Carol, Denton, Christopher, Henes, Jörg, Santamaria, Vera Ortiz, Heitmann, Stefan, Krasowska, Dorota, Seidel, Matthias, Oleszowsky, Mara, Burkhardt, Harald, Himsel, Andrea, Salvador, Maria J., Stamenkovic, Bojana, Stankovic, Aleksandra, Tikly, Mohammed, Starovoytova, Maya N., Engelhart, Merete, Strauss, Gitte, Nielsen, Henrik, Damgaard, Kirsten, Szücs, Gabriella, Zea Mendoza, Antonio, de la Puente Buijdos, Carlos, Sifuentes Giraldo, Walter A., Midtvedt, Øyvind, Garen, Torhild, Launay, David, Valesini, Guido, Riccieri, Valeria, Ionescu, Ruxandra Maria, Opris, Daniela, Groseanu, Laura, Wigley, Fredrick M., Mihai, Carmen M., Cornateanu, Roxana Sfrent, Ionitescu, Razvan, Gherghe, Ana Maria, Gorga, Marilena, Dobrota, Rucsandra, Bojinca, Mihai, Schett, Georg, Distler, Jörg HW, Meroni, Pierluigi, Zeni, Silvana, Mouthon, Luc, Keyser, Filip De, Smith, Vanessa, Cantatore, Francesco P., Corrado, Ada, Ullman, Susanne, Iversen, Line, Pozzi, Maria R., Eyerich, Kilian, Hein, Rüdiger, Knott, Elisabeth, Szechinski, Jacek, Wiland, Piotr, Szmyrka-Kaczmarek, Magdalena, Sokolik, Renata, Morgiel, Ewa, Krummel-Lorenz, Brigitte, Saar, Petra, Aringer, Martin, Günther, Claudia, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Radominski, Sebastião C., Müller, Carolina de Souza, Azevedo, Valderílio F., Agachi, Svetlana, Groppa, Liliana, Chiaburu, Lealea, Russu, Eugen, Zenone, Thierry, Stebbings, Simon, Highton, John, Stamp, Lisa, Chapman, Peter, Baron, Murray, OʼDonnell, John, Solanki, Kamal, Doube, Alan, Veale, Douglas, OʼRourke, Marie, Loyo, Esthela, Rosato, Edoardo, Pisarri, Simonetta, Tanaseanu, Cristina-Mihaela, Popescu, Monica, Dumitrascu, Alina, Tiglea, Isabela, Chirieac, Rodica, Ancuta, Codrina, Furst, Daniel E., Kafaja, Suzanne, Lefebvre, Paloma García de la Peña, Rubio, Silvia Rodriguez, Exposito, Marta Valero, Sibilia, Jean, Chatelus, Emmanuel, Gottenberg, Jacques Eric, Chifflot, Hélène, Litinsky, Ira, Venalis, Algirdas, Butrimiene, Irena, Venalis, Paulius, Rugiene, Rita, Karpec, Diana, Kerzberg, Eduardo, Montoya, Fabiana, and Cosentino, Vanesa

Published
2016
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8. Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database

