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3. Risk loci involved in giant cell arteritis susceptibility: a genome-wide association study

Author

Callejas, José Luis, Caminal-Montero, Luis, Corbera-Bellalta, Marc, de Miguel, Eugenio, Díaz-López, J. Bernardino, García-Villanueva, María Jesús, Gómez-Vaquero, Carmen, Guijarro-Rojas, Mercedes, Hidalgo-Conde, Ana, Marí-Alfonso, Begoña, Martínez-Berriochoa, Agustín, Morado, Inmaculada C., Narváez, Javier, Ramentol-Sintas, Marc, Martínez-Zapico, Aleida, Martínez-Taboada, Víctor Manuel, Miranda-Filloy, José A., Monfort, Jordi, Pérez-Conesa, Mercedes, Prieto-González, Sergio, Raya, Enrique, Ríos-Fenández, Raquel, Sánchez-Martín, Julio, Sopeña, Bernardo, Tío, Laura, Unzurrunzaga, Ainhoa, Wordsworth, Oliver, Whitwell, Isobel, Brock, Jessica, Douglas, Victoria, Hettiarachchi, Chamila, Bartholomew, Jacqui, Jarrett, Stephen, Smithson, Gayle, Green, Michael, Brown, Pearl Clark, Lawson, Cathy, Gordon, Esther, Lane, Suzanne, Francis, Rebecca, Dasgupta, Bhaskar, Masunda, Bridgett, Calver, Jo, Patel, Yusuf, Thompson, Charlotte, Gregory, Louise, Levy, Sarah, Menon, Ajit, Thompson, Amy, Dyche, Lisa, Martin, Michael, Li, Charles, Laxminarayan, Ramasharan, Wilcox, Louise, de Guzman, Ralph, Isaacs, John, Lorenzi, Alice, Farley, Ross, Hinchcliffe-Hume, Helain, Bejarano, Victoria, Hope, Susan, Nandi, Pradip, Stockham, Lynne, Wilde, Catherine, Durrant, Donna, Lloyd, Mark, Ye, Chee-Seng, Stevens, Rob, Jilani, Amjad, Collins, David, Pegler, Suzannah, Rivett, Ali, Price, Liz, McHugh, Neil, Skeoch, Sarah, O'Kane, Diana, Kirkwood, Sue, Vadivelu, Saravanan, Pugmire, Susan, Sultan, Shabina, Dooks, Emma, Armstrong, Lisa, Sadik, Hala, Nandagudi, Anupama, Abioye, Tolu, Ramos, Angelo, Gumus, Steph, Sofat, Nidhi, Harrison, Abiola, Seward, Abi, Mollan, Susan, Rahan, Ray, Hawkins, Helen, Emsley, Hedley, Bhargava, Anna, Fleming, Vicki, Hare, Marianne, Raj, Sonia, George, Emmanuel, Allen, Nicola, Hunter, Karl, O'Sullivan, Eoin, Bird, Georgina, Magliano, Malgorzata, Manzo, Katarina, Sanghera, Bobbie, Hutchinson, David, Hammonds, Fiona, Sharma, Poonam, Cooper, Richard, McLintock, Graeme, Al-Saffar, Zaid S., Green, Mike, Elliott, Kerry, Neale, Tania, Mallinson, Janine, Lanyon, Peter, Pradere, Marie-Josephe, Jordan, Natasha, Htut, Ei Phyu, Mushapaidzi, Thelma, Abercrombie, Donna, Wright, Sam, Rowlands, Jane, Mukhtyar, Chetan, Kennedy, James, Makkuni, Damodar, Wilhelmsen, Elva, Kouroupis, Michael, John, Lily, Hughes, Rod, Walsh, Margaret, Buckley, Marie, Mackay, Kirsten, Camden-Woodley, Tracey, Redome, Joan, Pearce, Kirsty, Marianayagam, Thiraupathy, Cruz, Carina, Warner, Elizabeth, Atchia, Ishmael, Walker, Claire, Black, Karen, Duffy, Stacey, Fothergill, Lynda, Jefferey, Rebecca, Toomey, Jackie, Rhys-Dillon, Ceril, Pothecary, Carla, Green, Lauren, Toms, Tracey, Maher, Linda, Davis, Diana, Sayan, Amrinder, Thankachen, Mini, Abusalameh, Mahdi, Record, Jessica, Khan, Asad, Stafford, Sam, Hussein, Azza, Williams, Clare, Fletcher, Alison, Johson, Laura, Burnett, Richard, Moots, Robert, Frankland, Helen, Dale, James, Moar, Kirsten, Hollas, Carol, Parker, Ben, Ridings, Derek, Eapen, Sandhya, John, Sindhu, Robson, Jo, Guthrie, Lucy Belle, Fyfe, Rose, Tait, Moira, Marks, Jonathan, Gunter, Emma, Hernandez, Rochelle, Bhat, Smita, Johnston, Paul, Khurshid, Muhammad, Barclay, Charlotte, Kapur, Deepti, Jeffrey, Helen, Hughes, Anna, Slack, Lauren, Thomas, Eleri, Royon, Anna, Hall, Angela, King, Jon, Nyathi, Sindi, Morris, Vanessa, Castelino, Madhura, Hawkins, Ellie, Tomson, Linda, Singh, Animesh, Nunag, Annalyn, O'Connor, Stella, Rushby, Nathan, Hewitson, Nicola, O'Sunmboye, Kenny, Lewszuk, Adam, Boyles, Louise, Perry, Martin, Williams, Emma, Graver, Christine, Defever, Emmanuel, Kamanth, Sanjeet, Kay, Dominic, Ogor, Joe, Winter, Louise, Horton, Sarah, Welch, Gillian, Hollinshead, Kath, Peters, James, Labao, Julius, Dmello, Andrea, Dawson, Julie, Graham, Denise, De Lord, Denise, Deery, Jo, Hazelton, Tracy, Carette, Simon, Chung, Sharon, Cuthbertson, David, Forbess, Lindsy J., Gewurz-Singer, Ora, Hoffman, Gary S., Koening, Curry L., Maksimowicz-McKinnon, Kathleen M., McAlear, Carol A., Moreland, Larry W., Pagnoux, Christian, Seo, Philip, Specks, Ulrich, Spiera, Robert F., Sreih, Antoine, Warrington, Kenneth J., Monach, Paul A., Weisman, Michael, Borrego-Yaniz, Gonzalo, Ortiz-Fernández, Lourdes, Madrid-Paredes, Adela, Kerick, Martin, Hernández-Rodríguez, José, Mackie, Sarah L, Vaglio, Augusto, Castañeda, Santos, Solans, Roser, Mestre-Torres, Jaume, Khalidi, Nader, Langford, Carol A, Ytterberg, Steven, Beretta, Lorenzo, Govoni, Marcello, Emmi, Giacomo, Cimmino, Marco A, Witte, Torsten, Neumann, Thomas, Holle, Julia, Schönau, Verena, Pugnet, Gregory, Papo, Thomas, Haroche, Julien, Mahr, Alfred, Mouthon, Luc, Molberg, Øyvind, Diamantopoulos, Andreas P, Voskuyl, Alexandre, Daikeler, Thomas, Berger, Christoph T, Molloy, Eamonn S, Blockmans, Daniel, van Sleen, Yannick, Iles, Mark, Sorensen, Louise, Luqmani, Raashid, Reynolds, Gary, Bukhari, Marwan, Bhagat, Shweta, Ortego-Centeno, Norberto, Brouwer, Elisabeth, Lamprecht, Peter, Klapa, Sebastian, Salvarani, Carlo, Merkel, Peter A, Cid, María C, González-Gay, Miguel A, Morgan, Ann W, Martin, Javier, and Márquez, Ana

Published
2024
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4. A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis

Author

Schmidt, Wolfgang A., Dasgupta, Bhaskar, Sloane, Jennifer, Giannelou, Angeliki, Xu, Yuqing, Unizony, Sebastian H., Mackie, Sarah L., Gonzalez-Gay, Miguel A., Spiera, Robert, Warrington, Kenneth J., Villiger, Peter M., Nivens, Michael C., Akinlade, Bolanle, Lin, Yong, Buttgereit, Frank, and Stone, John H.

Published
2023
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5. The impact of treatment with avacopan on health-related quality of life in antineutrophil cytoplasmic antibody-associated vasculitis: a post-hoc analysis of data from the ADVOCATE trial

