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Öğe Phenotypes Determined by Cluster Analysis and Their Survival in the Prospective European Scleroderma Trials and Research Cohort of Patients With Systemic Sclerosis(Wiley, 2019) Sobanski, Vincent; Giovannelli, Jonathan; Allanore, Yannick; Riemekasten, Gabriela; Airo, Paolo; Vettori, Serena; Cozzi, Franco; Distler, Oliver; Matucci-Cerinic, Marco; Denton, Christopher; Launay, David; Hachulla, Eric; Cerinic, Marco Matucci; Guiducci, Serena; Walker, Ulrich; Kyburz, Diego; Lapadula, Giovanni; Iannone, Florenzo; Distler, Oliver; Maurer, Britta; Jordan, Suzana; Becvar, Radim; Sierakowsky, Stanislaw; Bielecka, Otylia Kowal; Cutolo, Maurizio; Sulli, Alberto; Valentini, Gabriele; Cuomo, Giovanna; Vettori, Serena; Siegert, Elise; Rednic, Simona; Nicoara, Ileana; Kahan, Andre; Allanore, Yannick; Vlachoyiannopoulos, Panayiotis; Montecucco, Carlo; Caporali, Roberto; Stork, Jiri; Inanc, Murat; Carreira, Patricia E.; Novak, Srdan; Czirjak, Laszlo; 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; Airo, Paolo; Hesselstrand, Roger; Wollheim, Frank; Wuttge, Dirk M.; Andreasson, Kristofer; Martinovic, Duska; Balbir-Gurman, Alexandra; Braun-Moscovici, Yolanda; Trotta, Francesco; Lo Monaco, Andrea; Hunzelmann, Nicolas; Pellerito, Raffaele; Bambara, Lisa Maria; Caramaschi, Paola; Morovic-Vergles, Jadranka; Black, Carol; Denton, Christopher; Damjanov, Nemanja; Henes, Joerg; Ortiz Santamaria, Vera; Heitmann, Stefan; Krasowska, Dorota; Seidel, Matthias; Hasler, Paul; Burkhardt, Harald; Himsel, Andrea; Bajocchi, Gianluigi; Nuova, Arcispedale Santa Maria; Salvador, Maria Joao; Pereira Da Silva, Jose Antonio; Stamenkovic, Bojana; Stankovic, Aleksandra; Selmi, Carlo Francesco; De Santis, Maria; Marasini, Bianca; Tikly, Mohammed; Ananieva, Lidia P.; Denisov, Lev N.; Mueller-Ladner, Ulf; Frerix, Marc; Tarner, Ingo; Scorza, Raffaella; Puppo, Francesco; Engelhart, Merete; Strauss, Gitte; Nielsen, Henrik; Damgaard, Kirsten; Szucs, Gabriella; Szamosi, Szilvia; Zea Mendoza, Antonio; de la Puente, Carlos; Sifuentes Giraldo, Walter Alberto; Midtvedt, Oyvind; Reiseter, Silje; Garen, Torhild; Hachulla, Eric; Launay, David; Valesini, Guido; Riccieri, Valeria; Ionescu, Ruxandra Maria; Opris, Daniela; Groseanu, Laura; Wigley, Fredrick M.; Cornateanu, Roxana Sfrent; Ionitescu, Razvan; Gherghe, Ana Maria; Soare, Alina; Gorga, Marilena; Bojinca, Mihai; Mihai, Carina; Milicescu, Mihaela; Sunderkoetter, Cord; Kuhn, Annegret; Sandorfi, Nora; Schett, Georg; Distler, Joerg H. W.; Beyer, Christian; Meroni, Pierluigi; Ingegnoli, Francesca; Mouthon, Luc; De Keyser, Filip; Smith, Vanessa; Cantatore, Francesco Paolo; Corrado, Ada; Ullman, Susanne; Iversen, Line; von Muehlen, Carlos Alberto; Bohn, Jussara Marilu; Lonzetti, Lilian Scussel; Pozzi, Maria Rosa; Eyerich, Kilian; Hein, Ruediger; Knott, Elisabeth; Wiland, Piotr; Szmyrka-Kaczmarek, Magdalena; Sokolik, Renata; Morgiel, Ewa; Madej, Marta; Houssiau, Frederic A.; Jose Alegre-Sancho, Juan; Krummel-Lorenz, Brigitte; Saar, Petra; Aringer, Martin; Guenther, Claudia; Westhovens, Rene; de Langhe, Ellen; Lenaerts, Jan; Anic, Branimir; Baresic, Marko; Mayer, Miroslav; Uprus, Maria; Otsa, Kati; Yavuz, Sule; Granel, Brigitte; Radominski, Sebastiao Cezar; Mueller, Carolina de