Author

Maurer, Britta, Graf, Nicole, Michel, Beat A, Müller-Ladner, Ulf, Czirják, László, Denton, Christopher P, Tyndall, Alan, Metzig, Carola, Lanius, Vivian, Khanna, Dinesh, Distler, Oliver, Tarner, Ingo H, Cerinic, Marco Matucci, Guiducci, Serena, Walker, Ulrich, Lapadula, Giovanni, Iannone, Florenzo, Becvar, Radim, Sierakowsky, Stanislaw, Bielecka, Otylia Kowal, Cutolo, Maurizio, Sulli, Alberto, Valentini, Gabriele, Cuomo, Giovanna, Vettori, Serena, Riemekasten, Gabriele, Rednic, Simona, Nicoara, Ileana, Kahan, André, Allanore, Yannick, Vlachoyiannopoulos, P, Montecucco, C, Caporali, Roberto, Carreira, Patricia E, Novak, Srdan, Varju, Cecilia, Chizzolini, Carlo, Kucharz, Eugene J, Kotulska, Anna, Kopec-Medrek, Magdalena, Widuchowska, Malgorzata, Cozzi, Franco, Rozman, Blaz, Mallia, Carmel, Coleiro, Bernard, Gabrielli, Armando, Farge, Dominique, Hij, Adrian, Airò, Paolo, Hesselstrand, Roger, Scheja, Agneta, Wollheim, Frank, Martinovic, Duska, Gurman, Alexandra Balbir, Braun-Moscovici, Yolanda, Govoni, M, Monaco, Andrea Lo, Hunzelmann, Nicolas, Pellerito, Raffaele, Bambara, Lisa Maria, Caramaschi, Paola, Black, Carol, Damjanov, Nemanja, Santamaria, Vera Ortiz, Heitmann, Stefan, Krasowska, Dorota, Seidel, Matthias, Oleszowsky, Mara, Burkhardt, Harald, Himsel, Andrea, Salvador, Maria J, Stamenkovic, Bojana, Stankovic, Aleksandra, Tikly, Mohammed, Starovoytova, Maya N, Ananieva, Lidia P, Scorza, Raffaella, Engelhart, Merete, Strauss, Gitte, Nielsen, Henrik, Damgaard, Kirsten, Szücs, Gabriella, Mendoza, Antonio Zea, Buijdos, Carlos de la Puente, Sifuentes Giraldo, Walter A., Midtvedt, Øyvind, Garen, Torhild, Hachulla, Eric, Launay, David, Valesini, Guido, Riccieri, Valeria, Ionescu, Ruxandra Maria, Opris, Daniela, Groseanu, Laura, Wigley, Fredrick M, Mihai, Carmen M, Cornateanu, Roxana Sfrent, Ionitescu, Razvan, Gherghe, Ana Maria, Gorga, Marilena, Dobrota, Rucsandra, Bojinca, Mihai, Schett, Georg, Distler, Jörg HW, Meroni, Pierluigi, Zeni, Silvana, Mouthon, Luc, Keyser, Filip De, Cantatore, Francesco P, Corrado, Ada, Ullman, Susanne, Iversen, Line, Pozzi, Maria R, Eyerich, Kilian, Hein, Rüdiger, Knott, Elisabeth, Szechinski, Jacek, Wiland, Piotr, Szmyrka-Kaczmarek, Magdalena, Sokolik, Renata, Morgiel, Ewa, Krummel-Lorenz, Brigitte, Saar, Petra, Aringer, Martin, Günther, Claudia, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Radominski, Sebastião C, Müller, Carolina de Souza, Azevedo, Valderílio F, Agachi, Svetlana, Groppa, Liliana, Chiaburu, Lealea, Russu, Eugen, Zenone, Thierry, Highton, John, Stamp, Lisa, Chapman, Peter, OʼDonnell, John, Solanki, Kamal, Doube, Alan, Veale, Douglas, O’Rourke, Marie, Loyo, Esthela, Li, Mengtao, Rosato, Edoardo, Pisarri, Simonetta, Tanaseanu, Cristina-Mihaela, Popescu, Monica, Dumitrascu, Alina, Tiglea, Isabela, Chirieac, Rodica, Ancuta, Codrina, E Furst, Daniel, Kafaja, Suzanne, Lefebvre, Paloma García de la Peña, Rubio, Silvia Rodriguez, Exposito, Marta Valero, Sibilia, Jean, Chatelus, Emmanuel, Gottenberg, Jacques Eric, Chifflot, Hélène, Litinsky, Ira, Venalis, Algirdas, Butrimiene, Irena, Venalis, Paulius, Rugiene, Rita, Karpec, Diana, Kerzberg, Eduardo, Montoya, Fabiana, and Cosentino, Vanesa

Published
2015
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10. The Effect of Three or Six Years of Denosumab Exposure in Women With Postmenopausal Osteoporosis: Results From the FREEDOM Extension

Author

Bone, Henry G., Chapurlat, Roland, Brandi, Maria-Luisa, Brown, Jacques P., Czerwiński, Edward, Krieg, Marc-Antoine, Mellström, Dan, Radominski, Sebastião C., Reginster, Jean-Yves, Resch, Heinrich, Ivorra, Jose A. Román, Roux, Christian, Vittinghoff, Eric, Daizadeh, Nadia S., Wang, Andrea, Bradley, Michelle N., Franchimont, Nathalie, Geller, Michelle L., Wagman, Rachel B., Cummings, Steven R., and Papapoulos, Socrates

Published
2013

11. Treatment of Early Rheumatoid Arthritis in a Multinational Inception Cohort of Latin American Patients: The GLADAR Experience

Author

Cardiel, Mario H., Pons-Estel, Bernardo A., Sacnun, Mónica P., Wojdyla, Daniel, Saurit, Verónica, Marcos, Juan Carlos, Pinto, María Raquel C., Cordeiro de Azevedo, Ana Beatriz, da Silveira, Inês Guimarães, Radominski, Sebastião C., Ximenes, Antônio C., Massardo, Loreto, Ballesteros, Francisco, Rojas-Villarraga, Adriana, Oñate, Rafael Valle, Hernandez, Margarita Portela, Esquivel-Valerio, Jorge A., García-De La Torre, Ignacio, Khoury, Vianna J., Millán, Alberto, and Soriano, Enrique Roberto

Published
2012
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12. High Levels of Polypharmacy in Rheumatoid Arthritis—A Challenge Not Covered by Current Management Recommendations: Data From a Large Real-Life Study