Author

Au Peh, Chen, Chakera, Aron, Cooper, Bruce, Kurtkoti, Jagadeesh, Langguth, Daman, Levidiotis, Vicki, Luxton, Grant, Mount, Peter, Mudge, David, Noble, Euan, Phoon, Richard, Ranganathan, Dwarakanathan, Ritchie, Angus, Ryan, Jessica, Suranyi, Michael, Rosenkranz, Alexander, Lhotta, Karl, Kronbichler, Andreas, Demoulin, Nathalie, Bovy, Christophe, Hellemans, Rachel, Hougardy, Jean-Michel, Sprangers, Ben, Wissing, Karl Martin, Pagnoux, Christian, Barbour, Sean, Brachemi, Soumeya, Cournoyer, Serge, Girard, Louis-Philippe, Laurin, Louis-Philippe, Liang, Patrick, Philibert, David, Walsh, Michael, Tesar, Vladimir, Becvar, Radim, Horak, Pavel, Rychlik, Ivan, Szpirt, Wladimir, Dieperink, Hans, Gregersen, Jon Waarst, Ivarsen, Per, Krarup, Elizabeth, Lyngsoe, Cecilie, Rigothier, Claire, Augusto, Jean-Francois, Belot, Alexandre, Chauveau, Dominique, Cornec, Divi, Jourde-Chiche, Noemie, Ficheux, Maxence, Karras, Alexandre, Klein, Alexandre, Maurier, Francois, Mesbah, Rafik, Moranne, Olivier, Neel, Antoine, Quemeneur, Thomas, Saadoun, David, Terrier, Benjamin, Zaoui, Philippe, Schaier, Matthias, Benck, Urs Tobias, Bergner, Raoul, Busch, Martin, Floege, Juergen, Grundmann, Franziska, Haller, Hermann, Haubitz, Marion, Hellmich, Bernhard, Henes, Joerg Christoph, Hohenstein, Bernd, Hugo, Christian, Iking-Konert, Christof, Arndt, Fabian, Kubacki, T, Kotter, Ina, Lamprecht, Peter, Lindner, Tom, Halbritter, Jan, Mehling, Heidrun, Schönermarck, Ulf, Venhoff, Nils, Vielhauer, Volker, Witzke, Oliver, Szombati, Istvan, Szucs, Gabriella, Garibotto, Giacomo, Alberici, Federico, Brunetta, Enrico, Dagna, Lorenzo, De Vita, Salvatore, Emmi, Giacomo, Gabrielli, Armando, Manenti, Lucio, Pieruzzi, Federico, Roccatello, Dario, Salvarani, Carlo, Harigai, Masayoshi, Dobashi, Hiroaki, Atsumi, Tatsuya, Fujimoto, Shoichi, Hagino, Noboru, Ihata, Atsushi, Kaname, Shinya, Kaneko, Yuko, Katagiri, Akira, Katayama, Masao, Kirino, Yohei, Kitagawa, Kiyoki, Komatsuda, Atsushi, Kono, Hajime, Kurasawa, Takahiko, Matsumura, Ryutaro, Mimura, Toshihide, Morinobu, Akio, Murakawa, Yohko, Naniwa, Taio, Nanki, Toshihiro, Ogawa, Noriyoshi, Oshima, Hisaji, Sada, Kenei, Sugiyama, Eiji, Takeuchi, Tohru, Taki, Hirofumi, Tamura, Naoto, Tsukamoto, Tatsuo, Yamagata, Kunihiro, Yamamura, Masahiro, van Daele, Paulus Leon Arthur, Rutgers, Abraham, Teng, Y.K. Onno, Walker, Robert, Chua, Ignatius, Collins, Michael, Rabindranath, Kannaiyan, de Zoysa, Janak, Svensson, My Hanna Sofia, Grevbo, Bard-Waldum, Kalstad, Synove, Little, Mark, Clarkson, Michael, Molloy, Eamonn, Agraz Pamplona, Irene, Anton, Jordi, Barrio Lucia, Vicente, Ciggaran, Secundino, Cinta Cid, Maria, Diaz Encarnacion, Montserrat, Fulladosa Oliveras, Xavier, Jose Soler, Maria, Marco Rusinol, Helena, Praga, Manuel, Quintana Porras, Luis, Segarra, Alfons, Bruchfeld, Annette, Segelmark, Marten, Soveri, Inga, Thomaidi, Eleni, Westman, Kerstin, Neumann, Thomas, Burnier, Michel, Daikeler, Thomas, Dudler, Jean, Hauser, Thomas, Seeger, Harald, Vogt, Bruno, Burton, James, Al Jayyousi, Reem, Amin, Tania, Andrews, Jacqueline, Baines, Laura Anne, Brogan, Paul, Dasgupta, Bhaskar, Doulton, Timothy William Ronald, Flossmann, Oliver, Griffin, Sian V., Harper, Janice Marian, Harper, Lorraine, Kidder, Dana, Klocke, Rainer, Lanyon, Peter Charles, Luqmani, Raashid, McLaren, John Stuart, Makanjuola, David Osagie, McCann, Liza, Nandagudi, Anupama C., Selvan, Shilpa, O'Riordan, Edmond, Patel, Mumtaz, Patel, Rajan Kantilal, Pusey, Charles Dickson, Rajakariar, Ravindra, Robson, Joanna C., Robson, Michael, Salama, Alan David, Smyth, Lucy, Sznajd, Jan, Taylor, Joanne, Sreih, Antonie G., Belilos, Elise, Bomback, Andrew S., Carlin, Jeffrey, Chang Chen Lin, Yih, Derebail, Vimal K., Dragoi, Serban, Dua, Anisha, Forbess, Lindsy, Geetha, Duvuru, Gipson, Patrick, Gohh, Reginald, Greenwood, Gregory Todd, Hugenberg, Steven T., Jimenez, Richard A.H., Kaskas, Marwan Omar, Kermani, Tanaz, Kivitz, Alan J., Koening, Curry, Langford, Carol A., Marder, Galina, Mohamed, Amr Ahmed El-Huesseini, Monach, Paul, Neyra, Nilda Roxana, Niemer, Gregory W., Niles, John, Obi, Reginald, Owens, Charles, Parks, Deborah L., Podoll, Amber S., Rovin, Brad, Sam, R, Shergy, William Julius, Silva, Arnold Lawrence, Specks, Ulrich, Spiera, Robert, Springer, Jason M., Striebich, Christopher Charles, Swarup, Areena, Thakar, Surabhi, Tiliakos, Athan N., Tsai, Yong, Waguespack, Dia R., Chester Wasko, Mary, Strand, Vibeke, Jayne, David R W, Horomanski, Audra, Yue, Huibin, Bekker, Pirow, and Merkel, Peter A

Published
2023
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6. Patterns of patient-reported symptoms and association with sociodemographic and systemic sclerosis disease characteristics: a scleroderma Patient-centered Intervention Network (SPIN) Cohort cross-sectional study

Author

Adams, Claire E., Henry, Richard S., Fortuné, Catherine, Gottesman, Karen, Guillot, Geneviève, Hummers, Laura K., Lawrie-Jones, Amanda, Mayes, Maureen D., Richard, Michelle, Sauvé, Maureen, Assassi, Shervin, El-Baalbaki, Ghassan, Fligelstone, Kim, Frech, Tracy, Gietzen, Amy, Harel, Daphna, Hinchcliff, Monique, Johnson, Sindhu R., Larche, Maggie, Leite, Catarina, Nguyen, Christelle, Nielsen, Karen, Pope, Janet, Rannou, François, Rodriguez-Reyna, Tatiana Sofia, Schouffoer, Anne A., Suarez-Almazor, Maria E., Agard, Christian, Abdallah, Nassim Ait, André, Marc, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Bruns, Alessandra, Carreira, Patricia, Casadevall, Marion, Chaigne, Benjamin, Chung, Lorinda, Crichi, Benjamin, Denton, Christopher, Domsic, Robyn, Dunne, James V., Dunogue, Bertrand, Fare, Regina, Farge-Bancel, Dominique, Fortin, Paul R., Gordon, Jessica, Granel-Rey, Brigitte, Guffroy, Aurélien, Gyger, Genevieve, Hachulla, Eric, Hoa, Sabrina, Ikic, Alena, Kafaja, Suzanne, Khalidi, Nader, Lakin, Kimberly, Lambert, Marc, Launay, David, Lee, Yvonne C., Maillard, Hélène, Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Lopez, Maria Martin, Martin, Thierry, Masetto, Ariel, Maurier, François, Mekinian, Arsene, Díaz, Sheila Melchor, Nikpour, Mandana, Olagne, Louis, Poindron, Vincent, Proudman, Susanna, Régent, Alexis, Rivière, Sébastien, Robinson, David, Almazar, Esther Rodríguez, Roux, Sophie, Smets, Perrine, Sobanski, Vincent, Spiera, Robert, Steen, Virginia, Sutton, Evelyn, Thorne, Carter, Varga, John, Wilcox, Pearce, Ayala, Mara Cañedo, Cook, Vanessa, Hu, Sophie, Matthews, Bianca, Nassar, Elsa-Lynn, Neyer, Marieke Alexandra, Nordlund, Julia, Provencher, Sabrina, Wojeck, Robyn K., Knisely, Mitchell R., Bailey, Donald E., Somers, Tamara J., Kwakkenbos, Linda, Carrier, Marie-Eve, Nielson, Warren R., Bartlett, Susan J., Malcarne, Vanessa L., Hudson, Marie, Levis, Brooke, Benedetti, Andrea, Mouthon, Luc, Thombs, Brett D., and Silva, Susan G.

Published
2023
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7. Validity, Reliability, and Differential Item Functioning of English and French Versions of the 10‐Item Connor‐Davidson Resilience Scale in Systemic Sclerosis: A Scleroderma Patient‐Centered Intervention Network Cohort Study

Author

Neyer, Marieke A., Henry, Richard S., Carrier, Marie‐Eve, Kwakkenbos, Linda, Wojeck, Robyn K., Gietzen, Amy, Gottesman, Karen, Guillot, Geneviève, Lawrie‐Jones, Amanda, Mayes, Maureen D., Mouthon, Luc, Nielson, Warren R., Richard, Michelle, Worron‐Sauvé, Maureen, Harel, Daphna, Malcarne, Vanessa L., Bartlett, Susan J., Thombs, Brett D., Fortuné, Catherine, Hudson, Marie, Benedetti, Andrea, Hummers, Laura K., Adams, Claire Elizabeth, Ayala, Mara Cañedo, Cook, Vanessa, Hu, Sophie, Matthews, Bianca, Nassar, Elsa‐Lynn, Nordlund, Julia, Provencher, Sabrina, Assassi, Shervin, El‐Baalbaki, Ghassan, Fligelstone, Kim, Frech, Tracy, Hinchcliff, Monique, Johnson, Sindhu R., Larche, Maggie, Khalidi, Nader, Leite, Catarina, Nguyen, Christelle, Rannou, François, Nielsen, Karen, Pope, Janet, Rodriguez‐Reyna, Tatiana Sofia, Schouffoer, Anne A., Suarez‐Almazor, Maria E., Agard, Christian, André, Marc, Olagne, Louis, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Bruns, Alessandra, Masetto, Ariel, Roux, Sophie, Cacciatore, Carlotta, Crichi, Benjamin, Farge‐Bancel, Dominique, Carreira, Patricia, Fare, Regina, Lopez, Maria Martin, Díaz, Sheila Melchor, Almazar, Esther Rodríguez, Casadevall, Marion, Chaigne, Benjamin, Dunogue, Bertrand, Régent, Alexis, Chung, Lorinda, Domsic, Robyn, Dunne, James V., Wilcox, Pearce, Fortin, Paul R., Ikic, Alena, Gordon, Jessica, Lakin, Kimberly, Spiera, Robert, Granel‐Rey, Brigitte, Guffroy, Aurélien, Martin, Thierry, Poindron, Vincent, Gyger, Genevieve, Hachulla, Eric, Hoa, Sabrina, Jones, Niall, Lambert, Marc, Launay, David, Maillard, Hélène, Sobanski, Vincent, Lee, Yvonne C., Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Maurier, François, Mekinian, Arsene, Rivière, Sébastien, Nikpour, Mandana, Proudman, Susanna, Robinson, David, Smets, Perrine, Steen, Virginia, Sutton, Evelyn, and Thorne, Carter

