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2. Stroke frequency, associated factors, and clinical features in primary systemic vasculitis: a multicentric observational study

Author

Geraldes, Ruth, Santos, Monica, Ponte, Cristina, Craven, Anthea, Barra, Lillian, Robson, Joanna C., Hammam, Nevin, Springer, Jason, Henes, Jöerg, Hocevar, Alojzija, Putaala, Jukka, Santos, Ernestina, Rajasekhar, Liza, Daikeler, Thomas, Karadag, Omer, Costa, Andreia, Khalidi, Nader, Pagnoux, Christian, Canhão, Patrícia, Melo, Teresa Pinho e, Fonseca, Ana Catarina, Ferro, José M., Fonseca, João Eurico, Suppiah, Ravi, Watts, Richard A., Grayson, Peter, Merkel, Peter A., and Luqmani, Raashid A.

Published
2024
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3. The Association Between Age at Diagnosis and Disease Characteristics and Damage in Patients With ANCA-Associated Vasculitis.

Author

Corbridge, Thomas, Khalidi, Nader, Koening, Curry, Langford, Carol, McAlear, Carol, Monach, Paul, Moreland, Larry, Pagnoux, Christian, Rhee, Rennie, Seo, Philip, Silver, Jared, Specks, Ulrich, Warrington, Kenneth, Wechsler, Michael, Merkel, Peter, Bloom, Jessica, Pickett-Nairn, Kaci, Silveira, Lori, Fuhlbrigge, Robert, Cuthbertson, David, and Akuthota, Praveen

Subjects
Child, Middle Aged, Young Adult, Humans, Female, Aged, Male, Antibodies, Antineutrophil Cytoplasmic, Prospective Studies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Hemorrhage, Churg-Strauss Syndrome
Abstract

OBJECTIVE: This study examined the relationship between age at diagnosis and disease characteristics and damage in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). METHODS: Analysis of a prospective longitudinal cohort of patients with granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic GPA (EGPA) in the Vasculitis Clinical Research Consortium (2013-2021). Disease cohorts were divided by age at diagnosis (years): children (65). Data included demographics, ANCA type, clinical characteristics, Vasculitis Damage Index (VDI) scores, ANCA Vasculitis Index of Damage (AVID) scores, and novel disease-specific and non-disease-specific damage scores built from VDI and AVID items. RESULTS: Analysis included data from 1020 patients with GPA/MPA and 357 with EGPA. Female predominance in GPA/MPA decreased with age at diagnosis. AAV in childhood was more often GPA and proteinase 3-ANCA positive. Children with GPA/MPA experienced more subglottic stenosis and alveolar hemorrhage; children and young adults with EGPA experienced more alveolar hemorrhage, need for intubation, and gastrointestinal involvement. Older adults (GPA/MPA) had more neurologic manifestations. After adjusting for disease duration, medications, tobacco, and ANCA, all damage scores increased with age at diagnosis for GPA/MPA (P

Published
2023

4. A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research

Author

Cronholm, Peter F., Applequist, Janelle, Krischer, Jeffrey, Fontenot, Ebony, Davis, Trocon, Burroughs, Cristina, McAlear, Carol A., Borchin, Renée, Kullman, Joyce, Carette, Simon, Khalidi, Nader, Koening, Curry, Langford, Carol A., Monach, Paul, Moreland, Larry, Pagnoux, Christian, Specks, Ulrich, Sreih, Antoine G., Ytterberg, Steven R., and Merkel, Peter A.

Published
2024
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6. Hypothyroidism in vasculitis.