Author

Gomides, Ana Paula M., primary, Albuquerque, Cleandro P., additional, Santos, Ana B.V., additional, Amorim, Rodrigo B. C., additional, Bértolo, Manoel B., additional, Júnior, Paulo L., additional, Santos, Isabela A., additional, Giorgi, Rina D., additional, Sacilotto, Nathália C., additional, Radominski, Sebastião C., additional, Borghi, Fernanda M., additional, Guimarães, Maria F. B. R., additional, Pinto, Maria R. C., additional, Resende, Gustavo G., additional, Bonfiglioli, Karina R., additional, Carriço, Henrique, additional, Sauma, Maria F. L. C., additional, Sauma, Marcel L., additional, Medeiros, Júlia B., additional, Pereira, Ivânio A., additional, Castro, Gláucio R. W., additional, Brenol, Claiton V., additional, Xavier, Ricardo M., additional, Mota, Licia M. H., additional, and Pinheiro, Geraldo R. C., additional

Published
2019
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13. FRI0155 A COMPARISON OF UPADACITINIB PLUS METHOTREXATE AND UPADACITINIB PLUS OTHER CSDMARDS IN PATIENTS WITH RHEUMATOID ARTHRITIS: AN ANALYSIS OF TWO PHASE 3 STUDIES

Author

Kremer, Joel, primary, Bosch, Filip van den, additional, Rubbert-Roth, Andrea, additional, Radominski, Sebastião C., additional, Burmester, Gerd Rüdiger, additional, Camp, Heidi, additional, Meerwein, Sebastian, additional, Howard, Mark, additional, Song, Yanna, additional, Zhong, Sheng, additional, and Combe, Bernard, additional

Published
2019
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14. High Levels of Polypharmacy in Rheumatoid Arthritis—A Challenge Not Covered by Current Management Recommendations: Data From a Large Real-Life Study.

Author

Gomides, Ana Paula M., Albuquerque, Cleandro P., Santos, Ana B.V., Amorim, Rodrigo B. C., Bértolo, Manoel B., Júnior, Paulo L., Santos, Isabela A., Giorgi, Rina D., Sacilotto, Nathália C., Radominski, Sebastião C., Borghi, Fernanda M., Guimarães, Maria F. B. R., Pinto, Maria R. C., Resende, Gustavo G., Bonfiglioli, Karina R., Carriço, Henrique, Sauma, Maria F. L. C., Sauma, Marcel L., Medeiros, Júlia B., and Pereira, Ivânio A.

Subjects
RESEARCH, POLYPHARMACY, CROSS-sectional method, MEDICAL cooperation, RHEUMATOID arthritis
Abstract

Background: Rheumatoid arthritis (RA) is associated with high frequency of comorbidities and increased risk of polypharmacy. Although there is a great potential for complications, there is a gap in literature on polypharmacy in patients with rheumatic arthritis. Objective: To evaluate the prevalence and factors associated with polypharmacy in a population in a real-life setting. Methods: A cross-sectional multicenter study was conducted in Brazil. Patients underwent clinical evaluation and medical records analysis. Polypharmacy was considered as a dependent variable. To test independent variables, we used Poisson regression. Results: We evaluated 792 patients (89% female, median age 56.6 years). Median duration of disease was 12.7 years, 78.73% had a positive rheumatoid factor. The median of disease activity score-28 was 3.5 (disease with mild activity), median of the clinical disease activity index score was 9, and median of health assessment questionnaire-disability index was 0.875; 47% used corticosteroids, 9.1% used nonsteroidal anti-inflammatory drugs, 90.9% used synthetic disease-modifying antirheumatic drugs, 35.7% used biologic disease-modifying antirheumatic drugs (DMARDs). In total, 537 (67.9%) patients used 5 or more drugs. Polypharmacy showed a relationship with a number of comorbidities and use of specific drugs (corticosteroids, methotrexate, and biological DMARDs). Conclusion: We found a high prevalence of polypharmacy (67.9%) in RA. Solutions to management this problem should be stimulated. [ABSTRACT FROM AUTHOR]

Published
2021
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15. Incidences and risk factors of organ manifestations in the early course of systemic sclerosis: A longitudinal EUSTAR study