Souza; Azevedo, Valderilio Feijo; Jimenez, Sergio; Busquets, Joanna; Agachi, Svetlana; Groppa, Liliana; Chiaburu, Lealea; Russu, Eugen; Popa, Sergei; Zenone, Thierry; Pileckyte, Margarita; Stebbings, Simon; Highton, John; Mathieu, Alessandro; Vacca, Alessandra; Sampaio-Barros, Percival D.; Yoshinari, Natalino H.; Marangoni, Roberta G.; Martin, Patricia; Fuocco, Luiza; Stamp, Lisa; Chapman, Peter; O'Donnell, John; Solanki, Kamal; Doube, Alan; Veale, Douglas; O'Rourke, Marie; Loyo, Esthela; Li, Mengtao; Mohamed, Walid Ahmed Abdel Atty; Rosato, Edoardo; Amoroso, Antonio; Gigante, Antonietta; Oksel, Fahrettin; Yargucu, Figen; Tanaseanu, Cristina-Mihaela; Popescu, Monica; Dumitrascu, Alina; Tiglea, Isabela; Foti, Rosario; Chirieac, Rodica; Ancuta, Codrina; Furst, Daniel E.; Villiger, Peter; Adler, Sabine; van Laar, Jacob; Kayser, Cristiane; Eduardo, Andrade Luis C.; Fathi, Nihal; Hassanien, Manal; de la Pena Lefebvre, Paloma Garcia; Rodriguez Rubio, Silvia; Valero Exposito, Marta; Sibilia, Jean; Chatelus, Emmanuel; Gottenberg, Jacques Eric; Chifflot, Helene; Litinsky, Ira; Emery, Paul; Buch, Maya; Del Galdo, Francesco; 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; Rosner, Itzhak; Rozenbaum, Michael; Slobodin, Gleb; Boulman, Nina; Rimar, Doron; Couto, Maura; Spertini, Francois; Ribi, Camillo; Buss, Guillaume; Kahl, Sarah; Hsu, Vivien M.; Chen, Fei; McCloskey, Deborah; Malveaux, Halina; Pasquali, Jean Louis; Martin, Thierry; Gorse, Audrey; Guffroy, Aurelien; Poindron, VincentObjective Systemic sclerosis (SSc) is a heterogeneous connective tissue disease that is typically subdivided into limited cutaneous SSc (lcSSc) and diffuse cutaneous SSc (dcSSc) depending on the extent of skin involvement. This subclassification may not capture the entire variability of clinical phenotypes. The European Scleroderma Trials and Research (EUSTAR) database includes data on a prospective cohort of SSc patients from 122 European referral centers. This study was undertaken to perform a cluster analysis of EUSTAR data to distinguish and characterize homogeneous phenotypes without any a priori assumptions, and to examine survival among the clusters obtained. Methods A total of 11,318 patients were registered in the EUSTAR database, and 6,927 were included in the study. Twenty-four clinical and serologic variables were used for clustering. Results Clustering analyses provided a first delineation of 2 clusters showing moderate stability. In an exploratory attempt, we further characterized 6 homogeneous groups that differed with regard to their clinical features, autoantibody profile, and mortality. Some groups resembled usual dcSSc or lcSSc prototypes, but others exhibited unique features, such as a majority of lcSSc patients with a high rate of visceral damage and antitopoisomerase antibodies. Prognosis varied among groups and the presence of organ damage markedly impacted survival regardless of cutaneous involvement. Conclusion Our findings suggest that restricting subsets of SSc patients to only those based on cutaneous involvement may not capture the complete heterogeneity of the disease. Organ damage and antibody profile should be taken into consideration when individuating homogeneous groups of patients with a distinct prognosis.