Published
2023
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8. Evaluation of Measurement Properties and Differential Item Functioning in the English and French Versions of the University of California, Los Angeles, Loneliness Scale‐6: A Scleroderma Patient‐Centered Intervention Network (SPIN) Study

Author

S. Rapoport, Chelsea, Choi, Alyssa K., Kwakkenbos, Linda, Carrier, Marie‐Eve, Henry, Richard S., Mouthon, Luc, Roesch, Scott C., Thombs, Brett D., Malcarne, Vanessa L., Fortuné, Catherine, Gietzen, Amy, Guillot, Geneviève, Lewis, Nancy, Nielsen, Karen, Sauvé, Maureen, Richard, Michelle, Welling, Joep, Varga, John, Adams, Claire E., Ayala, Mara Cañedo, Cook, Vanessa, Hu, Sophie, Nassar, Elsa‐Lynn, Neyer, Marieke Alexandra, Nordlund, Julia, Provencher, Sabrina, Bartlett, Susan J., Hudson, Marie, Benedetti, Andrea, Gottesman, Karen, Hummers, Laura K., Lawrie‐Jones, Amanda, Mayes, Maureen D., Assassi, Shervin, Nielson, Warren R., El‐Baalbaki, Ghassan, van den Ende, Cornelia, Fligelstone, Kim, Frech, Tracy, Harel, Daphna, Hinchcliff, Monique, Johnson, Sindhu R., Larche, Maggie, Khalidi, Nader, Leite, Catarina, Nguyen, Christelle, Rannou, François, Pope, Janet, Reyna, Tatiana Sofia Rodriguez, Schouffoer, Anne A., Suarez‐Almazor, Maria E., Agard, Christian, Abdallah, Nassim Ait, Crichi, Benjamin, Farge‐Bancel, Dominique, André, Marc, Olagne, Louis, Smets, Perrine, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Bruns, Alessandra, Masetto, Ariel, Roux, Sophie, Carreira, Patricia, Fare, Regina, Martin, Maria, Díaz, Sheila Melchor, Almazar, Esther Rodríguez, Casadevall, Marion, Chaigne, Benjamin, Dunogue, Bertrand, Régent, Alexis, Chung, Lorinda, Denton, Christopher, Domsic, Robyn, Dunne, James V., Wilcox, Pearce, Fortin, Paul R., Ikic, Alena, Gordon, Jessica, Lakin, Kimberly, Spiera, Robert, Granel‐Rey, Brigitte, Guffroy, Aurélien, Martin, Thierry, Poindron, Vincent, Gyger, Genevieve, Hachulla, Eric, Lambert, Marc, Launay, David, Maillard, Hélène, Sobanski, Vincent, Hoa, Sabrina, Jones, Niall, Kafaja, Suzanne, Lee, Yvonne C., Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Maurier, François, Mekinian, Arsene, Rivière, Sébastien, Nikpour, Mandana, Proudman, Susanna, Robinson, David, Steen, Virginia, Sutton, Evelyn, Thorne, Carter, and Varga, John

Published
2023
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9. Pain levels and associated factors in the Scleroderma Patient-centered Intervention Network (SPIN) cohort: a multicentre cross-sectional study

Author

Henry, Richard S., Gottesman, Karen, Hudson, Marie, Hummers, Laura K., Malcarne, Vanessa L., Mayes, Maureen D., Nielson, Warren R., Riggs, Robert, Assassi, Shervin, El-Baalbaki, Ghassan, Ells, Carolyn, Fligelstone, Kim, Fortuné, Catherine, Frech, Tracy, Gietzen, Amy, Guillot, Geneviève, Harel, Daphna, Hinchcliff, Monique, Johnson, Sindhu R., Larche, Maggie, Leite, Catarina, Nguyen, Christelle, Nielsen, Karen, Pope, Janet, Rannou, François, Richard, Michelle, Rodriguez-Reyna, Tatiana Sofia, Schouffoer, Anne A., Suarez-Almazor, Maria E., Agard, Christian, Ait Abdallah, Nassim, Albert, Alexandra, André, Marc, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Bruns, Alessandra, Carreira, Patricia, Casadevall, Marion, Chaigne, Benjamin, Chung, Lorinda, Correia, Chase, Crichi, Benjamin, Denton, Christopher, Domsic, Robyn, Dunne, James V., Dunogue, Bertrand, Fare, Regina, Farge-Bancel, Dominique, Fortin, Paul R., Gordon, Jessica, Granel-Rey, Brigitte, Gyger, Genevieve, Hachulla, Eric, Herrick, Ariane L, Hoa, Sabrina, Ikic, Alena, Jones, Niall, Kafaja, Suzanne, Khalidi, Nader, Lambert, Marc, Launay, David, Maillard, Hélène, Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Martin, Maria, Martin, Thierry, Masetto, Ariel, Maurier, François, Mekinian, Arsene, Melchor, Sheila, Nikpour, Mandana, Olagne, Louis, Poindron, Vincent, Proudman, Susanna, Régent, Alexis, Rivière, Sébastien, Robinson, David, Rodriguez, Esther, Roux, Sophie, Smets, Perrine, Sobanski, Vincent, Spiera, Robert, Steen, Virginia, Sutton, Evelyn, Thorne, Carter, Wilcox, Pearce, Bourgeault, Angelica, Cañedo Ayala, Mara, Carboni Jiménez, Andrea, Discepola, Marie-Nicole, Gagarine, Maria, Nordlund, Julia, Østbø, Nora, Lee, Yvonne C, Fox, Rina S, Kwakkenbos, Linda, Levis, Brooke, Carrier, Marie-Eve, Welling, Joep, Sauvé, Maureen, Mouthon, Luc, Benedetti, Andrea, Bartlett, Susan J, Varga, John, and Thombs, Brett D

Published
2021
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12. Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients

Author

Fortuné, Catherine, Gietzen, Amy, Guillot, Geneviève, Lewis, Nancy, Nielsen, Karen, Richard, Michelle, Sauvé, Maureen, Welling, Joep, Baron, Murray, Furst, Daniel E., Gottesman, Karen, Malcarne, Vanessa, Mayes, Maureen D., Mouthon, Luc, Nielson, Warren R., Riggs, Robert, Wigley, Fredrick, Assassi, Shervin, Boutron, Isabelle, Ells, Carolyn, van den Ende, Cornelia, Fligelstone, Kim, Frech, Tracy, Godard, Dominique, Harel, Daphna, Hinchcliff, Monique, Hudson, Marie, Johnson, Sindhu R., Larche, Maggie, Leite, Catarina, Nguyen, Christelle, Pope, Janet, Portales, Alexandra, Rannou, François, Reyna, Tatiana Sofia Rodriguez, Schouffoer, Anne A., Suarez-Almazor, Maria E., Agard, Christian, Albert, Alexandra, André, Marc, Arsenault, Guylaine, Benzidia, Ilham, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Boire, Gilles, Bruns, Alessandra, Carreira, Patricia, Casadevall, Marion, Chaigne, Benjamin, Chung, Lorinda, Cohen, Pascal, Correia, Chase, Dagenais, Pierre, Denton, Christopher, Domsic, Robyn, Dubois, Sandrine, Dunne, James V., Dunogue, Bertrand, Fare, Regina, Farge-Bancel, Dominique, Fortin, Paul R., Gill, Anna, Gordon, Jessica, Granel-Rey, Brigitte, Gyger, Genevieve, Hachulla, Eric, Hatron, Pierre-Yves, Herrick, Ariane L., Hij, Adrian, Hoa, Sabrina, Ikic, Alena, Jones, Niall, de B. Fernandes, Artur Jose, Kafaja, Suzanne, Khalidi, Nader, Lambert, Marc, Launay, David, Liang, Patrick, Maillard, Hélène, Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Martin, Maria, Martin, Thierry, Masetto, Ariel, Maurier, François, Mekinian, Arsene, Melchor, Sheila, Nikpour, Mandana, Olagne, Louis, Poindron, Vincent, Proudman, Susanna, Régent, Alexis, Rivière, Sébastien, Robinson, David, Rodriguez, Esther, Roux, Sophie, Smets, Perrine, Smith, Doug, Sobanski, Vincent, Spiera, Robert, Steen, Virginia, Stevens, Wendy, Sutton, Evelyn, Terrier, Benjamin, Thorne, Carter, Varga, John, Wilcox, Pearce, Ayala, Mara Cañedo, Ostbo, Nora, Thombs, Brett D., Kwakkenbos, Linda, Carrier, Marie-Eve, Bourgeault, Angelica, Tao, Lydia, Harb, Sami, Gagarine, Maria, Rice, Danielle, Bustamante, Laura, Ellis, Kelsey, Duchek, Delaney, Wu, Yin, Bhandari, Parash Mani, Neupane, Dipika, Carboni-Jiménez, Andrea, Henry, Richard S., Krishnan, Ankur, Sun, Ying, Levis, Brooke, He, Chen, Turner, Kimberly A., Benedetti, Andrea, Culos-Reed, Nicole, El-Baalbaki, Ghassan, Hebblethwaite, Shannon, Bartlett, Susan J., Dyas, Laura, and Patten, Scott

Published
2020
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16. Validation of the Body Concealment Scale for Scleroderma (BCSS): Replication in the Scleroderma Patient-centered Intervention Network (SPIN) Cohort

