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5. Sex-specific risk of anti-topoisomerase antibodies on mortality and disease severity in systemic sclerosis: 10-year analysis of the Leiden CCISS and EUSTAR cohorts

Author

Liem, S.I.E., Boonstra, M., Cessie, S. le, Riccardi, A., Airo, P., Distler, O., Matucci-Cerinic, M., Caimmi, C., Siegert, E., Allanore, Y., Huizinga, T.W.J., Toes, R.E.M., Scherer, H.U., Vries-Bouwstra, J.K. de, and EUSTAR Collaborators

Abstract

Background We aimed to evaluate sex-specific risk of anti-topoisomerase I antibodies (ATA) on mortality, diffuse cutaneous systemic sclerosis, interstitial lung disease, and pulmonary hypertension in two cohorts of people with systemic sclerosis.Methods This study was a 10-year analysis of the prospective Leiden Combined Care in Systemic Sderosis (CCISS) cohort in the Netherlands and the international European Scleroderma Trials and Research (EUSTAR) cohort. We included participants with systemic sderosis according to the 2013 American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) classification criteria; available autoantibody status; available skin subtyping; at least one available radiographic assessment of interstitial lung disease; and with a known date of disease onset. People with systemic sclerosis were categorised in six risk groups by sex and autoantibody status (anti-centromere antibody [ACA]-positive female, ACA-positive male, ACA and ATA-negative female, ACA and ATA-negative male, ATA-positive female, and ATA-positive male). We constructed Kaplan-Meier curves and Cox proportional hazard models, accounting for left-truncated survival to prevent bias because the date of disease onset (first non-Raynaud's symptom) preceded the date of cohort entry for all patients. The primary outcome was all-cause mortality and the secondary outcomes were diffuse cutaneous systemic sclerosis, interstitial lung disease, and pulmonary hypertension.Findings 445 (63%) of 708 participants between April 1,2009, and Jan 1,2022, in CCISS (101 [23%] male and 344[77%] female) and 4263 (50%) of 8590 between June 1, 2004, and March 28,2018, in EUSTAR (783[18%] male and 3480 [82%] female) were eligible for this study. In both cohorts, ATA expression occurred significantly more often in males than in females (39 [39%] of 101 males vs 67 [19%] of 344 females in CCISS; p

Published
2022

6. Association of anti-RNA polymerase III antibody with silicone breast implants rupture in a multicentre series of Italian patients with systemic sclerosis

Author

Lazzaroni, M. G., Campochiaro, C., Eugenia Bertoldo, Luca, G. D., Caimmi, C., Tincani, A., Franceschini, F., Airo, P., Lazzaroni, Maria Grazia, Campochiaro, Corrado, Bertoldo, Eugenia, De Luca, Giacomo, Caimmi, Cristian, Tincani, Angela, Franceschini, Franco, and Airò, Paolo

Subjects
Scleroderma, Systemic, Italy, Rheumatology, Breast Implants, Immunology, Silicones, Humans, RNA Polymerase III, Immunology and Allergy, Female, Autoantibodies, Retrospective Studies
Abstract

Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct subsets identified by specific autoantibodies. Some environmental agents might play a role in SSc pathogenesis, including silicone breast implants (SBI). This association has been controversial in previous literature and only few studies reported the auto-antibody status in these SSc women. The objective of this study was to evaluate the association of SBI with SSc in a large cohort of Italian patients, classified according to their SSc-related autoantibodies and to their history of breast cancer.Three Italian referral centres retrospectively collected clinical and laboratory data of consecutive SSc women, that were included when fulfilling the 2013 ACR/EULAR criteria and when SSc specific auto-antibodies status was available (anti-centromere (ACA), anti-Topoisomerase I (anti-Topo I) and anti-RNA Polymerase III antibodies (anti-RNAP3)). Data regarding history of SBI, SBI rupture and breast cancer were recorded.Among 742 SSc women, a history of SBI was recorded in 12 patients (1.6%); in only 1 case the implantation occurred after SSc diagnosis. In SSc patients with anti- RNAP3+ a significantly higher frequency of SBI rupture and SBI rupture without breast cancer were observed, as compared to anti-RNAP3-negative patients. No association was noted for SBI without rupture.In this study we demonstrated a link between SBI rupture and induction of anti-RNAP3+ SSc; further studies are needed to better define the characteristics of this syndrome and the possible effects of SBI removal and immunosuppressive treatment.

Published
2021
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8. Racial differences in systemic sclerosis disease presentation: A European Scleroderma Trials and Research group study

