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101. Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials

Author

Saketkoo, Lesley Ann, primary, Mittoo, Shikha, additional, Huscher, Dörte, additional, Khanna, Dinesh, additional, Dellaripa, Paul F, additional, Distler, Oliver, additional, Flaherty, Kevin R, additional, Frankel, Sid, additional, Oddis, Chester V, additional, Denton, Christopher P, additional, Fischer, Aryeh, additional, Kowal-Bielecka, Otylia M, additional, LeSage, Daphne, additional, Merkel, Peter A, additional, Phillips, Kristine, additional, Pittrow, David, additional, Swigris, Jeffrey, additional, Antoniou, Katerina, additional, Baughman, Robert P, additional, Castelino, Flavia V, additional, Christmann, Romy B, additional, Christopher-Stine, Lisa, additional, Collard, Harold R, additional, Cottin, Vincent, additional, Danoff, Sonye, additional, Highland, Kristin B, additional, Hummers, Laura, additional, Shah, Ami A, additional, Kim, Dong Soon, additional, Lynch, David A, additional, Miller, Frederick W, additional, Proudman, Susanna M, additional, Richeldi, Luca, additional, Ryu, Jay H, additional, Sandorfi, Nora, additional, Sarver, Catherine, additional, Wells, Athol U, additional, Strand, Vibeke, additional, Matteson, Eric L, additional, Brown, Kevin K, additional, and Seibold, James R, additional

Published
2013
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102. Reliability and validity of the University of California, Los Angeles scleroderma clinical trial consortium gastrointestinal tract instrument

Author

University of Michigan Scleroderma Program, Ann Arbor, University of California, Los Angeles ; Division of Rheumatology, Department of Medicine, David Geffen School of Medicine, 1000 Veteran Avenue, Room 32-59, Rehabilitation Building, Los Angeles, CA 90095, University of California, Los Angeles, and RAND Corporation, Santa Monica, California, University of California, Los Angeles, University of Texas, Houston ; Dr. Mayes has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Novartis and United Therapeutics, and (more than $10,000) from Actelion., Assiut University Hospital, Assiut, Egypt, Khanna, Dinesh, Hays, Ron D., Maranian, Paul, Seibold, James R., Impens, Ann, Mayes, Maureen D., Clements, Philip J., Getzug, Terri, Fathi, Nihal, Bechtel, Amber, Furst, Daniel E., University of Michigan Scleroderma Program, Ann Arbor, University of California, Los Angeles ; Division of Rheumatology, Department of Medicine, David Geffen School of Medicine, 1000 Veteran Avenue, Room 32-59, Rehabilitation Building, Los Angeles, CA 90095, University of California, Los Angeles, and RAND Corporation, Santa Monica, California, University of California, Los Angeles, University of Texas, Houston ; Dr. Mayes has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Novartis and United Therapeutics, and (more than $10,000) from Actelion., Assiut University Hospital, Assiut, Egypt, Khanna, Dinesh, Hays, Ron D., Maranian, Paul, Seibold, James R., Impens, Ann, Mayes, Maureen D., Clements, Philip J., Getzug, Terri, Fathi, Nihal, Bechtel, Amber, and Furst, Daniel E.

Abstract

Objective To refine the previously developed scleroderma (systemic sclerosis [SSc]) gastrointestinal tract (GIT) instrument (SSC-GIT 1.0). Methods We administered the SSC-GIT 1.0 and the Short Form 36 to 152 patients with SSc; 1 item was added to the SSC-GIT 1.0 to assess rectal incontinence. In addition, subjects completed a rating of the severity of their GIT involvement (from very mild to very severe). Evaluation of psychometric properties included internal consistency reliability, test???retest reliability (mean time interval 1.1 weeks), and multitrait scaling analysis. Results Study participants were mostly women (84%) and white (81%); 55% had diffuse SSc. Self-rated severity of GIT involvement ranged from no symptoms to very mild (39%), mild (21%), moderate (31%), and severe/very severe (9%). Of an initial 53 items in the SSC-GIT 1.0, 19 items were excluded, leaving a 34-item revised instrument (the University of California, Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 [UCLA SCTC GIT 2.0]). Analyses supported 7 multi-item scales: reflux, distention/bloating, diarrhea, fecal soilage, constipation, emotional well-being, and social functioning. Test???retest reliability estimates were ???0.68 and coefficient alphas were ???0.67. Participants who rated their GIT disease as mild had lower scores on a 0???3 scale on all 7 scales. Symptom scales were also able to discriminate subjects with corresponding clinical GIT diagnoses. The Total GIT Score, developed by averaging 6 of 7 scales (excluding constipation), was reliable and provided greater discrimination between mild, moderate, and severe self-rated GIT involvement than individual scales. Conclusion This study provides support for the reliability and validity of the UCLA SCTC GIT 2.0, an improvement over the SSC-GIT 1.0, and supports a Total GIT Score in SSc patients with GIT.