Author

Baron, Murray, Bartlett, Susan J., Furst, Dan, Gottesman, Karen, van den Hoogen, Frank, Mouthon, Luc, Nielson, Warren R., Poiraudeau, Serge, Riggs, Robert, Sauve, Maureen, Wigley, Fredrick, Boutron, Isabelle, Costa Maia, Angela, El-Baalbaki, Ghassan, Ells, Carolyn, van den Ende, Cornelia, Fligelstone, Kim, Fortune, Catherine, Frech, Tracy, Godard, Dominique, Harel, Daphna, Hudson, Marie, Impens, Ann, Jang, Yeona, Johnson, Sindhu R., Kennedy, Ann Tyrell, Khanna, Dinesh, Larche, Maggie, Leite, Catarina, Marra, Carlo, Nielsen, Karen, Poole, Janet L., Pope, Janet, Rodriguez Reyna, Tatiana Sofia, Schouffoer, Anne A., Steele, Russell J., Suarez-Almazor, Maria E., Welling, Joep, Wong-Rieger, Durhane, Albert, Alexandra, Arsenault, Guylaine, Bissonnette, Lyne, Boire, Gilles, Bruns, Alessandra, Carreira, Patricia, Chung, Lorinda, Dagenais, Pierre, Denton, Christopher, Domsic, Robyn, Dunne, James V., Fortin, Paul, Gill, Anna, Gordon, Jessica, Gyger, Genevieve, Herrick, Ariane L., Hinchcliff, Monique, Ikic, Alena, Jones, Niall, de B. Fernandes, Artur Jose, Kafaja, Suzanne, Khalidi, Nader, Korman, Benjamin, Liang, Patrick, Manning, Joanne, Masetto, Ariel, Robinson, David, Roux, Sophie, Schiopu, Elena, Smith, Doug, Spiera, Robert, Steen, Virginia, Sutton, Evelyn, Thorne, Carter, Varga, John, Wilcox, Pearce, Delisle, Vanessa C., Fedoruk, Claire, Levis, Brooke, Pepin, Mia R., Persmann, Jennifer, Jewett, Lisa R., Kwakkenbos, Linda, Carrier, Marie-Eve, Malcarne, Vanessa L., Harcourt, Diana, Rumsey, Nichola, Mayes, Maureen D., Assassi, Shervin, Körner, Annett, Fox, Rina S., Gholizadeh, Shadi, Mills, Sarah D., Portales, Alexandra, and Thombs, Brett D.

Published
2017
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17. Sarilumab for Relapse of Polymyalgia Rheumatica during Glucocorticoid Taper.

Author

Spiera, Robert F., Unizony, Sebastian, Warrington, Kenneth J., Sloane, Jennifer, Giannelou, Angeliki, Nivens, Michael C., Alkinlade, Bolanle, Wanling Wong, Bhore, Rafia, Yong Lin, Buttgereit, Frank, Devauchelle-Pensec, Valerie, Rubbert-Roth, Andrea, Yancopoulos, George D., Marrache, Frederic, Patel, Naimish, and Dasgupta, Bhaskar

Subjects
*POLYMYALGIA rheumatica, *INTERLEUKIN-6 receptors, *GLUCOCORTICOIDS, *CLINICAL trials, *DISEASE relapse, *SUBCUTANEOUS injections
Abstract

BACKGROUND More than half of patients with polymyalgia rheumatica have a relapse during tapering of glucocorticoid therapy. Previous studies have suggested that interleukin-6 blockade may be clinically useful in the treatment of polymyalgia rheumatica. Sarilumab, a human monoclonal antibody, binds interleukin-6 receptor α and efficiently blocks the interleukin-6 pathway. METHODS In this phase 3 trial, we randomly assigned patients in a 1:1 ratio to receive 52 weeks of a twice-monthly subcutaneous injection of either sarilumab (at a dose of 200 mg) plus a 14-week prednisone taper or placebo plus a 52-week prednisone taper. The primary outcome at 52 weeks was sustained remission, which was defined as the resolution of signs and symptoms of polymyalgia rheumatica by week 12 and sustained normalization of the C-reactive protein level, absence of disease flare, and adherence to the prednisone taper from weeks 12 through 52. RESULTS A total of 118 patients underwent randomization (60 to receive sarilumab and 58 to receive placebo). At week 52, sustained remission occurred in 28% (17 of 60 patients) in the sarilumab group and in 10% (6 of 58 patients) in the placebo group (difference, 18 percentage points; 95% confidence interval, 4 to 32; P=0.02). The median cumulative glucocorticoid dose at 52 weeks was significantly lower in the sarilumab group than in the placebo group (777 mg vs. 2044 mg; P<0.001). The most common adverse events with sarilumab as compared with placebo were neutropenia (15% vs. 0%), arthralgia (15% vs. 5%), and diarrhea (12% vs. 2%). More treatment-related discontinuations were observed in the sarilumab group than in the placebo group (12% vs. 7%). CONCLUSIONS Sarilumab showed significant efficacy in achieving sustained remission and reducing the cumulative glucocorticoid dose in patients with a relapse of polymyalgia rheumatica during glucocorticoid tapering. (Funded by Sanofi and Regeneron Pharmaceuticals; SAPHYR ClinicalTrials.gov number, NCT03600818. opens in new tab.) [ABSTRACT FROM AUTHOR]

Published
2023
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19. Efficacy and Safety of Lenabasum, a Cannabinoid Type 2 Receptor Agonist, in a Phase 3 Randomized Trial in Diffuse Cutaneous Systemic Sclerosis.

Author

Spiera, Robert, Kuwana, Masataka, Khanna, Dinesh, Hummers, Laura, Frech, Tracy M., Stevens, Wendy, Matucci‐Cerinic, Marco, Kafaja, Suzanne, Distler, Oliver, Jun, Jae‐Bum, Levy, Yair, Leszcyzński, Piotr, Gordon, Jessica, Steen, Virginia, Lee, Eun Bong, Jankowski, Tomasz, Litinsky, Irena, Chung, Lorina, Hsu, Vivien, and Mayes, Maureen

Subjects
*DRUG dosage, *DRUG efficacy, *RESEARCH, *NEUROTRANSMITTERS, *SYSTEMIC scleroderma, *MYCOPHENOLIC acid, *IMMUNOSUPPRESSION, *PLACEBOS, *VITAL capacity (Respiration), *DRUGS, *BLIND experiment, *REPEATED measures design, *STATISTICAL sampling, *STATISTICAL models, *IMMUNOSUPPRESSIVE agents, *PATIENT safety, *EVALUATION, *THERAPEUTICS
Abstract

Objective: This phase 3 study was undertaken to investigate the efficacy and safety of lenabasum, a cannabinoid type 2 receptor agonist, in patients with diffuse cutaneous systemic sclerosis (dcSSc). Methods: A multinational double‐blind study was conducted in 365 dcSSc patients who were randomized and dosed 1:1:1 with lenabasum 20 mg, lenabasum 5 mg, or placebo, each twice daily and added to background treatments, including immunosuppressive therapies (IST). Results: The primary end point, the American College of Rheumatology combined response index in dcSSc (CRISS) at week 52 for lenabasum 20 mg twice a day versus placebo, was not met, with CRISS score of 0.888 versus 0.887 (P = 0.4972, using mixed models repeated measures [MMRM]). The change in the modified Rodnan skin thickness score (MRSS) at week 52 for lenabasum 20 mg twice a day versus placebo was −6.7 versus −8.1 (P = 0.1183, using MMRM). Prespecified analyses showed higher CRISS scores, greater improvement in MRSS, and lower decline in forced vital capacity in patients on background mycophenolate and those who were taking IST for ≤1 year. No deaths or excess in serious or severe adverse events related to lenabasum were observed. Conclusion: A benefit of lenabasum in dcSSc was not demonstrated. Most patients were treated with background IST, and treatment with mycophenolate mofetil in particular was associated with better outcomes. These findings support the use of IST in the treatment of dcSSc and highlight the challenge of demonstrating a treatment effect when investigational treatment is added to standard of care IST. These findings have relevance to trial design in SSc, as well as to clinical care. [ABSTRACT FROM AUTHOR]

Published
2023
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20. Dendritic cells maintain dermal adipose-derived stromal cells in skin fibrosis

Author

Chia, Jennifer J., Zhu, Tong, Chyou, Susan, Dasoveanu, Dragos C., Carballo, Camila, Tian, Sha, Magro, Cynthia M., Rodeo, Scott, Spiera, Robert F., Ruddle, Nancy H., McGraw, Timothy E., Browning, Jeffrey L., Lafyatis, Robert, Gordon, Jessica K., and Lu, Theresa T.

Subjects
Cell death -- Physiological aspects -- Research, Fibrosis -- Risk factors -- Research, Adipose tissues -- Physiological aspects -- Research, Dendritic cells -- Physiological aspects -- Research, Health care industry
Abstract

Scleroderma is a group of skin-fibrosing diseases for which there are no effective treatments. A feature of the skin fibrosis typical of scleroderma is atrophy of the dermal white adipose tissue (DWAT). Adipose tissue contains adipose-derived mesenchymal stromal cells (ADSCs) that have regenerative and reparative functions; however, whether DWAT atrophy in fibrosis is accompanied by ADSC loss is poorly understood, as are the mechanisms that might maintain ADSC survival in fibrotic skin. Here, we have shown that DWAT ADSC numbers were reduced, likely because of cell death, in 2 murine models of scleroderma skin fibrosis. The remaining ADSCs showed a partial dependence on dendritic cells (DCs) for survival. Lymphotoxin β (LTβ) expression in DCs maintained ADSC survival in fibrotic skin by activating an LTβ receptor/[β.sub.1] integrin (LTβR/[β.sub.1] integrin) pathway on ADSCs. Stimulation of LTΒR augmented the engraftment of therapeutically injected ADSCs, which was associated with reductions in skin fibrosis and improved skin function. These findings provide insight into the effects of skin fibrosis on DWAT ADSCs, identify a DC-ADSC survival axis in fibrotic skin, and suggest an approach for improving mesenchymal stromal cell therapy in scleroderma and other diseases., Introduction Scleroderma is a group of skin-fibrosing diseases that includes systemic sclerosis, which is characterized by skin and internal organ fibrosis, and localized scleroderma, which affects mainly the skin (1, [...]