Author

Jaeger, Veronika K., Wirz, Elina G., Allanore, Yannick, Rossbach, Philipp, Riemekasten, Gabriela, Hachulla, Eric, Distler, Oliver, Airò, Paolo, Carreira, Patricia E., Gurman, Alexandra Balbir, Tikly, Mohammed, Vettori, Serena, Damjanov, Nemanja, Müller Ladner, Ulf, Distler, Jörg H. W., Mangtao, Li, Walker, Ulrich A., Ananieva, Lidia, Heitmann, Stefan, Rednic, Simona, Riccieri, Valeria, Szmyrka Kaczmarek, Magdalena, Farge, Dominique, Lapadula, Giovanni, Matucci Cerinic, Marco, Guiducci, Serena, Hunzelmann, Nicolas, Ricci, Massimo, Mihai, Carina, Veale, Douglas, Hesselstrand, Roger, Mariok, Eduardo, Smith, Vanessa, Tarner, Ingo H., Kucharz, Eugene J., Czirják, László, Martinovic, Duska, Solanki, Kamal, Ancuta, Codrina Mihaela, Sibilia, Jean, Paola, Caramaschi, Hassanien, Manal, Kahl, Sarah, Wigley, Frederick, Vanthuyne, Marie, Opris, Daniela, Radominski, Sebastião C., Monaco, Andrea Lo, Corrado, Ada, Koehm, Michaela, Codullo, Veronica, Radim, Bevcar, Loyo, Esthela, Üprus, Maria, Pellerito, Raffaele, Zenone, Thierry, Gabrielli, Armando, Kowal Bielecka, Otylia, Rozman, Blaz, Scorza, Raffaella, Saketkoo, Lesley Ann, Midtvedt, Oyvind, Von Mühlen, Carlos Alberto, Henes, Jörg, Branimir, Ani, Hasler, Paul, Yavuz, Sule, Adler, Sabine, Krummel Lorenz, Brigitte, Posa, Magdalena, Engelhart, Merete, Denton, Christopher, Krasowska, Dorota, Lefebvre, Paloma Garcia De La Peña, Cozzi, Franco, Mouthon, Luc, Rosato, Edoardo, Selmi, Carlo, Sancho, Juan José Alegre, Mallia, Carmel, Limonta, Massimiliano, Seidel, Matthias, Foti, Rosario, Stamp, Lisa, Ullman, Susanne, Stebbings, Simon, Santamaria, Vera Ortiz, Del Galdo, Francesco, De Langhe, Ellen, Mathieu, Alessandro, Sunderkötter, Cord, Eyerich, Kilian, Stamenkovic, Bojana, Novak, Srdan, Sampaio Barros, Percival D., Kayser, Cristiane, Litinsky, Ira, Couto, Maura, Jaeger, Veronika K., Wirz, Elina G., Allanore, Yannick, Rossbach, Philipp, Riemekasten, Gabriela, Hachulla, Eric, Distler, Oliver, Airã², Paolo, Carreira, Patricia E., Gurman, Alexandra Balbir, Tikly, Mohammed, Vettori, Serena, Damjanov, Nemanja, Mã¼ller ladner, Ulf, Distler, Jã¶rg H. W., Li, Mangtao, Walker, Ulrich A., Ananieva, Lidia, Heitmann, Stefan, Rednic, Simona, Riccieri, Valeria, Szmyrka kaczmarek, Magdalena, Farge, Dominique, Lapadula, Giovanni, Matucci cerinic, Marco, Guiducci, Serena, Hunzelmann, Nicola, Ricci, Massimo, Mihai, Carina, Veale, Dougla, Hesselstrand, Roger, Mariok, Eduardo, Smith, Vanessa, Tarner, Ingo H., Kucharz, Eugene J., Czirjã¡k, Lã¡szlã³, Martinovic, Duska, Solanki, Kamal, Ancuta, Codrina Mihaela, Sibilia, Jean, Paola, Caramaschi, Hassanien, Manal, Kahl, Sarah, Wigley, Frederick, Vanthuyne, Marie, Opris, Daniela, Radominski, Sebastiã£o C., Monaco, Andrea Lo, Corrado, Ada, Koehm, Michaela, Codullo, Veronica, Radim, Bevcar, Loyo, Esthela, Ãœprus, Maria, Pellerito, Raffaele, Zenone, Thierry, Gabrielli, Armando, Kowal bielecka, Otylia, Rozman, Blaz, Scorza, Raffaella, Saketkoo, Lesley Ann, Midtvedt, Oyvind, Von Mã¼hlen, Carlos Alberto, Henes, Jã¶rg, Branimir, Ani, Hasler, Paul, Yavuz, Sule, Adler, Sabine, Krummel lorenz, Brigitte, Posa, Magdalena, Engelhart, Merete, Denton, Christopher, Krasowska, Dorota, Lefebvre, Paloma Garcia De La Peã±a, Cozzi, Franco, Mouthon, Luc, Rosato, Edoardo, Selmi, Carlo, Sancho, Juan Josã© Alegre, Mallia, Carmel, Limonta, Massimiliano, Seidel, Matthia, Foti, Rosario, Stamp, Lisa, Ullman, Susanne, Stebbings, Simon, Santamaria, Vera Ortiz, Del Galdo, Francesco, De Langhe, Ellen, Mathieu, Alessandro, Sunderkã¶tter, Cord, Eyerich, Kilian, Stamenkovic, Bojana, Novak, Srdan, Sampaio barros, Percival D., Kayser, Cristiane, Litinsky, Ira, Couto, Maura, and University of Zurich

