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1. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries

Author

Codreanu C and Damjanov N

Subjects
Medicine (General), R5-920
Abstract

Catalin O Codreanu,1 Nemanja Damjanov2 1Rheumatology Department, Center of Rheumatic Diseases, Bucharest, Romania; 2Institute of Rheumatology, School of Medicine, University of Belgrade, Belgrade, SerbiaAbstract: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA). Biologics selectively target components of the immune system, resulting in better disease control. However, the growing use of biologics in RA has increased safety concerns among rheumatologists. Randomized controlled trials (RCTs) and registries are the most reliable sources of clinical safety data. Although safety data from RCTs provide certain insights into the clinical safety profile of an agent, strict constraints in study design (eg, exclusion criteria and restrictive treatment protocols) often do not accurately reflect possible safety issues in the use of the agent, either in the clinical setting or over long-term treatment. Registries, on the other hand, are not restrictive regarding patient enrollment, making them more reliable in evaluating long-term safety. A number of registries have been established globally: in Europe, the United States, and Asia. However, the availability of registry data from Eastern Europe is lacking. The notable exceptions so far are registries from the Czech Republic (ATTRA, a registry of patients treated with anti-tumor necrosis factor-alpha drugs) and Serbia (National registry of patients with rheumatoid arthritis in Serbia [NARRAS]). The current report provides an overview of safety data with biologics in RA from RCTs and registries. Availability of regional safety data from Eastern Europe is of great importance to its clinicians for making evidence-based treatment decisions in RA. Keywords: biologic therapy, biologic drugs, adverse events, infections, pregnancy, malignancies

Published
2015

6. Cohort Enrichment Strategies for Progressive Interstitial Lung Disease in Systemic Sclerosis From European Scleroderma Trials and Research

Author

Hoffmann-Vold A. -M., Brunborg C., Airo P., Ananyeva L. P., Czirjak L., Guiducci S., Hachulla E., Li M., Mihai C., Riemekasten G., Sfikakis P. P., Valentini G., Kowal-Bielecka O., Allanore Y., Distler O., Vacca A., Giollo A., Balbir-Gurman A., Gheorghiu A. M., Marcoccia A., Herrick A., Radic M., Stamenkovic B., Anic B., Granel B., Ribi C., Selmi C. F., Carlos de la Puente M., de Souza Muller C., Denton C., Kayser C., Tanaseanu C. -M., Majewski D., Rimar D., Krasowska D., Veale D., Walker U., Kerzberg E., Rezus E., Zanatta E., Siegert E., De Langhe E., Oksel F., Ingegnoli F., Cantatore F. P., Szucs G., Cuomo G., Seskute G., Litinsky V., Castellvi I., Morovic-Vergles J., Sibilia J., Henes J., Solanki K., Perdan-Pirkmajer K., Herrmann K., Saketkoo L. A., Stamp L., Mouthon L., Salvador M. J., Pozzi M. R., Uprus M., Vanthuyne M., Engelhart M., Kohm M., Iudici M., Inanc M., Fathi N., Pamuk N., Garcia de la Pena Lefebv P., Carreira P. E., Bancel D. F., Moroncini L., Montecucco C., Ancuta C., Sunderkotter C., Muller-Ladner U., Rosato E., Kucharz E. J., Iannone F., Del Galdo F., Poormoghim H., Kotter I., Distler J., Cutolo M., Tikly M., Damjanov N., Hunzelmann N., Vlachoyiannopoulos P., Hasler P., Sarzi Puttini P., Wiland P., Becvar R., Yavuz S., Zdrojewski Z., Pellerito R., Foti R., Ionescu R. M., Adler S., Kahl S., Moiseev S., Stebbings S., Rednic S., Negrini S., Heitmann S., Ullman S., Agachi S., Martin T., Schmeiser T., Riccieri V., Smith V., Bernardino V., Ortiz-Santamaria V., Hsu V. M., Abdel Atty Mohamed W. A., Hoffmann-Vold, A. -M., Brunborg, C., Airo, P., Ananyeva, L. P., Czirjak, L., Guiducci, S., Hachulla, E., Li, M., Mihai, C., Riemekasten, G., Sfikakis, P. P., Valentini, G., Kowal-Bielecka, O., Allanore, Y., Distler, O., Vacca, A., Giollo, A., Balbir-Gurman, A., Gheorghiu, A. M., Marcoccia, A., Herrick, A., Radic, M., Stamenkovic, B., Anic, B., Granel, B., Ribi, C., Selmi, C. F., Carlos de la Puente, M., de Souza Muller, C., Denton, C., Kayser, C., Tanaseanu, C. -M., Majewski, D., Rimar, D., Krasowska, D., Veale, D., Walker, U., Kerzberg, E., Rezus, E., Zanatta, E., Siegert, E., De Langhe, E., Oksel, F., Ingegnoli, F., Cantatore, F. P., Szucs, G., Cuomo, G., Seskute, G., Litinsky, V., Castellvi, I., Morovic-Vergles, J., Sibilia, J., Henes, J., Solanki, K., Perdan-Pirkmajer, K., Herrmann, K., Saketkoo, L. A., Stamp, L., Mouthon, L., Salvador, M. J., Pozzi, M. R., Uprus, M., Vanthuyne, M., Engelhart, M., Kohm, M., Iudici, M., Inanc, M., Fathi, N., Pamuk, N., Garcia de la Pena Lefebv, P., Carreira, P. E., Bancel, D. F., Moroncini, L., Montecucco, C., Ancuta, C., Sunderkotter, C., Muller-Ladner, U., Rosato, E., Kucharz, E. J., Iannone, F., Del Galdo, F., Poormoghim, H., Kotter, I., Distler, J., Cutolo, M., Tikly, M., Damjanov, N., Hunzelmann, N., Vlachoyiannopoulos, P., Hasler, P., Sarzi Puttini, P., Wiland, P., Becvar, R., Yavuz, S., Zdrojewski, Z., Pellerito, R., Foti, R., Ionescu, R. M., Adler, S., Kahl, S., Moiseev, S., Stebbings, S., Rednic, S., Negrini, S., Heitmann, S., Ullman, S., Agachi, S., Martin, T., Schmeiser, T., Riccieri, V., Smith, V., Bernardino, V., Ortiz-Santamaria, V., Hsu, V. M., and Abdel Atty Mohamed, W. A.

Subjects
interstitial lung disease, Pulmonary and Respiratory Medicine, enrichment, systemic sclerosis, clinical trial, Cardiology and Cardiovascular Medicine, Critical Care and Intensive Care Medicine
Abstract

BACKGROUND: Enrichment strategies from clinical trials for progressive systemic sclerosis-associated interstitial lung disease (SSc-ILD) have not been tested in a real-life cohort.RESEARCH QUESTION: Do enrichment strategies for progressive ILD impact efficacy, repre-sentativeness, and feasibility in patients with SSc-ILD from the European Scleroderma Trials and Research (EUSTAR) database?STUDY DESIGN AND METHODS: We applied the inclusion criteria of major recent SSc-ILD trials (Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis [focuSSced], Scleroderma Lung Study II [SLS II], and Safety and Efficacy of Nintedanib in Systemic Sclerosis [SENSCIS]) and assessed progressive ILD, which was defined as absolute change in FVC and as significant progression (FVC decline $10%). Data were compared with all patients and with patients who did not fulfill any inclusion criteria. RESULTS: In total, 2,258 patients with SSc-ILD were included: 31.2% of the patients met SENSCIS criteria; 5.8% of the patients met SLS II criteria; 1.6% of the patients met focuSSced criteria, and 67.7% (1,529) of the patients did not meet any criteria. In the first 12 + 3 months, the absolute FVC decline in all patients and in patients who fulfilled criteria from SENSCIS was -0.1%, in patients who fulfilled criteria from focuSSced was -3.7%, and in patients who fulfilled criteria from SLS II was 2.3%, with accompanying more progressors in focuSSced. The patient populations that fulfilled the different study inclusion criteria significantly differed in various clinical parameters. In the second 12-month period, SENSCIS-enriched patients had a further absolute FVC% decline as described for the total cohort. In contrast, patients who fulfilled the focuSSced and SLS II criteria showed numeric improvement of lung function. There were no significant associations of enrichment criteria and ILD progression.INTERPRETATION: The application of enrichment criteria from previous clinical trials showed enrichment for progression with variable success, which led to selected patient populations reducing feasibility of recruitment. These findings are important for future clinical trial design and interpretation of the results of published trials.CHEST 2023; 163(3):586-598