Published
2009

104. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative

Author

van den Hoogen, Frank, primary, Khanna, Dinesh, additional, Fransen, Jaap, additional, Johnson, Sindhu R, additional, Baron, Murray, additional, Tyndall, Alan, additional, Matucci-Cerinic, Marco, additional, Naden, Raymond P, additional, Medsger, Thomas A, additional, Carreira, Patricia E, additional, Riemekasten, Gabriela, additional, Clements, Philip J, additional, Denton, Christopher P, additional, Distler, Oliver, additional, Allanore, Yannick, additional, Furst, Daniel E, additional, Gabrielli, Armando, additional, Mayes, Maureen D, additional, van Laar, Jacob M, additional, Seibold, James R, additional, Czirjak, Laszlo, additional, Steen, Virginia D, additional, Inanc, Murat, additional, Kowal-Bielecka, Otylia, additional, Müller-Ladner, Ulf, additional, Valentini, Gabriele, additional, Veale, Douglas J, additional, Vonk, Madelon C, additional, Walker, Ulrich A, additional, Chung, Lorinda, additional, Collier, David H, additional, Ellen Csuka, Mary, additional, Fessler, Barri J, additional, Guiducci, Serena, additional, Herrick, Ariane, additional, Hsu, Vivien M, additional, Jimenez, Sergio, additional, Kahaleh, Bashar, additional, Merkel, Peter A, additional, Sierakowski, Stanislav, additional, Silver, Richard M, additional, Simms, Robert W, additional, Varga, John, additional, and Pope, Janet E, additional

Published
2013
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105. Open label study of escalating doses of oral treprostinil diethanolamine in patients with systemic sclerosis and digital ischemia: pharmacokinetics and correlation with digital perfusion

Author

Shah, Ami A, primary, Schiopu, Elena, additional, Hummers, Laura K, additional, Wade, Michael, additional, Phillips, Kristine, additional, Anderson, Cynthia, additional, Wise, Robert, additional, Boin, Francesco, additional, Seibold, James R, additional, Wigley, Fredrick, additional, and Rollins, Kristan D, additional

Published
2013
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106. Gastric Antral Vascular Ectasia and Its Clinical Correlates in Patients with Early Diffuse Systemic Sclerosis in the SCOT Trial

Author

Hung, Emily W., primary, Mayes, Maureen D., additional, Sharif, Roozbeh, additional, Assassi, Shervin, additional, Machicao, Victor I., additional, Hosing, Chitra, additional, St. Clair, E. William, additional, Furst, Daniel E., additional, Khanna, Dinesh, additional, Forman, Stephen, additional, Mineishi, Shin, additional, Phillips, Kristine, additional, Seibold, James R., additional, Bredeson, Christopher, additional, Csuka, Mary Ellen, additional, Nash, Richard A., additional, Wener, Mark H., additional, Simms, Robert, additional, Ballen, Karen, additional, Leclercq, Sharon, additional, Storek, Jan, additional, Goldmuntz, Ellen, additional, Welch, Beverly, additional, Keyes-Elstein, Lynette, additional, Castina, Sharon, additional, Crofford, Leslie J., additional, Mcsweeney, Peter, additional, and Sullivan, Keith M., additional

Published
2013
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107. Impact of oral cyclophosphamide on health-related quality of life in patients with active scleroderma lung disease: Results from the scleroderma lung study

Author

University of Michigan, Ann Arbor, University of Cincinnati, Cincinnati, Ohio ; Division of Immunology, Department of Medicine, University of Cincinnati, PO Box 670563, Cincinnati, OH 45267-0563, University of California, Los Angeles, Medical University of South Carolina, Charleston, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, University of Illinois, Chicago, Boston University, Boston, Massachusetts, Boston University, Boston, Massachusetts ; Dr. Simms has received consulting fees, speaking fees, and honoraria (less than $10,000) from Actelion. Dr. Mayes has received honoraria (less than $10,000 each) from Actelion and Encysive. Dr. Mubarak has received consulting fees, speaking fees, and honoraria (less than $10,000 each) from Actelion, Encysive, Myogen, Pfizer, InterMune, and United Therapeutics., Johns Hopkins School of Medicine, Baltimore, Maryland, Georgetown University, Washington, DC, University of Texas–Houston Medical School, Wayne State University, Detroit, Michigan, University of California, San Francisco, University of Alabama, Birmingham, University of Connecticut Health Center, Farmington, Khanna, Dinesh, Yan, Xiaohong, Tashkin, Donald P., Furst, Daniel E., Elashoff, Robert, Roth, Michael D., Silver, Richard, Strange, Charlie, Bolster, Marcy, Seibold, James R., Riley, David J., Hsu, Vivien M., Varga, John, Schraufnagel, Dean E., Theodore, Arthur, Simms, Robert, Wise, Robert, Wigley, Fredrick, White, Barbara, Steen, Virginia, Read, Charles, Mayes, Maureen, Parsley, Ed, Mubarak, Kamal, Connolly, M. Kari, Golden, Jeffrey, Olman, Mitchell, Fessler, Barri, Rothfield, Naomi, Metersky, Mark, Clements, Philip J., University of Michigan, Ann Arbor, University of Cincinnati, Cincinnati, Ohio ; Division of Immunology, Department of Medicine, University of Cincinnati, PO Box 670563, Cincinnati, OH 45267-0563, University of California, Los Angeles, Medical University of South Carolina, Charleston, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, University of Illinois, Chicago, Boston University, Boston, Massachusetts, Boston University, Boston, Massachusetts ; Dr. Simms has received consulting fees, speaking fees, and honoraria (less than $10,000) from Actelion. Dr. Mayes has received honoraria (less than $10,000 each) from Actelion and Encysive. Dr. Mubarak has received consulting fees, speaking fees, and honoraria (less than $10,000 each) from Actelion, Encysive, Myogen, Pfizer, InterMune, and United Therapeutics., Johns Hopkins School of Medicine, Baltimore, Maryland, Georgetown University, Washington, DC, University of Texas–Houston Medical School, Wayne State University, Detroit, Michigan, University of California, San Francisco, University of Alabama, Birmingham, University of Connecticut Health Center, Farmington, Khanna, Dinesh, Yan, Xiaohong, Tashkin, Donald P., Furst, Daniel E., Elashoff, Robert, Roth, Michael D., Silver, Richard, Strange, Charlie, Bolster, Marcy, Seibold, James R., Riley, David J., Hsu, Vivien M., Varga, John, Schraufnagel, Dean E., Theodore, Arthur, Simms, Robert, Wise, Robert, Wigley, Fredrick, White, Barbara, Steen, Virginia, Read, Charles, Mayes, Maureen, Parsley, Ed, Mubarak, Kamal, Connolly, M. Kari, Golden, Jeffrey, Olman, Mitchell, Fessler, Barri, Rothfield, Naomi, Metersky, Mark, and Clements, Philip J.