Published
2016
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24. Activation of a Latent Epitope Causing Differential Binding of Antineutrophil Cytoplasmic Antibodies to Proteinase 3.

Author

Casal Moura, Marta, Thompson, Gwen E., Nelson, Darlene R., Fussner, Lynn A., Hummel, Amber M., Jenne, Dieter E., Emerling, Daniel, Fervenza, Fernando C., Kallenberg, Cees G. M., Langford, Carol A., McCune, W. Joseph, Merkel, Peter A., Monach, Paul A., Seo, Philip, Spiera, Robert F., St. Clair, E. William, Ytterberg, Steven R., Stone, John H., Robinson, William H., and Specks, Ulrich

Subjects
GENETIC mutation, ANTINEUTROPHIL cytoplasmic antibodies, PROTEOLYTIC enzymes, MONOCLONAL antibodies, GRANULOMATOSIS with polyangiitis, IMMUNOASSAY, COMPARATIVE studies, ANTIGENS, VASCULITIS, LONGITUDINAL method
Abstract

Objective: Proteinase 3 (PR3) is the major antigen for antineutrophil cytoplasmic antibodies (ANCAs) in the systemic autoimmune vasculitis, granulomatosis with polyangiitis (GPA). PR3‐targeting ANCAs (PR3‐ANCAs) recognize different epitopes on PR3. This study was undertaken to study the effect of mutations on PR3 antigenicity. Methods: The recombinant PR3 variants, iPR3 (clinically used to detect PR3‐ANCAs) and iHm5 (containing 3 point mutations in epitopes 1 and 5 generated for epitope mapping studies) immunoassays and serum samples from patients enrolled in ANCA‐associated vasculitis (AAV) trials were used to screen for differential PR3‐ANCA binding. A patient‐derived monoclonal ANCA 518 (moANCA518) that selectively binds to iHm5 within the mutation‐free epitope 3 and is distant from the point mutations of iHm5 was used as a gauge for remote epitope activation. Selective binding was determined using inhibition experiments. Results: Rather than reduced binding of PR3‐ANCAs to iHm5, we found substantially increased binding of the majority of PR3‐ANCAs to iHm5 compared to iPR3. This differential binding of PR3‐ANCA to iHm5 is similar to the selective moANCA518 binding to iHm5. Binding of iPR3 to monoclonal antibody MCPR3‐2 also induced recognition by moANCA518. Conclusion: The preferential binding of PR3‐ANCAs from patients, such as the selective binding of moANCA518 to iHm5, is conferred by increased antigenicity of epitope 3 on iHm5. This can also be induced on iPR3 when captured by monoclonal antibody MCPR2. This previously unrecognized characteristic of PR3‐ANCA interactions with its target antigen has implications for studying antibody‐mediated autoimmune diseases, understanding variable performance characteristics of immunoassays, and design of potential novel treatment approaches. [ABSTRACT FROM AUTHOR]

Published
2023
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25. Autoreactive Plasmablasts After B Cell Depletion With Rituximab and Relapses in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis.

Author

Berti, Alvise, Hillion, Sophie, Konig, Maximilian F., Moura, Marta Casal, Hummel, Amber M., Carmona, Eva, Peikert, Tobias, Fervenza, Fernando C., Kallenberg, Cees G.M., Langford, Carol A., Merkel, Peter A., Monach, Paul A., Seo, Philip, Spiera, Robert F., Brunetta, Paul, St. Clair, E. William, Harris, Kristina M., Stone, John H., Grandi, Guido, and Pers, Jacques‐Olivier

Subjects
RITUXIMAB, FLOW cytometry, B cells, ANTINEUTROPHIL cytoplasmic antibodies, DISEASE relapse, RESEARCH funding, VASCULITIS, DISEASE remission
Abstract

Objective: Autoreactive B cells are responsible for antineutrophil cytoplasmic antibody (ANCA) production in ANCA‐associated vasculitis (AAV). Rituximab (RTX) depletes circulating B cells, including autoreactive B cells. We aimed to evaluate changes and associations with relapse of the circulating autoreactive B cell pool following therapeutic B cell depletion in AAV. Methods: Sequential flow cytometry was performed on 148 samples of peripheral blood mononuclear cells from 23 patients with proteinase 3 (PR3)–ANCA–positive AAV who were treated with RTX for remission induction and monitored after stopping therapy during long‐term follow‐up in a prospective clinical trial. PR3 was used as a ligand to target autoreactive PR3‐specific (PR3+) B cells. B cell recurrence was considered as the first blood sample with ≥10 B cells/μl after RTX treatment. Results: At B cell recurrence, PR3+ B cell frequency among B cells was higher than baseline (P < 0.01). Within both PR3+ and total B cells, frequencies of transitional and naive subsets were higher at B cell recurrence than at baseline, while memory subsets were lower (P < 0.001 for all comparisons). At B cell recurrence, frequencies of B cells and subsets did not differ between patients who experienced relapse and patients who remained in remission. In contrast, the plasmablast frequency within the PR3+ B cell pool was higher in patients who experienced relapse and associated with a shorter time to relapse. Frequencies of PR3+ plasmablasts higher than baseline were more likely to be found in patients who experienced relapse within the following 12 months compared to those in sustained remission (P < 0.05). Conclusion: The composition of the autoreactive B cell pool varies significantly following RTX treatment in AAV, and early plasmablast enrichment within the autoreactive pool is associated with future relapses. [ABSTRACT FROM AUTHOR]

Published
2023
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26. Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial.

Author

Denton, Christopher P, Goh, Nicole S, Humphries, Stephen M, Maher, Toby M, Spiera, Robert, Devaraj, Anand, Ho, Lawrence, Stock, Christian, Erhardt, Elvira, Alves, Margarida, and Wells, Athol U

Subjects
LUNG physiology, CONFIDENCE intervals, ANTI-inflammatory agents, SYSTEMIC scleroderma, INTERSTITIAL lung diseases, FIBROSIS, RISK assessment, SEVERITY of illness index, VITAL capacity (Respiration), DESCRIPTIVE statistics, PULMONARY fibrosis, COMPUTED tomography, SECONDARY analysis, DISEASE risk factors, DISEASE complications
Abstract

Objective To assess associations between the extent of fibrotic interstitial lung disease (ILD) and forced vital capacity (FVC) at baseline and change in FVC over 52 weeks in patients with systemic sclerosis-associated ILD (SSc-ILD) in the SENSCIS trial. Material and methods We used generalized additive models, which involve few assumptions and allow for interaction between non-linear effects, to assess associations between the extent of fibrotic ILD on high-resolution computed tomography (HRCT), and the interplay of extent of fibrotic ILD on HRCT and FVC % predicted, at baseline and FVC decline over 52 weeks. Results In the placebo group (n  = 288), there was weak evidence of a modest association between a greater extent of fibrotic ILD at baseline and a greater decline in FVC % predicted at week 52 [r: –0.09 (95% CI –0.2, 0.03)]. Higher values of both the extent of fibrotic ILD and FVC % predicted at baseline tended to be associated with greater decline in FVC % predicted at week 52. In the nintedanib group (n  = 288), there was no evidence of an association between the extent of fibrotic ILD at baseline and decline in FVC % predicted at week 52 [r: 0.01 (95% CI: -0.11, 0.12)] or between the interplay of extent of fibrotic ILD and FVC % predicted at baseline and decline in FVC % predicted at week 52. Conclusions Data from the SENSCIS trial suggest that patients with SSc-ILD are at risk of ILD progression and benefit from nintedanib largely irrespective of their extent of fibrotic ILD at baseline. Study registration ClinicalTrials.gov, https://clinicaltrials.gov , NCT02597933. [ABSTRACT FROM AUTHOR]

Published
2023
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27. Systemic sclerosis and COVID-19 vaccines: a SPIN Cohort study

Author

Gordon, Jessica K, Showalter, Kimberly, Wu, Yin, Kwakkenbos, Linda, Carrier, Marie-Eve, Henry, Richard S, Østbø, Nora, Nordlund, Julia, Bourgeault, Angelica, Cañedo-Ayala, Mara, Carboni-Jiménez, Andrea, Denton, Christopher P, Mouthon, Luc, Thombs, Brett D, and Spiera, Robert F

Published
2022
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28. Digital ulcers in SSc treated with oral treprostinil: a randomized, double-blind, placebo-controlled study with open-label follow-up

Author

Seibold, James R., Wigley, Fredrick M., Schiopu, Elena, Denton, Christopher P., Silver, Richard M., Steen, Virginia D., Domsic, Robyn, Medsger, Thomas A., Jr, Mayes, Maureen D., Chatterjee, Soumya, Chung, Lorinda, Csuka, Mary Ellen, Khanna, Dinesh, Collier, David, Frech, Tracy M., Molitor, Jerry A., Rothfield, Naomi, Herrick, Ariane L., Simms, Robert, Pope, Janet E., Baron, Murray, Hsu, Vivien M., Peng, Stanford L., Spiera, Robert, Fessler, Barri J., Kahaleh, Bashar, Varga, John, Laliberte, Kevin, Wade, Michael, and Rollins, Kristan

Published
2017
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30. The Pharmacogenomic Association of Fcγ Receptors and Cytochrome P450 Enzymes With Response to Rituximab or Cyclophosphamide Treatment in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

Author

Cartin‐Ceba, Rodrigo, Indrakanti, Divya, Specks, Ulrich, Stone, John H., Hoffman, Gary S., Kallenberg, Cees G. M., Langford, Carol A., Merkel, Peter A., Spiera, Robert F., Monach, Paul A., St.Clair, E. William, Seo, Philip, Tchao, Nadia K., Ytterberg, Steven R., Brunetta, Paul G., Song, Huijuan, Birmingham, Dan, and Rovin, Brad H.

Published
2017
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33. Association of baseline soluble immune checkpoints with the risk of relapse in PR3-ANCA vasculitis following induction of remission.

