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4. Late Skin Fibrosis in Systemic Sclerosis: A Study from the EUSTAR Cohort

Author

Michael Hughes 1 2, Suiyuan Huang 3 4, Juan Jose Alegre-Sancho 5, Patricia E Carreira 6, Merete Engelhart 7, Eric Hachulla 8, Joerg Henes 9, Eduardo Kerzberg 10, Maria Rosa Pozzi 11, Gabriela Riemekasten 12, Vanessa Smith 13, Gabriella Szücs 14, Marie Vanthuyne 15, Elisabetta Zanatta 16, Oliver Distler 17, Armando G Gabrielli 18, Anna-Maria Hoffmann-Vold 19, Virginia D Steen 20, Dinesh Khanna 3 21, EUSTAR Airò P, Allanore A, Ananieva Lp, Anic B, Balbir-Gurman A, Becvar R, Benvenuti F, Cantatore F P, Chung L S, Cuomo G, Cutolo M, Czirják L, Damjanov N, de Vries-Bouwstra J, Del Galdo F, Distler J, Eyerich K, Farge D, Foti R, Gheorghiu A M, Giollo A, Heitmann S, Herrick A, Hesselstrand R, Hsu I M, Hunzelmann N, Iannone F, Iudici M, Ionescuc M R, Ingegnoli F, Jose J, Joven B E, Kerzberg E, Kucharz E J, Kuwana M, Langhe E D, Launay D, Lefebvre P, Litinsky I, García de la Peña Lefebvre P, González-Martín J J, Li M, Loyo E, Martin T, Matucci-Cerinic M, Maurer B, Moroncini G, Mouthon L, Müller Cs, Müller-Ladner U, Novak S, Pastor P, Pecher A-C, Pellerito R, Pozzi M R, Oksel F, Rednic S, Rezus E, Riccieri V, Rosato E, Saketkoo L A, Salvador M J, Schmeiser T, Selmi C F, Sibilia J, Siegert E, Solanki K, Sommerlatte S, Spertini F, Stamenkovic B, Stamp L, Tanaseanu C-M, Tikly M, Tineo C, Ullman S, Üprus M, Vanthuyne M, Veale D, Walker U, Wiland P, Yargucu F, Yavuz S, University of Zurich, Michael Hughes, 1 2, Suiyuan Huang, 3 4, Juan Jose Alegre-Sancho, 5, Patricia, E Carreira 6, Merete Engelhart, 7, Eric Hachulla, 8, Joerg Henes, 9, Eduardo Kerzberg, 10, Maria Rosa Pozzi, 11, Gabriela Riemekasten, 12, Vanessa Smith, 13, Gabriella Szücs, 14, Marie Vanthuyne, 15, Elisabetta Zanatta, 16, Oliver Distler, 17, Armando, G Gabrielli 18, Anna-Maria Hoffmann-Vold, 19, Virginia, D Steen 20, Dinesh Khanna, 3 21, EUSTAR Airò, P, Allanore, A, Ananieva, Lp, Anic, B, Balbir-Gurman, A, Becvar, R, Benvenuti, F, Cantatore, F P, Chung, L S, Cuomo, G, Cutolo, M, Czirják, L, Damjanov, N, de Vries-Bouwstra, J, Del Galdo, F, Distler, J, Eyerich, K, Farge, D, Foti, R, Gheorghiu, A M, Giollo, A, Heitmann, S, Herrick, A, Hesselstrand, R, Hsu, I M, Hunzelmann, N, Iannone, F, Iudici, M, Ionescuc, M R, Ingegnoli, F, Jose, J, Joven, B E, Kerzberg, E, Kucharz, E J, Kuwana, M, Langhe, E D, Launay, D, Lefebvre, P, Litinsky, I, García de la Peña Lefebvre, P, González-Martín, J J, Li, M, Loyo, E, Martin, T, Matucci-Cerinic, M, Maurer, B, Moroncini, G, Mouthon, L, Müller, C, Müller-Ladner, U, Novak, S, Pastor, P, Pecher, A-C, Pellerito, R, Pozzi, M R, Oksel, F, Rednic, S, Rezus, E, Riccieri, V, Rosato, E, Saketkoo, L A, Salvador, M J, Schmeiser, T, Selmi, C F, Sibilia, J, Siegert, E, Solanki, K, Sommerlatte, S, Spertini, F, Stamenkovic, B, Stamp, L, Tanaseanu, C-M, Tikly, M, Tineo, C, Ullman, S, Üprus, M, Vanthuyne, M, Veale, D, Walker, U, Wiland, P, Yargucu, F, and Yavuz, S

Subjects
Rheumatology, Cohort enrichment, 10051 Rheumatology Clinic and Institute of Physical Medicine, Late disease, Systemic sclerosis, Pharmacology (medical), 610 Medicine & health, Fibrosis, Clinical trial design, Scleroderma, Skin
Abstract

