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

Author

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

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

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

Published
2019

114. Generation of a Core Set of Items to Develop Classification Criteria for Scleroderma Renal Crisis Using Consensus Methodology

Author

Butler, E-A, Baron, M, Fogo, AB, Frech, T, Ghossein, C, Hachulla, E, Hoa, S, Johnson, SR, Khanna, D, Mouthon, L, Nikpour, M, Proudman, S, Steen, V, Stern, E, Varga, J, Denton, C, Hudson, M, Barnado, A, Bernstein, EJ, Boin, F, Braun-Moscovici, Y, Castelino, FV, Catoggio, LJ, Matucci-Cerinic, M, Chung, L, Clements, P, Csuka, ME, De langhe, E, Distler, J, Distler, O, Farge, DC, Fischer, A, Gabrielli, A, Hasegawa, M, Hayat, S, Herrick, A, Hesselstrand, R, Hsu, V, Hughes, M, Hunzelmann, N, Hummers, L, Iannone, F, Ingegnoli, F, Jacobsen, S, Kawaguchi, Y, Koenig, M, Kuwana, M, Lenaerts, J, Martin, T, Mayes, MD, McMahan, Z, Medsger, T, Merkel, P, Narain, S, Ong, V, Pauling, JD, Pope, J, de la Puente, C, Rischmueller, M, Sofia Rodriguez-Reyna, T, Sahhar, J, Saketkoo, LA, Senecal, J-L, Shah, A, Shah, AA, Alberto Sifuentes-Giraldo, W, Silver, R, Stevens, W, Sutton, E, Thakkar, V, Valentini, G, de Vries-Bouwstra, J, Vonk, M, Walker, UA, Butler, E-A, Baron, M, Fogo, AB, Frech, T, Ghossein, C, Hachulla, E, Hoa, S, Johnson, SR, Khanna, D, Mouthon, L, Nikpour, M, Proudman, S, Steen, V, Stern, E, Varga, J, Denton, C, Hudson, M, Barnado, A, Bernstein, EJ, Boin, F, Braun-Moscovici, Y, Castelino, FV, Catoggio, LJ, Matucci-Cerinic, M, Chung, L, Clements, P, Csuka, ME, De langhe, E, Distler, J, Distler, O, Farge, DC, Fischer, A, Gabrielli, A, Hasegawa, M, Hayat, S, Herrick, A, Hesselstrand, R, Hsu, V, Hughes, M, Hunzelmann, N, Hummers, L, Iannone, F, Ingegnoli, F, Jacobsen, S, Kawaguchi, Y, Koenig, M, Kuwana, M, Lenaerts, J, Martin, T, Mayes, MD, McMahan, Z, Medsger, T, Merkel, P, Narain, S, Ong, V, Pauling, JD, Pope, J, de la Puente, C, Rischmueller, M, Sofia Rodriguez-Reyna, T, Sahhar, J, Saketkoo, LA, Senecal, J-L, Shah, A, Shah, AA, Alberto Sifuentes-Giraldo, W, Silver, R, Stevens, W, Sutton, E, Thakkar, V, Valentini, G, de Vries-Bouwstra, J, Vonk, M, and Walker, UA

Abstract

OBJECTIVE: To generate a core set of items to develop classification criteria for scleroderma renal crisis (SRC) using consensus methodology. METHODS: An international, multidisciplinary panel of experts was invited to participate in a 3-round Delphi exercise developed using a survey based on items identified by a scoping review. In round 1, participants were asked to identify omissions and clarify ambiguities regarding the items in the survey. In round 2, participants were asked to rate the validity and feasibility of the items using Likert-type scales ranging from 1 to 9 (where 1 = very invalid/unfeasible, 5 = uncertain, and 9 = very valid/feasible). In round 3, participants reviewed the results and comments from round 2 and were asked to provide final ratings. Items rated as highly valid and feasible (median scores ≥7 for each) in round 3 were selected as the provisional core set of items. A consensus meeting using a nominal group technique was conducted to further reduce the core set of items. RESULTS: Ninety-nine experts from 16 countries participated in the Delphi exercise. Of the 31 items in the survey, consensus was achieved on 13, in the categories hypertension, renal insufficiency, proteinuria, and hemolysis. Eleven experts took part in the nominal group technique discussion, where consensus was achieved in 5 domains: blood pressure, acute kidney injury, microangiopathic hemolytic anemia, target organ dysfunction, and renal histopathology. CONCLUSION: A core set of items that characterize SRC was identified using consensus methodology. This core set will be used in future data-driven phases of this project to develop classification criteria for SRC.