Öğe Predictors of disease worsening defined by progression of organ damage in diffuse systemic sclerosis: a European Scleroderma Trials and Research (EUSTAR) analysis(Bmj Publishing Group, 2019) Becker, Mike; Graf, Nicole; Sauter, Rafael; Allanore, Yannick; Curram, John; Denton, Christopher P.; Khanna, Dinesh; Matucci-Cerinic, Marco; Pena, Janethe de Oliveira; Pope, Janet E.; Distler, Oliver; Matucci-Cerinic, Marco; Guiducci, Serena; Walker, Ulrich; Jaeger, Veronika; Bannert, Bettina; Lapadula, Giovanni; Becvarare, Radim; Cutolo, Maurizio; Valentini, Gabriele; Siegert, Elise; Rednic, Simona; Allanore, Yannick; Montecucco, C.; Carreira, Patricia E.; Novak, Srdan; Czirjak, Laszlo; Varju, Cecilia; Chizzolini, Carlo; Allai, Daniela; Kucharz, Eugene J.; Cozzi, Franco; Rozman, Blaz; Mallia, Carmel; Gabrielli, Armando; Bancel, Dominique Farge; Airo, Paolo; Hesselstrand, Roger; Martinovic, Duska; Balbir-Gurman, Alexandra; Braun-Moscovici, Yolanda; Hunzelmann, Nicolas; Pellerito, Raffaele; Caramaschi, Paola; Black, Carol; Damjanov, Nemanja; Henes, Joerg; Ortiz Santamaria, Vera; Heitmann, Stefan; Seidel, Matthias; Pereira Da Silva, Jose Antonio; Stamenkovic, Bojana; Selmi, Carlo Francesco; Tikly, Mohammed; Denisov, Lev N.; Mueller-Ladner, Ulf; Engelhart, Merete; Hachulla, Eric; Riccieri, Valeria; Ionescu, Ruxandra Maria; Mihai, Carina; Sunderkoetter, Cord; Kuhn, Annegret; Schett, Georg; Distler, Joerg; Meroni, Pierluigi; Ingegnoli, Francesca; Mouthon, Luc; De Keyser, Filip; Smith, Vanessa; Cantatore, Francesco Paolo; Corrado, Ada; Ullman, Susanne; Iversen, Line; Pozzi, Maria Rosa; Eyerich, Kilian; Hein, Ruediger; Knott, Elisabeth; Wiland, Piotr; Szmyrka-Kaczmarek, Magdalena; Sokolik, Renata; Morgiel, Ewa; Madej, Marta; Jose Alegre-Sancho, Juan; Krummel-Lorenz, Brigitte; Saar, Petra; Aringer, Martin; Guenther, Claudia; Anne, Erler; Westhovens, Rene; De langhe, Ellen; Lenaerts, Jan; Anic, Branimir; Baresic, Marko; Mayer, Miroslav; Uprus, Maria; Otsa, Kati; Yavuz, Sule; Radominski, Sebastiao Cezar; Mueller, Carolina de Souza; Azevedo, Valderilio Feijo; Popa, Sergei; Zenone, Thierry; Stebbings, Simon; Highton, John; Mathieu, Alessandro; Vacca, Alessandra; Stamp, Lisa; Chapman, Peter; O'Donnell, John; Solanki, Kamal; Doube, Alan; Veale, Douglas; O'Rourke, Marie; Loyo, Esthela; Li, Mengtao; Rosato, Edoardo; Amoroso, Antonio; Gigante, Antonietta; Oksel, Fahrettin; Yargucu, Figen; Tanaseanu, Cristina-Mihaela; Popescu, Monica; Dumitrascu, Alina; Tiglea, Isabela; Foti, Rosario; Visalli, Elisa; Benenati, Alessia; Amato, Giorgio; Ancuta, Codrina; Chirieac, Rodica; Villiger, Peter; Adler, Sabine; Dan, Diana; de la Pena Lefebvre, Paloma Garcia; Rodriguez Rubio, Silvia; Valero Exposito, Marta; Sibilia, Jean; Chatelus, Emmanuel; Gottenberg, Jacques Eric; Chifflot, Helene; Litinsky, Ira; Del Galdo, Francesco; Venalis, Algirdas; Saketkoo, Lesley Ann; Lasky, Joseph A.; Kerzberg, Eduardo; Montoya, Fabiana; Cosentino, Vanesa; Limonta, Massimiliano; Brucato, Antonio Luca; Lupi, Elide; Spertini, Francois; Ribi, Camillo; Buss, Guillaume; Martin, Thierry; Guffroy, Aurelien; Poindron, Vincent; Chung, Lori; Schmeiser, Tim; Zebryk, Pawel; Riso, Nuno; Riemekasten, Gabriela; Rezus, Elena; Puttini, Piercarlo SarziObjectives Mortality and worsening of organ function are desirable endpoints for clinical