Published
2023

7. OP0062 EULAR POINTS TO CONSIDER FOR THE DEFINITION OF CLINICAL AND IMAGING FEATURES SUSPICIOUS FOR PROGRESSION TO PSORIATIC ARTHRITIS

Author

Zabotti, A., primary, De Marco, G., additional, Gossec, L., additional, Baraliakos, X., additional, Aletaha, D., additional, Iagnocco, A., additional, Gisondi, P., additional, Balint, P., additional, Bertheussen, H., additional, Boehncke, W. H., additional, Damjanov, N., additional, De Wit, M., additional, Errichetti, E., additional, Marzo-Ortega, H., additional, Protopopov, M., additional, Puig, L., additional, Queiró Silva, R., additional, Ruscitti, P., additional, Savage, L., additional, Schett, G., additional, Siebert, S., additional, Stamm, T., additional, Studenic, P., additional, Tinazzi, I., additional, Van den Bosch, F., additional, Van der Helm – van Mil, A., additional, Watad, A., additional, Smolen, J. S., additional, and Mcgonagle, D., additional

Published
2023
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9. POS0847 UPADACITINIB AS MONOTHERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE TO METHOTREXATE: RESULTS AT 260 WEEKS FROM THE SELECT-MONOTHERAPY STUDY

Author

Smolen, J. S., primary, Emery, P., additional, Rigby, W., additional, Tanaka, Y., additional, Ignacio Vargas, J., additional, Damjanov, N., additional, Jain, M., additional, Kato, K., additional, Carter, K., additional, Khan, N., additional, Camp, H., additional, and Cohen, S. B., additional

Published
2023
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10. 59P Efficacy of derazantinib in intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions, mutations or amplifications

Author

Borad, M., primary, Javle, M., additional, Shaib, W.L., additional, Mody, K., additional, Bergamo, F., additional, Harris, W.P., additional, Damjanov, N., additional, Macarulla, T., additional, Brandi, G., additional, Masi, G., additional, Droz Dit Busset, M., additional, Boncompagni, A., additional, Dimova-Dobreva, M., additional, Engelhardt, M., additional, Saulay, M., additional, Halfdanarson, T.R., additional, Knox, J., additional, Abou-Alfa, G.K., additional, Personeni, N., additional, and Mazzaferro, V., additional

Published
2022
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11. ACE inhibitors in SSc patients display a risk factor for scleroderma renal crisis—a EUSTAR analysis

Author

Bütikofer L, Varisco PA, Distler O, Kowal-Bielecka O, Allanore Y, Riemekasten G, Villiger PM, Adler S, Avouac J, Walker UA, Guiducci S, Airò P, Hachulla E, Valentini G, Carreira PE, Cozzi F, Gurman AB, Braun-Moscovici Y, Damjanov N, Ananieva LP, Scorza R, Jimenez S, Busquets J, Li M, Müller-Ladner U, Maurer B, Tyndall A, Lapadula G, Iannone F, Becvar R, Sierakowsky S, Bielecka OK, Cutolo M, Sulli A, Cuomo G, Vettori S, Rednic S, Nicoara I, Vlachoyiannopoulos P, Montecucco C, Caporali R, Novak S, Czirják L, Varju C, Chizzolini C, Kucharz EJ, 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, Monaco AL, Hunzelmann N, Pellerito R, Bambara LM, Caramaschi P, Black C, Denton C, Henes J, Santamaria VO, Heitmann S, Krasowska D, Seidel M, Oleszowsky M, Burkhardt H, Himsel A, Salvador MJ, Stamenkovic B, Stankovic A, Tikly M, Starovoytova MN, Engelhart M, Strauss G, Nielsen H, Damgaard K, Szücs G, Mendoza AZ, de la Puente Buijdos C, Sifuentes Giraldo WA, Midtvedt Ø, Garen T, Launay D, Valesini G, Riccieri V, Ionescu RM, Opris D, Groseanu L, Wigley FM, Mihai CM, Cornateanu RS, Ionitescu R, Gherghe AM, Gorga M, Dobrota R, Bojinca M, Schett G, Distler JHW, Meroni P, Zeni S, Mouthon L, De Keyser F, Smith V, Cantatore FP, Corrado A, Ullman S, Iversen L, Pozzi MR, Eyerich K, Hein R, Knott E, Szechinski J, Wiland P, Szmyrka-Kaczmarek M, Sokolik R, Morgiel E, Krummel-Lorenz B, Saar P, Aringer M, Günther C, Anic B, Baresic M, Mayer M, Radominski SC, de Souza Müller C, Azevedo VF, Agachi S, Groppa L, Chiaburu L, Russu E, Zenone T, Stebbings S, Highton J, Stamp L, Chapman P, Baron M, O'Donnell J, Solanki K, Doube A, Veale D, O'Rourke M, Loyo E, Rosato E, Pisarri S, Tanaseanu CM, Popescu M, Dumitrascu A, Tiglea I, Chirieac R, Ancuta C, Furst DE, Kafaja S, de la Peña Lefebvre PG, Rubio SR, Exposito MV, Sibilia J, Chatelus E, Gottenberg JE, Chifflot H, Litinsky I, Venalis A, Butrimiene I, Venalis P, Rugiene R, Karpec D, Kerzberg E, Montoya F, Cosentino V, Castellvi I., Publica, Bütikofer, L, Varisco, Pa, Distler, O, Kowal-Bielecka, O, Allanore, Y, Riemekasten, G, Villiger, Pm, Adler, S, Avouac, J, Walker, Ua, Guiducci, S, Airò, P, Hachulla, E, Valentini, G, Carreira, Pe, Cozzi, F, Gurman, Ab, Braun-Moscovici, Y, Damjanov, N, Ananieva, Lp, Scorza, R, Jimenez, S, Busquets, J, Li, M, Müller-Ladner, U, Maurer, B, Tyndall, A, Lapadula, G, Iannone, F, Becvar, R, Sierakowsky, S, Bielecka, Ok, Cutolo, M, Sulli, A, Cuomo, G, Vettori, S, Rednic, S, Nicoara, I, Vlachoyiannopoulos, P, Montecucco, C, Caporali, R, Novak, S, Czirják, L, Varju, C, Chizzolini, C, Kucharz, Ej, 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, Monaco, Al, Hunzelmann, N, Pellerito, R, Bambara, Lm, Caramaschi, P, Black, C, Denton, C, Henes, J, Santamaria, Vo, Heitmann, S, Krasowska, D, Seidel, M, Oleszowsky, M, Burkhardt, H, Himsel, A, Salvador, Mj, Stamenkovic, B, Stankovic, A, Tikly, M, Starovoytova, Mn, Engelhart, M, Strauss, G, Nielsen, H, Damgaard, K, Szücs, G, Mendoza, Az, de la Puente Buijdos, C, Sifuentes Giraldo, Wa, Midtvedt, Ø, Garen, T, Launay, D, Valesini, G, Riccieri, V, Ionescu, Rm, Opris, D, Groseanu, L, Wigley, Fm, Mihai, Cm, Cornateanu, R, Ionitescu, R, Gherghe, Am, Gorga, M, Dobrota, R, Bojinca, M, Schett, G, Distler, Jhw, Meroni, P, Zeni, S, Mouthon, L, De Keyser, F, Smith, V, Cantatore, Fp, Corrado, A, Ullman, S, Iversen, L, Pozzi, Mr, Eyerich, K, Hein, R, Knott, E, Szechinski, J, Wiland, P, Szmyrka-Kaczmarek, M, Sokolik, R, Morgiel, E, Krummel-Lorenz, B, Saar, P, Aringer, M, Günther, C, Anic, B, Baresic, M, Mayer, M, Radominski, Sc, de Souza Müller, C, Azevedo, Vf, Agachi, S, Groppa, L, Chiaburu, L, Russu, E, Zenone, T, Stebbings, S, Highton, J, Stamp, L, Chapman, P, Baron, M, O'Donnell, J, Solanki, K, Doube, A, Veale, D, O'Rourke, M, Loyo, E, Rosato, E, Pisarri, S, Tanaseanu, Cm, Popescu, M, Dumitrascu, A, Tiglea, I, Chirieac, R, Ancuta, C, Furst, De, Kafaja, S, de la Peña Lefebvre, Pg, Rubio, Sr, Exposito, Mv, Sibilia, J, Chatelus, E, Gottenberg, Je, Chifflot, H, Litinsky, I, Venalis, A, Butrimiene, I, Venalis, P, Rugiene, R, Karpec, D, Kerzberg, E, Montoya, F, Cosentino, V, and Castellvi, I.