Author

Jaeger, Veronika K, Tikly, Mohammed, Dong, Xu, Siegert, Elise, Hachulla, Eric, Airò, Paolo, Valentini, Gabriele, Matucci Cerinic, Marco, Distler, Oliver, Cozzi, Franco, Carreira, Patricia, Allanore, Yannick, Müller-Ladner, Ulf, Ananieva, Lidia P, Balbir-Gurman, Alexandra, Distler, Jörg H W, Czirják, Laszlo, Mengtao, Li, Henes, Jörg, Jimenez, Sergio A, Smith, Vanessa, Damjanov, Nemanja, Denton, Christopher P, Delgaldo, Francesco, Saketkoo, Lesley Ann, Walker, Ulrich, A, Randone, Sb, Bannert, B, Iannone, F, Maurer, B, Jordan, S, Dobrota, R, Becker, M, Mihai, C, Becvarare, R, Tomčík, M, Bielecka, Ok, Gindzienska-Sieskiewicz, E, Karaszewska, K, Cutolo, M, Pizzorni, C, Paolino, S, Sulli, A, Ruaro, B, Alessandri, E, Riccardi, A, Giacco, V, Messitini, V, Irace, R, Kedor, C, Casteleyn, V, Hilger, J, Hoeppner, J, Rednic, S, Szabo, I, Petcu, A, Avouac, J, Camelia, F, Desbas, C, Vlachoyiannopoulos, P, Montecucco, C, Caporali, R, Cavagna, L, Stork, J, Inanc, M, Joven, Be, Novak, S, Anic, F, Varju, C, Minier, T, Chizzolini, C, Allai, D, Kucharz, Ej, Kotulska, A, Kopec-Medrek, M, Widuchowska, M, Dolnicar, As, Coleiro, B, Gabrielli, A, Manfredi, L, Benfaremo, D, Ferrarini, A, Bancel, Df, Hij, A, Lansiaux, P, Lazzaroni, Mg, Hesselstrand, R, Wuttge, D, Andréasson, R, Martinovic, D, Bozic, I, Radic, M, Braun-Moscovici, Y, Monaco, Al, Furini, F, Hunzelmann, N, Moinzadeh, P, Pellerito, R, Caimmi, C, Bertoldo, E, Morovic-Vergles, J, Culo, Im, Pecher, Ac, Santamaria, Vo, Heitmann, S, Codagnone, M, Pflugfelder, J, Krasowska, D, Michalska-Jakubus, M, Seidel, M, Hasler, P, Kretschmar, S, Kohm, M, Bajocchi, G, Salvador, Mj, Silva, Japd, Stamenkovic, B, Stankovic, A, Selmi, Cf, Santis, M, Ceribelli, A, Garzanova, L, Koneva, O, Starovoytova, M, Herrick, A, Puppo, F, Negrini, S, Murdaca, G, Engelhart, M, Szücs, G, Szamosi, S, de la Puente, C, Grande, Cs, Villanueva, Mjg, Midtvedt, Sø, Hoffmann-Vold, Am, Launay, D, Sobanski, V, Riccieri, V, Vasile, M, Ionescu, Rm, Opris, D, Sha, A, Woods, A, Gheorghiu, Am, Bojinca, M, Sunderkötter, C, Ehrchen, J, Ingegnoli, F, Mouthon, L, Dunogue, B, Chaigne, B, Legendre, P, Cantatore, Fp, Corrado, A, Ullman, S, Iversen, L, von Mühlen CA, Pozzi, Mr, Eyerich, K, Lauffer, F, Wiland, P, Szmyrka-Kaczmarek, M, Sokolik, R, Morgiel, E, Madej, M, Vanthuyne, M, Frédéric, H, Alegre-Sancho, Jj, Aringer, M, Herrmann, K, Günther, C, Westhovens, R, Langhe, E, Lenaerts, J, Anic, B, Baresic, M, Mayer, M, Üprus, M, Otsa, K, Yavuz, S, Granel, B, Radominski, Sc, De, C, Müller, S, Azevedo, Vf, Mendoza, F, Busquets, J, Popa, S, Agachi, S, Zenone, T, Pileckyte, M, Stebbings, S, Mathieu, A, Vacca, A, Sampaio-Barros, Pd, Stamp, L, Solanki, K, Silva, C, Schollum, J, Barns-Graham, H, Veale, D, O'Rourke, M, Loyo, E, Tineo, C, Paulino, G, Mohamed, Waaa, Rosato, E, Gigante, A, Oksel, F, Yargucu, F, Tanaseanu, Cm, Popescu, M, Dumitrascu, A, Tiglea, I, Foti, R, Visalli, E, Benenati, A, Amato, G, Ancuta, C, Villiger, P, Adler, S, Fröhlich, J, Kayser, C, Eduardo, Al, Fathi, N, Alii, S, Ahmed, M, Hasaneen, S, Hakeem, Ee, de la PG, Lefebvre, P, Martin, Jjg, Sibilia, J, Chatelus, E, Gottenberg, Je, Chifflot, H, Litinsky, I, Galdo, Fd, Abignano, G, Eng, S, Seskute, G, Butrimiene, I, Rugiene, R, Karpec, D, Pascal, M, Kerzberg, E, Bianchi, W, Bianchi, Bv, Bianchi, Dv, Barcellos, Y, Castellví, I, Millan, M, Limonta, M, Rimar, D, Rosner, I, Slobodin, G, Couto, M, Spertini, F, Ribi, C, Buss, G, Marcoccia, A, Bondanini, F, Ciani, A, Kahl, S, Hsu, Vm, Martin, T, Poindron, V, Meghit, K, Moiseev, S, Novikov, P, Chung, L, Kolstad, K, Stark, M, Schmeiser, T, Thiele, A, Majewski, D, Zdrojewski, Z, Zaneta, S, Wierzba, K, Martínez-Barrio, J, López-Longo, Fj, Bernardino, V, Moraes-Fontes, Mf, Rodrigues, Ac, Riemekasten, G, Sommerlatte, S, Jendreck, S, Arnold, S, Levy, Y, Rezus, E, Cardoneanu, A, Burlui, Am, Pamuk, On, Puttini, Ps, Talotta, R, Bongiovanni, S, Poormoghim, H, Andalib, E, Almasi, S, Kötter, I, Krusche, M, Cuomo, G, Danzo, F, Masini, F, Gaches, F, Michaud, M, Cartos, F, Belloli, L, Casu, C, Sfikakis, P, Tektonidou, M, Furst, D, Feldman, Gr, Ramazan, Am, Nurmambet, E, Miroto, A, Suta, C, Andronache, I, Huizinga, Twj, de Vries-Bouwstra, J., Chizzolini, Carlo, Jaeger, Veronika K, Tikly, Mohammed, Xu, Dong, Siegert, Elise, Hachulla, Eric, Airò, Paolo, Valentini, Gabriele, Matucci Cerinic, Marco, Distler, Oliver, Cozzi, Franco, Carreira, Patricia, Allanore, Yannick, Müller-Ladner, Ulf, Ananieva, Lidia P, Balbir-Gurman, Alexandra, Distler, Jörg H W, Czirják, Laszlo, Li, Mengtao, Henes, Jörg, Jimenez, Sergio A, Smith, Vanessa, Damjanov, Nemanja, Denton, Christopher P, Delgaldo, Francesco, Saketkoo, Lesley Ann, Walker, Ulrich A, University of Zurich, Cerinic, Marco Matucci, Walker Ulrich, A, Randone, Silvia Bellando, Bannert, Bettina, Iannone, Florenzoaa, Maurer, Brittaab, Jordan, Suzanaab, Dobrota, Rucsandraab, Becker, Mikeab, Mihai, Carinaa, Becvarare, Radima, Tomcik, Michala, Bielecka, Otylia Kowala, Gindzienska-Sieskiewicz, Ewaa, Karaszewska, Katarzynaa, Cutolo, Maurizioa, Pizzorni, Carmena, Paolino, Sabrinaae, Sulli, Albertoa, Ruaro, Barbara, Alessandri, Elisa, Riccardi, Antonella, Giacco, Veronica, Messitini, Valentina, Irace, Rosaria, Kedor, Claudia, Casteleyn, Vincent, Hilger, Julia, Hoeppner, Jakob, Rednic, Simona, Szabo, Iulia, Petcu, Ana, Avouac, Jérome, Camelia, Frantz, Desbas, Carole, Vlachoyiannopoulos, Panayioti, Montecucco, Carlo Maurizio, Caporali, Roberto, Cavagna, Lorenzo, Stork, Jiri, Inanc, Murat, Joven, Beatriz E., Novak, Srdan, Anic, Felina, Varju, Cecilia, Minier, Tunde, Allai, Daniela, Kucharz, Eugene J., Kotulska, Anna, Kopec-Medrek, Magdalena, Widuchowska, Malgorzata, Dolnicar, Alenka Sipek, Coleiro, Bernard, Gabrielli, Armando, Manfredi, Lucia, Benfaremo, Devi, Ferrarini, Alessia, Bancel, Dominique Farge, Hij, Adrian, Lazzaroni, Maria Grazia, Hesselstrand, Roger, Wuttge, Dirk, Andréasson, Kristofer, Martinovic, Duska, Bozic, Ivona, Radic, Mislav, Braun-Moscovici, Yolanda, Monaco, Andrea Lo, Furini, Federica, Hunzelmann, Nicola, Moinzadeh, Pia, Pellerito, Raffaele, Caimmi, Cristian, Bertoldo, Eugenia, Morovic-Vergles, Jadranka, Culo, Ivana Melanie, Pecher, Ann-Christian, Santamaria, Vera Ortiz, Heitmann, Stefan, Codagnone, Medeleine, Pflugfelder, Johanne, Krasowska, Dorota, Michalska-Jakubus, Malgorzata, Seidel, Matthia, Hasler, Paul, Kretschmar, Samuel, Kohm, Michaela, Bajocchi, Gianluigi, Salvador, Maria João, Da Silva, JoséAntonio Pereira, Stamenkovic, Bojana, Stankovic, Aleksandra, Selmi, Carlo Francesco, De Santis, Maria, Ceribelli, Angela, Garzanova, Ludmila, Koneva, Olga, Starovoytova, Maya, Herrick, Ariane, Puppo, Francesco, Negrini, Simone, Murdaca, Giuseppe, Engelhart, Merete, Szücs, Gabriela, Szamosi, Szilvia, De La Puente, Carlo, Grande, Cristina Sobrino, Villanueva, Maria Jesus Garcia, Midtve, Øyvindbw, Hoffmann-Vold, Anna-Mariabw, Launay, Davidbx, Sobanski, Vincentbx, Riccieri, Valeriaby, Vasile, Massimilianoby, Stefantoni, Katia, Ionescu, Ruxandra Maria, Opris, Daniela, Sha, Ami, Woods, Adrianne, Gheorghiu, Ana Maria, Bojinca, Mihai, Sunderkötter, Cord, Ehrchen, Jan, Ingegnoli, Francesca, Mouthon, Luc, Dunogue, Bertrand, Chaigne, Benjamin, Legendre, Paul, Cantatore, Francesco Paolo, Corrado, Ada, Ullman, Susanne, Iversen, Line, Von Mühlen, Carlos Alberto, Pozzi, Maria Rosa, Eyerich, Kilian, Lauffer, Felix, Wiland, Piotr, Szmyrka-Kaczmarek, Magdalena, Sokolik, Renata, Morgiel, Ewa, Madej, Marta, Vanthuyne, Marie, Frédéric, Houssiau, Alegre-Sancho, Juan Jose, Aringer, Martin, Herrmann, Kristine, Günther, Claudia, Westhovens, Rene, De Langhe, Ellen, Lenaerts, Jan, Anic, Branimir, Baresic, Marko, Mayer, Miroslav, Üprus, Maria, Otsa, Kati, Yavuz, Sule, Granel, Brigitte, Radominski, Sebastião Cezar, De Souza Müller, Carolina, Feijóazevedo, Valderílio, Mendoza, Fabian, Busquets, Joanna, Popa, Sergei, Agachi, Svetlana, Zenone, Thierry, Pileckyte, Margarita, Stebbings, Simon, Jordan, Sarah, Mathieu, Alessandro, Vacca, Alessandra, Sampaio-Barros, Percival D., Stamp, Lisa, Solanki, Kamal, Silva, Cherumi, Schollum, Joanne, Barns-Graham, Helen, Veale, Dougla, O'Rourke, Marie, Loyo, Esthela, Tineo, Carmen, Paulino, Glenny, Mohamed, Walid Ahmed Abdel Atty, Rosato, Edoardo, 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, Villiger, Peter, Adler, Sabine, Fröhlich, Johanne, Kayser, Cristiane, Eduardo, Andrade Lui, Fathi, Nihal, Alii, Safa, Ahmed, Marrow, Hasaneen, Samar, El Hakeem, Eman, De La Peña Lefebvre, Paloma García, Martin, Jorge Juan Gonzalez, Sibilia, Jean, Chatelus, Emmanuel, Gottenberg, Jacques Eric, Chifflot, Hélène, Litinsky, Ira, Del Galdo, Francesco, Abignano, Giuseppina, Eng, Sookho, Seskute, Goda, Butrimiene, Irena, Rugiene, Rita, Karpec, Diana, Pascal, Melanie, Kerzberg, Eduardo, Bianchi, Washington, Bianchi, Breno Valdetaro, Bianchi, Dante Valdetaro, Barcellos, Yeda, Castellví, Ivan, Millan, Milena, Limonta, Massimiliano, Rimar, Doron, Rosner, Itzhak, Slobodin, Gleb, Couto, Maura, Spertini, Françoi, Ribi, Camillo, Buss, Guillaume, Marcoccia, Antonella, Bondanini, Francesco, Ciani, Aldo, Kahl, Sarah, Hsu, Vivien M., Martin, Thierry, Poindron, Vincent, Meghit, Kilifa, Moiseev, Sergey, Novikov, Pavel, Chung, Lori, Kolstad, Kathleen, Stark, Marianna, Schmeiser, Tim, Thiele, Astrid, Majewski, Dominik, Zdrojewski, Zbigniew, Zaneta, Smolenska, Wierzba, Karol, Martínez-Barrio, Julia, López-Longo, Francisco Javier, Bernardino, Vera, Moraes-Fontes, Maria Francisca, Rodrigues, Ana Catarina, Riemekasten, Gabriela, Sommerlatte, Sabine, Jendreck, Sebastian, Arnold, Sabrina, Levy, Yair, Rezus, Elena, Cardoneanu, Anca, Burlui, Alexandra Maria, Pamuk, Omer Nuri, Puttini, Piercarlo Sarzi, Talotta, Rossella, Bongiovanni, Sara, Poormoghim, Hadi, Andalib, Elham, Almasi, Simin, Kötter, Ina, Krusche, Matrin, Cuomo, Giovanna, Danzo, Fiammetta, Masini, Francesco, Gaches, Franci, Michaud, Martin, Cartos, Florian, Belloli, Laura, Casu, Cinzia, Sfikakis, Petro, Tektonidou, Maria, Furst, Daniel, Feldman, Gary R., Ramazan, Ana-Maria, Nurmambet, Emel, Miroto, Amalia, Suta, Cristina, Andronache, Iulia, Huizinga, Tom W. J., De Vries-Bouwstra, Jeska, and Walker, Ulrich A.