Subjects
Male, Genetics and Molecular Biology (all), Pulmonology, Blood Pressure, Vascular Medicine, Biochemistry, Scleroderma, Diagnostic Radiology, 0302 clinical medicine, Retrospective Studie, Longitudinal Studies, lcsh:Science, integumentary system, Incidence, Arteries, Systolic Pressure, 3. Good health, Echocardiography, Cohort, Regression Analysis, Human, medicine.medical_specialty, Imaging Techniques, Gastrointestinal Disease, Immunology, 1100 General Agricultural and Biological Sciences, Skin Diseases, 03 medical and health sciences, FEV1/FVC ratio, Rheumatology, 1300 General Biochemistry, Genetics and Molecular Biology, Humans, Autoantibodies, Retrospective Studies, Aged, 1000 Multidisciplinary, Biochemistry, Genetics and Molecular Biology (all), Proportional hazards model, lcsh:R, Biology and Life Sciences, Proteins, medicine.disease, Agricultural and Biological Sciences (all), Blood Vessels, lcsh:Q, Clinical Medicine, Ejection Fraction, Lung Diseases, Kidney Disease, Physiology, Gastrointestinal Diseases, lcsh:Medicine, Longitudinal Studie, Kaplan-Meier Estimate, Medicine (all), Lung Disease, Pericardial effusion, Risk Factors, Medizinische Fakultät, Immune Physiology, Ultrasound Imaging, Medicine and Health Sciences, 030212 general & internal medicine, Pulmonary Arteries, Connective Tissue Diseases, Immune System Proteins, Pulmonary Hypertension, Multidisciplinary, Ejection fraction, Radiology and Imaging, Incidence (epidemiology), 10051 Rheumatology Clinic and Institute of Physical Medicine, Middle Aged, Autoantibodie, Heart Disease, Kidney Diseases, Female, Anatomy, Research Article, Adult, Heart Diseases, Cardiology, 610 Medicine & health, Research and Analysis Methods, Antibodies, Regression Analysi, Autoimmune Diseases, Diagnostic Medicine, Internal medicine, medicine, ddc:610, 030203 arthritis & rheumatology, Scleroderma, Systemic, business.industry, Risk Factor, Skin Disease, Raynaud Disease, Retrospective cohort study, Surgery, Cardiovascular Anatomy, Clinical Immunology, business
Abstract

Objective Systemic sclerosis (SSc) is a rare and clinically heterogeneous autoimmune disorder characterised by fibrosis and microvascular obliteration of the skin and internal organs. Organ involvement mostly manifests after a variable period of the onset of Raynaud's phenomenon (RP). We aimed to map the incidence and predictors of pulmonary, cardiac, gastrointestinal (GI) and renal involvement in the early course of SSc. Methods In the EUSTAR cohort, patients with early SSc were identified as those who had a visit within the first year after RP onset. Incident SSc organ manifestations and their risk factors were assessed using Kaplan-Meier methods and Cox regression analysis. Results Of the 695 SSc patients who had a baseline visit within 1 year after RP onset, the incident non-RP manifestations (in order of frequency) were: skin sclerosis (75%) GI symptoms (71%), impaired diffusing capacity for monoxide40mmHg (14%), and renal crisis (3%). In the heart, incidence rates were highest for diastolic dysfunction, followed by conduction blocks and pericardial effusion. While the main baseline risk factor for a short timespan to develop FVC impairment was diffuse skin involvement, for PAPsys>40mmHg it was higher patient age. The main risk factors for incident cardiac manifestations were anti-topoisomerase autoantibody positivity and older age. Male sex, anti-RNA-polymerase-III positivity, and older age were risk factors associated with incident renal crisis. Conclusion In SSc patients presenting early after RP onset, approximately half of all incident organ manifestations occur within 2 years and have a simultaneous rather than a sequential onset. These findings have implications for the design of new diagnostic and therapeutic strategies aimed to ‘widen' the still very narrow ‘window of opportunity'. They may also enable physicians to counsel and manage patients presenting early in the course of SSc more accurately.

Published
2016

16. Two-year Efficacy and Safety of Subcutaneous Tocilizumab in Combination with Disease-modifying Antirheumatic Drugs Including Escalation to Weekly Dosing in Rheumatoid Arthritis

Author

Kivitz, Alan, primary, Olech, Ewa, additional, Borofsky, Michael A., additional, Zazueta, Beatriz, additional, Navarro-Sarabia, Federico, additional, Radominski, Sebastião C., additional, Merrill, Joan T., additional, Pacheco-Tena, César, additional, Pei, Jinglan, additional, Nasmyth-Miller, Clare, additional, and Pope, Janet E., additional

Published
2017
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17. Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials.