Published
2019

125. Preservation of Lung Function Observed in a Phase 3 Randomized Controlled Trial of Tocilizumab for the Treatment of Early Systemic Sclerosis

Author

Khanna, D., primary, Lin, C.J.F., additional, Goldin, J., additional, Kim, G., additional, Kuwana, M., additional, Allanore, Y., additional, Batalov, A., additional, Butrimiene, I., additional, Carreira, P., additional, Matucci-Cerinic, M., additional, Distler, O., additional, Martinovic Kaliterna, D., additional, Mihai, C.-M., additional, Mogensen, M., additional, Olesinska, M., additional, Pope, J.E., additional, Riemekasten, G., additional, Rodriguez-Reyna, T.S., additional, Santos, M.J., additional, van Laar, J., additional, Spotswood, H., additional, Siegel, J., additional, Jahreis, A., additional, Furst, D., additional, and Denton, C.P., additional

Published
2019
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127. Psychosocial issues and care for patients with systemic sclerosis

Author

Jewett, L.R., Kwakkenbos, L., Delisle, V.C., Levis, B., Thombs, B.D., Varga, J., Denton, C.P., Wigley, F.M., Allanore, Y., Kuwana, M., Varga, J., Denton, C.P., Wigley, F.M., Allanore, Y., and Kuwana, M.

Subjects
030203 arthritis & rheumatology, Activities of daily living, integumentary system, business.industry, Disease, Mental health, Experimental Psychopathology and Treatment, 03 medical and health sciences, Distress, 0302 clinical medicine, Sexual dysfunction, Quality of life (healthcare), Medicine, Anxiety, 030212 general & internal medicine, medicine.symptom, business, skin and connective tissue diseases, Psychosocial, Clinical psychology
Abstract

Item does not contain fulltext People living with chronic medical conditions face challenges not only with respect to their physical health but also to their emotional and social well-being. Chronic conditions, such as systemic sclerosis (SSc or scleroderma), often result in significant disruptions to activities of daily living, including employment and homecare, as well as social and leisure activities, and can lead to reduced health-related quality of life (HRQL). Therefore, it is important to identify factors associated with decreased HRQL and psychosocial functioning in SSc and to develop and implement strategies to help individuals with the disease manage these problems. Traditionally, there has been little research on patient-reported outcomes in SSc, and this has posed a significant clinical challenge to the field. However, recent research has highlighted important problems that have an influence on HRQL for many people living with SSc, including depression, anxiety and fear of disease progression, fatigue and sleep problems, pain, pruritus (itch), body image distress, and sexual dysfunction.

Published
2016
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128. RITUXIMAB IN SYSTEMIC SCLEROSIS : SAFETY AND EFFICACY DATA FROM THE EUSTAR NETWORK

Author

Elhai, M., Distler, O., Smith, V., Matucci-Cerinic, M., Alegre-Sancho, J. J., Truchetet, M. -E., Braun-Moscovici, Y., Iannone, F., Chotchaeva, F., Lescoat, A., Siegert, E., Castellvi, I., Airo, P., Vettori, S., Hachulla, E., Erler, A., Ananieva, L., Krusche, M., Lopez-Longo, F., Distler, J., Hunzelmann, N., Hoffmann-Vold, A. -M., Riccieri, V., Hsu, V., Pozzi, M., Ancuta, C., Rosato, E., Mihai, C., Kuwana, M., Allanore, Y., Elhai, M., Distler, O., Smith, V., Matucci-Cerinic, M., Alegre-Sancho, J. J., Truchetet, M. -E., Braun-Moscovici, Y., Iannone, F., Chotchaeva, F., Lescoat, A., Siegert, E., Castellvi, I., Airo, P., Vettori, S., Hachulla, E., Erler, A., Ananieva, L., Krusche, M., Lopez-Longo, F., Distler, J., Hunzelmann, N., Hoffmann-Vold, A. -M., Riccieri, V., Hsu, V., Pozzi, M., Ancuta, C., Rosato, E., Mihai, C., Kuwana, M., and Allanore, Y.

Published
2018

130. INFLAMMATORY MYOPATHIES

Author

Inoue, M., primary, Uruha, A., additional, Charuel, J., additional, Musset, L., additional, Suzuki, S., additional, Kuwana, M., additional, Mimori, T., additional, and Nishino, I., additional

Published
2018
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133. AB0495 Post-marketing surveillance of tofacitinib in japanese patients with rheumatoid arthritis: an interim report of safety data

Author

Tamura, N., primary, Kuwana, M., additional, Atsumi, T., additional, Takei, S., additional, Harigai, M., additional, Fujii, T., additional, Matsuno, H., additional, Mimori, T., additional, Momohara, S., additional, Yamamoto, K., additional, Nomura, K., additional, Endo, Y., additional, Sugiyama, N., additional, Hirose, T., additional, Morishima, Y., additional, Yoshii, N., additional, and Takagi, M., additional

Published
2018
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134. 521 DRB1 is the primary genetic locus contributing to susceptibility to dermatomyositis positive for anti-TIF1γ antibody in Japanese

Author

Yamaguchi, Y., primary, Kuwana, M., additional, Kanaoka, M., additional, Watanabe, T., additional, Okiyama, N., additional, Gono, T., additional, Kodera, M., additional, Kambara, T., additional, Hamaguchi, Y., additional, Seishima, M., additional, Takehara, K., additional, Fujimoto, M., additional, and Aihara, M., additional

Published
2018
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142. PHARMACOKINETICS AND PHARMACODYNAMICS OF METHOTREXATE POLYGLUTAMATE IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH LOW OR HIGH DOSE-METHOTREXATE IN COMBINATION WITH ADALIMUMAB: RESULTS FROM THE MIRACLE TRIAL.