Subjects
Male, Vital capacity, Organ manifestations, systemic sclerosis, Type I, race difference, Systemic scleroderma, Gastroenterology, Scleroderma, immunology, 0302 clinical medicine, Diffusing capacity, middle aged, pulmonary hypertension, Medicine, Pharmacology (medical), 030212 general & internal medicine, organ manifestations, races, skin and connective tissue diseases, Lung, race, pathophysiology, African Continental Ancestry Group, ddc:616, integumentary system, disease course, Hazard ratio, Races, 10051 Rheumatology Clinic and Institute of Physical Medicine, Pulmonary, Middle Aged, Blacks, cohort analysis, Autoantibodie, 3. Good health, Asians, female, priority journal, DNA Topoisomerases, Type I, Black, centromere, Cohort, Hypertension, organ manifestation, Systemic sclerosis, Female, systemic sclerosi, Human, Adult, Asian Continental Ancestry Group, medicine.medical_specialty, Hypertension, Pulmonary, European Continental Ancestry Group, Black People, 610 Medicine & health, complication, Caucasian, White People, Article, lung, 03 medical and health sciences, Black person, Rheumatology, Asian People, forced vital capacity, Internal medicine, geographic distribution, Humans, controlled study, human, DNA topoisomerase, Aged, Autoantibodies, 030203 arthritis & rheumatology, Scleroderma, Systemic, Asian, business.industry, Whites, Systemic, Odds ratio, medicine.disease, Pulmonary hypertension, major clinical study, mortality, clinical feature, business, DNA Topoisomerases, autoantibody
Abstract

Objectives Racial factors play a significant role in SSc. We evaluated differences in SSc presentations between white patients (WP), Asian patients (AP) and black patients (BP) and analysed the effects of geographical locations. Methods SSc characteristics of patients from the EUSTAR cohort were cross-sectionally compared across racial groups using survival and multiple logistic regression analyses. Results The study included 9162 WP, 341 AP and 181 BP. AP developed the first non-RP feature faster than WP but slower than BP. AP were less frequently anti-centromere (ACA; odds ratio (OR) = 0.4, P < 0.001) and more frequently anti-topoisomerase-I autoantibodies (ATA) positive (OR = 1.2, P = 0.068), while BP were less likely to be ACA and ATA positive than were WP [OR(ACA) = 0.3, P < 0.001; OR(ATA) = 0.5, P = 0.020]. AP had less often (OR = 0.7, P = 0.06) and BP more often (OR = 2.7, P < 0.001) diffuse skin involvement than had WP. AP and BP were more likely to have pulmonary hypertension [OR(AP) = 2.6, P < 0.001; OR(BP) = 2.7, P = 0.03 vs WP] and a reduced forced vital capacity [OR(AP) = 2.5, P < 0.001; OR(BP) = 2.4, P < 0.004] than were WP. AP more often had an impaired diffusing capacity of the lung than had BP and WP [OR(AP vs BP) = 1.9, P = 0.038; OR(AP vs WP) = 2.4, P < 0.001]. After RP onset, AP and BP had a higher hazard to die than had WP [hazard ratio (HR) (AP) = 1.6, P = 0.011; HR(BP) = 2.1, P < 0.001]. Conclusion Compared with WP, and mostly independent of geographical location, AP have a faster and earlier disease onset with high prevalences of ATA, pulmonary hypertension and forced vital capacity impairment and higher mortality. BP had the fastest disease onset, a high prevalence of diffuse skin involvement and nominally the highest mortality.