Objectives The early trajectory of skin fibrosis provides insights into the disease course of systemic sclerosis (SSc) including mortality; however, little is known about late skin fibrosis. The aims of our study were to ascertain the prevalence and characteristics of late skin fibrosis in SSc. Methods We developed and tested three conceptual scenarios of late (>5 years after first non-RP feature) skin fibrosis including new worsening of skin disease, and failure to improve after worsening within 5-year window. We defined skin worsening as change in modified Rodnan skin score (mRSS) ≥5 units or ≥25%. Using strict inclusion criteria including complete mRSS, we identified 1,043 (out of 19 115) patients within the EUSTAR database for our analysis. We further restricted analysis within 887 (out of 1043) patients who had lcSSc or dcSSc at baseline. Results One-fifth of patients among the whole cohort (n = 208/1043, 19.9%) experienced mRSS worsening, including in patients with lcSSc or dcSSc at baseline (n = 193/887, 21.8%). This was largely due to new skin worsening after the 5-year window or failure to improve with worsening within the 5-year window. Patients with lower baseline mRSS and lcSSc were more likely to develop late skin fibrosis. Anti-Scl-70 was associated with progression from baseline lcSSc to dcSSc, and anticentromere was protective. Conclusions Late skin fibrosis is not uncommon in SSc. We have identified different patterns relevant to clinical practice and trial design. Late skin fibrosis is a neglected manifestation of SSc and warrants further investigation including to determine clinical outcomes and optimal therapeutic strategy.

Published
2022

7. Conservative treatment of an incomplete calcaneal fracture in a pony using a tarsal sleeve cast.

Author

Marcatili, M., Cantatore, F., Riley, G., and Withers, J.

Subjects
*HEEL bone fractures, *CONSERVATIVE treatment, *HOSPITAL admission & discharge, *HORSE breeds, *FITNESS walking, *PONIES
Abstract

Summary: A 9‐year‐old 390 kg games pony presented with acute onset of grade 5/5 (AAEP) right hindlimb (RH) lameness. During clinical examination, the source of lameness was localised to the tarsal region. Radiographic examination identified a closed, simple, nondisplaced, incomplete fracture of the calcaneal shaft. The pony was initially treated with box rest; however, despite an initial good response, the horse re‐presented with a grade 5/5 (AAEP) RH lameness, 2 weeks after initial presentation. The decision was made to treat the fracture using a tarsal sleeve cast extending from mid‐third of the tibia/crus to the level of distal metatarsus. The cast was replaced every 2 weeks and maintained for a total of 8 weeks. After cast removal, the horse was kept on strict box rest for 3 weeks. After discharge from the hospital, in‐hand walking exercise from the stable was commenced and gradually increased over a 4‐week period. The horse was then gradually reintroduced to small paddock turnout exercise for eight further weeks. The horse was able to return to full athletic function. Conservative treatment using a tarsal sleeve cast should be considered only in horses presenting an incomplete nondisplaced fracture of the calcaneal shaft. [ABSTRACT FROM AUTHOR]

Published
2022
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8. Author Correction: Visual field loss and vision-related quality of life in the Italian Primary Open Angle Glaucoma Study

Author

Rulli, Eliana, Quaranta, Luciano, Riva, Ivano, Poli, Davide, Hollander, Lital, Galli, Fabio, Katsanos, Andreas, Oddone, Francesco, Torri, Valter, Weinreb, N Varano L, Robert, Carchedi, T, Talarico, S, Frezzotti, P, Parravano, F, Motolese, I, Bagaglia, Sa, Rossi, Gcm, Lateri, S, Bossolesi, L, Carmassi, L, Rolle, T, Piccini, R, Ratiglia, R, Rossi, A, Gandolfi, S, Tagliavini, V, Ungaro, N, Fossarello, M, Cucca, A, Zucca, I, Uva, M, Bonacci, E, Cardarella, G, Tognetto, D, Vattovani, O, Vallon, P, Iannacone, F, Fontana, L, Marchi, S, Manni, Gl, Jannetta, D, Roberti, G, Rossetti, L, Maggiolo, E, Oneta, O, Sborgia, C, Cantatore, F, Mastropasqua, L, Agnifili, L, Campos, E, Gizzi, C, Giannaccare, G, Pucci, V, Cassamali, M, Costagliola, C, Traverso, C, Scotto, R, Musolino, M, Landi, L, Bagnis, A., Rulli, Eliana, Quaranta, Luciano, Riva, Ivano, Poli, Davide, Hollander, Lital, Galli, Fabio, Katsanos, Andrea, Oddone, Francesco, Torri, Valter, Weinreb, Robert, N Varano L, Carchedi, T, Talarico, S, Frezzotti, P, Parravano, F, Motolese, I, Bagaglia, Sa, Rossi, Gcm, Lateri, S, Bossolesi, L, Carmassi, L, Rolle, T, Piccini, R, Ratiglia, R, Rossi, A, Gandolfi, S, Tagliavini, V, Ungaro, N, Fossarello, M, Cucca, A, Zucca, I, Uva, M, Bonacci, E, Cardarella, G, Tognetto, D, Vattovani, O, Vallon, P, Iannacone, F, Fontana, L, Marchi, S, Manni, Gl, Jannetta, D, Roberti, G, Rossetti, L, Maggiolo, E, Oneta, O, Sborgia, C, Cantatore, F, Mastropasqua, L, Agnifili, L, Campos, E, Gizzi, C, Giannaccare, G, Pucci, V, Cassamali, M, Costagliola, C, Traverso, C, Scotto, R, Musolino, M, Landi, L, and Bagnis, A.