Abstract

Objective To assess the impact of cyclophosphamide (CYC) on the health-related quality of life (HRQOL) of patients with scleroderma after 12 months of treatment. Methods One hundred fifty-eight subjects participated in the Scleroderma Lung Study, with 79 each randomized to CYC and placebo arms. The study evaluated the results of 3 measures of health status: the Short Form 36 (SF-36), the Health Assessment Questionnaire (HAQ) disability index (DI), and Mahler's dyspnea index, and the results of 1 preference-based measure, the SF-6D. The differences in the HRQOL between the 2 groups at 12 months were calculated using a linear mixed model. Responsiveness was evaluated using the effect size. The proportion of subjects in each treatment group whose scores improved at least as much as or more than the minimum clinically important difference (MCID) in HRQOL measures was assessed. Results After adjustment for baseline scores, differences in the HAQ DI, SF-36 role physical, general health, vitality, role emotional, mental health scales, and SF-36 mental component summary (MCS) score were statistically significant for CYC versus placebo ( P < 0.05). Effect sizes were negligible (<0.20) for all of the scales of the SF-36, HAQ DI, and SF-6D at 12 months. In contrast, a higher proportion of patients who received CYC achieved the MCID compared with placebo in the HAQ DI score (30.9% versus 14.8%), transitional dyspnea index score (46.4% versus 12.7%), SF-36 MCS score (33.3% versus 18.5%), and SF-6D score (21.3% versus 3.8%). Conclusion One year of treatment with CYC leads to an improvement in HRQOL in patients with scleroderma lung disease.

Published
2007

108. Recombinant human anti–transforming growth factor Β1 antibody therapy in systemic sclerosis: A multicenter, randomized, placebo-controlled phase I/II trial of CAT-192

Author

Royal Free Hospital, London, UK ; Boston University School of Medicine, Boston, Massachusetts ; University of California, Los Angeles ; Leeds University, Leeds, UK ; University of Medicine and Dentistry of New Jersey, New Brunswick ; Genzyme, Boston, Massachusetts ; Cambridge Antibody Technology, Cambridge, UK ; Lund University Hospital, Lund, Sweden ; Walsgrave Hospital, Coventry, UK ; University Hospital, Nijmegen, The Netherlands ; Hope Hospital, Salford, UK ; University of Texas Health Science Center at Houston ; St. Vincent's Hospital, Dublin, Ireland ; University of Michigan, Ann Arbor ; Dr. Korn is deceased., University of Michigan, Ann Arbor, Royal Free Hospital, London, UK ; Centre for Rheumatology, Royal Free and University College Medical School, Royal Free Hospital, Pond Street, London NW3 2QG, UK, Boston University School of Medicine, Boston, Massachusetts, University of California, Los Angeles, Leeds University, Leeds, UK, University of Medicine and Dentistry of New Jersey, New Brunswick, Genzyme, Boston, Massachusetts ; Drs. Silliman, Streisand, Haas, and Ledbetter own stock and/or hold stock options in Genzyme. Dr. Powell owns stock and/or holds stock options in Cambridge Antibody Technology. Dr. van den Hoogen has received consulting fees and/or honoraria (less than $10,000 each) from Abbott and Bristol-Myers Squibb. Dr. Mayes has received consulting fees or honoraria (less than $10,000 each) from Actelion, Encysive, and Novartis., Genzyme, Boston, Massachusetts, Cambridge Antibody Technology, Cambridge, UK, Lund University Hospital, Lund, Sweden, Walsgrave Hospital, Coventry, UK, University Hospital, Nijmegen, The Netherlands, Hope Hospital, Salford, UK, University of Texas Health Science Center at Houston, St. Vincent's Hospital, Dublin, Ireland, Royal Free Hospital, London, UK, Denton, Christopher P., Merkel, Peter A., Furst, Daniel E., Khanna, Dinesh, Emery, Paul, Hsu, Vivien M., Silliman, Nancy, Streisand, James, Powell, John, Åkesson, Anita, Coppock, John, Hoogen, Frank van den, Herrick, Ariane, Mayes, Maureen D., Veale, Douglas, Haas, Joanna, Ledbetter, Stephen, Korn, Joseph H., Black, Carol M., Seibold, James R., Royal Free Hospital, London, UK ; Boston University School of Medicine, Boston, Massachusetts ; University of California, Los Angeles ; Leeds University, Leeds, UK ; University of Medicine and Dentistry of New Jersey, New Brunswick ; Genzyme, Boston, Massachusetts ; Cambridge Antibody Technology, Cambridge, UK ; Lund University Hospital, Lund, Sweden ; Walsgrave Hospital, Coventry, UK ; University Hospital, Nijmegen, The Netherlands ; Hope Hospital, Salford, UK ; University of Texas Health Science Center at Houston ; St. Vincent's Hospital, Dublin, Ireland ; University of Michigan, Ann Arbor ; Dr. Korn is deceased., University of Michigan, Ann Arbor, Royal Free Hospital, London, UK ; Centre for Rheumatology, Royal Free and University College Medical School, Royal Free Hospital, Pond Street, London NW3 2QG, UK, Boston University School of Medicine, Boston, Massachusetts, University of California, Los Angeles, Leeds University, Leeds, UK, University of Medicine and Dentistry of New Jersey, New Brunswick, Genzyme, Boston, Massachusetts ; Drs. Silliman, Streisand, Haas, and Ledbetter own stock and/or hold stock options in Genzyme. Dr. Powell owns stock and/or holds stock options in Cambridge Antibody Technology. Dr. van den Hoogen has received consulting fees and/or honoraria (less than $10,000 each) from Abbott and Bristol-Myers Squibb. Dr. Mayes has received consulting fees or honoraria (less than $10,000 each) from Actelion, Encysive, and Novartis., Genzyme, Boston, Massachusetts, Cambridge Antibody Technology, Cambridge, UK, Lund University Hospital, Lund, Sweden, Walsgrave Hospital, Coventry, UK, University Hospital, Nijmegen, The Netherlands, Hope Hospital, Salford, UK, University of Texas Health Science Center at Houston, St. Vincent's Hospital, Dublin, Ireland, Royal Free Hospital, London, UK, Denton, Christopher P., Merkel, Peter A., Furst, Daniel E., Khanna, Dinesh, Emery, Paul, Hsu, Vivien M., Silliman, Nancy, Streisand, James, Powell, John, Åkesson, Anita, Coppock, John, Hoogen, Frank van den, Herrick, Ariane, Mayes, Maureen D., Veale, Douglas, Haas, Joanna, Ledbetter, Stephen, Korn, Joseph H., Black, Carol M., and Seibold, James R.