trials in systemic sclerosis (SSc). The aim of this study was to identify factors that allow enrichment of patients with these endpoints, in a population of patients from the European Scleroderma Trials and Research group database. Methods Inclusion criteria were diagnosis of diffuse SSc and follow-up over 12 +/- 3 months. Disease worsening/organ progression was fulfilled if any of the following events occurred: new renal crisis; decrease of lung or heart function; new echocardiography-suspected pulmonary hypertension or death. In total, 42 clinical parameters were chosen as predictors for the analysis by using (1) imputation of missing data on the basis of multivariate imputation and (2) least absolute shrinkage and selection operator regression. Results Of 1451 patients meeting the inclusion criteria, 706 had complete data on outcome parameters and were included in the analysis. Of the 42 outcome predictors, eight remained in the final regression model. There was substantial evidence for a strong association between disease progression and age, active digital ulcer (DU), lung fibrosis, muscle weakness and elevated C-reactive protein (CRP) level. Active DU, CRP elevation, lung fibrosis and muscle weakness were also associated with a significantly shorter time to disease progression. A bootstrap validation step with 10 000 repetitions successfully validated the model. Conclusions The use of the predictive factors presented here could enable cohort enrichment with patients at risk for overall disease worsening in SSc clinical trials.Öğe Progressive skin fibrosis is associated with a decline in lung function and worse survival in patients with diffuse cutaneous systemic sclerosis in the European Scleroderma Trials and Research (EUSTAR) cohort(Bmj Publishing Group, 2019) Wu, Wanlong; Jordan, Suzana; Graf, Nicole; Pena, Janethe de Oliveira; Curram, John; Allanore, Yannick; Matucci-Cerinic, Marco; Pope, Janet E.; Denton, Christopher P.; Khanna, Dinesh; Distler, Oliver; Matucci-Cerinic, Marco; Guiducci, Serena; Walker, Ulrich; Jaeger, Veronika; Bannert, Bettina; Lapadula, Giovanni; Becvarare, Radim; Cutolo, Maurizio; Valentini, Gabriele; Siegert, Elise; Rednic, Simona; Allanore, Yannick; Montecucco, C.; Carreira, Patricia E.; Novak, Srdan; Czirjak, Laszlo; Varju, Cecilia; Chizzolini, Carlo; Allai, Daniela; Kucharz, Eugene J.; Cozzi, Franco; Rozman, Blaz; Mallia, Carmel; Gabrielli, Armando; Bancel, Dominique Farge; Airo, Paolo; Hesselstrand, Roger; Martinovic, Duska; Balbir-Gurman, Alexandra; Braun-Moscovici, Yolanda; Hunzelmann, Nicolas; Pellerito, Raffaele; Caramaschi, Paola; Black, Carol; Damjanov, Nemanja; Henes, Joerg; Ortiz Santamaria, Vera; Heitmann, Stefan; Seidel, Matthias; Pereira Da Silva, Jose Antonio; Stamenkovic, Bojana; Selmi, Carlo Francesco; Tikly, Mohammed; Denisov, Lev N.; Mueller-Ladner, Ulf; Engelhart, Merete; Hachulla, Eric; Riccieri, Valeria; Ionescu, Ruxandra Maria; Mihai, Carina; Sunderkoetter, Cord; Kuhn, Annegret; Schett, Georg; Distler, Joerg; Meroni, Pierluigi; Ingegnoli, Francesca; Mouthon, Luc; De Keyser, Filip; Smith, Vanessa; Cantatore, Francesco Paolo; Corrado, Ada; Ullman, Susanne; Iversen, Line; Pozzi, Maria Rosa; Eyerich, Kilian; Hein, Ruediger; Knott, Elisabeth; Wiland, Piotr; Szmyrka-Kaczmarek, Magdalena; Sokolik, Renata; Morgiel, Ewa; Madej, Marta; Jose