Subjects
Multidisciplinary, Open angle glaucoma, business.industry, Published Erratum, lcsh:R, MEDLINE, lcsh:Medicine, Italian Study Group on QoL in Glaucoma, Eye, Quality of life (healthcare), Medicine, Optometry, lcsh:Q, Visual field loss, business, lcsh:Science
Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

13. Author Correction: Vision-related quality of life and symptom perception change over time in newly-diagnosed primary open angle glaucoma patients (Scientific Reports, (2019), 9, 1, (6735), 10.1038/s41598-019-43203-9)

Author

Riva, I., Legramandi, L., Rulli, E., Konstas, A. G., Katsanos, A., Oddone, F., Weinreb, R. N., Quaranta, L., Varano, L., Carchedi, T., Talarico, S., Frezzotti, P., Parravano, F., Motolese, I., Bagaglia, S. A., Rossi, G. C. M., Lateri, S., Bossolesi, L., Carmassi, L., Rolle, T., Piccini, R., Ratiglia, R., Rossi, A., Gandolfi, S., Tagliavini, V., Ungaro, N., Fossarello, M., Cuccu, A., Zucca, I., Uva, M., Bonacci, E., Cardarella, G., Tognetto, D., Vattovani, O., Vallon, P., Iannacone, F., Fontana, L., Marchi, S., Manni, G. L., Jannetta, D., Roberti, G., Rossetti, L., Maggiolo, E., Oneta, O., Sborgia, C., Cantatore, F., Mastropasqua, L., Agnifili, L., Campos, E., Gizzi, C., Giannaccare, G., Pucci, V., Cassamali, M., Costagliola, C., Traverso, C., Scotto, R., Musolino, M., Landi, L., and Bagnis, A.

Subjects
Settore MED/30
Published
2020

14. Author Correction: Visual field loss and vision-related quality of life in the Italian Primary Open Angle Glaucoma Study (Scientific Reports, (2018), 8, 1, (619), 10.1038/s41598-017-19113-z)

Author

Rulli, E., Quaranta, L., Riva, I., Poli, D., Hollander, L., Galli, F., Katsanos, A., Oddone, F., Torri, V., Weinreb, R. N., Varano, L., Carchedi, T., Talarico, S., Frezzotti, P., Parravano, F., Motolese, I., Bagaglia, S. A., Rossi, G. C. M., Lateri, S., Bossolesi, L., Carmassi, L., Rolle, T., Piccini, R., Ratiglia, R., Rossi, A., Gandolfi, S., Tagliavini, V., Ungaro, N., Fossarello, M., Cucca, A., Zucca, I., Uva, M., Bonacci, E., Cardarella, G., Tognetto, D., Vattovani, O., Vallon, P., Iannacone, F., Fontana, L., Marchi, S., Manni, G. L., Jannetta, D., Roberti, G., Rossetti, L., Maggiolo, E., Oneta, O., Sborgia, C., Cantatore, F., Mastropasqua, L., Agnifili, L., Campos, E., Gizzi, C., Giannaccare, G., Pucci, V., Cassamali, M., Costagliola, C., Traverso, C., Scotto, R., Musolino, M., Landi, L., and Bagnis, A.

Subjects
Settore MED/30
Published
2020

21. Lateral patellar instability in Standardbred horses at the weanling age: Clinical and morphological features in four cases (2017–2019).

Author

Pagliara, E., Cantatore, F., Pallante, M., Valazza, A., Riccio, B., and Bertuglia, A.

Subjects
*DYSPLASIA, *COVID-19, *PATELLAR tendon, *HORSES, *FEMUR neck, *COMPUTED tomography, *ANATOMICAL variation, *PATELLA
Abstract