Author

Ruperto, Nicolino, Brunner, Hermine I., Quartier, Pierre, Constantin, Tamàs, Wulffraat, Nico M., Horneff, Gerd, Kasapcopur, Ozgur, Schneider, Rayfel, Anton, Jordi, Barash, Judith, Berner, Reinhard, Corona, Fabrizia, Cuttica, Ruben, Fouillet-desjonqueres, Marine, Fischbach, Michel, Foster, Helen E., Foell, Dirk, Radominski, Sebastião C., Ramanan, Athimalaipet V., and Trauzeddel, Ralf

Abstract

Objectives: To evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA).Methods: Patients (2-19 years) entered two phase III studies and continued in the long-term extension (LTE) study. Efficacy assessments were performed every 3 months, including adapted JIA American College of Rheumatology (aJIA-ACR) criteria, Juvenile Arthritis Disease Activity Score (JADAS) and ACR clinical remission on medication criteria (CRACR). Efficacy analyses are reported as per the intent-to-treat population.Results: 144 of the 177 patients (81%) enrolled in the core study entered the LTE. Overall, 75 patients (42%) completed and 102 (58%) discontinued mainly for inefficacy (63/102, 62%), with higher discontinuation rates noted in the late responders group (n=25/31, 81%) versus early responders (n=11/38, 29%). At 2 years, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively. CRACR was achieved by 20% of patients at month 6; 32% at 2 years. A JADAS low disease activity score was achieved by 49% of patients at 2 years. Efficacy results were maintained up to 5 years. Of the 128/177 (72.3%) patients on glucocorticoids, 20 (15.6%) discontinued and 28 (22%) tapered to 0.150 mg/kg/day. Seven patients discontinued canakinumab due to CR. There were 13 macrophage activation syndrome (three previously reported) and no additional deaths (three previously reported). No new safety findings were observed.Conclusion: Response to canakinumab treatment was sustained and associated with substantial glucocorticoid dose reduction or discontinuation and a relatively low retention-on-treatment rate. No new safety findings were observed on long-term use of canakinumab.Trial Registration Numbers: NCT00886769, NCT00889863, NCT00426218 and NCT00891046. [ABSTRACT FROM AUTHOR]

Published
2018
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19. Subcutaneous Tocilizumab Versus Placebo in Combination With Disease‐Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis

Author

Kivitz, Alan, primary, Olech, Ewa, additional, Borofsky, Michael, additional, Zazueta, Beatriz M., additional, Navarro‐Sarabia, Federico, additional, Radominski, Sebastião C., additional, Merrill, Joan T., additional, Rowell, Lucy, additional, Nasmyth‐Miller, Clare, additional, Bao, Min, additional, Wright, Stephen, additional, and Pope, Janet E., additional

Published
2014
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20. Five years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension

Author

Papapoulos, Socrates, primary, Chapurlat, Roland, additional, Libanati, Cesar, additional, Brandi, Maria Luisa, additional, Brown, Jacques P, additional, Czerwiński, Edward, additional, Krieg, Marc‐Antoine, additional, Man, Zulema, additional, Mellström, Dan, additional, Radominski, Sebastião C, additional, Reginster, Jean‐Yves, additional, Resch, Heinrich, additional, Ivorra, José A Román, additional, Roux, Christian, additional, Vittinghoff, Eric, additional, Austin, Matthew, additional, Daizadeh, Nadia, additional, Bradley, Michelle N, additional, Grauer, Andreas, additional, Cummings, Steven R, additional, and Bone, Henry G, additional

Published
2012
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21. Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database