Abstract

Objective To evaluate CAT-192, a recombinant human antibody that neutralizes transforming growth factor Β1 (TGFΒ1), in the treatment of early-stage diffuse cutaneous systemic sclerosis (dcSSc). Methods Patients with SSc duration of <18 months were randomly assigned to the placebo group or to 1 of 3 CAT-192 treatment groups: 10 mg/kg, 5 mg/kg, 0.5 mg/kg. Infusions were given on day 0 and weeks 6, 12, and 18. The primary objective of this study was to evaluate the safety, tolerability, and pharmacokinetics of CAT-192. Secondary outcomes included the modified Rodnan skin thickness score (MRSS), the Scleroderma Health Assessment Questionnaire, assessment of organ-based disease, serum levels of soluble interleukin-2 receptor, collagen propeptides (N propeptide of type I [PINP] and type III collagen), and tissue levels of messenger RNA for procollagens I and III and for TGFΒ1 and TGFΒ2. Results Forty-five patients were enrolled. There was significant morbidity and mortality, including 1 death in the group receiving 0.5 mg/kg of CAT-192 and 3 deaths in the group receiving 5 mg/kg of CAT-192. There were more adverse events and more serious adverse events in patients receiving CAT-192 than in those receiving placebo, although these events were not more frequent in the high-dose treatment group. The MRSS improved in all groups during the study, but there was no evidence of a treatment effect for CAT-192. Improvement in the MRSS correlated with the disease duration (r = −0.54, P = 0.0008). Changes in the PINP level from baseline correlated with changes in the MRSS (r = 0.37, P = 0.027). Conclusion We report the first evaluation of a systemically administered and repeatedly dosed anti-TGFΒ1 drug. In this pilot study, CAT-192, in doses up to 10 mg/kg, showed no evidence of efficacy. The utility of clinical and biochemical outcome measures and the feasibility of multicenter trials of early dcSSc were confirmed.

Published
2007

109. Reconciling Healthcare Professional and Patient Perspectives in the Development of Disease Activity and Response Criteria in Connective Tissue Disease–related Interstitial Lung Diseases

