1. Is there a role for TNF-alpha antagonists in the treatment of SSc? EUSTAR expert consensus development using the Delphi technique
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Distler, J. H. W., Jordan, S., Airo, P., Alegre-Sancho, J. J., Allanore, Y., Gurman, A. B., Caporali, R., Caramaschi, P., Carreira, P. E., Chizzolini, C., Cutolo, M., Duruoz, M. T., Farge-Bancel, D., Hesselstrand, R., Iannone, F., Keyser, F., Kucharz, E. J., David Launay, Lefebvre, P. G. D., Lukacova, O., Marasini, B., Martinovic, D., Neto, J. F. M., Radic, M., Rednic, S., Riemekasten, G., Rovensky, J., Seidel, M. F., Senel, S., Smith, V., Sunderkotter, C., Ton, E., Laar, J. M., Matucci-Cerinic, M., Muller-Ladner, U., Distler, O., [Jordan, S. -- Distler, O.] Univ Zurich Hosp, Dept Rheumatol, CH-8091 Zurich, Switzerland -- [Distler, J. H. W.] Univ Erlangen Nurnberg, Dept Rheumatol, Erlangen, Germany -- [Airo, P.] Spedali Civil Brescia, Unit Rheumatol & Clin Immunol, I-25125 Brescia, Italy -- [Alegre-Sancho, J. J.] Hosp Univ Dr Peset Valencia, Valencia, Spain -- [Allanore, Y.] Univ Paris 05, Paris, France -- [Allanore, Y.] Hop Cochin, Serv Rhumatol A, F-75674 Paris, France -- [Gurman, A. Balbir] Rambam Hlth Care Campus, B Shine Rheumatol Unit, Haifa, Israel -- [Caporali, R.] Univ Pavia, Div Rheumatol, IRCCS S, Matteo Fdn, I-27100 Pavia, Italy -- [Caramaschi, P.] Rheumatol Unit, Verona, Italy -- [Carreira, P. E.] Hosp Univ 12 Octubre, Serv Reumatol, Madrid, Spain -- [Chizzolini, C.] Univ Hosp Geneva, Geneva, Switzerland -- [Cutolo, M.] Univ Genoa, Dept Internal Med, Res Lab, I-16126 Genoa, Italy -- [Cutolo, M.] Univ Genoa, Dept Internal Med, Acad Unit Clin Rheumatol, I-16126 Genoa, Italy -- [Duruoz, M. Tuncay] Celal Bayar Univ, Sch Med, PM&R Dept, Div Rheumatol, Manisa, Turkey -- [Farge-Bancel, D.] Hop St Louis, INSERM, U976, Serv Med Interne & Pathol Vasc, Paris, France -- [Hesselstrand, R.] Univ Lund Hosp, Dept Rheumatol, S-22185 Lund, Sweden -- [Iannone, F.] Univ Bari, Rheumatol Unit, DiMIMP, I-70121 Bari, Italy -- [De Keyser, F. -- Smith, V.] Ghent Univ Hosp, Dept Rheumatol, Ghent, Belgium -- [Kucharz, E. J.] Med Univ Silesia, Dept Internal Med & Rheumatol, Katowice, Poland -- [Launay, D.] Univ Lille 2, Dept Internal Med, Lille, France -- [de la Pena Lefebvre, P. Garcia] Hosp Univ Madrid Norte Sanchinarro, Madrid, Spain -- [Lukacova, O. -- Rovensky, J.] Natl Inst Rheumat Dis, Piestany, Slovakia -- [Marasini, B.] Univ Milan, Ist Clin Humanitas, I-20122 Milan, Italy -- [Martinovic, D. -- Radic, M.] Univ Hosp Split, Dept Rheumatol, Split, Croatia -- [Marques Neto, J. F.] Univ Estadual Campinas, FCM, Campinas, Brazil -- [Rednic, S.] Univ Med & Pharm Iuliu Hatieganu Cluj, Clin Reumatol, Cluj Napoca, Romania -- [Riemekasten, G.] Charite, Med Klin Schwerpunkt Rheumatol & Klin Immunol, D-13353 Berlin, Germany -- [Seidel, M. F.] Med Klin & Poliklin 1, Bonn, Germany -- [Senel, S.] Cumhuriyet Univ, Sch Med, Div Rheumatol, Sivas, Turkey -- [Sunderkoetter, C.] Univ Hosp Munster, Dept Dermatol, Munster, Germany -- [Ton, E.] Univ Med Ctr Utrecht, Dept Rheumatol & Clin Immunol, Utrecht, Netherlands -- [van Laar, J. M.] Med Sch Newcastle Upon Tyne, Inst Cellular Med, Musculoskeletal Res Grp, Newcastle Upon Tyne NE2 4HH, Tyne & Wear, England -- [Matucci-Cerinic, M.] Univ Florence, Dept Biomed, Div Rheumatol AOUC, Florence, Italy -- [Mueller-Ladner, U.] Univ Giessen, Dept Rheumatol & Clin Immunol, Kerckhoff Clin Bad Nauheim, Bad Nauheim, Germany, Radic, Mislav -- 0000-0003-0350-6800, Launay, David -- 0000-0003-1840-1817, Duruoz, Mehmet Tuncay -- 0000-0003-3584-2788, Carreira, Patricia -- 0000-0001-8279-3806, and Iannone, Florenzo -- 0000-0003-0474-5344