Published
2020

9. Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study

Author

Elhai, M, Boubaya, M, Distler, O, Smith, V, Matucci-Cerinic, M, Sancho, JJ, Truchetet, ME, Braun-Moscovici, Y, Iannone, F, Novikov, PI, Lescoat, A, Siegert, E, Castellvi, I, Airo, P, Vettori, S, Langhe, E, Hachulla, E, Erler, A, Ananieva, L, Krusche, M, Lopez-Longo, FJ, Distler, JHW, Hunzelmann, N, Hoffmann-Vold, AM, Riccieri, V, Hsu, VM, Pozzi, MR, Ancuta, C, Rosato, E, Mihai, C, Kuwana, M, Saketkoo, LA, Chizzolini, C, Hesselstrand, R, Ullman, S, Yavuz, S, Rednic, S, Caimmi, C, Bloch-Queyrat, C, Allanore, Y, Guiducci, S, Walker, UA, Kyburz, D, Lapadula, G, Maurer, B, Jordan, S, Dobrota, R, Becvar, R, Sierakowsky, S, Bielecka, OK, Sulli, A, Cutolo, M, Cuomo, G, Nicoara, I, Kahan, A, Vlachoyiannopoulos, PG, Montecucco, CM, Caporali, R, Stork, J, Inanc, M, Carreira, PE, Novak, S, Czirjak, L, Varju, C, Kucharz, EJ, Kotulska, A, Kopec-Medrek, M, Widuchowska, M, Cozzi, F, Rozman, B, Mallia, C, Coleiro, B, Gabrielli, A, Farge, D, Wu, C, Marjanovic, Z, Faivre, H, Hij, D, Dhamadi, R, Wollheim, F, Scheja, A, Wuttge, DM, Andreasson, K, Martinovic, D, Balbir-Gurman, A, Trotta, F, Lo Monaco, A, Pellerito, R, Mauriziano, O, Caramaschi, P, Morovic-Vergles, J, Black, C, Denton, C, Damjanov, N, Henes, J, Santamaria, VO, Heitmann, S, Krasowska, D, Matthias, Hasler, P, Burkhardt, H, Himsel, A, Bajocchi, G, Da Silva, JAP, Salvador, MJ, Stamenkovic, B, Stankovic, A, Selmi, CF, De Santis, M, Tikly, M, Denisov, LN, Herrick, A, Muller-Ladner, U, Frerix, M, Tarner, I, Scorza, R, Puppo, F, Engelhart, M, Strauss, G, Nielsen, H, Damgaard, K, Szucs, G, Mendoza, AZ, de la Puente, C, Giraldo, WAS, Midtvedt, O, Reiseter, S, Garen, T, Launay, D, Valesini, G, Ionescu, RM, Groseanu, L, Opris, D, Cornateanu, RS, Ionitescu, R, Gherghe, AM, Soare, A, Gorga, M, Bojinca, M, Milicescu, M, Sunderkotter, C, Kuhn, A, Sandorfi, N, Schett, G, Beyer, C, Meroni, P, Ingegnoli, F, Mouthon, L, De Keyser, F, Melsens, K, Cantatore, FP, Corrado, A, Iversen, L, von Muhlen, CA, Bohn, JM, Lonzetti, LS, Eyerich, K, Hein, R, Knott, E, Wiland, P, Szmyrka-Kaczmarek, M, Sokolik, R, Morgiel, E, Madej, M, Houssiau, FA, Krummel-Lorenz, B, Saar, P, Aringer, M, Gunther, C, Westhovens, R, Lenaerts, J, Anic, B, Baresic, M, Mayer, M, Uprus, M, Otsa, K, Granel, B, Muller, CD, Radominski, SC, Azevedo, VF, Jimenez, S, Busquets, J, Agachi, S, Groppa, L, Chiaburu, L, Russu, E, Popa, S, Zenone, T, Pileckyte, M, Mathieu, A, Vacca, A, Sampaio-Barros, PD, Yoshinari, NH, Marangoni, RG, Martin, P, Fuocco, L, Stebbings, S, Highton, J, Chapman, P, O'Donnell, J, Stamp, L, Doube, A, Solanki, K, Veale, D, O'Rourke, M, Loyo, E, Li, MT, Mohamed, WAAA, Amoroso, A, Gigante, A, Oksel, F, Yargucu, F, Tanaseanu, CM, Popescu, M, Dumitrascu, A, Tiglea, I, Foti, R, Chirieac, R, Furst, D, Villiger, P, Adler, S, van Laar, J, Kayser, C, Fathi, N, Hassanien, M, Lefebvre, PGD, Rubio, SR, Exposito, MV, Chatelus, E, Sibilia, J, Gottenberg, JE, Chifflot, H, Litinsky, I, Emery, P, Buch, M, Del Galdo, F, Venalis, A, Butrimiene, I, Venalis, P, Rugiene, R, Karpec, D, Lasky, JA, Cosentino, V, Kerzberg, E, Montoya, F, Bianchi, W, Carneiro, S, Maretti, GB, Bianchi, DV, Limonta, M, Lupi, ALBE, Lupi, E, Rosner, I, Rozenbaum, M, Slobodin, G, Boulman, N, Rimar, D, Couto, M, Kahl, S, Chen, F, McCloskey, D, Malveaux, H, Spertini, F, Ribi, C, Buss, G, Martin, T, Guffroy, A, Poindron, V, Chotchaeva, F, Mukhin, NA, Moiseev, S, EUSTAR Network, Elhai, Muriel, Boubaya, Marouane, Distler, Oliver, Smith, Vanessa, Matucci-Cerinic, Marco, Alegre Sancho, Juan José, Truchetet, Marie-Elise, Braun-Moscovici, Yolanda, Iannone, Florenzo, Novikov, Pavel I, Lescoat, Alain, Siegert, Elise, Castellví, Ivan, Airó, Paolo, Vettori, Serena, De Langhe, Ellen, Hachulla, Eric, Erler, Anne, Ananieva, Lidia, Krusche, Martin, López-Longo, F. J., Distler, Jörg H W, Hunzelmann, Nicola, Hoffmann-Vold, Anna-Maria, Riccieri, Valeria, Hsu, Vivien M, Pozzi, Maria R, Ancuta, Codrina, Rosato, Edoardo, Mihai, Carina, Kuwana, Masataka, Saketkoo, Lesley Ann, Chizzolini, Carlo, Hesselstrand, Roger, Ullman, Susanne, Yavuz, Sule, Rednic, Simona, Caimmi, Cristian, Bloch-Queyrat, Coralie, Allanore, Yannick, and Cuomo, Giovanna

Subjects
Male, Vital capacity, systemic sclerosis, Pulmonary Fibrosis, Vital Capacity, Scleroderma, lung fibrosis, rituximab, skin fibrosis, immune system diseases, DLCO, hemic and lymphatic diseases, Immunology and Allergy, Medicine, Prospective Studies, Registries, skin and connective tissue diseases, Prospective cohort study, Lung, skin fibrosi, Skin, ddc:616, integumentary system, Orvostudományok, Middle Aged, Respiratory Function Tests, lung fibrosis, rituximab, skin fibrosis, systemic sclerosis, Treatment Outcome, lung fibrosi, Antirheumatic Agents, Systemic sclerosis, Rituximab, Female, systemic sclerosi, medicine.drug, Adult, medicine.medical_specialty, Immunology, Klinikai orvostudományok, General Biochemistry, Genetics and Molecular Biology, FEV1/FVC ratio, Rheumatology, Internal medicine, Humans, Adverse effect, Propensity Score, Aged, Biochemistry, Genetics and Molecular Biology (all), Scleroderma, Systemic, Skin fibrosis, business.industry, medicine.disease, Fibrosis, Lung fibrosis, business
Abstract

ObjectiveTo assess the safety and efficacy of rituximab in systemic sclerosis (SSc) in clinical practice.MethodsWe performed a prospective study including patients with SSc from the European Scleroderma Trials and Research (EUSTAR) network treated with rituximab and matched with untreated patients with SSc. The main outcomes measures were adverse events, skin fibrosis improvement, lung fibrosis worsening and steroids use among propensity score-matched patients treated or not with rituximab.Results254 patients were treated with rituximab, in 58% for lung and in 32% for skin involvement. After a median follow-up of 2 years, about 70% of the patients had no side effect. Comparison of treated patients with 9575 propensity-score matched patients showed that patients treated with rituximab were more likely to have skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; OR: 2.79 [1.47–5.32]; p=0.002). Treated patients did not have significantly different rates of decrease in forced vital capacity (FVC)>10% (OR: 1.03 [0.55–1.94]; p=0.93) nor in carbon monoxide diffusing capacity (DLCO) decrease. Patients having received rituximab were more prone to stop or decrease steroids (OR: 2.34 [1.56–3.53], pConclusionRituximab use was associated with a good safety profile in this large SSc-cohort. Significant change was observed on skin fibrosis, but not on lung. However, the limitation is the observational design. The potential stabilisation of lung fibrosis by rituximab has to be addressed by a randomised trial.

Published
2019

10. Smoking in Systemic Sclerosis: A Longitudinal European Scleroderma Trials and Research Group Study

Author

Jaeger, VK, Valentini, G, Hachulla, E, Cozzi, F, Distler, O, Airó, P, Czirják, L, Allanore, Y, Siegert, E, Rosato, E, Matucci-Cerinic, M, Caimmi, C, Henes, J, Carreira, PE, Smith, V, del Galdo, F, Denton, CP, Ullman, S, Langhe, ED, Riccieri, V, Alegre-Sancho, JJ, Rednic, S, Müller-Ladner, U, Walker, UA, and EUSTAR coauthors

Subjects
smoking, systemic sclerosis, scleroderma, respiratory tract diseases
Abstract

OBJECTIVE: Data on the role of tobacco exposure in systemic sclerosis (SSc ; scleroderma) severity and progression are scarce. We aimed to assess the effects of smoking on the evolution of pulmonary and skin manifestations, based on the European Scleroderma Trials and Research group database. METHODS: Adult SSc patients with data on smoking history and a 12-24-month follow-up visit were included. Associations of severity and progression of organ involvement with smoking history and the Comprehensive Smoking Index were assessed using multivariable regression analyses. RESULTS: A total of 3, 319 patients were included (mean age 57 years, 85% female) ; 66% were never smokers, 23% were ex-smokers, and 11% were current smokers. Current smokers had a lower percentage of antitopoisomerase autoantibodies than previous or never smokers (31% versus 40% and 45%, respectively). Never smokers had a higher baseline forced expiratory volume in 1 second/forced vital capacity (FEV1 /FVC) ratio than previous and current smokers (P < 0.001). The FEV1 /FVC ratio declined faster in current smokers than in never smokers (P = 0.05) or ex-smokers (P = 0.01). The baseline modified Rodnan skin thickness score (MRSS) and the MRSS decline were comparable across smoking groups. Although heavy smoking (>25 pack- years) increased the odds of digital ulcers by almost 50%, there was no robust adverse association of smoking with digital ulcer development. CONCLUSION: The known adverse effect of smoking on bronchial airways and alveoli is also observed in SSc patients ; however, robust adverse effects of smoking on the progression of SSc-specific pulmonary or cutaneous manifestations were not observed.