Summary: The objective of this study was to describe lateral patellar instability (LPI) in a population of weanling Standardbreds and characterise the prevalence, clinical features, imaging findings and long‐term follow‐up. A total of 222 weanling Standardbreds were examined between June 2017 and December 2019 for presales examination, and LPI was identified in four horses. Presumptive diagnosis was made on clinical and dynamic examination at walk and confirmed by radiography. One horse was subject to euthanasia for causes related to LPI (Case 3), and computed tomography (CT) of both hindlimbs was performed post‐mortem in order to better characterise the anatomical variations of the affected stifle. The intertrochlear groove angle (IGA), the angle of anteversion (AA) of the femoral neck, the anatomical lateral distal femoral angle (aLDFA) and the degree of tibial torsion (TT) were measured. LPI prevalence in Standardbreds weanlings was 1.8%, and it carried a poor athletic prognosis. Radiographic abnormalities were observed in the shape of the patella, characterised by a rounder profile and a less pronounced sagittal crest. The abnormal limb also presented a wider IGA, an outward rotation of the proximal aspect of the tibia and varus deformity of the femorotibial joint compared with the contralateral limb. LPI seems to occur with a high prevalence in the Standardbred weanling population, and our findings suggest that LPI is related to a combination of epiphyseal dysplasia and rotational and angular abnormalities of the affected limb. No effective treatments have been reported. [ABSTRACT FROM AUTHOR]

Published
2022
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31. What have multicentre registries across the world taught us about the disease features of systemic sclerosis?

Author

Proudman S. M., Huq M., Stevens W., Wilson M. E., Sahhar J., Baron M., Hudson M., Pope J., Allanore Y., Distler O., Kowal-Bielecka O., Matucci-Cerinic M., H. L. Low A., Teng G. G., Law W. G., Santosa A., Nikpour M., Hill C., Lester S., Nash P., Ngian G. -S., Proudman S., Rischmueller M., Roddy J., Strickland G., Thakkar V., Walker J., Zochling J., Markland J., Robinson D., Jones N., Khalidi N., Docherty P., Kaminska E., Masetto A., Sutton E., Mathieu J. -P., Ligier S., Grodzicky T., LeClercq S., Thorne C., Gyger G., Smith D., Fortin P. R., Larche M., Abu-Hakima M., Rodriguez-Reyna T. S., Cabral A. R., Fritzler M., Avouac J., Walker U. A., Guiducci S., Riemekasten G., Air P., Hachulla E., Valentini G., Carreira P. E., Cozzi F., Gurman A. B., Braun-Moscovici Y., Damjanov N., Ananieva L. P., Scorza R., Jimenez S., Busquets J., Li M., Muller-Ladner U., Maurer B., Tyndall A., Lapadula G., Iannone F., Becvar R., Sierakowsky S., Cutolo M., Sulli A., Cuomo G., Vettori S., Rednic S., Nicoara I., Vlachoyiannopoulos P., Montecucco C., Caporali R., Novak S., Czirjak L., Varju C., Chizzolini C., Kucharz E. J., Kotulska A., Kopec-Medrek M., Widuchowska M., Rozman B., Mallia C., Coleiro B., Gabrielli A., Farge D., Hij A., Hesselstrand R., Scheja A., Wollheim F., Martinovic D., Govoni M., Lo Monaco A., Hunzelmann N., Pellerito R., Bambara L. M., Caramaschi P., Black C., Denton C., Henes J., 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., Engelhart M., Strauss G., Nielsen H., Damgaard K., Szucs G., Mendoza A. Z., de la Puente Buijdos C., Giraldo W. A. S., Midtvedt O., Garen T., 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 S., Mouthon L., De Keyser F., Smith V., 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., de Souza Muller C., Azevedo V. F., Agachi S., Groppa L., Chiaburu L., Russu E., Zenone T., Stebbings S., Highton J., Stamp L., Chapman P., O'Donnell J., Solanki K., Doube A., Veale D., O'Rourke M., Loyo E., Rosato E., Pisarri S., Tanaseanu C. -M., Popescu M., Dumitrascu A., Tiglea I., Chirieac R., Ancuta C., Furst D. E., Kafaja S., Garcia de la Pena Lefebvre 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., Low A. H. L., Teng G., Chan G., Lim A. Y. N., Ng S. C., Proudman, S. M., Huq, M., Stevens, W., Wilson, M. E., Sahhar, J., Baron, M., Hudson, M., Pope, J., Allanore, Y., Distler, O., Kowal-Bielecka, O., Matucci-Cerinic, M., H. L. Low, A., Teng, G. G., Law, W. G., Santosa, A., Nikpour, M., Hill, C., Lester, S., Nash, P., Ngian, G. -S., Proudman, S., Rischmueller, M., Roddy, J., Strickland, G., Thakkar, V., Walker, J., Zochling, J., Markland, J., Robinson, D., Jones, N., Khalidi, N., Docherty, P., Kaminska, E., Masetto, A., Sutton, E., Mathieu, J. -P., Ligier, S., Grodzicky, T., Leclercq, S., Thorne, C., Gyger, G., Smith, D., Fortin, P. R., Larche, M., Abu-Hakima, M., Rodriguez-Reyna, T. S., Cabral, A. R., Fritzler, M., Avouac, J., Walker, U. A., Guiducci, S., Riemekasten, G., Air, P., Hachulla, E., Valentini, G., Carreira, P. E., Cozzi, F., Gurman, A. B., Braun-Moscovici, Y., Damjanov, N., Ananieva, L. P., Scorza, R., Jimenez, S., Busquets, J., Li, M., Muller-Ladner, U., Maurer, B., Tyndall, A., Lapadula, G., Iannone, F., Becvar, R., Sierakowsky, S., Cutolo, M., Sulli, A., Cuomo, G., Vettori, S., Rednic, S., Nicoara, I., Vlachoyiannopoulos, P., Montecucco, C., Caporali, R., Novak, S., Czirjak, L., Varju, C., Chizzolini, C., Kucharz, E. J., Kotulska, A., Kopec-Medrek, M., Widuchowska, M., Rozman, B., Mallia, C., Coleiro, B., Gabrielli, A., Farge, D., Hij, A., Hesselstrand, R., Scheja, A., Wollheim, F., Martinovic, D., Govoni, M., Lo Monaco, A., Hunzelmann, N., Pellerito, R., Bambara, L. M., Caramaschi, P., Black, C., Denton, C., Henes, J., 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., Engelhart, M., Strauss, G., Nielsen, H., Damgaard, K., Szucs, G., Mendoza, A. Z., de la Puente Buijdos, C., Giraldo, W. A. S., Midtvedt, O., Garen, T., 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, S., Mouthon, L., De Keyser, F., Smith, V., 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., de Souza Muller, C., Azevedo, V. F., Agachi, S., Groppa, L., Chiaburu, L., Russu, E., Zenone, T., Stebbings, S., Highton, J., Stamp, L., Chapman, P., O'Donnell, J., Solanki, K., Doube, A., Veale, D., O'Rourke, M., Loyo, E., Rosato, E., Pisarri, S., Tanaseanu, C. -M., Popescu, M., Dumitrascu, A., Tiglea, I., Chirieac, R., Ancuta, C., Furst, D. E., Kafaja, S., Garcia de la Pena Lefebvre, 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., Low, A. H. L., Teng, G., Chan, G., Lim, A. Y. N., and Ng, S. C.