Author

Gamerith, Gabriele, Mildner, Finn, Merkel, Peter A., Harris, Kristina, Cooney, Laura, Lim, Noha, Spiera, Robert, Seo, Philip, Langford, Carol A., Hoffman, Gary S., St Clair, E. William, Fervenza, Fernando C., Monach, Paul, Ytterberg, Steven R., Geetha, Duvuru, Amann, Arno, Wolf, Dominik, Specks, Ulrich, Stone, John H., and Kronbichler, Andreas

Published
2023
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35. genomic meta-analysis of clinical variables and their association with intrinsic molecular subsets in systemic sclerosis.

Author

Franks, Jennifer M, Toledo, Diana M, Martyanov, Viktor, Wang, Yue, Huang, Suiyuan, Wood, Tammara A, Spino, Cathie, Chung, Lorinda, Denton, Christopher P, Derrett-Smith, Emma, Gordon, Jessica K, Spiera, Robert, Domsic, Robyn, Hinchcliff, Monique, Khanna, Dinesh, and Whitfield, Michael L

Subjects
RNA analysis, AUTOANTIBODIES, META-analysis, BIOPSY, SKIN, SYSTEMIC scleroderma, FIBROSIS, GENE expression, SEX distribution, DATABASE management, SYMPTOMS, GENOMICS, DISEASE duration, DESCRIPTIVE statistics, OLIGONUCLEOTIDE arrays, ETHNIC groups, LONGITUDINAL method
Abstract

Objectives Four intrinsic molecular subsets (inflammatory, fibroproliferative, limited, normal-like) have previously been identified in SSc and are characterized by unique gene expression signatures and pathways. The intrinsic subsets have been linked to improvement with specific therapies. Here, we investigated associations between baseline demographics and intrinsic molecular subsets in a meta-analysis of published datasets. Methods Publicly available gene expression data from skin biopsies of 311 SSc patients measured by DNA microarray were classified into the intrinsic molecular subsets. RNA-sequencing data from 84 participants from the ASSET trial were used as a validation cohort. Baseline clinical demographics and intrinsic molecular subsets were tested for statistically significant associations. Results Males were more likely to be classified in the fibroproliferative subset (P  = 0.0046). SSc patients who identified as African American/Black were 2.5 times more likely to be classified as fibroproliferative compared with White/Caucasian patients (P  = 0.0378). ASSET participants sera positive for anti-RNA pol I and RNA pol III autoantibodies were enriched in the inflammatory subset (P  = 5.8 × 10−5, P  = 9.3 × 10−5, respectively), while anti-Scl-70 was enriched in the fibroproliferative subset. Mean modified Rodnan Skin Score (mRSS) was statistically higher in the inflammatory and fibroproliferative subsets compared with normal-like (P  = 0.0027). The average disease duration for inflammatory subset was less than fibroproliferative and normal-like intrinsic subsets (P  = 8.8 × 10−4). Conclusions We identified multiple statistically significant differences in baseline demographics between the intrinsic subsets that may represent underlying features of disease pathogenesis (e.g. chronological stages of fibrosis) and have implications for treatments that are more likely to work in certain SSc populations. [ABSTRACT FROM AUTHOR]

Published
2023
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36. IgA and IgG antineutrophil cytoplasmic antibody engagement of Fc receptor genetic variants influences granulomatosis with polyangiitis

Author

Kelley, James M., Monach, Paul A., Ji, Chuanyi, Zhou, Yebin, Wu, Jianming, Tanaka, Sumiaki, Mahr, Alfred D., Johnson, Sharleen, McAlear, Carol, Cuthbertson, David, Carette, Simon, Davis,, John C., Dellaripa, Paul F., Hoffman, Gary S., Khalidi, Nader, Langford, Carol A., Seo, Phillip, St. Clair, E. William, Specks, Ulrich, Stone, John H., Spiera, Robert F., Ytterberg, Steven R., Merkel, Peter A., Edberg, Jeffrey C., and Kimberly, Robert P.