Author

Saketkoo, Lesley Ann, Mittoo, Shikha, Frankel, Sid, LeSage, Daphne, Sarver, Catherine, Phillips, Kristine, Strand, Vibeke, Matteson, Eric L., Baughman, Robert P., Brown, Kevin K., Christmann, Romy B., Dellaripa, Paul, Denton, Christopher P., Distler, Oliver, Fischer, Aryeh, Flaherty, Kevin, Huscher, Dörte, Khanna, Dinesh, Kowal-Bielecka, Otylia, Merkel, Peter A., Oddis, Chester V., Pittrow, David, Sandorfi, Nora, Seibold, James R., Swigris, Jeffrey, Wells, Athol, Antoniou, Katerina, Castelino, Flavia V., Christopher-Stine, Lisa, Collard, Harold R., Cottin, Vincent, Danoff, Sonye, Hedlund, Robert, Highland, Kristin B., Hummers, Laura, Lynch, David A., Kim, Dong Soon, Ryu, Jay H., Christopher-Stine, Lisa, Miller, Frederick W., Nichols, Karen, Proudman, Susanna M., Richeldi, Luca, Shah, Ami A., van den Assum, Pieter, Aggarwal, Rohit, Ainslie, Gillian, Alkassab, Firas, Allanore, Yannick, Anderson, Marina E., Andonopoulos, Andrew P., Antin-Ozerkis, Danielle, Antoniou, Katerina, Arrobas, Ana, Ascherman, Dana P., Assassi, Shervin, Baron, Murray, Bathon, Joan M., Baughman, Robert P., Behr, Juergen, Beretta, Lorenzo, Bingham, Clifton O., Binnie, Matthew, Birring, Surinder S., Boin, Francesco, Bongartz, Tim, Bourdin, Arnaud, Bouros, Demosthenes, Brasington, Richard, Bresser, Paul, Brown, Kevin K., Buch, Maya H., Burge, P. Sherwood, Carmona, Loreto, Castelino, Flavia V., Carreira, Patricia E., Carvalho, Carlos R.R., Catoggio, Luis J., Chan, Kevin M., Chapman, Jeffrey, Chatterjee, Soumya, Christmann, Romy B., Christopher-Stine, Lisa, Chua, Felix, Chung, Lorinda, Conron, Matthew, Corte, Tamera, Cosgrove, Gregory, Costabel, Ulrich, Cottin, Vincent, Cox, Gerard, Crestani, Bruno, Crofford, Leslie J., Csuka, Mary E., Curbelo, Pablo, Czirják, László, Daniil, Zoe, Danoff, Sonye, D’Arsigny, Christine L., Davis, Gerald S., de Andrade, Joao A., Dellaripa, Paul F., De Vuyst, Paul, Dempsey, Owen J., Denton, Christopher P., Derk, Chris T., Distler, Jörg, Distler, Oliver, Dixon, William G., Downey, Gregory, Doyle, Mittie K., Drent, Marjolein, Durairaj, Lakshmi, Emery, Paul, Espinoza, Luis R., Farge, Dominique, Fathi, Maryam, Fell, Charlene D., Fessler, Barri J., Fischer, Aryeh, Fitzgerald, John E., Flaherty, Kevin R., Foeldvari, Ivan, Fox, George A., Frech, Tracy M., Freitas, Sara, Furst, Daniel E., Gabrielli, Armando, García-Vicuña, Rosario, Georgiev, Ognian B., Gerbino, Anthony, Gillisen, Adrian, Gladman, Dafna D., Glassberg, Marilyn, Gochuico, Bernadette R., Gogali, Athena, Goh, Nicole S., Goldberg, Avram, Goldberg, Hilary J., Gourley, Mark F., Griffing, Leroy, Grutters, Jan C., Gunnarsson, Ragnar, Hachulla, Eric, Hall, Frances C., Harari, Sergio, Herrick, Ariane L., Herzog, Erica L., Hesselstrand, Roger, Highland, Kristin, Hirani, Nikhil, Hodgson, Ulla, Hollingsworth, Helen M., Homer, Robert J., Hoyles, Rachel K., Hsu, Vivien M., Hubbard, Richard B., Hummers, Laura, Hunzelmann, Nicolas, Huscher, Dörte, Isasi, Maria Eloisa, Isasi, Elida Susana, Jacobsen, Soren, Jimenez, Sergio A., Johnson, Sindhu R., Jones, Christine H., Kahaleh, Bashar, Kairalla, Ronaldo A., Kalluri, Meena, Kalra, Sanjay, Kaner, Robert J., Khanna, Dinesh, Kim, Dong Soon, Kinder, Brent W., Kiter, Goksel, Klingsberg, Ross C., Kokosi, Maria, Kolb, Martin R.J., Kowal-Bielecka, Otylia M., Kur-Zalewska, Joanna, Kuwana, Masataka, Lake, Fiona R., Lally, Edward V., Lasky, Joseph A., Laurindo, Ileda M., Able, Lawrence, Lee, Peter, Leonard, Colm T., Lien, Dale C., Limper, Andrew H., Liossis, Stamatis-Nick C., Lohr, Kristine M., Loyd, James E., Lundberg, Ingrid E., Mageto, Yolanda N., Maher, Toby M., Mahmud, Tafazzul H., Manganas, Helene, Marie, Isabelle, Marras, Theodore K., Martinez, José Antônio Baddini, Martinez, Fernando J., Mathieu, Alessandro, Matucci-Cerinic, Marco, Mayes, Maureen D., McKown, Kevin M., Medsger, Thomas A., Meehan, Richard T., Mendes, Ana Cristina, Merkel, Peter A., Meyer, Keith C., Millar, Ann B., Miller, Frederick W., Moğulkoç, Nesrin, Molitor, Jerry A., Morais, António, Mouthon, Luc, Müller, Veronika, Müller-Quernheim, Joachim, Nadashkevich, Oleg, Nador, Roland, Nash, Peter, Nathan, Steven D., Navarro, Carmen, Neves, Sofia, Noth, Imre, Nunes, Hilario, Oddis, Chester V., Olson, Amy L., Opitz, Christian F., Padilla, Maria, Pappas, Dimitrios, Parfrey, Helen, Pego-Reigosa, José M., Pereira, Carlos A.C., Perez, Rafael, Phillips, Kristine, Pittrow, David, Pope, Janet E., Porter, Joanna C., Proudman, Susanna M., Renzoni, Elisabeth A., Richeldi, Luca, Riemekasten, Gabriela, Riley, David J., Rischmueller, Maureen, Rodriguez-Reyna, Tatiana S., Rojas-Serrano, J., Roman, Jesse, Rosen, Glenn D., Rossman, Milton, Rothfield, Naomi, Ryu, Jay H., Sahn, Steven A., Sandorfi, Nora, Sanduzzi, Alessandro, Scholand, Mary Beth, Seibold, James R., Selman, Moises, Senécal, Jean-Luc, Seo, Philip, Shah, Ami, Silver, Richard M., Solomon, Joshua J., Steen, Virginia, Stevens, Wendy, Strange, Charlie, Sussman, Robert, Sutton, Evelyn D., Sweiss, Nadera J., Swigris, Jeffrey, Tornling, Göran, Tzelepis, George E., Undurraga, Alvaro, Vacca, Allessandra, Vancheri, Carlo, Varga, Janos, Veale, Douglas J., Volkov, Suncica, Walker, Ulrich A., Wells, Athol U., Wencel, Mark, Wesselius, Lewis J., Wickremasinghe, Melissa, Wilcox, Pearce, Wilsher, Margaret L., Wollheim, Frank A., Wuyts, Wim A., Yung, Gordon, Zanon, Pietro, Zappala, Christopher J., Groshong, Steve D., Leslie, Kevin O., Myers, Jeffrey L., Padera, Robert F., Desai, Sujal R., Goldin, Jonathan, Kazerooni, Ella A., Klein, Jeffrey S., Lynch, David A., and Keen, Kevin J.