Published
2018

13. AB0397 Prevalence and factors associated with depression among patients affected by chronic inflammatory arthritis: preliminary results of a single-centre experience in italy

Author

Pezzato, S., primary, Tomassi, S., additional, Fracassi, E., additional, Giollo, A., additional, Caimmi, C., additional, Martinis, F., additional, Gnatta, M.G., additional, Cristofalo, D., additional, Bonetto, C., additional, Marognolli, M.L., additional, Tosato, S., additional, and Carletto, A., additional

Published
2018
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16. High rate of disease remission in moderate rheumatoid arthritis on etanercept therapy: data from GISEA, the Italian biologics register

Author

Iannone, F, Gremese, E, Gallo, G, Sarzi Puttini, P, Botsios, C, Trotta, F, Gasperini, S, Galeazzi, Mauro, Adami, S, Cantini, F, Sebastiani, M, Gorla, R, Marchesoni, A, Giardina, A, Foti, R, Mele, A, Bruschi, E, Bagnato, G, Erre, G. L., Lapadula, G, Scioscia, C, Fedele, A. L., Ferraccioli, G, Atzeni, F, Bongiovanni, S, Punzi, L, Bernardi, L, Bagnari, V, Govoni, M, Grassi, W, Salaffi, F, Manganelli, S, Frati, Elena, Carletto, A, Caimmi, C, Palloni, A, Niccoli, L, Ferri, C, Favalli, E. G., Triolo, G, and Di Gangi, M.

Subjects
rheumatoid arthritis, Male, Settore MED/16 - REUMATOLOGIA, Disease, Severity of Illness Index, Receptors, Tumor Necrosis Factor, Etanercept, Arthritis, Rheumatoid, Disease remission, Surveys and Questionnaires, Prospective Studies, Registries, Young adult, skin and connective tissue diseases, Prospective cohort study, GISEA, TNF-α inhibitors, Aged, 80 and over, Remission Induction, General Medicine, Middle Aged, rheumatoid artritis, Treatment Outcome, Italy, Antirheumatic Agents, Rheumatoid arthritis, Drug Therapy, Combination, Female, medicine.drug, Adult, musculoskeletal diseases, medicine.medical_specialty, Adolescent, Young Adult, remission, Rheumatology, Internal medicine, Severity of illness, medicine, Humans, DAS28, Glucocorticoids, Aged, Biological Products, Tumor Necrosis Factor-alpha, business.industry, HAQ, medicine.disease, Surgery, Methotrexate, Immunoglobulin G, business, etanercept
Abstract

The aim of this study was to evaluate the clinical outcomes of etanercept in rheumatoid arthritis (RA) patients with moderate or severe disease activity. We analyzed data from the Italian biologics register Gruppo Italiano Studio Early Arthritides (GISEA) to investigate the rate of disease remission and functional improvement, based on the 28-Joint Disease Activity Score (DAS28) and the (Health Assessment Questionnaire (HAQ) score in RA patients with moderate or severe disease activity beginning etanercept therapy. Disease was defined as severe (H-RA) with DAS28 ≥5.1 and moderate (M-RA) with DAS28 ≥3.2 to 5.1 at baseline. Patients were considered in remission if DAS28 was ≤2.6, and HAQ ≤0.5 defined normal function. We enrolled 953 RA patients, 320 with M-RA and 633 H-RA. Age and disease duration were similar in the two cohorts, but H-RA patients had significantly more comorbidities (p < 0.01) and took significantly more disease-modifying antirheumatic drugs (p < 0.001) than M-RA patients. After 1 year, the percentage of patients achieving disease remission and normal function (DAS28 ≤2.6 plus HAQ ≤0.5) was higher in M-RA (21.4 %) than in H-RA patients (14.8 %, p = 0.007), regardless of the disease duration. Additionally, female gender (p = 0.006) and H-RA class (p = 0.002) negatively predicted disease remission at 1 year. However, the drug survival rate did not differ between the two subsets. This study confirms that etanercept was effective in the treatment of active RA, but best response, in terms of disease remission and normal function ability, was greater and easier to attain in M-RA patients. These findings may aid clinicians to choose the best strategy to treat RA.

Published
2013
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21. Bone metabolism in patients with anorexia nervosa and amenorrhoea

Author

Idolazzi, L., primary, El Ghoch, M., additional, Dalle Grave, R., additional, Bazzani, P. V., additional, Calugi, S., additional, Fassio, S., additional, Caimmi, C., additional, Viapiana, O., additional, Bertoldo, F., additional, Braga, V., additional, Rossini, M., additional, and Gatti, D., additional

Published
2016
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24. FRI0214 Six-Year Retention Rate of Abatacept in Rheumatoid Arthritis: A Multicentric Retrospective Analysis

Author

Favalli, E.G., primary, Botsios, C., additional, Bazzani, C., additional, Raffainer, B., additional, Ciancio, G., additional, Giollo, A., additional, Marchesoni, A., additional, Gorla, R., additional, Caimmi, C., additional, Becciolini, A., additional, Crotti, C., additional, Piantoni, S., additional, Biggioggero, M., additional, and Carletto, A., additional

Published
2016
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25. Endoscopic Treatment for Nonhypertrophic Idiopathic Pyloric Stenosis in an Adolescent Patient

Author

Ferlini Ferlini, De Lorenzi De Lorenzi, Belgiovine Belgiovine, Cereda Cereda, Caimmi Caimmi, and Raffaele Raffaele

Subjects
nonhypertrophic, idiopathic, pyloric, stenosis, endoscopic, dilation, multidisciplinary approach, Pediatrics, RJ1-570, Surgery, RD1-811
Abstract

Nonhypertrophic idiopathic pyloric stenosis (NHIPS) is a rare occurrence in children. It could be related to peptic ulcers, but a definitive cause is yet to be found. Treatment is a matter of debate, ranging from medical to surgical. We report the case of a 15-year-old boy suffering postprandial vomiting and weight loss in the previous 3 months. NHIPS was diagnosed and successfully treated with several sessions of endoscopic pyloric dilation and jejunal feeding. In association with a multidisciplinary approach, endoscopic dilation should be considered as a first-line treatment to avoid surgery.

Published
2023
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30. Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients: results from the GISEA register

Author

Sebastiani, M, Anelli, Mg, Atzeni, F, Bazzani, C, Farina, I, Fedele, Anna Laura, Favalli, Eg, Fineschi, I, Cino, N, Dal Forno, I, Gasparini, S, Cassarà, E, Giardina, R, Bruschi, E, Addimanda, O, Cassone, G, Lopriore, S, Sarzi Puttini, P, Filippini, M, Pignatti, F, Gremese, Elisa, Biggioggero, M, Manganelli, S, Amato, G, Caimmi, C, Salaffi, F, Iannone, F, Ferri, C, Sandri, G, Lapadula, G, Gorla, R, Govoni, M, Ferraccioli, Gianfranco, Marchesoni, A, Galeazzi, M, Foti, R, Carletto, A, Cantini, F, Triolo, G, Epis, Om, Salvarani, C., Gremese, Elisa (ORCID:0000-0002-2248-1058), Ferraccioli, Gianfranco (ORCID:0000-0001-6246-2428), Sebastiani, M, Anelli, Mg, Atzeni, F, Bazzani, C, Farina, I, Fedele, Anna Laura, Favalli, Eg, Fineschi, I, Cino, N, Dal Forno, I, Gasparini, S, Cassarà, E, Giardina, R, Bruschi, E, Addimanda, O, Cassone, G, Lopriore, S, Sarzi Puttini, P, Filippini, M, Pignatti, F, Gremese, Elisa, Biggioggero, M, Manganelli, S, Amato, G, Caimmi, C, Salaffi, F, Iannone, F, Ferri, C, Sandri, G, Lapadula, G, Gorla, R, Govoni, M, Ferraccioli, Gianfranco, Marchesoni, A, Galeazzi, M, Foti, R, Carletto, A, Cantini, F, Triolo, G, Epis, Om, Salvarani, C., Gremese, Elisa (ORCID:0000-0002-2248-1058), and Ferraccioli, Gianfranco (ORCID:0000-0001-6246-2428)

Abstract

Rituximab (RTX) is a monoclonal anti-CD20 antibody approved for the treatment of rheumatoid arthritis (RA) in association with methotrexate (MTX).

Published
2014

31. Vitamin D and rheumatic diseases

Author

Rossini, M., primary, Gatti, D., additional, Viapiana, O., additional, Caimmi, C., additional, Idolazzi, L., additional, Fracassi, E., additional, and Adami, S., additional

Published
2014
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32. FRI0117 Analysis of risk for cardiovascular events and assessment of diagnostic and therapeutic management of patients with rheumatoid arthritis in clinical practice: the epidauro registry.