Subjects
INVOLVEMENT, Male, Hypertension, Renal, ACE inhibitors, lcsh:Diseases of the musculoskeletal system, Scleroderma Renal Crisis, MULTICENTER, Angiotensin-Converting Enzyme Inhibitors, Scleroderma, Scleroderma renal crisis, 0302 clinical medicine, Risk Factors, Medicine and Health Sciences, Medicine, 030212 general & internal medicine, Prospective Studies, 610 Medicine & health, Renal, Antihypertensive drugs, Outcome, antihypertensive drugs, arterial hypertension, outcome, scleroderma renal crisis, Incidence (epidemiology), Incidence, Hazard ratio, Acute Kidney Injury, Middle Aged, Europe, Treatment Outcome, Population Surveillance, Cohort, Hypertension, Female, 360 Social problems & social services, Proto-oncogene tyrosine-protein kinase Src, Research Article, Arterial hypertension, medicine.medical_specialty, 03 medical and health sciences, ENDOTHELIN-1, Internal medicine, Humans, Risk factor, Aged, 030203 arthritis & rheumatology, Scleroderma, Systemic, business.industry, SYSTEMIC-SCLEROSIS, Systemic, medicine.disease, Concomitant, lcsh:RC925-935, business
Abstract

Objectives To investigate the effect of ACE inhibitors (ACEi) on the incidence of scleroderma renal crisis (SRC) when given prior to SRC in the prospectively collected cohort from the European Scleroderma Trial and Research Group (EUSTAR). Methods SSc patients without prior SRC and at least one follow-up visit were included and analyzed regarding SRC, arterial hypertension, and medication focusing on antihypertensive medication and glucocorticoids (GC). Results Out of 14,524 patients in the database, we identified 7648 patients with at least one follow-up. In 27,450 person-years (py), 102 patients developed SRC representing an incidence of 3.72 (3.06–4.51) per 1000 py. In a multivariable time-to-event analysis adjusted for age, sex, disease severity, and onset, 88 of 6521 patients developed SRC. The use of ACEi displayed an increased risk for the development of SRC with a hazard ratio (HR) of 2.55 (95% confidence interval (CI) 1.65–3.95). Adjusting for arterial hypertension resulted in a HR of 2.04 (95%CI 1.29–3.24). There was no evidence for an interaction of ACEi and arterial hypertension (HR 0.83, 95%CI 0.32–2.13, p = 0.69). Calcium channel blockers (CCB), angiotensin receptor blockers (ARB), endothelin receptor antagonists, and GC—mostly in daily dosages below 15 mg of prednisolone—did not influence the hazard for SRC. Conclusions ACEi in SSc patients with concomitant arterial hypertension display an independent risk factor for the development of SRC but are still first choice in SRC treatment. ARBs might be a safe alternative, yet the overall safety of alternative antihypertensive drugs in SSc patients needs to be further studied.

Published
2020

12. 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

13. Criterion validity of ultrasound in the identification of calcium pyrophosphate crystal deposits at the knee: an OMERACT ultrasound study

Author

Filippou, G, Scanu, A, Adinolfi, A, Toscano, C, Gambera, D, Largo, R, Naredo, E, Calvo, E, Herrero-Beaumont, G, Zufferey, P, Bonjour, C, Maccarter, D, Makman, S, Weber, Z, Figus, F, Moller, I, Gutierrez, M, Pineda, C, Clavijo Cornejo, D, Garcia, H, Ilizaliturri, V, Mendoza Torres, J, Pichardo, R, Rodriguez Delgado, L, Filippucci, E, Cipolletta, E, Serban, T, Cirstoiu, C, Vreju, F, Grecu, D, Mouterde, G, Govoni, M, Punzi, L, Damjanov, N, Keen, H, Bruyn, G, Terslev, L, D'Agostino, M, Scire, C, Iagnocco, A, Filippou G., Scanu A., Adinolfi A., Toscano C., Gambera D., Largo R., Naredo E., Calvo E., Herrero-Beaumont G., Zufferey P., Bonjour C. M., Maccarter D. K., Makman S., Weber Z., Figus F., Moller I., Gutierrez M., Pineda C., Clavijo Cornejo D., Garcia H., Ilizaliturri V., Mendoza Torres J., Pichardo R., Rodriguez Delgado L. C., Filippucci E., Cipolletta E., Serban T., Cirstoiu C., Vreju F. A., Grecu D., Mouterde G., Govoni M., Punzi L., Damjanov N. S., Keen H. I., Bruyn G. A. W., Terslev L., D'agostino M. -A., Scire C. A., Iagnocco A., Filippou, G, Scanu, A, Adinolfi, A, Toscano, C, Gambera, D, Largo, R, Naredo, E, Calvo, E, Herrero-Beaumont, G, Zufferey, P, Bonjour, C, Maccarter, D, Makman, S, Weber, Z, Figus, F, Moller, I, Gutierrez, M, Pineda, C, Clavijo Cornejo, D, Garcia, H, Ilizaliturri, V, Mendoza Torres, J, Pichardo, R, Rodriguez Delgado, L, Filippucci, E, Cipolletta, E, Serban, T, Cirstoiu, C, Vreju, F, Grecu, D, Mouterde, G, Govoni, M, Punzi, L, Damjanov, N, Keen, H, Bruyn, G, Terslev, L, D'Agostino, M, Scire, C, Iagnocco, A, Filippou G., Scanu A., Adinolfi A., Toscano C., Gambera D., Largo R., Naredo E., Calvo E., Herrero-Beaumont G., Zufferey P., Bonjour C. M., Maccarter D. K., Makman S., Weber Z., Figus F., Moller I., Gutierrez M., Pineda C., Clavijo Cornejo D., Garcia H., Ilizaliturri V., Mendoza Torres J., Pichardo R., Rodriguez Delgado L. C., Filippucci E., Cipolletta E., Serban T., Cirstoiu C., Vreju F. A., Grecu D., Mouterde G., Govoni M., Punzi L., Damjanov N. S., Keen H. I., Bruyn G. A. W., Terslev L., D'agostino M. -A., Scire C. A., and Iagnocco A.