Subjects
0301 basic medicine, medicine.medical_specialty, Pediatrics, Survival, Immunology, Disease, Scleroderma, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Internal medicine, Immunology and Allergy, Medicine, Multicentre registrie, 030203 arthritis & rheumatology, Clinical features, Cohort study, Multicentre registries, Systemic sclerosis, business.industry, Interstitial lung disease, Autoantibody, Clinical features, medicine.disease, 030104 developmental biology, Clinical feature, Cohort, business, Cohort study, Rheumatism
Abstract

Introduction The aim of this study is to compare the clinical features, mortality and causes of death of systemic sclerosis (SSc) patients in four large multicentre registries. Methods Patients seen at least once in the Australian Scleroderma Cohort Study (ASCS) (n = 1714), the Canadian Scleroderma Research Group (CSRG) (n = 1628), the European League Against Rheumatism Scleroderma Trials and Research (EUSTAR) Network (n = 13,996) and the Systemic Sclerosis Cohort in Singapore (SCORE) (n = 500) before August 2016 were included. Clinical manifestations and survival in cohorts and disease subtypes were compared. Results Among 17,838 SSc patients, most were female (86.1%), Caucasian (84.6%) and had the limited cutaneous subtype (lcSSc) (65.0%). The anti-centromere autoantibody was the most prevalent (37.6%). More patients in SCORE had the diffuse subtype (dcSSc) (49.3%) and Scl-70 autoantibody (38.8%) (pConclusions This meta-cohort of SSc patients, the largest reported to date, provides insights into the impact of race and sex on disease manifestations and survival and confirms the early mortality in this disease.

Published
2017
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36. Do we trust scientific evidence? A multicentre retrospective analysis of first IVF/ICSI cycles before and after the OPTIMIST trial.

Author

Papaleo, E, Revelli, A, Costa, M, Bertoli, M, Zaffagnini, S, Tomei, F, Manno, M, Rebecchi, A, Villanacci, R, Vanni, V S, Cantatore, F, Ruffa, A, Colia, D, Sironi, M, Tessari, T, Parissone, F, Romanello, I, Reschini, M, Dallagiovanna, C, and Somigliana, E

Subjects
OVARIAN hyperstimulation syndrome, RETROSPECTIVE studies, OVARIAN reserve, FERTILIZATION in vitro, REPRODUCTIVE technology, RESEARCH, BIRTH rate, RESEARCH methodology, MEDICAL cooperation, EVALUATION research, PREGNANCY outcomes, COMPARATIVE studies, INDUCED ovulation
Abstract