Abstract

Interstitial lung diseases (ILD), including those related to connective tissue disease (CTD), and idiopathic pulmonary fibrosis (IPF) carry high morbidity and mortality. Great efforts are under way to develop and investigate meaningful treatments in the context of clinical trials. However, efforts have been challenged by a lack of validated outcome measures and by inconsistent use of measures in clinical trials. Lack of consensus has fragmented effective use of strategies in CTD-ILD and IPF, with a history of resultant difficulties in obtaining agency approval of treatment interventions. Until recently, the patient perspective to determine domains and outcome measures in CTD-ILD and IPF had never been applied. Efforts described here demonstrate unequivocally the value and influence of patient involvement on core set development. Regarding CTD-ILD, this is the first OMERACT working group to directly address a manifestation/comorbidity of a rheumatic disease (ILD) as well as a disease not considered rheumatic (IPF). The OMERACT 11 proceedings of the CTD-ILD Working Group describe the forward and lateral process to include both the medical and patient perspectives in the urgently needed identification of a core set of preliminary domains and outcome measures in CTD-ILD and IPF.

Published
2014
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110. Developing A Disease Activity And Therapeutic Response Index In Connective Tissue Disease Related Interstitial Lung Disease: Results From A Delphi Exercise: Consensus On Domains

Author

Saketkoo, Lesley Ann, primary, Huscher, Dörte, additional, Khanna, Dinesh, additional, Dellaripa, Paul, additional, Flaherty, Kevin R., additional, Matteson, Eric L., additional, Oddis, Chester V., additional, Phillips, Kristine, additional, Wells, Athol, additional, Denton, Christopher P., additional, Distler, Oliver, additional, Kowal-Bielecka, Otylia M., additional, Pittrow, David, additional, Strand, Vibeke, additional, Seibold, James R., additional, and Brown, Kevin K., additional

Published
2012
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111. Items for developing revised classification criteria in systemic sclerosis: Results of a consensus exercise

Author

Fransen, Jaap, primary, Johnson, Sindhu R., additional, van den Hoogen, Frank, additional, Baron, Murray, additional, Allanore, Yannick, additional, Carreira, Patricia E., additional, Czirják, László, additional, Denton, Christopher P., additional, Distler, Oliver, additional, Furst, Daniel E., additional, Gabrielli, Armando, additional, Herrick, Ariane, additional, Inanc, Murat, additional, Kahaleh, Bashar, additional, Kowal‐Bielecka, Otylia, additional, Medsger, Thomas A., additional, Mueller‐Ladner, Ulf, additional, Riemekasten, Gabriela, additional, Sierakowski, Stanislaw, additional, Valentini, Gabriele, additional, Veale, Doug, additional, Vonk, Madelon C., additional, Walker, Ulrich, additional, Chung, Lorinda, additional, Clements, Philip J., additional, Collier, David H., additional, Csuka, Mary E., additional, Jimenez, Sergio, additional, Merkel, Peter A., additional, Seibold, James R., additional, Silver, Richard, additional, Steen, Virginia, additional, Tyndall, Alan, additional, Matucci‐Cerinic, Marco, additional, Pope, Janet E., additional, and Khanna, Dinesh, additional

Published
2012
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112. Analysis of the Validation Status of Quality of Life and Functional Disability Measures in Pulmonary Arterial Hypertension Related to Systemic Sclerosis: Results of a Systematic Literature Analysis by the Expert Panel on Outcomes Measures in Pulmonary Arterial Hypertension Related to Systemic Sclerosis (EPOSS)

Author

KOWAL-BIELECKA, OTYLIA, primary, AVOUAC, JEROME, additional, PITTROW, DAVID, additional, HUSCHER, DOERTE, additional, BEHRENS, FRANK, additional, DENTON, CHRISTOPHER P., additional, FOELDVARI, IVAN, additional, HUMBERT, MARC, additional, MATUCCI-CERINIC, MARCO, additional, NASH, PETER, additional, OPITZ, CHRISTIAN F., additional, RUBIN, LEWIS J., additional, SEIBOLD, JAMES R., additional, STRAND, VIBEKE, additional, FURST, DANIEL E., additional, and DISTLER, OLIVER, additional

Published
2011
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115. Systemic sclerosis-associated pulmonary hypertension: why disease-specific composite endpoints are needed