Abstract

Objective To evaluate the discriminatory ability of ultrasound in calcium pyrophosphate deposition disease (CPPD), using microscopic analysis of menisci and knee hyaline cartilage (HC) as reference standard. Methods Consecutive patients scheduled for knee replacement surgery, due to osteoarthritis (OA), were enrolled. Each patient underwent ultrasound examination of the menisci and HC of the knee, scoring each site for presence/absence of CPPD. Ultrasound signs of inflammation (effusion, synovial proliferation and power Doppler) were assessed semiquantitatively (0-3). The menisci and condyles, retrieved during surgery, were examined microscopically by optical light microscopy and by compensated polarised microscopy. CPPs were scored as present/absent in six different samples from the surface and from the internal part of menisci and cartilage. Ultrasound and microscopic analysis were performed by different operators, blinded to each other's findings. Results 11 researchers from seven countries participated in the study. Of 101 enrolled patients, 68 were included in the analysis. In 38 patients, the surgical specimens were insufficient. The overall diagnostic accuracy of ultrasound for CPPD was of 75% -sensitivity of 91% (range 71%-87% in single sites) and specificity of 59% (range 68%-92%). The best sensitivity and specificity were obtained by assessing in combination by ultrasound the medial meniscus and the medial condyle HC (88% and 76%, respectively). No differences were found between patients with and without CPPD regarding ultrasound signs of inflammation. Conclusion Ultrasound demonstrated to be an accurate tool for discriminating CPPD. No differences were found between patents with OA alone and CPPD plus OA regarding inflammation.

Published
2021

16. EULAR/eumusc.net standards of care for rheumatoid arthritis: cross-sectional analyses of importance, level of implementation and care gaps experienced by patients and rheumatologists across 35 European countries

Author

Meisters, R, Putrik, P, Ramiro, S, Hifinger, M, Keszei, A, Van Eijk-Hustings, Y, Woolf, A, Smolen, J, Stamm, T, Stoffer-Marx, M, Uhlig, T, Moe, R, De Wit, M, Tafaj, A, Mukuchyan, V, Studenic, P, Verschueren, P, Shumnalieva, R, Charalambous, P, Vencovsky, J, Varvouni, M, Kull, M, Puolakka, K, Gossec, L, Gobejishvili, N, Detert, J, Sidiropoulos, P, Pentek, M, Kane, D, Scire, C, Arad, U, Andersone, D, Van De Laar, M, Van Der Helm-Van Mil, A, Gluszko, P, Cunha-Miranda, L, Berghea, F, Damjanov, N, Tomsic, M, Carmona, L, Turesson, C, Ciurea, A, Shukurova, S, Inanc, N, Verstappen, S, Boonen, A, Meisters R., Putrik P., Ramiro S., Hifinger M., Keszei A. P., Van Eijk-Hustings Y., Woolf A. D., Smolen J. S., Stamm T. A., Stoffer-Marx M., Uhlig T., Moe R. H., De Wit M., Tafaj A., Mukuchyan V., Studenic P., Verschueren P., Shumnalieva R., Charalambous P., Vencovsky J., Varvouni M., Kull M., Puolakka K., Gossec L., Gobejishvili N., Detert J., Sidiropoulos P., Pentek M., Kane D., Scire C. A., Arad U., Andersone D., Van De Laar M., Van Der Helm-Van Mil A., Gluszko P., Cunha-Miranda L., Berghea F., Damjanov N. S., Tomsic M., Carmona L., Turesson C., Ciurea A., Shukurova S., Inanc N., Verstappen S. M. M., Boonen A., Meisters, R, Putrik, P, Ramiro, S, Hifinger, M, Keszei, A, Van Eijk-Hustings, Y, Woolf, A, Smolen, J, Stamm, T, Stoffer-Marx, M, Uhlig, T, Moe, R, De Wit, M, Tafaj, A, Mukuchyan, V, Studenic, P, Verschueren, P, Shumnalieva, R, Charalambous, P, Vencovsky, J, Varvouni, M, Kull, M, Puolakka, K, Gossec, L, Gobejishvili, N, Detert, J, Sidiropoulos, P, Pentek, M, Kane, D, Scire, C, Arad, U, Andersone, D, Van De Laar, M, Van Der Helm-Van Mil, A, Gluszko, P, Cunha-Miranda, L, Berghea, F, Damjanov, N, Tomsic, M, Carmona, L, Turesson, C, Ciurea, A, Shukurova, S, Inanc, N, Verstappen, S, Boonen, A, Meisters R., Putrik P., Ramiro S., Hifinger M., Keszei A. P., Van Eijk-Hustings Y., Woolf A. D., Smolen J. S., Stamm T. A., Stoffer-Marx M., Uhlig T., Moe R. H., De Wit M., Tafaj A., Mukuchyan V., Studenic P., Verschueren P., Shumnalieva R., Charalambous P., Vencovsky J., Varvouni M., Kull M., Puolakka K., Gossec L., Gobejishvili N., Detert J., Sidiropoulos P., Pentek M., Kane D., Scire C. A., Arad U., Andersone D., Van De Laar M., Van Der Helm-Van Mil A., Gluszko P., Cunha-Miranda L., Berghea F., Damjanov N. S., Tomsic M., Carmona L., Turesson C., Ciurea A., Shukurova S., Inanc N., Verstappen S. M. M., and Boonen A.

Abstract

Objective As part of European League against Rheumatism (EULAR)/European Musculoskeletal Conditions Surveillance and Information Network, 20 user-focused standards of care (SoCs) for rheumatoid arthritis (RA) addressing 16 domains of care were developed. This study aimed to explore gaps in implementation of these SoCs across Europe. Methods Two cross-sectional surveys on the importance, level of and barriers (patients only) to implementation of each SoC (0-10, 10 highest) were designed to be conducted among patients and rheumatologists in 50 European countries. Care gaps were calculated as the difference between the actual and maximum possible score for implementation (ie, 10) multiplied by the care importance score, resulting in care gaps (0-100, maximal gap). Factors associated with the problematic care gaps (ie, gap≥30 and importance≥6 and implementation<6) and strong barriers (≥6) were further analysed in multilevel logistic regression models. Results Overall, 26 and 31 countries provided data from 1873 patients and 1131 rheumatologists, respectively. 19 out of 20 SoCs were problematic from the perspectives of more than 20% of patients, while this was true for only 10 SoCs for rheumatologists. Rheumatologists in countries with lower gross domestic product and non-European Union countries were more likely to report problematic gaps in 15 of 20 SoCs, while virtually no differences were observed among patients. Lack of relevance of some SoCs (71%) and limited time of professionals (66%) were the most frequent implementation barriers identified by patients. Conclusions Many problematic gaps were reported across several essential aspects of RA care. More efforts need to be devoted to implementation of EULAR SoCs.

Published
2020

17. AB0889 Association Between Clinically Meaningful Improvements in Patient-Reported Outcomes and Stringent Measures of Disease Activity in Patients With Psoriatic Arthritis Treated With Upadacitinib Versus Placebo or Adalimumab: Results From a Phase 3 Trial

Author

Gossec, L., primary, Damjanov, N., additional, Tsuji, S., additional, Lertratanakul, A., additional, Lippe, R., additional, Patel, J., additional, Zueger, P., additional, and De Vlam, K., additional

Published
2022
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18. AB0350 ASSESSMENT OF REAL-LIFE PATIENT HANDLING EXPERIENCE OF AVT02 ADMINISTERED SUBCUTANEOUSLY VIA AUTOINJECTOR IN PATIENTS WITH MODERATE-TO-SEVERE ACTIVE RHEUMATOID ARTHRITIS: AN OPEN-LABEL, SINGLE-ARM CLINICAL TRIAL, THEN AN EXTENSION PHASE OF AVT02 ADMINISTERED WITH A PRE-FILLED SYRINGE (ALVOPAD-PEN)

Author

Damjanov, N., primary, Stroissnig, H., additional, Steiger, M., additional, Sobierska, J., additional, Guenzi, E., additional, Otto, H., additional, Sattar, A., additional, Haliduola, H. N., additional, Edwald, E., additional, and Berti, F., additional

Published
2022
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19. POS0383 CLINICAL CHARACTERISTICS AND PROGNOSIS OF PATIENTS WITH SYSTEMIC SCLEROSIS SINE SCLERODERMA: DATA FROM THE INTERNATIONAL EUSTAR DATABASE.