Alegre-Sancho, Juan; Krummel-Lorenz, Brigitte; Saar, Petra; Aringer, Martin; Guenther, Claudia; Anne, Erler; Westhovens, Rene; De Langhe, Ellen; Lenaerts, Jan; Anic, Branimir; Baresic, Marko; Mayer, Miroslav; Uprus, Maria; Otsa, Kati; Yavuz, Sule; Radominski, Sebastiao Cezar; Mueller, Carolina de Souza; Azevedo, Valderilio Feijo; Popa, Sergei; Zenone, Thierry; Stebbings, Simon; Highton, John; Mathieu, Alessandro; Vacca, Alessandra; Stamp, Lisa; Chapman, Peter; O'Donnell, John; Solanki, Kamal; Doube, Alan; Veale, Douglas; O'Rourke, Marie; Loyo, Esthela; Li, Mengtao; Rosato, Edoardo; Amoroso, Antonio; Gigante, Antonietta; Oksel, Fahrettin; Yargucu, Figen; Tanaseanu, Cristina-Mihaela; Popescu, Monica; Dumitrascu, Alina; Tiglea, Isabela; Foti, Rosario; Visalli, Elisa; Benenati, Alessia; Amato, Giorgio; Ancuta, Codrina; Chirieac, Rodica; Villiger, Peter; Adler, Sabine; Dan, Diana; de la Pena Lefebvre, Paloma Garcia; Rodriguez Rubio, Silvia; Valero Exposito, Marta; Sibilia, Jean; Chatelus, Emmanuel; Gottenberg, Jacques Eric; Chifflot, Helene; Litinsky, Ira; Del Galdo, Francesco; Venalis, Algirdas; Saketkoo, Lesley Ann; Lasky, Joseph A.; Kerzberg, Eduardo; Montoya, Fabiana; Cosentino, Vanesa; Limonta, Massimiliano; Brucato, Antonio Luca; Lupi, Elide; Spertini, Francois; Ribi, Camillo; Buss, Guillaume; Martin, Thierry; Guffroy, Aurelien; Poindron, Vincent; Chung, Lori; Schmeiser, Tim; Zebryk, Pawel; Riso, Nuno; Riemekasten, Gabriela; Rezus, Elena; Puttini, Piercarlo SarziObjectives To determine whether progressive skin fibrosis is associated with visceral organ progression and mortality during follow-up in patients with diffuse cutaneous systemic sclerosis (dcSSc). Methods We evaluated patients from the European Scleroderma Trials and Research database with dcSSc, baseline modified Rodnan skin score (mRSS) >= 7, valid mRSS at 12 +/- 3 months after baseline and >= 1 annual follow-up visit. Progressive skin fibrosis was defined as an increase in mRSS >5 and >= 25% from baseline to 12 +/- 3 months. Outcomes were pulmonary, cardiovascular and renal progression, and all-cause death. Associations between skin progression and outcomes were evaluated by Kaplan-Meier survival analysis and multivariable Cox regression. Results Of 1021 included patients, 78 (7.6%) had progressive skin fibrosis (skin progressors). Median follow-up was 3.4 years. Survival analyses indicated that skin progressors had a significantly higher probability of FVC decline >= 10% (53.6% vs 34.4%; p<0.001) and all-cause death (15.4% vs 7.3%; p=0.003) than non-progressors. These significant associations were also found in subgroup analyses of patients with either low baseline mRSS (<= 22/51) or short disease duration (<= 15 months). In multivariable analyses, skin progression within 1 year was independently associated with FVC decline >= 10% (HR 1.79, 95% CI 1.20 to 2.65) and all-cause death (HR 2.58, 95% CI 1.31 to 5.09). Conclusions Progressive skin fibrosis within 1 year is associated with decline in lung function and worse survival in dcSSc during follow-up. These results confirm mRSS as a surrogate marker in dcSSc, which will be helpful for cohort enrichment in future trials and risk stratification in clinical practice.