Author

Viapiana, O., primary, Faden, G., additional, Fischetti, F., additional, Cioffi, G., additional, Rossini, M., additional, Caimmi, C., additional, Faggiano, P., additional, Gatti, D., additional, Faganello, G., additional, Di Lenarda, A., additional, Filippini, M., additional, Adami, S., additional, and Tincani, A., additional

Published
2013
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42. Overall mortality in combined pulmonary fibrosis and emphysema related to systemic sclerosis

Author

Vanessa Hax, Carlo Alberto Scirè, Eugenio Arrigoni, Enrico Fusaro, Giuseppe Paolazzi, Flavio Cesare Bodini, G. Lucchini, Daniele Santilli, Alessandro Volpe, Mario Silva, Alarico Ariani, Rafael Mendonça da Silva Chakr, Markus Bredemeier, Giuseppina Bertorelli, M. Saracco, E. Bravi, Emanuele Michieletti, Fabio De Gennaro, Emanuele Bacchini, Valeria Seletti, Maria De Santis, F. Girelli, F. Mozzani, Luca Idolazzi, D. Imberti, Veronica Alfieri, Federica Lumetti, Alfredo Chetta, Dilia Giuggioli, Cristian Caimmi, Simone Parisi, Nicola Sverzellati, Ariani, A, Silva, M, Bravi, E, Parisi, S, Saracco, M, De Gennaro, F, Caimmi, C, Girelli, F, De Santis, M, Volpe, A, Lumetti, F, Hax, V, Bredemeier, M, Alfieri, V, Santilli, D, Bodini, F, Lucchini, G, Mozzani, F, Seletti, V, Bacchini, E, Arrigoni, E, Giuggioli, D, Chakr, R, Idolazzi, L, Bertorelli, G, Imberti, D, Michieletti, E, Paolazzi, G, Fusaro, E, Chetta, A, Scire, C, and Sverzellati, N

Subjects
Male, pulmonary fibrosi, systemic sclerosis, Kaplan-Meier Estimate, Gastroenterology, Scleroderma, Pulmonary function testing, 0302 clinical medicine, Pulmonary fibrosis, Prevalence, Immunology and Allergy, combined pulmonary fibrosis and emphysema, pulmonary fibrosis, semiquantitative chest CT, systemic sclerosis, skin and connective tissue diseases, Tomography, Lung function, combined pulmonary fibrosis and emphysema, pulmonary fibrosis, semiquantitative chest CT, Aged, Biomarkers, Female, Humans, Middle Aged, Prognosis, Pulmonary Emphysema, Pulmonary Fibrosis, Scleroderma, Systemic, Tomography, X-Ray Computed, Anticentromere antibodies, Enfisema pulmonar, integumentary system, respiratory system, Combined pulmonary fibrosis and emphysema, X-Ray Computed, medicine.anatomical_structure, Mortalidade, systemic sclerosi, Fibrose pulmonar idiopática, medicine.medical_specialty, Declaração de Helsinki, Estimativa de Kaplan-Meier, Immunology, Método, NO, 03 medical and health sciences, Rheumatology, Internal medicine, medicine, In patient, 030203 arthritis & rheumatology, Lung, business.industry, Systemic, Escleroderma sistêmico, medicine.disease, respiratory tract diseases, 030228 respiratory system, business
Abstract

ObjectivesThis multicentre study aimed to investigate the overall mortality of combined pulmonary fibrosis and emphysema (CPFE) in systemic sclerosis (SSc) and to compare CPFE-SSc characteristics with those of other SSc subtypes (with interstitial lung disease—ILD, emphysema or neither).MethodsChest CTs, anamnestic data, immunological profile and pulmonary function tests of patients with SSc were retrospectively collected. Each chest CT underwent a semiquantitative assessment blindly performed by three radiologists. Patients were clustered in four groups: SSc-CPFE, SSc-ILD, SSc-emphysema and other-SSc (without ILD nor emphysema). The overall mortality of these groups was calculated by Kaplan-Meier method and compared with the stratified log-rank test; Kruskal-Wallis test, t-Student test and χ² test assessed the differences between groups. PResultsWe enrolled 470 patients (1959 patient-year); 15.5 % (73/470) died during the follow-up. Compared with the SSc-ILD and other-SSc, in SSc-CPFE there was a higher prevalence of males, lower anticentromere antibodies prevalence and a more reduced pulmonary function (pConclusionsCPFE increases the mortality risk in SSc along with a highly impaired lung function. These findings strengthen the importance to take into account emphysema in patients with SSc with ILD.

Published
2019

43. Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients: Results from the GISEA register

Author

Rita Giardina, Olga Addimanda, Giovanni Lapadula, Fabrizio Cantini, Fabiola Atzeni, Gianfranco Ferraccioli, Fausto Salaffi, Giorgio Amato, Marcello Govoni, M.G. Anelli, Stefania Manganelli, Carlo Salvarani, Roberto Gorla, Marco Sebastiani, I. Farina, Federica Pignatti, Mauro Galeazzi, Nicolò Cino, Martina Biggioggero, Irene Fineschi, Ennio Giulio Favalli, Cristian Caimmi, Elisa Gremese, Antonio Marchesoni, Piercarlo Sarzi-Puttini, Stefania Gasparini, Matteo Filippini, Rosario Foti, Gilda Sandri, Simona Lopriore, Ilaria Dal Forno, Clodoveo Ferri, Oscar Massimiliano Epis, Giulia Cassone, Giovanni Triolo, Eleonora Bruschi, Chiara Bazzani, Anna Laura Fedele, Antonio Carletto, Emanuele Cassarà, Florenzo Iannone, Sebastiani, M, Anelli, MG, Atzeni, F, Bazzani, C, Farina, I, Fedele, AL, Favalli, EG, Fineschi, I, Cino, N, Dal Forno, I1, Gasparini, S1, Cassarà, E, Giardina, AR, Bruschi, E, Addimanda, O, Cassone, G, Lopriore, S, Sarzi-Puttini, P, Filippini, M, Pignatti, F, Gremese, E, Biggioggero, M, Manganelli, S, Amato, G, Caimmi, C, Salaffi, F, Iannone, F, Ferri, C, Sandri, G, Lapadula, G, Gorla, R, Govoni, M, Ferraccioli, G, Marchesoni, A, Galeazzi, M, Foti, R, Carletto, A, Cantini, F, Triolo, G, Epis, OM, Salvarani, C, Sebastiani, Marco, Anelli, Maria Grazia, Atzeni, Fabiola, Bazzani, Chiara, Farina, Ilaria, Fedele, Anna Laura, Favalli, Ennio Giulio, Fineschi, Irene, Cino, Nicolò, Dal Forno, Ilaria, Gasparini, Stefania, Cassarà, Emanuele, Giardina, Rita, Bruschi, Eleonora, Addimanda, Olga, Cassone, Giulia, Lopriore, Simona, Sarzi-Puttini, Piercarlo, Filippini, Matteo, Pignatti, Federica, Gremese, Elisa, Biggioggero, Martina, Manganelli, Stefania, Amato, Giorgio, Caimmi, Cristian, Salaffi, Fausto, Iannone, Florenzo, Ferri, Clodoveo, Sandri, Gilda, Lapadula, Giovanni, Gorla, Roberto, Govoni, Marcello, Ferraccioli, Gianfranco, Marchesoni, Antonio, Galeazzi, Mauro, Foti, Rosario, Carletto, Antonio, Cantini, Fabrizio, Triolo, Giovanni, Epis, Oscar Massimiliano, and Salvarani, Carlo

Subjects
Registrie, Male, anti-CD20 rituximab, rheumatoid arthritis, GISEA, Settore MED/16 - REUMATOLOGIA, Anti-CD20, Arthritis, Rheumatoid, Antibodies, Monoclonal, Murine-Derived, Rheumatoid, Monoclonal, Registries, Prospective cohort study, Methotrexate, Rheumatoid arthritis, Rituximab, Adult, Aged, Antibodies, Monoclonal, Antirheumatic Agents, Drug Therapy, Combination, Female, Humans, Middle Aged, Treatment Outcome, Antirheumatic Agent, Rituximab, rheumatoid arthritis, Combination, Human, medicine.drug, musculoskeletal diseases, Murine-Derived, medicine.medical_specialty, Combination therapy, Antibodies, NO, Drug Therapy, Rheumatology, Internal medicine, medicine, Adverse effect, Rheumatoid arthriti, business.industry, Arthritis, medicine.disease, Surgery, Discontinuation, business
Abstract

Introduction Rituximab (RTX) is a monoclonal anti-CD20 antibody approved for the treatment of rheumatoid arthritis (RA) in association with methotrexate (MTX). Objectives To evaluate the efficacy and safety of RTX–MTX combination therapy compared with RTX alone in the treatment of RA. Methods We analyzed data from a prospective cohort study, the Italian biologic register GISEA, to investigate the efficacy and safety of rituximab. Moreover, the adverse events (AE) and the causes of discontinuation therapy were analyzed. Results We identified 338 RA patients, 162 treated with RTX and 176 with RTX–MTX. After 52 and 104 weeks of therapy the disease activity score in 28 joints and the Health Assessment Questionnaire Score were available in 168 patients (78 with RTX–MTX and 60 with RTX alone), showing significant reduction without differences among the two groups. AE were reported in 142 patients (42%), for a total of 368 recorded side effects. The majority (90.5%) of AE were mild to moderate in severity. Comparable percentages of severe AE were reported in the 2 groups (9.9% for RTX alone and 9.3% for RTX + MTX). A poor disease control was observed in 14.2% and 13.5% of patients treated with RTX + MTX and RTX, respectively; while 12 patients (4.5% in RTX + MTX, and 2.5% in RTX group) suspended therapy for AE. Conclusions RTX showed a good efficacy and safety profile in the real-life management of RA patients regardless of the association with MTX.