Study Question: Has the practice of individualizing the recombinant-FSH starting dose been superseded after the largest randomized controlled trial (RCT) in assisted reproduction technology (ART), the OPTIMIST trial?Summary Answer: The OPTIMIST trial has influenced our ART daily practice to a limited degree, but adherence is still generally poor.What Is Known Already: Although the 'one size fits all' approach has been discouraged for decades by most authors, the OPTIMIST study group demonstrated in a large prospective RCT that, in general, dosage individualization does not improve the prospects for live birth, although it may decrease ovarian hyperstimulation syndrome (OHSS) risk in expected high responders.Study Design, Size, Duration: Retrospective analysis of all first in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles from 1st January 2017 to 31st December 2018, before and after the OPTIMIST publication on November 2017.Participants/materials, Setting, Methods: Two thousand six hundred and seventy-seven patients, between 18 and 42 years old, undergoing their first IVF-ICSI cycle in seven Italian fertility centres, were included. Patients were allocated to three groups according to their ovarian reserve markers: predicted poor ovarian responders (POR), predicted normo-responders (NR) and expected hyper-responders (HRs).Main Results and the Role Of Chance: Between 2017 and 2018, there was an overall increase in prescription of the standard 150 IU dose proposed by the OPTIMIST trial and a reduction in the use of a starting dose >300 IU. After subgroup analysis, the decrease in doses >300 IU remained significant in the POR and NR sub-groups.Limitations, Reasons For Caution: The retrospective nature of the study. Physicians need time to adapt to new scientific evidence and a comparison between 2017 and 2019 may have found a greater impact of the Optimist trial, although other changes over the longer time span might have increased confounding. We cannot be sure that the observed changes can be attributed to knowledge of the OPTIMIST trial.Wider Implications Of the Findings: Clinicians may be slow to adopt recommendations based on RCTs; more attention should be given to how these are disseminated and promoted.Study Funding/competing Interest(s): No external funding was used for this study. E.P. reports grants and personal fees from MSD, grants from Ferring, from IBSA, grants and personal fees from Merck, grants from TEVA, grants from Gedeon Richter, outside the submitted work. E.S. reports grants from Ferring, grants and personal fees from Merck-Serono, grants and personal fees from Theramex, outside the submitted work. All other authors do not have conflicts of interest to declare.Trial Registration Number: Not applicable. [ABSTRACT FROM AUTHOR]

Published
2021
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42. Evaluation of the influence of social, demographic, environmental, work-related factors and/or lifestyle habits on Raynaud's phenomenon: a case–control study.

Author

Prete, M., Favoino, E., Giacomelli, R., Afeltra, A., Cantatore, F. P., Bruno, C., Corrado, A., Emmi, L., Emmi, G., Grembiale, R. D., Navarini, L., Marcoccia, A., Liakouli, V., Riccardi, A., Valentini, G., and Perosa, F.

Subjects
RAYNAUD'S disease, SOCIAL influence, CASE-control method, CONTACT lenses, HABIT, CONNECTIVE tissues
Abstract

Raynaud's phenomenon (RP) is a clinical disorder characterized by recurrent, reversible episodes of digital vasospasm. RP can be classified as primary (pRP) or secondary, depending on whether it occurs as a benign condition (not disease-associated) or is associated with other diseases, mainly of the connective tissues. In both cases, it can be triggered by environmental factors, as indicated by the increased incidence of pRP episodes following exposure to cold, vibration injury or chemicals. The purpose of this prospective case–control study was to assess, in an Italian cohort of 132 pRP patients, the association of the phenomenon with demographic, lifestyle habits, environmental and work-related factors. Compared to healthy controls, pRP was found to be inversely associated with the use of contact lenses (OR = 0.4; p = 0.004) and of chlorous-based disinfectants (OR = 0.3; p < 0.001) and directly associated with the presence of prosthesis implants (OR = 5.3; p = 0.001) and the use of hydrogen peroxide-based compounds (OR = 2.6; p = 0.002), suggesting that the latter should be avoided in RP affected patients. Multivariate and multivariable analysis confirmed the associations. Further investigations are needed to understand the mechanism(s) underlying these findings. [ABSTRACT FROM AUTHOR]

Published
2020
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45. The Italian observational study on severe osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment

Author

Window, Trova@UniTO(opens in a. new, Export, Download | Add to List | More,, Rheumatology, Clinical, Experimental, Volume 34, Issue 2, The Italian observational study on severe osteoporosis: 24 month results on incidence of fractures, adherence to treatment Idolazzi, L. Abb, Maugeri, D. B, Monti, S. C, Massarotti, M. D, Osella, G. E, Barbagallo, M. F, Del Fiacco, R. G, Silvestri, S. G, Adami, S. H, Altomonte, L. I, Bardoscia, A. J, Bertoldo, F. K, Bevilacqua, M. L, Bianchi, G. M, Brancati, A. N, Cagnoni, C. O, Cantatore, F. P. P, Capone, A. Q, Costanzo, G. R, D'Avola, G. S, De Giorgi, G. T, Di Matteo, L. U, Di Munno, O. V, Filipponi, P. W, Frisina, N. X, Fusco, A. Y, Giannini, S. Z, Guiducci, S. Aa, Iolascon, G. Ab, Isaia, Giovanni Carlo, Lombardi, G. Ad, Malavolta, N. Ae, Marcocci, C. Af, Migliaccio, S. Ag, Migliore, A. Ah, Muratore, M. Ai, Nardi, A. Aj, Ortolani, S. Ak, Pasquali, R. Al, Petto, H. Am, Pietrogrande, L. An, Pola, E. Ao, Previti, B. Ap, Resmini, G. Aq, Rubinacci, A. Ar, Russo, E. As, Scillitani, A. At, Silveri, F. Au, Leali, P. T. Av, Trotta, F. Aw, Ulivieri, M. Ax, Verdoia, C. Ay, Versace, F. Az, Vinicola, V. Ba, Idolazzi, Luca, Maugeri, Domenico, Monti, Salvatore, Massarotti, Marco, Osella, Giangiacomo, Barbagallo, Mario, Del Fiacco, Romano, Silvestri, Sandra, Adami, S, Altomonte, L, Barbagallo, M, Bardoscia, A, delle Murge, C, Bertoldo, F, Bevilacqua, M, Bianchi, G, Brancati, A, Cagnoni, C, Cantatore, Fp, Capone, A, DI COSTANZO, Gennaro, D'Avola, G, De Giorgi, G, Di Matteo, L, Di Munno, O, Filipponi, P, Frisina, N, Fusco, A, Giannini, S, Guiducci, S, Iolascon, G, Isaia, G, Lombardi, G, Malavolta, N, Marcocci, C, Migliaccio, S, Migliore, A, Muratore, M, Nardi, A, Ortolani, S, Osella, G, Pasquali, R, Petto, H, Pietrogrande, L, Pola, E, Previti, B, Resmini, G, Rubinacci, A, Russo, Pina Elvira, Scillitani, A, Silveri, F, Leali, Pt, Trotta, F, Ulivieri, M, Verdoia, C, Versace, F, and Vinicola, V.

Subjects
Aged, 80 and over, Male, Spinal fracture, Incidence, Osteoporosi, Middle Aged, Parathyroid hormone, Spine, Medication Adherence, Fracture, Observational study, Osteoporosis therapy, Teriparatide, 80 and over, Settore MED/33 - Malattie Apparato Locomotore, Humans, Osteoporosis, Female, Prospective Studies, Aged, Osteoporotic Fractures
Abstract

Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study. Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study.

Published
2016

46. Gastrointestinal symptoms and association with medication use patterns, adherence, treatment satisfaction, quality of life, and resource use in osteoporosis: baseline results of the MUSIC-OS study

Author

Modi, A., Sen, S., Adachi, J., Adami, S., Cortet, B., Cooper, A., Geusens, P., Mellström, D., Weaver, J., van den Bergh, J., Nguyen, A., Sajjan, S., Khan, A., Schweitzer, B., Saunders, K., Du Preez, M., Bayly, K., Lichtenstein, T., Boroditsky, R., Corey, J., Sinha, J., Kooy, J., Nayar, A., Arndt, S., Mohamed, I., Olszynski, W., Legroux, I., Guinamand, S., De Vernejoul, M., Roux, C., Thomas, E., Lévy-Weil, F., Ursu, C., Barucq, F., Bisch, O., Bouche, P., Breton, N., Lacoin, F., Makridis, G., Marmor, P., Ruetsch, M., Taminau, D., Bismuth, M., Bourgoin, M., Sacareau, D., Scellier, C., Wurtz, J., Le Mouel, S., Bortolotti, C., Lauer, B., Amar, H., Cadinot, D., Thorngren, K., Akesson, K., Gandolini, G., Barbagallo, M., Nuti, R., Di Monaco, M., Bonaccorsi, G., Giannini, S., Del Puente, A., Minisola, S., Tarantino, U., Brandi, M., Di Munno, O., D'Avola, G., Caminiti, M., Frediani, B., Marcocci, C., Grimaldi, F., Falaschi, P., Biondi, M., Mauro, G., Cantatore, F., Muratore, M., den Heijer, N., Hamdy, N., Franke, H., Boermans, T., Kooy, A., Valk, N., Eavis, P., Brownlie, R., Brunskill, J., Gumbley, M., Gaunt, R., Litchfield, J., Martin, G., Mcconnell, B., Mccormack, T., Annamalai, N., Srinivasan, D., Takhar, A., Gooding, T., Conn, P., Parker, I., Redmond, M., Calvert, J., Cookson, N., Ainsworth, P., Heer, A., Wyatt, N., Modi, A., Sen, S, Adachi, J., Adami, S., Cortet, B, Cooper, A., Geusens, P., Mellstrom, D., Weaver, J., VAn den Berghe, J., Nguyen, A., Sajjan, S., MUSIC-OS Study Group, Barbagallo, M, Letizia Mauro, G, RS: CAPHRI School for Public Health and Primary Care, RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Interne Geneeskunde, and RS: NUTRIM - R3 - Chronic inflammatory disease and wasting