Published
2011

37. Contributors

Author

Abrams, Charles S., Adler, Ronald S., Agarwal, Anupam, Akin, Cem, Aksamit, Allen J., Jr., Al-Awqati, Qais, Allen, Upton D., Allos, Ban Mishu, Angus, Derek C., Appelbaum, Frederick R., Armitage, James O., Armstrong, April W., Armstrong, Deborah K., Arnaout, M. Amin, Arnold, Robert M., Aronson, Louise, Atkinson, John P., Attia, Evelyn, Auerbach, Andrew D., Ayanian, John Z., Baddour, Larry M., Baden, Lindsey R., Bailey, Thomas C., Bain, Barbara J., Bajorin, Dean F., Baloh, Robert W., Bangham, Charles R.M., Barasch, Jonathan, Barrett, Bruce, Bartholomew, John R., Bartleson, J.D., Barton, Mary B., Basner, Robert C., Bass, Adam J., Bass, Anne R., Bauman, Julie E., Bausch, Daniel G., Bayer, Arnold S., Bazarian, Jeffrey J., Bearman, Gonzalo M., Becker, Richard C., Beckham, J. David, Beckman, Joshua A., Beigel, John H., Bel, Elisabeth H., Belda, Walter, Jr., Benarroch, Eduardo E., Berger, Joseph R., Berliner, Nancy, Bernat, James L., Bessesen, Daniel H., Bibbins-Domingo, Kirsten, Biesecker, Leslie G., Biundo, Joseph J., Blankson, Joel N., Bloch, Karen C., Blom, Henk J., Boden, William E., Boivin, Guy, Bolognia, Jean, Bonomo, Robert A., Booth, Sarah L., Bosaeus, Ingvar G., Brenner, David J., Bridges, S. Louis, Jr., Brochard, Laurent, Brodsky, Robert A., Brook, Itzhak, Brown, Jennifer R., Brunetti, Enrico, Bryant, Amy E., Budge, Philip J., Buffet, Pierre A., Bushinsky, David A., Bykerk, Vivian P., Calabresi, Peter A., Calello, Diane P., Calfee, David P., Callahan, S. Todd, Camilleri, Michael, Canoso, Juan J., Cappellini, Maria Domenica, Carabello, Blase A., Carucci, Laura R., Castells, Mariana, Catherino, William H., Cederholm, Tommy E., Chalasani, Naga P., Chambers, Henry F., Chang, Larry W., Chang, Lin, Chao, Nelson J., Chatterjee, Mitali, Chaturvedi, Seemant, Chen, Lin H., C-A Chen, Sharon, Chon, Susan Y., Christiani, David C., Chu, Edward, Cieslak, Theodore J., Cioffi, George A., Clancy, Carolyn M., Clauss, Heather, Clauw, Daniel J., Clemmons, David R., Coffman, Thomas M., Cohen, David, Cohen, Jeffrey, Cohen, Myron S., Cohen, Steven P., Connors, Joseph M., Cook, Deborah J., Cook, Lucy B.M., Cooney, Kathleen A., Craigen, William J., Crandall, Jill P., Croft, Simon L., Crow, Mary K., Crump, John A., Cudkowicz, Merit E., Cunningham-Rundles, Charlotte, Dahir, Kathryn M., Damon, Inger K., Daras, Michael, Dart, Richard C., Davidson, Nancy E., Deane, Kevin D., DeAngelis, Lisa M., DeCamp, Malcolm M., DeLoughery, Thomas G., Rio, Carlos del, De Luca, Gabriele C., Denning, David W., Deuster, Patricia A., DeZern, Amy E., Dhatariya, Ketan K., Diasio, Robert B., Diemert, David J., Digre, Kathleen B., Dilsizian, Vasken, Dionne, Jodie A., Di Paola, Jorge, Dispenzieri, Angela, Dogra, Sunil, Doroshow, James H., Douglas, John M., Jr., Drazen, Jeffrey M., Drekonja, Dimitri, Dubberke, Erik R., DuBeau, Catherine E., Dumler, J. Stephen, Duvic, Madeleine, Ebi, Kristie, Edwards, Kathryn M., Edwards, N. Lawrence, Eikelboom, John W., Einhorn, Lawrence H., Elliott, Perry M., Emanuel, Ezekiel J., Falagas, Matthew E., Falk, Gary W., Fang, James C., Farley, Monica M., Feder, Gene, Feller-Kopman, David J., McDonald File, Thomas, Jr., Fishman, Glenn I., Flack, John M., Fleckenstein, James M., Fleisher, Lee A., Flint, Paul W., Fogel, Evan L., Fontana, Robert J., Forsmark, Chris E., Fournier, Pierre-Edouard, Fowler, Vance G., Jr., Franco, Manuel A., Fraser, Victoria J., Freeman, Roy, Freund, Karen M., Froberg, Blake A., Gallagher, Patrick G., Gandhi, Monica, Gandhi, Rajesh T., Ganz, Leonard, Garan, Hasan, Garcia-Tsao, Guadalupe, Geisler, William M., Gelfand, Joel M., George, Tony P., Gepstein, Lior, Gertz, Morie A., Ghanem, Khalil G., Gharavi, Ali G., Ghossein, Cybele, Gill, Christopher J., Ginsburg, Geoffrey S., Glesby, Marshall J., Gnann, John W., Jr., Goldman, David L., Goldman, Lee, Goldstein, Larry B., Gordon, Anthony C., Gotlib, Jason, Gotuzzo, Eduardo, Grasemann, Hartmut, Green-McKenzie, Judith, Greenberg, Harry B., Greenberg, Steven A., Greer, David M., Greysen, S. Ryan, Griffin, Marie R., Griggs, Robert C., Grossman, Daniel, Guay-Woodford, Lisa M., Gulick, Roy M., Haake, David A., Hagman, Melissa M., Hagspiel, Klaus D., Harris, Raymond C., Havers, Fiona P., Heath, Elisabeth I., Hecht, Frederick M., Hensrud, Donald D., Hess, Jeremy, Hewlett, Erik L., Hift, Richard J., Hill, David R., Hill, Nicholas S., Hillyer, Christopher D., Hirsch, Hans H., Hoeper, Marius M., Hoit, Brian D., Holers, V. Michael, Holland, Steven M., Hollenberg, Anthony N., Hollenberg, Steven M., Howard, Jo, Hunter, David J., Hussain, Khalid, Iannuzzi, Michael C., Inman, Robert D., Inouye, Sharon K., Ison, Michael G., Jen, Joanna C., Jensen, Dennis M., Jensen, Michael D., Jensen, Robert T., Johnston, S. Claiborne, Jones, Robin L., Jordan, Richard C., Kahi, Charles J., Kaiser, Laurent, Kaminski, Henry J., Kamya, Moses R., Kao, Louise W., Kaplan, Steven A., Kastner, Daniel L., Katzka, David A., Katzman, Debra K., Kaushansky, Kenneth, Kaye, Keith S., Keating, Armand, Kelley, Robin K., Kennedy, Richard B., Khuri, Fadlo R., Kim, Rose, Kirchhoff, Louis V., Kirking, Hannah, Kirtane, Ajay J., Kishnani, Priya S., Klausner, Jeffrey D., Klion, Amy D., Klompas, Michael, Knopman, David S., Ko, Christine J., Kodali, Susheel, Kontoyiannis, Dimitrios P., Koppel, Barbara S., Korenblat, Kevin M., Korf, Bruce R., Kortepeter, Mark G., Koshy, Anita A., Kottilil, Shyamasundaran, Kovacs, Joseph A., Kovacs, Thomas O., Kowdley, Kris V., Kraft, Monica, Kramer, Christopher M., Krasnewich, Donna M., Kraus, William E., Krause, Peter J., Kroger, Andrew T., Kroshinsky, Daniela, Kuemmerle, John F., Kuipers, Ernst J., Kutner, Jean S., Laheru, Daniel, Lampert, Rachel, Landefeld, C. Seth, Landovitz, Raphael J., Landry, Donald W., Lange, Richard A., Lee, Hochang B., Lee, Nelson, Levey, Andrew S., Levine, Stephanie M., Lichtenstein, Gary R., Liebmann, Jeffrey M., Liebschutz, Jane M., Lim, Henry W., Lima, Aldo A.M., Limaye, Ajit P., Limdi, Nita A., Link, Mark S., Liu, Catherine, Lloyd-Jones, Donald M., Lopez, Fred A., Louie, Arnold, Lyness, Jeffrey M., MacKenzie, C. Ronald, MacLennan, Calman A., MacMillan, Harriet L., Madoff, Robert D., Maher, Jacquelyn, Maier, Lisa A., Maldarelli, Frank, Malhotra, Atul, Manary, Mark J., Marcos, Luis A., Marelli, Ariane J., Marks, Andrew R., Marschall, Jonas, Martin, Paul, Martinez, Fernando J., Mason, Joel B., Masur, Henry, Mathers, Amy J., Matthay, Michael A., McCool, F. Dennis, McInnes, Iain B., McLaughlin, Vallerie, McMichael, Amy, McMurray, John J.V., McQuaid, Kenneth R., Mead, Paul S., Means, Robert T., Jr., Melia, Michael T., Mellinghoff, Ingo K., Melton, Genevieve B., Merrick, Samuel T., Miceli, Marisa H., Michel, Marc, Mokdad, Ali H., Moy, Ernest, Mukherjee, Debabrata, Murr, Andrew H., Myerburg, Robert J., Nadeau, Kari C., Nath, Avindra, Neal-Perry, Genevieve, Neilson, Eric G., Nelson, Christina A., Nelson, David B., Nelson, Lewis S., Nestler, Eric J., Neuzil, Kathleen M., Nieman, Lynnette K., Niven, Alexander S., O’Connor, Christopher M., O’Connor, Francis G., O’Connor, Patrick G., O’Donnell, Anne E., O’Donnell, James S., Oh, Jae K., Okun, Michael S., O’Leary, Sean T., Olgin, Jeffrey E., Olivier, Kenneth N., Olivotto, Iacopo, Olsen, Nancy J., Orenstein, Walter A., Ortel, Thomas L., O’Shea, John J., Osmon, Douglas R., Ostrem, Jill L., Ostrosky-Zeichner, Luis, Otto, Catherine M., Ottolini, Martin G., Ovsyannikova, Inna G., Pappas, Peter G., Park, Ben Ho, Patel, Robin, Patterson, Thomas F., Pawlotsky, Jean-Michel, Payne, Thomas H., Pearce, Elizabeth N., Pearson, Richard D., Perl, Trish M., Petersen, Brett W., Petri, William A., Jr., Pfeffer, Marc A., Philips, Jennifer A., Pisetsky, David S., Pletcher, Steven D., Plumb, Ian D., Poland, Gregory A., Powell, Frank, Pyeritz, Reed E., Quinn, Thomas C., Racaniello, Vincent, Radhakrishnan, Jai, Radich, Jerald, Rafailidis, Petros I., Raghu, Ganesh, Ragni, Margaret V., Rahman, Proton, Rajkumar, S. Vincent, Ralston, Stuart H., Raoult, Didier, Reboli, Annette C., Reddy, K. Rajender, Redelmeier, Donald A., Redlich, Carrie A., Reilly, John, Reller, Megan E., Reno, Hilary E.L., Resnick, Neil M., Rice, Louis B., Roach, E. Steve, Robinson, Jennifer G., Rogatsky, Inez, Rogers, Joseph G., Rolain, Jean-Marc, Rollins, Barrett J., Romero, José R., Rosen, Jennifer B., Rosenthal, Philip J., Russell, James A., Rustgi, Anil K., Safer, Joshua D., Saini, Sarbjit S., Salmon, Jane E., Salvana, Edsel Maurice T., Santoro, Nanette, Santucci, Peter A., Sarnak, Mark J., Savage, Kerry J., Savard, Patrice, Sawka, Michael N., Scanlon, Paul D., Schafer, Andrew I., Schiff, Manuel, Schilsky, Michael L., Schneider, Thomas Rudolf, Schooley, Robert T., Schriger, David L., Schuchter, Lynn M., Schwartz, Lawrence B., Seas, Carlos, Seifert, Steven A., Seifter, Julian Lawrence, Selcen, Duygu, Selim, Magdy, Semrad, Carol E., Sepulveda, Jorge, Shaw, Pamela J., Shaz, Beth H., Sheridan, Robert L., Sherman, Stuart, Shojania, Kaveh G., Shopsin, Bo, Shy, Michael E., Sidransky, Ellen, Sifri, Costi D., Siliciano, Robert F., Simel, David L., Skorecki, Karl, Slawski, Barbara A., Slutsky, Arthur S., Smetana, Gerald W., Smith, A. Gordon, Smith, Stephen R., Southwick, Frederick S., Spiegel, Allen M., Spiera, Robert, Spinola, Stanley M., Spong, Catherine Y., Stabler, Sally P., Stark, Paul, St. Clair, E. William, Steiner, Theodore S., Stephens, David S., Stevens, David A., Stevens, Dennis L., Stokes, M. Barry, Stoller, James K., Stone, John H., Stone, Richard M., Su, Edwin P., Swerdloff, Ronald S., Swygard, Heidi, Sykes, Megan, Talbot, H. Keipp, Tamimi, Rulla M., Tanofsky-Kraff, Marian, Tarlo, Susan M., Taylor, Stephanie N., Teirstein, Paul S., Telford, Sam R., III, Thakker, Rajesh V., Therrien, Judith, Thompson, George R., III, Tormoehlen, Laura, Tosti, Antonella, Trehan, Indi, Umpierrez, Guillermo E., Valeri, Anthony Michael, Varga, John, Vaughn, Bradley V., Venook, Alan P., Verbalis, Joseph G., Vose, Julie M., Wachter, Robert M., Walsh, B. Timothy, Walsh, Edward E., Walsh, Thomas J., Walston, Jeremy D., Walter, Roland B., Wang, Christina, Wang, Kenneth K., Ware, Lorraine B., Warren, Cirle A., Watkins, Paul B., Weber, Thomas J., Weimer, Louis H., Weinberg, Geoffrey A., Weinstein, Robert S., Weiss, Roger D., Weiss, Roy E., Weitz, Jeffrey I., Welt, Frederick G.P., Wenzel, Richard P., Werth, Victoria P., West, Sterling G., White, A. Clinton, Jr., White, Christopher J., White, Julian, White, Perrin C., Whitley, Richard J., Whyte, Michael P., Wiebe, Samuel, Wiener-Kronish, Jeanine P., Wilber, David J., Wilcox, Mark H., Winikoff, Beverly, Winter, Jane N., Wittink, Marsha N., Wolff, Tracy A., Wolin, Edward M., Wormser, Gary P., Yancy, Clyde W., Young, Neal S., Young, Vincent B., Young, William F., Jr., Yu, Alan S.L., Zimetbaum, Peter, and Zucker, Jane R.

Published
2024
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38. Clinical outcomes of treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis based on ANCA type

Author

Unizony, Sebastian, Villarreal, Miguel, Miloslavsky, Eli M, Lu, Na, Merkel, Peter A, Spiera, Robert, Seo, Philip, Langford, Carol A, Hoffman, Gary S, Kallenberg, CG M, St. Clair, E William, Ikle, David, Tchao, Nadia K, Ding, Linna, Brunetta, Paul, Choi, Hyon K, Monach, Paul A, Fervenza, Fernando, Stone, John H, and Specks, Ulrich

Published
2016
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39. Agreement Between Physician Evaluation and the Composite Response Index in Diffuse Cutaneous Systemic Sclerosis.

Author

Zheng, Boyang, Wang, Mianbo, McKenna, Kerry, Shapiro, Lee, Silver, Richard, Csuka, Mary Ellen, van den Hoogen, Frank, Robinson, David, Pauling, John D., Hummers, Laura, Krieg, Thomas, Del Galdo, Francesco, Spiera, Robert, Jones, Niall, Khalidi, Nader, Vacca, Alessandra, de Vries‐Bouwstra, Jeska K., Gordon, Jessica, Baron, Murray, and Pope, Janet E.