Author

Maurer, B., Graf, N., Michel, B. A., Muller Ladner, U., Czirjak, L., Denton, C. P., Tyndall, A., Metzig, C., Lanius, V., Khanna, D., Distler, O., Arner, I. H., Cerinic, M. M., Guiducci, S., Walker, U., Lapadula, G., Iannone, F., Becvar, R., Sierakowsky, S., Bielecka, O. K., Cutolo, M., Sulli, A., Valentini, G., Cuomo, G., Vettori, S., Riemekasten, G., Rednic, S., Nicoara, I., Kahan, A., Allanore, Y., Vlachoyiannopoulos, P., Montecucco, C., Caporali, R., Carreira, P. E., Novak, S., Varju, C., Chizzolini, C., Kucharz, E. J., Kotulska, A., Kopec Medrek, M., Widuchowska, M., Cozzi, F., Rozman, B., Mallia, C., Coleiro, B., Gabrielli, A., Farge, D., Hij, A., Airo, P., Hesselstrand, R., Scheja, A., Wollheim, F., Martinovic, D., Gurman, A. B., Braun Moscovici, Y., Govoni, Marcello, LO MONACO, Andrea, Hunzelmann, N., Pellerito, R., Bambara, L. M., Caramaschi, P., Black, C., Damjanov, N., Santamaria, V. O., Heitmann, S., Krasowska, D., Seidel, M., Oleszowsky, M., Burkhardt, H., Himsel, A., Salvador, M. J., Stamenkovic, B., Stankovic, A., Tikly, M., Starovoytova, M. N., Ananieva, L. P., Scorza, R., Engelhart, M., Strauss, G., Nielsen, H., Damgaard, K., Szucs, G., Mendoza, A. Z., Buijdos, C. d. l. P., Sifuentes Giraldo, W. A., Midtvedt, O., Garen, T., Hachulla, E., Launay, D., Valesini, G., Riccieri, V., Ionescu, R. M., Opris, D., Groseanu, L., Wigley, F. M., Mihai, C. M., Cornateanu, R. S., Ionitescu, R., Gherghe, A. M., Gorga, M., Dobrota, R., Bojinca, M., Schett, G., Distler, J. H., Meroni, P., Zeni, P., Mouthon, L., Keyser, F. D., Cantatore, F. P., Corrado, A., Ullman, S., Iversen, L., Pozzi, M. R., Eyerich, K., Hein, R., Knott, E., Szechinski, J., Wiland, P., Szmyrka Kaczmarek, M., Sokolik, R., Morgiel, E., Krummel Lorenz, B., Saar, P., Aringer, M., Gunther, C., Anic, B., Baresic, M., Mayer, M., Radominski, S. C., Muller, C. d. S., Azevedo, V. F., Agachi, S., Groppa, L., Chiaburu, L., Russu, E., Zenone, T., Highton, J., Stamp, L., Chapman, P., O'Donnell, J., Solanki, K., Doube, A., Veale, D., O'Rourke, M., Loyo, E., Li, M., Rosato, E., Pisarri, S., Tanaseanu, C. M., Popescu, M., Dumitrascu, A., Tiglea, I., Chirieac, R., Ancuta, C., Furst, D. E., Kafaja, S., Lefebvre, P. G. d. l. P., Rubio, S. R., Exposito, M. V., Sibilia, J., Chatelus, E., Gottenberg, J. E., Chifflot, H., Litinsky, I., Venalis, A., Butrimiene, I., Venalis, P., Rugiene, R., Karpec, D., Kerzberg, E., Montoya, F., Cosentino, V., Chizzolini, Carlo, Maurer, Britta, Graf, Nicole, Michel, Beat A, Müller Ladner, Ulf, Czirják, László, Denton, Christopher P, Tyndall, Alan, Metzig, Carola, Lanius, Vivian, Khanna, Dinesh, Distler, Oliver, Tarner, Ingo H, Cerinic, Marco Matucci, Guiducci, Serena, Walker, Ulrich, Lapadula, Giovanni, Iannone, Florenzo, Becvar, Radim, Sierakowsky, Stanislaw, Bielecka, Otylia Kowal, Cutolo, Maurizio, Sulli, Alberto, Valentini, Gabriele, Cuomo, Giovanna, Vettori, Serena, Riemekasten, Gabriele, Rednic, Simona, Nicoara, Ileana, Kahan, André, Allanore, Yannick, Vlachoyiannopoulos, P, Montecucco, Carlomaurizio, Caporali, Roberto, Carreira, Patricia E, Novak, Srdan, Varju, Cecilia, Kucharz, Eugene J, Kotulska, Anna, Kopec Medrek, Magdalena, Widuchowska, Malgorzata, Cozzi, Franco, Rozman, Blaz, Mallia, Carmel, Coleiro, Bernard, Gabrielli, Armando, Farge, Dominique, Hij, Adrian, Airò, Paolo, Hesselstrand, Roger, Scheja, Agneta, Wollheim, Frank, Martinovic, Duska, Gurman, Alexandra Balbir, Braun Moscovici, Yolanda, Govoni, M, Monaco, Andrea Lo, Hunzelmann, Nicola, Pellerito, Raffaele, Bambara, Lisa Maria, Caramaschi, Paola, Black, Carol, Damjanov, Nemanja, Santamaria, Vera Ortiz, Heitmann, Stefan, Krasowska, Dorota, Seidel, Matthia, Oleszowsky, Mara, Burkhardt, Harald, Himsel, Andrea, Salvador, Maria J, Stamenkovic, Bojana, Stankovic, Aleksandra, Tikly, Mohammed, Starovoytova, Maya N, Ananieva, Lidia P, Scorza, Raffaella, Engelhart, Merete, Strauss, Gitte, Nielsen, Henrik, Damgaard, Kirsten, Szücs, Gabriella, Mendoza, Antonio Zea, Buijdos, Carlos de la Puente, Giraldo, Walter A. Sifuente, Midtvedt, Øyvind, Garen, Torhild, Hachulla, Eric, Launay, David, Valesini, Guido, Riccieri, Valeria, Ionescu, Ruxandra Maria, Opris, Daniela, Groseanu, Laura, Wigley, Fredrick M, Mihai, Carmen M, Cornateanu, Roxana Sfrent, Ionitescu, Razvan, Gherghe, Ana Maria, Gorga, Marilena, Dobrota, Rucsandra, Bojinca, Mihai, Schett, Georg, Distler, Jörg HW, Meroni, Pierluigi, Zeni, Silvana, Mouthon, Luc, Keyser, Filip De, Cantatore, Francesco P, Corrado, Ada, Ullman, Susanne, Iversen, Line, Pozzi, Maria R, Eyerich, Kilian, Hein, Rüdiger, Knott, Elisabeth, Szechinski, Jacek, Wiland, Piotr, Szmyrka Kaczmarek, Magdalena, Sokolik, Renata, Morgiel, Ewa, Krummel Lorenz, Brigitte, Saar, Petra, Aringer, Martin, Günther, Claudia, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Radominski, Sebastião C, Müller, Carolina de Souza, Azevedo, Valderílio F, Agachi, Svetlana, Groppa, Liliana, Chiaburu, Lealea, Russu, Eugen, Zenone, Thierry, Highton, John, Stamp, Lisa, Chapman, Peter, O'Donnell, John, Solanki, Kamal, Doube, Alan, Veale, Dougla, O’Rourke, Marie, Loyo, Esthela, Li, Mengtao, Rosato, Edoardo, Pisarri, Simonetta, Tanaseanu, Cristina Mihaela, Popescu, Monica, and University of Zurich