Subjects
Gastrointestinal Diseases, Endocrinology, Diabetes and Metabolism, Health-related quality of life, Osteoporosis, FRACTURE RISK, RISEDRONATE, 0302 clinical medicine, Endocrinology, Quality of life, Back pain, 030212 general & internal medicine, Prospective Studies, HEALTH PLAN, Prospective cohort study, ALENDRONATE, Osteoporosis, Postmenopausal, POPULATION, education.field_of_study, Bone Density Conservation Agents, Diphosphonates, BISPHOSPHONATE THERAPY, Settore MED/34 - Medicina Fisica E Riabilitativa, TRACT SAFETY, Bisphosphonates, Middle Aged, Europe, Diabetes and Metabolism, POSTMENOPAUSAL WOMEN, Patient Satisfaction, Health Resources, Female, Original Article, Postmenopausal, medicine.symptom, Gastrointestinal, Treatment satisfaction, Aged, Canada, Humans, Medication Adherence, Psychometrics, Quality of Life, medicine.medical_specialty, Population, 030209 endocrinology & metabolism, NO, 03 medical and health sciences, Internal medicine, medicine, education, business.industry, PERSISTENCE, bisphosphonates, gastrointestyinal, osteoporosis, postmenopausal, treatment satisfaction, medicine.disease, Rheumatology, CLINICAL-PRACTICE, Orthopedic surgery, Observational study, business
Abstract

The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC-OS) is a prospective, observational study of women with osteoporosis in Europe and Canada. At baseline, patients with gastrointestinal symptoms reported lower adherence to osteoporosis treatment, treatment satisfaction, and health-related quality of life, than those without gastrointestinal symptoms. INTRODUCTION: The aim of the study was to examine gastrointestinal (GI) symptoms and the association between GI symptoms and treatment adherence, treatment satisfaction, and health-related quality of life (HRQoL) among osteoporotic women in Europe and Canada. METHODS: Baseline results are reported here for a prospective study which enrolled postmenopausal, osteoporotic women who were initiating (new users) or continuing (experienced users) osteoporosis treatment at study entry (baseline). A patient survey was administered at baseline and included the occurrence of GI symptoms during 6-month pre-enrolment, treatment adherence (adherence evaluation of osteoporosis (ADEOS), score 0-22), treatment satisfaction (Osteoporosis Treatment Satisfaction Questionnaire for Medications (OPSAT-Q), score 0-100) and HRQoL (EuroQol-5 dimension (EQ-5D) utility, score 0-1; OPAQ-SV, score 0-100). The association between GI symptoms and ADEOS (experienced users), OPSAT-Q (experienced users), and HRQoL (new and experienced users) was assessed by general linear models adjusted for patient characteristics. RESULTS: A total of 2959 patients (2275 experienced and 684 new users) were included. Overall, 68.1 % of patients experienced GI symptoms in the past 6 months. Compared with patients without GI symptoms, patients with GI symptoms had lower mean baseline scores on most measures. The mean adjusted differences were ADEOS, -0.43; OPSAT-Q, -5.68; EQ-5D, -0.04 (new users) and -0.06 (experienced users), all P < 0.01. GI symptoms were also associated with lower OPAQ-SV domain scores: physical function, -4.17 (experienced users); emotional status, -4.28 (new users) and -5.68 (experienced users); back pain, -5.82 (new users) and -11.33 (experienced users), all P < 0.01. CONCLUSIONS: Patients with GI symptoms have lower treatment adherence and treatment satisfaction and worse HRQoL than patients without GI symptoms.

Published
2016

47. Health-related quality of life in patients with primary open-angle glaucoma. An Italian multicentre observational study

Author

Floriani, I., Quaranta, L., Rulli, E., Katsanos, A., Varano, L., Frezzotti, P., Rossi G. C., M., Carmassi, L., Rolle, T., Ratiglia, R., Gandolfi, S., Fossarello, M., Uva, BIANCA MARIA, Hollander, L., Poli, D., Grignolo, F., Roberto, A., Clivio, L., Galli, F., Carlucci, L., Riva, I., Delcassi, L., Carchedi, T., Talarico, S., Motolese, I., Bagaglia S., A., Lanteri, Silvia, Bossolesi, L., Piccini, R., Rossi, A., Tagliavini, V., Ungaro, N., Cuccu, A., Zucca, I., Bonacci, E., Cardarella, G., Tognetto, D., Vattovani, O., Vallon, P., Iannacone, F., Fontana, L., Marchi, S., Manni G., L., Jannetta, D., Roberti, G., Rossetti, L., Maggiolo, E., Oneta, O., Sborgia, C., Cantatore, F., Mastropasqua, L., Agnifili, L., Campos, E., Gizzi, C., Giannaccare, G., Pucci, V., Cassamali, M., Costagliola, C., Traverso, Carlo, Scotto, Riccardo, Musolino, Maria, Landi, L., and Bagnis, A.

Published
2016

50. 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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