Published
2014
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44. Sex-specific risk of anti-topoisomerase antibodies on mortality and disease severity in systemic sclerosis: 10-year analysis of the Leiden CCISS and EUSTAR cohorts.

Author

Liem SIE, Boonstra M, le Cessie S, Riccardi A, Airo P, Distler O, Matucci-Cerinic M, Caimmi C, Siegert E, Allanore Y, Huizinga TWJ, Toes REM, Scherer HU, and de Vries-Bouwstra JK

Subjects
Humans, Female, Male, Prospective Studies, Autoantibodies, Patient Acuity, Isomerases, Scleroderma, Diffuse, Hypertension, Pulmonary, Scleroderma, Systemic, Scleroderma, Localized, Basidiomycota, Lung Diseases, Interstitial
Abstract

Background: We aimed to evaluate sex-specific risk of anti-topoisomerase I antibodies (ATA) on mortality, diffuse cutaneous systemic sclerosis, interstitial lung disease, and pulmonary hypertension in two cohorts of people with systemic sclerosis., Methods: This study was a 10-year analysis of the prospective Leiden Combined Care in Systemic Sclerosis (CCISS) cohort in the Netherlands and the international European Scleroderma Trials and Research (EUSTAR) cohort. We included participants with systemic sclerosis according to the 2013 American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) classification criteria; available autoantibody status; available skin subtyping; at least one available radiographic assessment of interstitial lung disease; and with a known date of disease onset. People with systemic sclerosis were categorised in six risk groups by sex and autoantibody status (anti-centromere antibody [ACA]-positive female, ACA-positive male, ACA and ATA-negative female, ACA and ATA-negative male, ATA-positive female, and ATA-positive male). We constructed Kaplan-Meier curves and Cox proportional hazard models, accounting for left-truncated survival to prevent bias because the date of disease onset (first non-Raynaud's symptom) preceded the date of cohort entry for all patients. The primary outcome was all-cause mortality and the secondary outcomes were diffuse cutaneous systemic sclerosis, interstitial lung disease, and pulmonary hypertension., Findings: 445 (63%) of 708 participants between April 1, 2009, and Jan 1, 2022, in CCISS (101 [23%] male and 344 [77%] female) and 4263 (50%) of 8590 between June 1, 2004, and March 28, 2018, in EUSTAR (783 [18%] male and 3480 [82%] female) were eligible for this study. In both cohorts, ATA expression occurred significantly more often in males than in females (39 [39%] of 101 males vs 67 [19%] of 344 females in CCISS; p<0·0001 and 381 [49%] of 783 males vs 1323 [38%] of 3480 females in EUSTAR; p<0·0001). According to estimated survival rates, 30% of ATA-positive males versus 12% of ATA-positive females died in the CCISS cohort and 33% versus 15% died in the EUSTAR cohort within 10 years. After adjustment for age, race, and autoantibody status, male sex remained the most important risk factor for all-cause mortality (HR 2·9 [95% CI 1·5-5·5] in CCISS, p=0·0018; and HR 2·6 [2·0-3·4] in EUSTAR, p<0·0001)., Interpretation: We show that the association between male sex and increased mortality in systemic sclerosis cannot be explained by higher ATA prevalence. However, additional research on the effect of sex-specific characteristics on people with systemic sclerosis is required., Funding: None., Competing Interests: Declaration of interests SIEL received a grant from ZonMw and Nationale vereniging voor mensen met lupus, APS, sclerodermie en MCTD to study physical therapy in primary care in systemic sclerosis. PA received consulting fees from Bristol Myers Squibb; payments or honoraria from Bristol Myers Squibb, Bohringer Ingelheim, and Novartis; and support for attending meetings and travel from CSL Behring, Janssen, Roche, and Bristol Myers Squibb. OD was a consultant, received research funding, or speaker fees, or both, from 4P-Pharma, 4P-Science, Abbvie, Acceleron, Alcimed, Altavant Sciences, Amgen, AnaMar, Arxx, AstraZeneca, Blade Therapeutics, Bayer, Boehringer Ingelheim Pharma, Corbus Pharmaceuticals, CSL Behring, Galapagos, Glenmark, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Miltenyi Biotec, Mitsubishi Tanabe Pharma, MSD, Novartis, Prometheus Biosciences, Pfizer, Redxpharma, Roivant, Sanofi, and Topadur. JKdV-B received research grants from Roche, Galapagos, and Janssen; and consulting fees from Abbvie, Janssen, and Boehringer Ingelheim. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Published
2022
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45. Depression is associated with increased disease activity and higher disability in a large Italian cohort of patients with rheumatoid arthritis.

Author

Pezzato S, Bonetto C, Caimmi C, Tomassi S, Montanari I, Gnatta MG, Fracassi E, Cristofalo D, Rossini M, Carletto A, and Tosato S

Subjects
Cohort Studies, Female, Humans, Italy epidemiology, Male, Middle Aged, Arthritis, Rheumatoid psychology, Depression epidemiology, Persons with Disabilities psychology, Persons with Disabilities statistics & numerical data
Abstract

Introduction: Depression is a quite common comorbidity in patients with rheumatoid arthritis (RA) and is thought to influence its severity. This study aims to estimate, in a large cohort of Italian patients with RA, the prevalence of depression and to investigate the clinical correlates of depression in terms of disease activity and disability., Methods: This is a cross-sectional study enrolling 490 outpatients with RA (80% female, mean age 59.5). The Hospital Anxiety and Depression Scale (HADS) was used to assess the presence of depression with a cut-off of 11. We collected data about disease activity and disability with DAS28, TJC-68, PhGA, PGA, VAS, DAS28, SDAI, CDAI and HAQ., Results: Prevalence of depression was 14.3% (95% CI: 11-17%). Depressed patients, when compared with not depressed ones, were found to have higher scores for TJC-68 (p = 0.011), PhGA (p = 0.001), PGA (p = 0.001), VAS (p = 0.001), DAS28 (p = 0.007), SDAI (p = 0.001), CDAI (p = 0.001) and HAQ (p = 0.001). Out of the 70 depressed patients, 30 subjects, already known to be depressed in the past, were still depressed at the time of the assessment, with only 11 (15.7%) under antidepressants. A multivariate analysis showed that male sex, higher PGA score, use of antidepressants and higher HAQ score were significantly associated with an increased risk of depression., Conclusions: Our study shows that depression is common in RA and may affect its activity mainly via an alteration in the perception of the disease. Although its important implications, depression is still under-diagnosed and its management is inadequate., (© 2021. The Author(s).)

Published
2021
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46. Effect of a tailored home-based exercise program in patients with systemic sclerosis: A randomized controlled trial.

Author

Filippetti M, Cazzoletti L, Zamboni F, Ferrari P, Caimmi C, Smania N, Tardivo S, and Ferrari M

Subjects
Aged, Disability Evaluation, Female, Home Care Services, Humans, Male, Middle Aged, Muscle Strength physiology, Quality of Life, Surveys and Questionnaires, Walk Test, Exercise Therapy methods, Scleroderma, Systemic rehabilitation
Abstract

Objective: The aim was to evaluate the effect of a home-based exercise program on functional capacity, health-related quality of life (HRQoL), and disability, in patients with systemic sclerosis (SSc)., Methods: A 6-month randomized controlled trial was conducted on SSc patients by comparing a home-based minimally supervised exercise program (exercise on a stationary cycle and strengthening of upper limbs; stretching of the hands) with usual care. At baseline and after 3 and 6 months, the patients underwent: 6 minutes walking test; hand mobility in scleroderma test; maximal exercise test on an ergocycle; strength measures (handgrip, quadriceps, and biceps). HRQoL (short-form 36 [SF-36]) and disability (health assessment questionnaire disability index [HAQ-DI]) were measured at the same time., Results: Forty-four patients participated in the study. Twenty-two were randomly assigned to the intervention group (IG, mean age 63.60 ± 10.40 years) and 22 to the control group (CG, 61.80 ± 14.40 years). At 6 months, the distance walked in 6 minutes increased by 46 m (baseline 486, 95% CI 458-513 m; 6 months 532, 95% CI 504-561 m) in IG, whereas it decreased by 5 m (baseline 464, 95% CI 431-497 m; 6 months 459, 95% CI 427-490 m) in CG with a significantly different temporal trend at the between-groups comparison (P < .001). An improvement was also observed for strength measures (handgrip, P = .003; quadriceps, P < .001; biceps, P < .001), for the SF-36 physical component score (P < .001) and for the HAQ-DI (P = .011)., Conclusions: This study indicates that in SSc patients, a minimally supervised home-based exercise program improves physical performance, quality of life, and disability in comparison with usual care., (© 2020 The Authors. Scandinavian Journal of Medicine & Science In Sports published by John Wiley & Sons Ltd.)