Author

Tamai, H., Ikeda, K., Miyamoto, T., Taguchi, H., Kuo, C. F., Shin, K., Hirata, S., Okano, Y., Sato, S., Yasuoka, H., Choi, I. A., Park, S. H., Weng, M. Y., Kuwana, M., Lee, Y. J., Ishii, T., Kim, J., Kameda, H., Kojima, T., and Baek, H. J.

Published
2023
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143. TRANS-ETHNIC META-ANALYSIS OF GENOME-WIDE ASSOCIATION STUDIES IDENTIFIES GSDMA AND PRDM1 AS SUSCEPTIBILITY GENES TO SYSTEMIC SCLEROSIS

Author

Terao, C., Kawaguchi, T., Dieude, P., Varga, J., Kuwana, M., Hudson, M., Kawaguchi, Y., Matucci-Cerinic, M., Ohmura, K., Riemekasten, G., Kawasaki, A., Airo, P., Horita, T., Oka, A., Hachulla, E., Yoshifuji, H., Caramaschi, P., Hunzelmann, N., Baron, M., Atsumi, T., Hassouns, P., Tochimoto, A., Ayuzawa, N., Yanagida, H., Furukawa, H., Tohma, S., Hasegawa, M., Fujimoto, M., Ishikawa, O., Yamamoto, T., Goto, D., Asano, Y., Jinnin, M., Endo, H., Takahashi, H., Takehara, K., Sato, S., Ihn, H., Raychaudhuri, S., Liao, K., Gregersen, P., Tsuchiya, N., Riccieri, V., Melchers, I., Valentini, G., Cauvet, A., Martinez, M., Mimori, T., Matsuda, F., Allanore, Y., Terao, C., Kawaguchi, T., Dieude, P., Varga, J., Kuwana, M., Hudson, M., Kawaguchi, Y., Matucci-Cerinic, M., Ohmura, K., Riemekasten, G., Kawasaki, A., Airo, P., Horita, T., Oka, A., Hachulla, E., Yoshifuji, H., Caramaschi, P., Hunzelmann, N., Baron, M., Atsumi, T., Hassouns, P., Tochimoto, A., Ayuzawa, N., Yanagida, H., Furukawa, H., Tohma, S., Hasegawa, M., Fujimoto, M., Ishikawa, O., Yamamoto, T., Goto, D., Asano, Y., Jinnin, M., Endo, H., Takahashi, H., Takehara, K., Sato, S., Ihn, H., Raychaudhuri, S., Liao, K., Gregersen, P., Tsuchiya, N., Riccieri, V., Melchers, I., Valentini, G., Cauvet, A., Martinez, M., Mimori, T., Matsuda, F., and Allanore, Y.

Published
2017

148. AB0431 Post-marketing surveillance of tofacitinib in japanese patients with rheumatoid arthritis: an interim report of safety data

Author

Mimori, T, primary, Harigai, M, additional, Atsumi, T, additional, Kuwana, M, additional, Takei, S, additional, Tamura, N, additional, Fujii, T, additional, Matsuno, H, additional, Momohara, S, additional, Yamamoto, K, additional, Kokubo, T, additional, Endo, Y, additional, Sugiyama, N, additional, Hirose, T, additional, Morishima, Y, additional, and Yoshii, N, additional

Published
2017
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149. THU0006 Trans-ethnic meta-analysis of genome-wide association studies identifies GSDMA and PRDM1 as susceptibility genes to systemic sclerosis

Author

Terao, C, primary, Kawaguchi, T, additional, Dieude, P, additional, Varga, J, additional, Kuwana, M, additional, Hudson, M, additional, Kawaguchi, Y, additional, Matucci-Cerinic, M, additional, Ohmura, K, additional, Riemekasten, G, additional, Kawasaki, A, additional, Airo, P, additional, Horita, T, additional, Oka, A, additional, Hachulla, E, additional, Yoshifuji, H, additional, Caramaschi, P, additional, Hunzelmann, N, additional, Baron, M, additional, Atsumi, T, additional, Hassouns, P, additional, Tochimoto, A, additional, Ayuzawa, N, additional, Yanagida, H, additional, Furukawa, H, additional, Tohma, S, additional, Hasegawa, M, additional, Fujimoto, M, additional, Ishikawa, O, additional, Yamamoto, T, additional, Goto, D, additional, Asano, Y, additional, Jinnin, M, additional, Endo, H, additional, Takahashi, H, additional, Takehara, K, additional, Sato, S, additional, Ihn, H, additional, Raychaudhuri, S, additional, Liao, K, additional, Gregersen, P, additional, Tsuchiya, N, additional, Riccieri, V, additional, Melchers, I, additional, Valentini, G, additional, Cauvet, A, additional, Martinez, M, additional, Mimori, T, additional, Matsuda, F, additional, and Allanore, Y, additional

Published
2017
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