Abstract

Objective: Diffuse cutaneous systemic sclerosis (SSc) is a highly heterogeneous disease. A provisionally approved Composite Response Index in diffuse cutaneous SSc (CRISS) was developed as a 1‐year outcome measure for clinical trials. Our goal was to further validate the CRISS by examining agreement between CRISS definitions for improved/non‐improved with physicians' evaluation of disease. Methods: Patient profiles from a large observational cohort were created for 50 random diffuse cutaneous SSc patients of <5 years disease duration with improved CRISS scores after 1 year and 50 with non‐improved CRISS scores. Profiles described disease features used during the initial CRISS development at baseline and at 1 year. Each profile was independently rated by 3 expert physicians. Majority opinion determined whether a patient was improved or not improved, and kappa agreement with the CRISS cutoff of 0.6 was calculated. Results: Patients had mean ± SD disease duration of 2.2 ± 1.3 years. There was substantial agreement between the physician majority opinion about each case and the CRISS (κ = 0.76 [95% confidence interval (95% CI) 0.64–0.88]). The agreement between each individual physician opinion and the CRISS was also substantial (κ = 0.70 [95% CI 0.62–0.78]). All CRISS non‐improvers were also rated as non‐improved by physician majority; however, 12 CRISS improvers were rated as non‐improved by physicians. Conclusion: There was substantial agreement between the dichotomous CRISS rating and physician assessment of diffuse cutaneous SSc patients after 1 year. This supports the use of a CRISS cutoff at 0.6 for improvement versus non‐improvement, although the CRISS tended to rate more patients as improved than did physicians. [ABSTRACT FROM AUTHOR]

Published
2022
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40. Prevalence of frailty in patients with polymyalgia rheumatica and association with health-related quality of life, cognition and sarcopenia.

Author

Sattui, Sebastian E, Jannat-Khah, Deanna, Lally, Lindsay, Lieber, Sarah B, Mandl, Lisa A, and Spiera, Robert F

Subjects
FRAIL elderly, CROSS-sectional method, SARCOPENIA, HEALTH outcome assessment, RISK assessment, PSYCHOLOGICAL tests, POLYMYALGIA rheumatica, QUALITY of life, DISEASE prevalence, DESCRIPTIVE statistics, COGNITIVE testing, LONGITUDINAL method, DISEASE complications
Abstract

Objective To describe the prevalence of frailty in a single-centre cohort of patients with PMR and describe its association with health-related quality of life (HRQoL), cognition and sarcopenia. Methods This was a cross-sectional study of patients with PMR, according to 2012 EULAR/ACR Classification Criteria, presenting within 12 months of diagnosis and on treatment with glucocorticoids. Frailty was defined according to the Fried frailty criteria. HRQoL was assessed using Patient-Reported Outcomes Measurement Information System Computerized Adaptive Test (PROMIS-CAT) and cognition was assessed using the Mini-Mental State Examination. Sarcopenia was measured by DXA. Results Forty-one patients were enrolled. Prevalence of frailty and pre-frailty was 17% and 59%, respectively. Frail patients had higher inflammatory markers at diagnosis compared with pre-frail and robust patients. Of 27 patients with DXA results, 26% were sarcopenic. Frail patients had worse physical function, and more pain behaviour and interference compared with pre-frail and robust patients. In univariable analyses, frail patients were more likely to have worse physical function, and more pain behaviour and pain interference, which remained significant after adjusting for age. There were no significant associations between cognition or sarcopenia and frailty. Conclusions In this cohort of PMR patients, there was a higher prevalence of frailty and pre-frailty compared with that reported in community-dwelling elderly. Frailty was associated with worse physical function, and increased pain behaviour and pain interference, differences that were also clinically meaningful. Larger prospective studies are needed to confirm these findings and analyse the association of frailty with other PMR disease outcomes. [ABSTRACT FROM AUTHOR]

Published
2022
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43. 2015 Recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative

Author

Dejaco, Christian, Singh, Yogesh P, Perel, Pablo, Hutchings, Andrew, Camellino, Dario, Mackie, Sarah, Abril, Andy, Bachta, Artur, Balint, Peter, Barraclough, Kevin, Bianconi, Lina, Buttgereit, Frank, Carsons, Steven, Ching, Daniel, Cid, Maria, Cimmino, Marco, Diamantopoulos, Andreas, Docken, William, Duftner, Christina, Fashanu, Billy, Gilbert, Kate, Hildreth, Pamela, Hollywood, Jane, Jayne, David, Lima, Manuella, Maharaj, Ajesh, Mallen, Christian, Martinez-Taboada, Victor, Maz, Mehrdad, Merry, Steven, Miller, Jean, Mori, Shunsuke, Neill, Lorna, Nordborg, Elisabeth, Nott, Jennifer, Padbury, Hannah, Pease, Colin, Salvarani, Carlo, Schirmer, Michael, Schmidt, Wolfgang, Spiera, Robert, Tronnier, David, Wagner, Alexandre, Whitlock, Madeline, Matteson, Eric L, and Dasgupta, Bhaskar

Published
2015
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44. Neutrophil-Related Gene Expression and Low-Density Granulocytes Associated With Disease Activity and Response to Treatment in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

Author

Grayson, Peter C., Carmona-Rivera, Carmelo, Xu, Lijing, Lim, Noha, Gao, Zhong, Asare, Adam L., Specks, Ulrich, Stone, John H., Seo, Philip, Spiera, Robert F., Langford, Carol A., Hoffman, Gary S., Kallenberg, Cees G. M., St.Clair, William E., Tchao, Nadia K., Ytterberg, Steven R., Phippard, Deborah J., Merkel, Peter A., Kaplan, Mariana J., and Monach, Paul A.

Published
2015
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48. A randomised, double-blind, placebo-controlled phase 3 study of lenabasum in diffuse cutaneous systemic sclerosis: RESOLVE-1 design and rationale

Author

Spiera, Robert, Khanna, Dinesh, Kuwana, Masataka, Furst, Daniel E, Frech, Tracy M, Hummers, Laura, Stevens, Wendy, Matucci-Cerinic, Marco, Baron, Murray, Distler, Oliver, Dgetluck, Nancy, Bloom, Bradley J, Dinh, Quinn, White, Barbara, Denton, Christopher P, and University of Zurich

Subjects
Adult, 2403 Immunology, Asia, Adolescent, 2745 Rheumatology, Immunology, 10051 Rheumatology Clinic and Institute of Physical Medicine, 610 Medicine & health, Europe, Treatment Outcome, Rheumatology, Double-Blind Method, Scleroderma, Diffuse, 2723 Immunology and Allergy, Immunology and Allergy, Humans, Israel
Abstract

The multi-systemic, heterogenous nature of diffuse cutaneous systemic sclerosis (dcSSc) presents challenges in designing clinical studies that can demonstrate a treatment effect on overall disease burden. We describe the design of the first Phase 3 study in dcSSc patients where the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score was chosen prospectively as the primary outcome. The CRISS measures key clinical disease parameters and patient-reported outcomes (PROs).RESOLVE-1 is a Phase 3, randomised, double-blind, placebo-controlled trial of dcSSc patients evaluating the efficacy and safety of lenabasum. Patients ≥18 years of age with dc-SSc and disease duration ≤6 years were eligible. Patients could continue stable background therapy for dcSSc, including stable immunosuppressive therapies. They were randomised to lenabasum 5 or 20 mg twice daily or placebo. The primary efficacy outcome was the mean change from baseline to 52 weeks in the ACR CRISS score.The study enrolled 365 patients over 1.5 years at 77 sites in 13 countries in North America, Europe, Israel, and Asia-Pacific, with the last patient first visit on May 1, 2019.RESOLVE-1 is the first Phase 3 interventional study to date in dcSSc to prospectively use the ACR CRISS as the primary efficacy outcome. Eligibility criteria allowed background therapy as might occur in clinical practice. This approach also facilitated timely patient enrolment. RESOLVE-1 provides a novel study design that may be used for future Phase 3 dcSSc studies to assess the holistic efficacy of therapy.

Published
2021

50. Mental Health Care Use and Associated Factors in Systemic Sclerosis: A Scleroderma Patient‐Centered Intervention Network Cohort Study.

Author

Becetti, Karima, Nguyen, Joseph T., Kwakkenbos, Linda, Carrier, Marie‐Eve, Tao, Lydia, Gordon, Jessica K., Mancuso, Carol A., Welling, Joep, Mouthon, Luc, Bartlett, Susan J., Malcarne, Vanessa L., Thombs, Brett D., and Spiera, Robert F.

Subjects
MENTAL health services, BODY image, MEDICAL care use, SYSTEMIC scleroderma, MENTAL health personnel, GENERAL practitioners, COHORT analysis, DISABILITY retirement
Abstract

Objective: Systemic sclerosis (SSc) has significant psychosocial implications. We aimed to evaluate the proportion of participants in a large international SSc cohort who used mental health services in a 3‐month period and to evaluate demographic, psychological, and disease‐specific factors associated with use. Methods: Baseline data of participants enrolled in the Scleroderma Patient‐Centered Intervention Network Cohort were analyzed. We determined the proportion that used mental health services and the source of services in the 3 months prior to enrollment. Multivariable logistic regression was used to identify variables associated with service use. Results: Of the 2319 participants included in the analysis, 417 (18%) used mental health services in the 3 months prior to enrollment. General practitioners were the most common mental health service providers (59%), followed by psychologists (25%) and psychiatrists (19%). In multivariable analysis, mental health service use was independently associated with higher education (odds ratio [OR] 1.07, 95% confidence interval [CI] 1.03‐1.11), smoking (OR 1.06, 95% CI 1.02‐1.11), being retired (OR 0.60, 95% CI 0.38‐0.93), having limited SSc (OR 1.39, 95% CI 1.02‐1.89), and having higher anxiety symptom scores (OR 1.04, 95% CI 1.03‐1.06) and lower self‐efficacy scores (OR 0.90, 95% CI 0.83‐0.97). Variables not significantly associated included age, race, disease manifestations, depression symptom scores, and body image distress. Conclusion: About 18% of participants in a large international cohort received mental health services in a 3‐month period, of whom the majority received these services from a general practitioner. [ABSTRACT FROM AUTHOR]

Published
2022
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