Author

Denton, Christopher P, primary, Avouac, Jerome, additional, Behrens, Frank, additional, Furst, Daniel E, additional, Foeldvari, Ivan, additional, Humbert, Marc, additional, Huscher, Doerte, additional, Kowal-Bielecka, Otylia, additional, Matucci-Cerinic, Marco, additional, Nash, Peter, additional, Opitz, Christian F, additional, Pittrow, David, additional, Rubin, Lewis J, additional, Seibold, James R, additional, and Distler, Oliver, additional

Published
2011
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116. Reply

Author

Seibold, James R., primary and Matucci-Cerinic, Marco, additional

Published
2010
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117. Echocardiography as an Outcome Measure in Scleroderma-related Pulmonary Arterial Hypertension: A Systematic Literature Analysis by the EPOSS Group

Author

KOWAL-BIELECKA, OTYLIA, primary, AVOUAC, JEROME, additional, PITTROW, DAVID, additional, HUSCHER, DOERTE, additional, BEHRENS, FRANK, additional, DENTON, CHRISTOPHER P., additional, FOELDVARI, IVAN, additional, HUMBERT, MARC, additional, MATUCCI-CERINIC, MARCO, additional, NASH, PETER, additional, OPITZ, CHRISTIAN F., additional, RUBIN, LEWIS J., additional, SEIBOLD, JAMES R., additional, STRAND, VIBEKE, additional, FURST, DANIEL E., additional, and DISTLER, OLIVER, additional

Published
2009
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118. Measures of Response in Clinical Trials of Systemic Sclerosis: The Combined Response Index for Systemic Sclerosis (CRISS) and Outcome Measures in Pulmonary Arterial Hypertension Related to Systemic Sclerosis (EPOSS)

Author

KHANNA, DINESH, primary, DISTLER, OLIVER, additional, AVOUAC, JEROME, additional, BEHRENS, FRANK, additional, CLEMENTS, PHILIP J., additional, DENTON, CHRISTOPHER, additional, FOELDVARI, IVAN, additional, GIANNINI, EDWARD, additional, HUSCHER, DOERTE, additional, KOWAL-BIELECKA, OTYLIA, additional, LOVELL, DANIEL, additional, MATUCCI-CERINIC, MARCO, additional, MAYES, MAUREEN, additional, MERKEL, PETER A., additional, NASH, PETER, additional, OPITZ, CHRISTIAN F., additional, PITTROW, DAVID, additional, RUBIN, LEWIS, additional, SEIBOLD, JAMES R., additional, STEEN, VIRGINIA, additional, STRAND, C. VIBEKE, additional, TUGWELL, PETER S., additional, VARGA, JOHN, additional, ZINK, ANGELA, additional, and FURST, DANIEL E., additional

Published
2009
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128. Systemic Sclerosis.

Author

Klippel, John H., Stone, John H., Crofford, Leslie J., White, Patience H., Buch, Maya H., and Seibold, James R.

Abstract

Systemic sclerosis (SSc; scleroderma) targets several aspects of disease pathophysiology: vascular features that are currently highly treatable; inflammatory features that are currently partly amenable to therapy; fibrotic features for which therapies of modest efficacy (at best) exist; and atrophic, end organ damage for which only supportive therapy is available.The extent of skin involvement is neither a robust primary outcome measure for clinical trials nor a reliable guide to the therapy of individual patients.Regular pulmonary function testing is a cornerstone of assessment.Continuous intravenous epoprostenol, subcutaneous or intravenous treprostinil, and bosentan all have important roles in selected patients with pulmonary arterial hypertension.Early recognition of scleroderma renal crisis (SRC) and prompt treatment with angiotensin-converting enzyme (ACE) inhibitors has improved outcomes in SRC dramatically.Cyclophosphamide is a cornerstone of interstitial lung disease treatment in SSc, but the therapeutic gains from this agent are relatively small.■ Long-term proton-pump inhibition is highly effective in treating the gastroesophageal reflux. High doses, sometimes two to three times the normal therapeutic dose, are required to alleviate symptoms. [ABSTRACT FROM AUTHOR]

Published
2008
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132. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative.

Author

den Hoogen, Frank van, Khanna, Dinesh, Fransen, Jaap, Johnson, Sindhu R., Baron, Murray, Tyndall, Alan, Matucci-Cerinic, Marco, Naden, Raymond P., Medsger Jr., Thomas A., Carreira, Patricia E., Riemekasten, Gabriela, Clements, Philip J., Denton, Christopher P., Distler, Oliver, Allanore, Yannick, Furst, Daniel E., Gabrielli, Armando, Mayes, Maureen D., van Laar, Jacob M., and Seibold, James R.

Abstract

Objective The 1980 American College of Rheumatology (ACR) classification criteria for systemic sclerosis (SSc) lack sensitivity for early SSc and limited cutaneous SSc. The present work, by a joint committee of the ACR and the European League Against Rheumatism (EULAR), was undertaken for the purpose of developing new classification criteria for SSc. Methods Using consensus methods, 23 candidate items were arranged in a multicriteria additive point system with a threshold to classify cases as SSc. The classification system was reduced by clustering items and simplifying weights. The system was tested by (1) determining specificity and sensitivity in SSc cases and controls with scleroderma-like disorders, and (2) validating against the combined view of a group of experts on a set of cases with or without SSc. Results It was determined that skin thickening of the fingers extending proximal to the metacarpophalangeal joints is sufficient for the patient to be classified as having SSc; if that is not present, seven additive items apply, with varying weights for each: skin thickening of the fingers, fingertip lesions, telangiectasia, abnormal nailfold capillaries, interstitial lung disease or pulmonary arterial hypertension, Raynaud's phenomenon, and SSc-related autoantibodies. Sensitivity and specificity in the validation sample were, respectively, 0.91 and 0.92 for the new classification criteria and 0.75 and 0.72 for the 1980 ACR classification criteria. All selected cases were classified in accordance with consensus-based expert opinion. All cases classified as SSc according to the 1980 ACR criteria were classified as SSc with the new criteria, and several additional cases were now considered to be SSc. Conclusions The ACR/EULAR classification criteria for SSc performed better than the 1980 ACR criteria for SSc and should allow for more patients to be classified correctly as having the disease. [ABSTRACT FROM AUTHOR]

Published
2013
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133. 2013 Classification Criteria for Systemic Sclerosis: An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative.