Author

Lescoat, A., primary, Huang, S., additional, Carreira, P., additional, Siegert, E., additional, De Vries-Bouwstra, J., additional, Distler, J. H. W., additional, Smith, V., additional, Del Galdo, F., additional, Anic, B., additional, Damjanov, N., additional, Rednic, S., additional, Ribi, C., additional, Farge, D., additional, Hoffmann-Vold, A. M., additional, Gabrielli, A., additional, Distler, O., additional, Khanna, D., additional, and Allanore, Y., additional

Published
2022
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21. CLINICAL CHARACTERISTICS AND PROGNOSIS OF PATIENTS WITH SYSTEMIC SCLEROSIS SINE SCLERODERMA: DATA FROM THE INTERNATIONAL EUSTAR DATABASE

Author

Lescoat, A, Huang, S., Carreira, P, Siegert, E., de Vries-Bouwstra, J., Distler, Jörg, Smith, V., del Galdo, F., Anic, B., Damjanov, N., Rednic, S., Ribi, C., Farge, D., Hoffmann-Vold, A. M., Gabrielli, A., Distler, O., Khanna, D., Allanore, Y, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), École des Hautes Études en Santé Publique [EHESP] (EHESP), University of Michigan [Ann Arbor], University of Michigan System, Hospital Universitario 12 de Octubre [Madrid], Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Universiteit Leiden, Friedrich-Alexander Universität Erlangen-Nürnberg (FAU), Ghent University Hospital, University of Leeds, University Hospital Centre Zagreb, Partenaires INRAE, University of Belgrade [Belgrade], Babes-Bolyai University [Cluj-Napoca] (UBB), Lausanne University Hospital, Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Oslo University Hospital [Oslo], Università Politecnica delle Marche [Ancona] (UNIVPM), University hospital of Zurich [Zurich], Hôpital Cochin [AP-HP], Universiteit Leiden [Leiden], and Chard-Hutchinson, Xavier

Subjects
[SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio]
Abstract

International audience

Published
2022

23. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update

Author

Gossec, L, Smolen, J S, Ramiro, S, de Wit, M, Cutolo, M, Dougados, M, Emery, P, Landewé, R, Oliver, S, Aletaha, D, Betteridge, N, Braun, J, Burmester, G, Cañete, J D, Damjanov, N, FitzGerald, O, Haglund, E, Helliwell, P, Kvien, T K, Lories, R, Luger, T, Maccarone, M, Marzo-Ortega, H, McGonagle, D, McInnes, I B, Olivieri, I, Pavelka, K, Schett, G, Sieper, J, van den Bosch, F, Veale, D J, Wollenhaupt, J, Zink, A, and van der Heijde, D

Published
2016
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24. OMERACT agreement and reliability study of ultrasonographic elementary lesions in osteoarthritis of the foot

Author

Zabotti, A, Filippou, G, Canzoni, M, Adinolfi, A, Picerno, V, Carrara, G, Balint, P, Bruyn, G, D'Agostino, M, Damjanov, N, Delle Sedie, A, Filippucci, E, Gonzalez Fernandez, M, Hammer, H, Karim, Z, Mandl, P, Moller, I, Morales Lozano, M, Naredo, E, Porta, F, Sakellariou, G, Terslev, L, Scire, C, Iagnocco, A, Zabotti A., Filippou G., Canzoni M., Adinolfi A., Picerno V., Carrara G., Balint P., Bruyn G., D'Agostino M. A., Damjanov N., Delle Sedie A., Filippucci E., Gonzalez Fernandez M. L., Hammer H. B., Karim Z., Mandl P., Moller I., Morales Lozano M. R., Naredo E., Porta F., Sakellariou G., Terslev L., Scire C. A., Iagnocco A., Zabotti, A, Filippou, G, Canzoni, M, Adinolfi, A, Picerno, V, Carrara, G, Balint, P, Bruyn, G, D'Agostino, M, Damjanov, N, Delle Sedie, A, Filippucci, E, Gonzalez Fernandez, M, Hammer, H, Karim, Z, Mandl, P, Moller, I, Morales Lozano, M, Naredo, E, Porta, F, Sakellariou, G, Terslev, L, Scire, C, Iagnocco, A, Zabotti A., Filippou G., Canzoni M., Adinolfi A., Picerno V., Carrara G., Balint P., Bruyn G., D'Agostino M. A., Damjanov N., Delle Sedie A., Filippucci E., Gonzalez Fernandez M. L., Hammer H. B., Karim Z., Mandl P., Moller I., Morales Lozano M. R., Naredo E., Porta F., Sakellariou G., Terslev L., Scire C. A., and Iagnocco A.

Abstract

Objective To evaluate the level of agreement on ultrasonographic (US) lesions among highly experienced sonographers as well as the intraobserver and interobserver reliability of inflammatory and structural US lesions in patients with osteoarthritis (OA) of the foot. Methods After a systematic literature review, a Delphi survey was performed to test definitions of US lesions in OA of the foot, including inflammatory lesions (ie, synovial hypertrophy [SH], joint effusion [JE], power Doppler signal [PD]), and structural abnormalities (ie, cartilage damage [CD] and osteophytes). Subsequently, the reliability of US in assessing the aforementioned lesions was tested on static images as well as during a live exercise. Reliability was assessed by kappa analyses and prevalence-adjusted bias-adjusted kappa (PABAK) on a dichotomous and an ordinal scale. Results Intraobserver and interobserver reliability for SH and JE evaluated by binary scoring was good for both components, while the intraobserver reliability for semiquantitative scoring of SH ranged from moderate in the web-based exercise (PABAK 0.49) to good (PABAK 0.8) in the live exercise. Reliability for CD and PD assessments were respectively good and excellent in all exercises (ranged from PABAK 0.61 to 0.79 for CD and 0.88 to 0.95 for PD). The interobserver reliability for the semiquantitative scoring of osteophytes was fair in the live exercise (PABAK 0.36) and moderate in the static exercise (PABAK 0.60). Conclusions Consensual US definitions were found to be reliable for assessing inflammatory lesions in OA of the foot, while the use of US to assess structural damage requires further studies.

Published
2019

25. A FRAMEWORK OF POTENTIAL INTERVENTIONS TO ACCELERATE GENDER-EQUITABLE CAREER ADVANCEMENT IN ACADEMIC RHEUMATOLOGY

Author

Ovseiko, P. V., Gossec, L., Andreoli, L., Kiltz, U., Van Mens, L., Hassan, N., Van der Leeden, M., Siddle, H. J., Alunno, A., Mcinnes, I., Damjanov, N., Apparailly, F., Ospelt, C., Van der Horst-Bruinsma, I., Nikiphorou, E., Druce, K., Szekanecz, Z., Sepriano, A., Avcin, T., Bertsias, G., Schett, G., Keenan, A. M., Coates, L. C., Rheumatology, AMS - Ageing & Vitality, AMS - Musculoskeletal Health, APH - Aging & Later Life, APH - Health Behaviors & Chronic Diseases, Rehabilitation medicine, AII - Inflammatory diseases, AMS - Tissue Function & Regeneration, and APH - Societal Participation & Health

Published
2021

26. 47P Derazantinib for patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements: Primary results from the phase II study FIDES-01

Author

Droz Dit Busset, M., primary, Shaib, W.L., additional, Mody, K., additional, Personeni, N., additional, Damjanov, N., additional, Harris, W.P., additional, Bergamo, F., additional, Brandi, G., additional, Masi, G., additional, Halfdanarson, T.R., additional, Tam, V., additional, Goff, L.W., additional, Knox, J., additional, Hollebecque, A., additional, Macarulla Mercade, T., additional, Cantero, F., additional, Saulay, M., additional, Braun, S., additional, Javle, M., additional, and Borad, M., additional

Published
2021
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27. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial)