Published
2020
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47. Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study.

Author

Fassio A, Adami G, Rossini M, Giollo A, Caimmi C, Bixio R, Viapiana O, Milleri S, Gatti M, and Gatti D

Subjects
Adolescent, Adult, Calcium blood, Dietary Supplements, Female, Healthy Volunteers, Humans, Italy, Male, Middle Aged, Osteomalacia drug therapy, Osteoporosis drug therapy, Phosphates blood, Serum Albumin, Vitamin D blood, Young Adult, Cholecalciferol administration & dosage, Cholecalciferol pharmacokinetics, Vitamin D Deficiency drug therapy
Abstract

Background: the aim of this study was to investigate the pharmacokinetic (PK) and safety profile of high-dose vitamin D supplementation, comparing different schedules (daily, weekly, or bi-weekly) in an otherwise healthy vitamin D-deficient population. Methods : single-center, open-label study on healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL), randomized to receive cholecalciferol (DIBASE ® , Abiogen Pharma, Italy) using three different schedules: Group A: 10,000 IU/day for eight weeks followed by 1000 IU/day for four weeks; Group B: 50,000 IU/week for 12 weeks, Group C: 100,000 IU/every other week for 12 weeks. Total cumulative doses were: 588,000 IU, 600,000 IU, 600,000 IU. The treatment regimens corresponded to the highest doses allowed for cholecalciferol for the correction of vitamin D deficiency in adults in Italy., Results: mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C. On day 28, all subjects showed 25 (OH)D levels ≥ 20 ng/mL and 93.1% had 25 (OH)D levels ≥ 30 ng/mL. On day 56 and 84, all subjects had 25 (OH)D levels ≥ 30 ng/mL. No serious adverse events occurred during the study., Conclusions: normalization of 25 (OH)D serum levels was quickly attained with all the studied regimens. A more refracted schedule provided a higher systemic 25 (OH)D exposure.

Published
2020
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48. Ultrasonography involvement of carotid, upper and lower limb arteries in a large cohort of systemic sclerosis patients.

Author

Caimmi C, De Marchi S, Bosello SL, Giuggioli D, Caramaschi P, Di Giorgio A, Spinella A, Astorino G, Canestrari G, Cocchiara E, Gremese E, Viapiana O, and Rossini M

Subjects
Adult, Aged, Carotid Arteries diagnostic imaging, Female, Humans, Italy epidemiology, Male, Middle Aged, Predictive Value of Tests, Prevalence, Scleroderma, Systemic epidemiology, Vascular Diseases epidemiology, Arteries diagnostic imaging, Lower Extremity blood supply, Scleroderma, Systemic diagnostic imaging, Ultrasonography, Doppler, Color, Upper Extremity blood supply, Vascular Diseases diagnostic imaging
Abstract

Objectives: Data on macrovascular involvement in systemic sclerosis (SSc) are still debatable. The aim of this study was to estimate its prevalence and possible determinants in a large cohort., Methods: One hundred and fifty-five outpatients with SSc were enrolled. Data about disease characteristics and cardiovascular risk factors were collected and patients underwent ecocolor Doppler ultrasonography of arteries of the neck and lower (LL) and upper (UL) limbs., Results: Mean age was 57.9 ± 14.5 years and most were female (88.4%) with a limited subset (63.2%). Mean disease duration was 11.4 ± 8.1 years. Twenty-three (14.8%) had hypertension, 7 (4.8%) diabetes, 64 (41.3%) hypercholesterolemia and 63 (40.6%) were active/past smokers. Seventy-nine (49%) patients had plaques at carotids, 49 (32.9%) at LL and 7 (4.9%) at UL. In multivariate analysis, patients with carotid plaques had more often a limited pattern (P = .001), patients with distal LL plaques pulmonary arterial hypertension (P = .006) and patients with proximal LL plaques lower diffusing capacity for carbon monoxide adjusted to hemoglobin and its ratio to alveolar volume (P = .004). In patients with UL plaques traditional cardiovascular risk factors were not more common, while forced vital capacity was lower (P = .023). Finally, upper limb and proximal LL plaques were as common in early disease patients as in longstanding ones, although the former were younger., Conclusions: This study shows that macrovascular involvement is quite common in SSc and that some disease characteristics linked to microvascular involvement are associated with atherosclerotic plaques, which can be present even in early disease. Our study suggests that a complete evaluation of macrocirculation is mandatory for rheumatologists treating SSc patients., (© 2020 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.)

Published
2020
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49. Ultrasonographic detection, definition and quantification of soft tissue oedema in psoriatic dactylitis.

Author

Tinazzi I, Idolazzi L, Zabotti A, Arancio L, Batticiotto A, Caimmi C, De Lucia O, Fassio A, Girolimetto N, Macchioni P, Murgo A, Sakellariou G, and Iagnocco A

Subjects
Arthritis, Psoriatic complications, Edema etiology, Humans, Ultrasonography methods, Arthritis, Psoriatic diagnostic imaging, Edema diagnostic imaging, Fingers diagnostic imaging
Abstract

Aim: To define and score finger soft tissue oedema in psoriatic dactylitis by ultrasound., Material and Methods: A systematic literature review (SLR) on ultrasound-detected finger soft tissue oedema was performed. Subsequently, based on the SLR, a Delphi survey was developed and circulated among a group of 13 expert sonographers, in order to obtain agreement on detection, definition and scoring of finger oedema by B-mode and power Doppler ultrasound. Agreement was considered achieved when each statement was approved by >75% of participants., Results: At the first Delphi round, 91 % agreement was obtained for the scanning technique to adopt, including the most appropriate area to evaluate. At the second round, 76% agreement was achieved on the definition of soft tissue finger oedema. At the third round, 76% agreement was obtained for B-mode and power Doppler scores. The volar aspect of the finger and comparisons with the contralateral side were agreed to be the most appropriate in terms of scanning technique. Agreed ultrasound definition of finger soft tissue oedema was "abnormal hypoechoic/anechoic areas, diffused or localized within the subcutaneous tissue between the epidermidis and the tendon-related anatomic structures (i.e. flexor tendon sheath, peritenonium, tendon pulleys), with local thickening, with or without local abnormal Doppler signal, visualised in two perpendicular planes and not evident on the contralateral side". Semiquantitative (0-3) scores for both B-mode and power Doppler were agreed to be the most appropriate to be used., Conclusion: Our work produced, for the first time, technical indications, definition and scoring for the ultrasound assessment of soft tissue oedema in psoriatic dactylitis.

Published
2019
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50. Osteoporosis in Rheumatic Diseases.

Author

Adami G, Fassio A, Rossini M, Caimmi C, Giollo A, Orsolini G, Viapiana O, and Gatti D

Subjects
Animals, Humans, Osteoporosis epidemiology, Osteoporosis etiology, Osteoporosis therapy, Rheumatic Diseases complications, Rheumatic Diseases epidemiology, Rheumatic Diseases therapy
Abstract

Osteoporosis is a chronic disease characterized by an increased risk of fragility fracture. Patients affected by rheumatic diseases are at greater risk of developing osteoporosis. The purpose of the present review is to discuss the pathogenesis, epidemiology, and treatment of osteoporosis in patients affected by rheumatic diseases with special focus for rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, systemic lupus erythematosus, systemic sclerosis, vasculitides, Sjogren syndrome, and crystal-induced arthritis., Competing Interests: Giovanni Adami, Cristian Caimmi, Alessandro Giollo, Giovanni Orsolini, Ombretta Viapiana, Angelo Fassio and Maurizio Rossini declare that they have no conflict of interest. Davide Gatti declares personal fees from Abiogen, Celgene, Eli-Lilly, Pfizer, UCB, the submitted work.

Published
2019
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