Author

Hoogen, Frank, Khanna, Dinesh, Fransen, Jaap, Johnson, Sindhu R., Baron, Murray, Tyndall, Alan, Matucci‐Cerinic, Marco, Naden, Raymond P., Medsger, Thomas A., Carreira, Patricia E., Riemekasten, Gabriela, Clements, Philip J., Denton, Christopher P., Distler, Oliver, Allanore, Yannick, Furst, Daniel E., Gabrielli, Armando, Mayes, Maureen D., Laar, Jacob M., and Seibold, James R.

Subjects
ACADEMIC medical centers, ASSOCIATIONS, institutions, etc., CHI-squared test, RESEARCH evaluation, RESEARCH funding, RHEUMATISM, DATA analysis, SYSTEMIC scleroderma, SEVERITY of illness index, DIAGNOSIS
Abstract

Objective The 1980 American College of Rheumatology (ACR) classification criteria for systemic sclerosis (SSc) lack sensitivity for early SSc and limited cutaneous SSc. The present work, by a joint committee of the ACR and the European League Against Rheumatism (EULAR), was undertaken for the purpose of developing new classification criteria for SSc. Methods Using consensus methods, 23 candidate items were arranged in a multicriteria additive point system with a threshold to classify cases as SSc. The classification system was reduced by clustering items and simplifying weights. The system was tested by 1) determining specificity and sensitivity in SSc cases and controls with scleroderma-like disorders, and 2) validating against the combined view of a group of experts on a set of cases with or without SSc. Results It was determined that skin thickening of the fingers extending proximal to the metacarpophalangeal joints is sufficient for the patient to be classified as having SSc; if that is not present, 7 additive items apply, with varying weights for each: skin thickening of the fingers, fingertip lesions, telangiectasia, abnormal nailfold capillaries, interstitial lung disease or pulmonary arterial hypertension, Raynaud's phenomenon, and SSc-related autoantibodies. Sensitivity and specificity in the validation sample were, respectively, 0.91 and 0.92 for the new classification criteria and 0.75 and 0.72 for the 1980 ACR classification criteria. All selected cases were classified in accordance with consensus-based expert opinion. All cases classified as SSc according to the 1980 ACR criteria were classified as SSc with the new criteria, and several additional cases were now considered to be SSc. Conclusion The ACR/EULAR classification criteria for SSc performed better than the 1980 ACR criteria for SSc and should allow for more patients to be classified correctly as having the disease. [ABSTRACT FROM AUTHOR]

Published
2013
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137. Serum antibody to retroviral gag proteins in systemic sclerosis

Author

Dang, Howard, Dauphinee, Michael J., Talal, Norman, Garry, Robert F., Seibold, James R., Medsger, Thomas A., Jr., and Alexander, Steven

Subjects
Systemic scleroderma -- Physiological aspects, Retroviruses -- Physiological aspects, Health
Abstract

Retroviruses are different from other organisms in the way that genetic material is copied. In most organisms, the information from DNA, the type of genetic material in chromosomes, is copied into RNA, the genetic material from which the information for protein structures is derived. However, retroviruses chiefly carry their information in RNA and induce host organisms to copy DNA from the viral RNA structure. Human immunodeficiency virus, the cause of AIDS, is the most well known retrovirus. Previous studies have found that patients with diseases such as Sjogren's syndrome had antibodies to a protein found in HIV, indicating exposure to the virus or to a protein that is very similar to the HIV protein. Sjogren's syndrome is one of the autoimmune disorders that leads to the formation of antibodies against the body's molecules. Blood samples from 115 patients with systemic sclerosis (SSc; scleroderma), another autoimmune disorder, were evaluated for the presence of antibodies against two retroviral proteins. Antibodies were present, chiefly against one protein known as p24gag, in 19 patients, and this was strongly associated with diffuse skin involvement. Exposure to HIV virus seems unlikely in these patients. Antibody formation may have been provoked by exposure to a protein similar to the viral protein of HIV. Alternatively, antibody-producing cells may have proliferated independently of exposure to a protein. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1991

149. Anti-Fibrillarin Antibody in African American Patients with Systemic Sclerosis: Immunogenetics, Clinical Features, and Survival Analysis.

Author

Sharif, Roozbeh, Fritzler, Marvin J., Mayes, Maureen D., Gonzalez, Emilio B., McNearney, Terry A., Draeger, Hilda, Baron, Murray, Furst, Daniel E., Khanna, Dinesh K., Del Junco, Deborah J., Molitor, Jerry A., Schiopu, Elena, Phillips, Kristine, Seibold, James R., Silver, Richard M., Simms, Robert W., Perry, Marilyn, Rojo, Carlos, Charles, Julio, and Xiaodong Zhou

Published
2011
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