Author

Isenberg, David, Gordon, Caroline, Licu, Daiana, Copt, Samuel, Rossi, Claudia Pena, Wofsy, David, Babini, A, Lazaro, M, Lucero, E, Merono, C, Rillo, O, Spindler, A, Tate, G, Velasco Zamora, B, Bossingham, D, Littlejohn, G, Nicholls, D, Reeves, G, Rischmueller, M, Zamani, O, Sato, E, Scheinberg, M, Zerbini, C, Rashkov, R, Glasnovic, M, Martinovic-Kaliterna, D, Morovic-Vergles, J, Novak, S, Tegzova, D, Vavrincova, P, Amoura, Z, Carle, P, Hachulla, E, Jorgensen, C, Sibilia, J, Viallard, J, Braun, J, Hiepe, F, Kuhn, A, Lorenz, H, Schmidt, R, Schulze-Koops, H, Wacker, J, Settas, L, Mouli Veeravalli, S, Balbir-Gurman, A, Langevitz, P, Mevorach, D, Molad, Y, Bae, S, Cho, CS, Kim, HY, Suh, C, Andersone, D, Ziade, N, Baranauskaite, A, Stropuviene, S, Gun, S, Kong, N, Sulaiman, W, Ramos Remus, C, Saldate Alonso, C, Huizinga, T, Tak, P, van Paassen, P, Arroyo, C, Gomez, H, Perez, E, Ramiterre, E, Salido, E, Brzosko, M, Chudzik, D, Dyczek, A, Jeka, S, Sierakowski, S, Zdrojewski, Z, Barbarash, O, Ershova, O, Gordienko, A, Lomareva, N, Shvarts, Y, Sorotskaya, V, Vezikova, N, Yakushin, S, Bogic, M, Dimic, A, Damjanov, N, Petrovic, R, Stojanovic, L, Kalla, A, Louw, I, Nayiager, S, Reuter, H, Spargo, C, Whitelaw, D, Carbonell Abello, J, Fernandez Nebro, A, Gomez Reino, J, Lopez Longo, F, von Kempis, J, Huang, CM, Lan, JL, Lin, HY, Liou, LB, Bruce, I, Tahir, H, Abrahamovych, O, Dyadyk, O, Nikirenkov, Y, Rudyk, Y, Smiyan, S, Stanislavchuk, M, Ter-Vartanyan, S, Aranow, C, Askanase, A, Chakravarty, E, Chatham, W, Clark, M, Dhar, P, Dikranian, A, Fiechtner, J, Ginzler, E, Harmon, C, Knibbe, W, Lee, E, Lockshin, M, Luggen, M, Massarotti, E, Mitri, G, Peng, S, and Singer, N

Published
2015
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28. Criterion validity of ultrasound in the identification of calcium pyrophosphate crystal deposits at the knee: an OMERACT ultrasound study

Author

Filippou, G., Scanu, A., Adinolfi, Annalisa, Toscano, Carlo Pompeo, Gambera, D., Largo, R., Naredo, E., Calvo, E., Herrero-Beaumont, G., Zufferey, P., Bonjour, C. M., Maccarter, D. K., Makman, S., Weber, Z., Figus, F., Moller, I., Gutierrez, M., Pineda, C., Clavijo Cornejo, D., Garcia, H., Ilizaliturri, V., Mendoza Torres, J., Pichardo, R., Rodriguez Delgado, L. C., Filippucci, E., Cipolletta, Eleonora, Serban, T., Cirstoiu, C., Vreju, F. A., Grecu, D., Mouterde, G., Govoni, M., Punzi, L., Damjanov, N. S., Keen, H. I., Bruyn, G. A. W., Terslev, L., D'Agostino, Maria Antonietta, Scire, C. A., Iagnocco, A., Adinolfi A., Toscano C., Cipolletta E., D'agostino M. A. (ORCID:0000-0002-5347-0060), Filippou, G., Scanu, A., Adinolfi, Annalisa, Toscano, Carlo Pompeo, Gambera, D., Largo, R., Naredo, E., Calvo, E., Herrero-Beaumont, G., Zufferey, P., Bonjour, C. M., Maccarter, D. K., Makman, S., Weber, Z., Figus, F., Moller, I., Gutierrez, M., Pineda, C., Clavijo Cornejo, D., Garcia, H., Ilizaliturri, V., Mendoza Torres, J., Pichardo, R., Rodriguez Delgado, L. C., Filippucci, E., Cipolletta, Eleonora, Serban, T., Cirstoiu, C., Vreju, F. A., Grecu, D., Mouterde, G., Govoni, M., Punzi, L., Damjanov, N. S., Keen, H. I., Bruyn, G. A. W., Terslev, L., D'Agostino, Maria Antonietta, Scire, C. A., Iagnocco, A., Adinolfi A., Toscano C., Cipolletta E., and D'agostino M. A. (ORCID:0000-0002-5347-0060)

Abstract

Objective To evaluate the discriminatory ability of ultrasound in calcium pyrophosphate deposition disease (CPPD), using microscopic analysis of menisci and knee hyaline cartilage (HC) as reference standard. Methods Consecutive patients scheduled for knee replacement surgery, due to osteoarthritis (OA), were enrolled. Each patient underwent ultrasound examination of the menisci and HC of the knee, scoring each site for presence/absence of CPPD. Ultrasound signs of inflammation (effusion, synovial proliferation and power Doppler) were assessed semiquantitatively (0-3). The menisci and condyles, retrieved during surgery, were examined microscopically by optical light microscopy and by compensated polarised microscopy. CPPs were scored as present/absent in six different samples from the surface and from the internal part of menisci and cartilage. Ultrasound and microscopic analysis were performed by different operators, blinded to each other's findings. Results 11 researchers from seven countries participated in the study. Of 101 enrolled patients, 68 were included in the analysis. In 38 patients, the surgical specimens were insufficient. The overall diagnostic accuracy of ultrasound for CPPD was of 75% -sensitivity of 91% (range 71%-87% in single sites) and specificity of 59% (range 68%-92%). The best sensitivity and specificity were obtained by assessing in combination by ultrasound the medial meniscus and the medial condyle HC (88% and 76%, respectively). No differences were found between patients with and without CPPD regarding ultrasound signs of inflammation. Conclusion Ultrasound demonstrated to be an accurate tool for discriminating CPPD. No differences were found between patents with OA alone and CPPD plus OA regarding inflammation.

Published
2021

30. OP0074 A FRAMEWORK OF POTENTIAL INTERVENTIONS TO ACCELERATE GENDER-EQUITABLE CAREER ADVANCEMENT IN ACADEMIC RHEUMATOLOGY

Author

Ovseiko, P. V., primary, Gossec, L., additional, Andreoli, L., additional, Kiltz, U., additional, Van Mens, L., additional, Hassan, N., additional, Van der Leeden, M., additional, Siddle, H. J., additional, Alunno, A., additional, Mcinnes, I., additional, Damjanov, N., additional, Apparailly, F., additional, Ospelt, C., additional, Van der Horst-Bruinsma, I., additional, Nikiphorou, E., additional, Druce, K., additional, Szekanecz, Z., additional, Sepriano, A., additional, Avcin, T., additional, Bertsias, G., additional, Schett, G., additional, Keenan, A. M., additional, and Coates, L. C., additional

Published
2021
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31. POS0317 THE PERFORMANCE OF DIFFUSING CAPACITY FOR MONOXIDE CARBON (DLCO) AND FORCED VITAL CAPACITY (FVC) IN PREDICTING THE ONSET OF SYSTEMIC SCLEROSIS (SSc)-INTERSTITIAL LUNG DISEASE (ILD) IN THE EUROPEAN SCLERODERMA TRIALS AND RESEARCH (EUSTAR) DATABASE