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fibrosis ,scleroderma ,TNF-alpha - Abstract
WOS: 000291117200007, PubMed ID: 21586217, Objective: To obtain experiences and expert opinion on treatment of SSc patients with TNF-alpha antagonists. Methods: An investigation was carried out among the EUSTAR centres into their expertise on use of TNF-alpha antagonists. Assessment forms on the frequency of TNF-alpha inhibitor use were distributed to EULAR Scleroderma Trials and Research Group (EUSTAR) centres. Afterwards, a three round Delphi exercise was performed to obtain expert consensus on the use of TNF-alpha inhibitors in SSc. Results: Seventy-nine centres returned information on use of TNF-alpha antagonists in SSc patients. A total of 65 patients were treated with TNF-alpha inhibitors in 14 different centres. Forty-eight of the 65 patients treated with TNF-alpha inhibitors improved. Improvement was mainly seen in patients with arthritis, whereas the effects on fibrosis varied. In the first round of the subsequent Delphi approach, 71 out of 79 experts stated that they would use TNF-alpha antagonists in SSc. Arthritis was suggested as an indication for TNF alpha antagonists by 75% of the experts. However; after the third stage of the Delphi exercise, the acceptance for the off-label use of TNF-alpha antagonists decreased and 59% recommended that TNF-alpha antagonists should not be used or only used in clinical trials in SSc patients, while 38% of the experts suggested the use of TNF-alpha antagonists for arthritis associated with SSc. Conclusions: Most of the experts do not recommend the routine use of TNF-alpha antagonists in systemic sclerosis. Arthritis might be a potential indication in SSc, although controlled clinical trials with TNF-alpha antagonists are needed before general recommendations can be given., Novartis; Bayer Schering Pharma; Cell Gen Therapeutics; NicOx; Array BioPharma; Bristol-Myers Squibb; Ergonex Pharma GmbH; Actelion Pharmaceuticals; Pfizer; GlaxoSmithKline; Merck; Amgen; Abbott; Roche; EUSTAR/EULAR; Sanofi-Aventis; United BioSource Corporation; Medac; Biovitrium; Active Biotech; Ergonex, Dr Jorg Distler has served as a consultant for Actelion Pharmaceuticals, Pfizer, and GlaxoSmithKline; has received grant support from Novartis, Bayer Schering Pharma, Cell Gen Therapeutics, NicOx, Array BioPharma, Bristol-Myers Squibb, and Ergonex Pharma GmbH; has received payment for development of educational presentations (including service on speakers' bureaus) from Actelion Pharmaceuticals, Pfizer, GlaxoSmithKline, and Bayer Schering Pharma.; Dr F. lannone has received speaker's and consultancy fees from Merck.; Dr Riemekasten has been invited for a meeting by Humira-People (Amgen) and has received speaker's fees and support for travel costs riembursed by Amgen.; Dr M.F. Seidel has received research grants from Pfizer and Abbott.; Dr J. van Laar has received speaker's and consultancy fees and research grants from Roche.; Dr U. Muller-Ladner has received research grants from EUSTAR/EULAR.; Dr Oliver Distler has a consultancy relationship and/or has received research funding from Actelion Pharmaceuticals, Pfizer, Ergonex Pharma GmbH, Bristol-Myers Squibb, Sanofi-Aventis, United BioSource Corporation, Medac, Biovitrium, Novartis and Active Biotech in the area of potential treatments of scleroderma and its complications. He has received lecture honoraria from Actelion Pharmaceuticals, Pfizer and Ergonex.