Subjects
Genetics and Molecular Biology (all), Male, Time Factors, Databases, Factual, systemic sclerosis, 2745 Rheumatology, computer.software_genre, Biochemistry, Severity of Illness Index, Outcomes Research, Qualitative Research, Systemic Sclerosis, Adult, Cohort Studies, Creatine Kinase, Decision Support Techniques, Deglutition Disorders, Dyspnea, Female, Fibrosis, Humans, Logistic Models, Middle Aged, Multivariate Analysis, Scleroderma, Diffuse, Sex Factors, Skin, Synovitis, Disease Progression, Rheumatology, Immunology, Biochemistry, Genetics and Molecular Biology (all), Immunology and Allergy, Medicine (all), Scleroderma, skin fibrosis, skin and connective tissue diseases, ddc:616, EUSTAR, Univariate analysis, Database, integumentary system, 10051 Rheumatology Clinic and Institute of Physical Medicine, Orvostudományok, Diffuse, Connective tissue disease, Cohort, 2723 Immunology and Allergy, Cohort study, medicine.medical_specialty, 610 Medicine & health, Klinikai orvostudományok, General Biochemistry, Genetics and Molecular Biology, NO, outcomes research, qualitative research, Databases, 1300 General Biochemistry, Genetics and Molecular Biology, Internal medicine, Severity of illness, medicine, Factual, 2403 Immunology, business.industry, medicine.disease, business, computer
Abstract

ObjectivesTo identify predictive parameters for the progression of skin fibrosis within 1 year in patients with diffuse cutaneous SSc (dcSSc).MethodsAn observational study using the EUSTAR database was performed. Inclusion criteria were dcSSc, American College of Rheumatology (ACR) criteria fulfilled, modified Rodnan skin score (MRSS) ≥7 at baseline visit, valid data for MRSS at 2nd visit, and available follow-up of 12±2 months. Worsening of skin fibrosis was defined as increase in MRSS >5 points and ≥25% from baseline to 2nd visit. In the univariate analysis, patients with progressive fibrosis were compared with non-progressors, and predictive markers with pResultsA total of 637 dcSSc patients were eligible. Univariate analyses identified joint synovitis, short disease duration (≤15 months), short disease duration in females/patients without creatine kinase (CK) elevation, low baseline MRSS (≤22/51), and absence of oesophageal symptoms as potential predictors for progressive skin fibrosis. In the multivariate analysis, by employing combinations of the predictors, 17 models with varying prediction success were generated, allowing cohort enrichment from 9.7% progressive patients in the whole cohort to 44.4% in the optimised enrichment cohort. Using a second validation cohort of 188 dcSSc patients, short disease duration, low baseline MRSS and joint synovitis were confirmed as independent predictors of progressive skin fibrosis within 1 year resulting in a 4.5-fold increased prediction success rate.ConclusionsOur study provides novel, evidence-based criteria for the enrichment of dcSSc cohorts with patients who experience worsening of skin fibrosis which allows improved clinical trial design.

Published
2014

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