Author

Lepri, G., primary, Bruni, C., additional, Tofani, L., additional, Moggi Pignone, A., additional, Orlandi, M., additional, Sara, T., additional, Hughes, M., additional, Del Galdo, F., additional, Irace, R., additional, Distler, O., additional, Riccieri, V., additional, Allanore, Y., additional, Gheorghiu, A. M., additional, Siegert, E., additional, De Vries-Bouwstra, J., additional, Hachulla, E., additional, Tikly, M., additional, Damjanov, N., additional, Spertini, F., additional, Mouthon, L., additional, Hoffmann-Vold, A. M., additional, Gabrielli, A., additional, Guiducci, S., additional, Matucci-Cerinic, M., additional, Furst, D., additional, and Bellando Randone, S., additional

Published
2021
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34. Identification of calcium pyrophosphate deposition disease (CPPD) by ultrasound: Reliability of the OMERACT definitions in an extended set of joints - An international multiobserver study by the OMERACT Calcium Pyrophosphate Deposition Disease Ultrasound Subtask Force

Author

Filippou, G, Scire, C, Adinolfi, A, Damjanov, N, Carrara, G, Bruyn, G, Cazenave, T, D'Agostino, M, Delle Sedie, A, Di Sabatino, V, Diaz Cortes, M, Filippucci, E, Gandjbakhch, F, Gutierrez, M, Maccarter, D, Micu, M, Moller Parera, I, Mouterde, G, Mortada, M, Naredo, E, Pineda, C, Porta, F, Reginato, A, Satulu, I, Schmidt, W, Serban, T, Terslev, L, Vlad, V, Vreju, F, Zufferey, P, Bozios, P, Toscano, C, Picerno, V, Iagnocco, A, Filippou G., Scire C. A., Adinolfi A., Damjanov N. S., Carrara G., Bruyn G. A. W., Cazenave T., D'Agostino M. A., Delle Sedie A., Di Sabatino V., Diaz Cortes M. E., Filippucci E., Gandjbakhch F., Gutierrez M., Maccarter D. K., Micu M., Moller Parera I., Mouterde G., Mortada M. A., Naredo E., Pineda C., Porta F., Reginato A. M., Satulu I., Schmidt W. A., Serban T., Terslev L., Vlad V., Vreju F. A., Zufferey P., Bozios P., Toscano C., Picerno V., Iagnocco A., Filippou, G, Scire, C, Adinolfi, A, Damjanov, N, Carrara, G, Bruyn, G, Cazenave, T, D'Agostino, M, Delle Sedie, A, Di Sabatino, V, Diaz Cortes, M, Filippucci, E, Gandjbakhch, F, Gutierrez, M, Maccarter, D, Micu, M, Moller Parera, I, Mouterde, G, Mortada, M, Naredo, E, Pineda, C, Porta, F, Reginato, A, Satulu, I, Schmidt, W, Serban, T, Terslev, L, Vlad, V, Vreju, F, Zufferey, P, Bozios, P, Toscano, C, Picerno, V, Iagnocco, A, Filippou G., Scire C. A., Adinolfi A., Damjanov N. S., Carrara G., Bruyn G. A. W., Cazenave T., D'Agostino M. A., Delle Sedie A., Di Sabatino V., Diaz Cortes M. E., Filippucci E., Gandjbakhch F., Gutierrez M., Maccarter D. K., Micu M., Moller Parera I., Mouterde G., Mortada M. A., Naredo E., Pineda C., Porta F., Reginato A. M., Satulu I., Schmidt W. A., Serban T., Terslev L., Vlad V., Vreju F. A., Zufferey P., Bozios P., Toscano C., Picerno V., and Iagnocco A.

Abstract

Objectives: To assess the reliability of the OMERACT ultrasound (US) definitions for the identification of calcium pyrophosphate deposition disease (CPPD) at the metacarpal-phalangeal, triangular fibrocartilage of the wrist (TFC), acromioclavicular (AC) and hip joints. Methods: A web-based exercise and subsequent patient-based exercise were carried out. A panel of 30 OMERACT members, participated at the web-based exercise by evaluating twice a set of US images for the presence/absence of CPPD. Afterwards, 19 members of the panel met in Siena, Italy, for the patient-based exercise. During the exercise, all sonographers examined twice eight patients for the presence/absence of CPPD at the same joints. Intraoberserver and interobserver kappa values were calculated for both exercises. Results: The web-based exercise yielded high kappa values both in intraobserver and interobserver evaluation for all sites, while in the patient-based exercise, inter-reader agreement was acceptable for the TFC and the AC. TFC reached high interobserver and intraobserver k values in both exercises, ranging from 0.75 to 0.87 (good to excellent agreement). AC reached moderate kappa values, from 0.51 to 0.85 (moderate to excellent agreement) and can readily be used for US CPPD identification. Conclusions: Based on the results of our exercise, the OMERACT US definitions for the identification of CPPD demonstrated to be reliable when applied to the TFC and AC. Other sites reached good kappa values in the web-based exercise but failed to achieve good reproducibility at the patient-based exercise, meaning the scanning method must be further refined.

Published
2018

35. EULAR task force on gender equity in academic rheumatology: preliminary survey findings

Author

Ovseiko, PV, Gossec, L, Andreoli, L, Kiltz, U, Van Mens, L, Hassan, N, Van der Leeden, M, Siddle, HJ, Alunno, A, Mcinnes, I, Damjanov, N, Apparailly, F, Ospelt, C, Van der Horst-Bruinsma, I, Nikiphorou, E, Druce, K, Szekanecz, Z, Sepriano, A, Avcin, T, Bertsias, G, Schett, G, Keenan, AM, Coates, LC, and Rheumatology, EULAR Task Force on Gender Equity in Academic

Published
2020

36. Zentrale Schmerzantwort und Krankheitsaktivität bei Patienten mit Rheumatoider Arthritis nach Therapie mit Certolizumab-pegol vs. Placebo: Eine post-hoc Analyse der PreCePRA Studie

Author

Schenker, H, Rech, J, Tascilar, K, Hagen, M, Schönau, V, Sergeeva, M, Konerth, L, Prade, J, Strobelt, S, Valor Mendez, L, Hueber, A, Simon, D, Kleyer, A, Behrens, F, Da Silva, JAP, Baerwald, C, Finzel, S, Voll, R, Feist, E, Dörfler, A, Damjanov, N, Hess, A, and Schett, G

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: In bisherigen Untersuchungen von RA Patienten konnten wir zeigen, dass die zentrale Schmerzantwort auf Kompression eines schmerzhaften Gelenks hin, dargestellt durch ein funktionelles MRT des Gehirns in Abhängigkeit von Blutsauerstoffgehalt (blood-oxygen level dependent=BOLD), [zum vollständigen Text gelangen Sie über die oben angegebene URL], Deutscher Rheumatologiekongress 2020, 48. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 34. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh)

Published
2020
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37. EULAR TASK FORCE ON GENDER EQUITY IN ACADEMIC RHEUMATOLOGY: PRELIMINARY SURVEY FINDINGS

Author

Ovseiko, P. V., Gossec, L., Andreoli, L., Kiltz, U., Van Mens, L., Hassan, N., Van der Leeden, M., Siddle, H. J., Alunno, A., Mcinnes, I., Damjanov, N., Apparailly, F., Ospelt, C., Van der Horst-Bruinsma, I., Nikiphorou, E., Druce, K., Szekanecz, Z., Sepriano, A., Avcin, T., Bertsias, G., Schett, G., Keenan, A. M., Coates, L. C., Rheumatology, Rehabilitation medicine, AMS - Ageing & Vitality, AMS - Musculoskeletal Health, APH - Aging & Later Life, APH - Health Behaviors & Chronic Diseases, AII - Inflammatory diseases, AMS - Tissue Function & Regeneration, and APH - Societal Participation & Health

Published
2020

39. Standardisation of nailfold capillaroscopy for the assessment of patients with Raynaud's phenomenon and systemic sclerosis

Author

Smith, V., Herrick, A.L., Ingegnoli, F., Damjanov, N., Angelis, R. De, Denton, C.P., Distler, O., Espejo, K., Foeldvari, I., Frech, T., Garro, B., Gutierrez, M., Gyger, G., Hachulla, E., Hesselstrand, R., Iagnocco, A., Kayser, C., Melsens, K., Muller-Ladner, U., Paolino, S., Pizzorni, C., Radic, M., Riccieri, V., Snow, M., Stevens, W.B.C., Sulli, A., Laar, J.M. van, Vonk, M.C., Vanhaecke, A., Cutolo, M., Smith, V., Herrick, A.L., Ingegnoli, F., Damjanov, N., Angelis, R. De, Denton, C.P., Distler, O., Espejo, K., Foeldvari, I., Frech, T., Garro, B., Gutierrez, M., Gyger, G., Hachulla, E., Hesselstrand, R., Iagnocco, A., Kayser, C., Melsens, K., Muller-Ladner, U., Paolino, S., Pizzorni, C., Radic, M., Riccieri, V., Snow, M., Stevens, W.B.C., Sulli, A., Laar, J.M. van, Vonk, M.C., Vanhaecke, A., and Cutolo, M.

Abstract

Contains fulltext : 219902.pdf (Publisher’s version ) (Open Access), Capillaroscopy is a non-invasive and safe tool which allows the evaluation of the morphology of the microcirculation. Since its recent incorporation in the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis together with its assessed role to monitor disease progression, capillaroscopy became a 'mainstream' investigation for rheumatologists. Given its increasing use by a variety of physicians internationally both in daily practice to differentiate primary from secondary Raynaud's phenomenon, as well as in research context to predict disease progression and monitor treatment effects, standardisation in capillaroscopic image acquisition and analysis seems paramount. To step forward to this need, experts in the field of capillaroscopy/microcirculation provide in this very consensus paper their view on image acquisition and analysis, different capillaroscopic techniques, normal and abnormal capillaroscopic characteristics and their meaning, scoring systems and reliability of image acquisition and interpretation.

Published
2020

40. Vorhersage des Ansprechens der RA auf die Behandlung mit Certolizumab-Pegol (CZP) mittels funktionellen MRT (fMRT) des ZNS. Eine international, randomisierte, doppelt-blinde Phase III Studie (PreCePRA)

Author

Rech, J, Tascilar, K, Schenker, H, Sergeeva, M, Selvakumar, M, Konerth, L, Prade, J, Strobelt, S, Hagen, M, Schönau, V, Valor Mendez, L, Hueber, A, Simon, D, Kleyer, A, Behrens, F, Da Silva, JAP, Baerwald, C, Finzel, S, Voll, R, Feist, E, Dörfler, A, Damjanov, N, Hess, A, Schett, G, Rech, J, Tascilar, K, Schenker, H, Sergeeva, M, Selvakumar, M, Konerth, L, Prade, J, Strobelt, S, Hagen, M, Schönau, V, Valor Mendez, L, Hueber, A, Simon, D, Kleyer, A, Behrens, F, Da Silva, JAP, Baerwald, C, Finzel, S, Voll, R, Feist, E, Dörfler, A, Damjanov, N, Hess, A, and Schett, G

Published
2020

41. Longitudinale Veränderungen der ZNS-Schmerzantwort unter Therapie mit Certolizumab-Pegol (CZP) bei rheumatoider Arthritis. Eine post-hoc Analyse der PreCePRA Studie

Author

Rech, J, Tascilar, K, Schenker, H, Hagen, M, Sergeeva, M, Selvakumar, M, Konerth, L, Prade, J, Strobelt, S, Schönau, V, Valor Mendez, L, Hueber, A, Simon, D, Kleyer, A, Behrens, F, Baerwald, C, Finzel, S, Voll, R, Feist, E, Da Silva, JAP, Dörfler, A, Damjanov, N, Hess, A, Schett, G, Rech, J, Tascilar, K, Schenker, H, Hagen, M, Sergeeva, M, Selvakumar, M, Konerth, L, Prade, J, Strobelt, S, Schönau, V, Valor Mendez, L, Hueber, A, Simon, D, Kleyer, A, Behrens, F, Baerwald, C, Finzel, S, Voll, R, Feist, E, Da Silva, JAP, Dörfler, A, Damjanov, N, Hess, A, and Schett, G

Published
2020

45. 45P Efficacy of derazantinib in intrahepatic cholangiocarcinoma patients with FGFR2 mutations or amplifications: Pooled analysis of clinical trials and early access programs

Author

Droz Dit Busset, M., primary, Shaib, W.L., additional, Harris, W.P., additional, Damjanov, N., additional, Borad, M., additional, Vogel, A., additional, Bridgewater, J.A., additional, Sellmann, L., additional, Dadduzio, V., additional, Borner, M., additional, Snider, J., additional, Cantero, F., additional, Saulay, M., additional, Braun, S., additional, Mazzaferro, V., additional, and Javle, M., additional

Published
2020
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46. OP0317 ACCURACY OF THE OMERACT DEFINITIONS FOR IDENTIFICATION OF CALCIUM PYROPHOSPHATE CRYSTALS WITH ULTRASOUND: FINAL RESULTS OF THE OMERACT US IN CPPD SUB-TASK FORCE STUDY

Author

Filippou, G., primary, Scanu, A., additional, Adinolfi, A., additional, Toscano, C., additional, Gambera, D., additional, Largo, R., additional, Naredo, E., additional, Calvo, E., additional, Herrero-Beaumont, G., additional, Zufferey, P., additional, Madelaine-Bonjour, C., additional, Maccarter, D., additional, Makman, S., additional, Weber, Z., additional, Figus, F., additional, Möller, I., additional, Gutierrez, M., additional, Pineda, C., additional, Clavijo Cornejo, D., additional, García, H., additional, Ilizaliturri, V., additional, Mendoza Torres, J., additional, Pichardo, R., additional, Rodriguez Delgado, L. C., additional, Filippucci, E., additional, Cipolletta, E., additional, Serban, T., additional, Cirstoiu, C., additional, Vreju, F. A., additional, Grecu, D., additional, Mouterde, G., additional, Govoni, M., additional, Punzi, L., additional, Damjanov, N., additional, Terslev, L., additional, Scirè, C. A., additional, and Iagnocco, A., additional

Published
2020
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48. THU0653-HPR BARRIERS FOR THE UPTAKE OF EULAR POSTGRADUATE EDUCATION FOR HEALTH PROFESSIONALS IN RHEUMATOLOGY IN EASTERN EUROPEAN COUNTRIES: RESULTS FROM 3 NATIONAL SURVEYS

Author

Van Bodegom-Vos, L., primary, Vliet Vlieland, T. P. M., additional, Carmona, L., additional, Damjanov, N., additional, Domjan, A., additional, Goehmann, A., additional, Iagnocco, A., additional, Kosanovic, M., additional, Moe, R. H., additional, Peter, W., additional, Segrt, M., additional, Tonga, E., additional, and Zabalan, C., additional

Published
2020
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50. SAT0050 PREDICTION OF RESPONSE TO CERTOLIZUMAB PEGOL TREATMENT BY FUNCTIONAL MRI OF THE BRAIN: AN INTERNATIONAL, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL (PRECEPRA)

Author

Rech, J., primary, Tascilar, K., additional, Schenker, H., additional, Sergeeva, M., additional, Selvakumar, M., additional, Konerth, L., additional, Prade, J., additional, Strobelt, S., additional, Hagen, M., additional, Schönau, V., additional, Valor, L., additional, Hueber, A., additional, Simon, D., additional, Kleyer, A., additional, Behrens, F., additional, Da Silva, J. A. P., additional, Baerwald, C., additional, Finzel, S., additional, Voll, R., additional, Feist, E., additional, Doerfler, A., additional, Damjanov, N., additional, Hess, A., additional, and Schett, G., additional

Published
2020
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