Author

Kermani, Tanaz, Cuthbertson, David, Carette, Simon, Khalidi, Nader, Koening, Curry, Langford, Carol, McAlear, Carol, Monach, Paul, Moreland, Larry, Pagnoux, Christian, Seo, Philip, Specks, Ulrich, Sreih, Antoine, Warrington, Kenneth, and Merkel, Peter

Subjects
GCA, Takayasu’s arteritis, antineutrophil cytoplasmic antibody, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, hypothyroidism, microscopic polyangiitis, polyarteritis nodosa, vasculitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antibodies, Antineutrophil Cytoplasmic, Churg-Strauss Syndrome, Female, Granulomatosis with Polyangiitis, Humans, Hypothyroidism, Longitudinal Studies, Male, Microscopic Polyangiitis, Middle Aged, Prospective Studies
Abstract

OBJECTIVE: To study the prevalence, risk and clinical associations of hypothyroidism among several forms of vasculitis. METHODS: Patients with GCA, Takayasus arteritis (TAK), PAN and the three forms of ANCA-associated vasculitis [AAV; granulomatosis with polyangiitis (GPA), microscopic polyangiitis and eosinophilic granulomatosis with polyangiitis (EGPA)] enrolled in a prospective, multicentre, longitudinal study were included. RESULTS: The study included data on 2085 patients [63% female, 90% White] with a mean age of 54.6 years (s.d. 17.2). Diagnoses were GCA (20%), TAK (11%), PAN (5%), GPA (42%), microscopic polyangiitis (8%) and EGPA (14%). Hypothyroidism was present in 217 patients (10%) (83% female), with a mean age 59.8 years (s.d. 14.5). Age- and sex-adjusted risk of hypothyroidism was GCA, odds ratio (OR) 0.61 (95% CI 0.41, 0.90); TAK, OR 0.57 (95% CI 0.31, 1.03); PAN, OR 0.59 (95% CI 0.25, 1.38); GPA, OR 1.51 (95% CI 1.12, 2.05); microscopic polyangiitis, OR 1.81 (95% CI 1.18, 2.80) and EGPA, OR 0.82 (95% CI 0.52, 1.30). Among patients with AAV, age- and sex-adjusted risk of hypothyroidism was higher with positive MPO-ANCA [OR 1.89 (95% CI 1.39, 2.76)]. The clinical manifestations of vasculitis were similar in patients with and without hypothyroidism, except transient ischaemic attacks, which were more frequently observed in patients with GCA and hypothyroidism (12% vs 2%; P = 0.001). CONCLUSIONS: Differences in the risk of hypothyroidism among vasculitides may be due to genetic susceptibilities or immune responses. This study confirms an association of hypothyroidism with MPO-ANCA.

Published
2022

8. 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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9. Patients’ perspectives on systemic sclerosis-related Raynaud's phenomenon in the feet: A qualitative study from the OMERACT Foot and Ankle Working Group

Author

Chapman, Lara S., Alcacer-Pitarch, Begonya, Pauling, John D., Flurey, Caroline A., Redmond, Anthony C., Richards, Pamela, Herrick, Ariane L., Merkel, Peter A., Proudman, Susanna, Menz, Hylton B., Helliwell, Philip S., Hannan, Marian T., Domsic, Robyn T., Saketkoo, Lesley A., Shea, Beverley, and Siddle, Heidi J.

Published
2024
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10. Urine and Plasma Complement Ba Levels During Disease Flares in Patients With Antineutrophil Cytoplasmic Autoantibody–Associated Vasculitis

Author

Almaani, Salem, Song, Huijuan, Suthanthira, Meshora, Toy, Christopher, Fussner, Lynn A., Meara, Alexa, Nagaraja, Haikady, Cuthbertson, David, Khalidi, Nader A., Koening, Curry L., Langford, Carol A., McAlear, Carol A., Moreland, Larry W., Pagnoux, Christian, Seo, Philip, Specks, Ulrich, Sreih, Antoine G., Warrington, Kenneth J., Monach, Paul A., Merkel, Peter A., Rovin, Brad, and Birmingham, Daniel

Published
2023
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13. 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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15. Using Research Networks to Compare Medicines for Autoimmune and Inflammatory Diseases – The Comparative Health Outcomes in Immune-mediated diseases CollaborativE (CHOICE) Study

Author

Curtis, Jeffrey, primary, Beukelman, Tim, additional, Annapureddy, Narender, additional, Oates, Jim, additional, Clowse, Megan, additional, Long, Millie, additional, Kappelman, Michael, additional, Bailey, Charley, additional, Ringold, Sarah, additional, Rhee, Rennie, additional, Merkel, Peter, additional, Nowell, Ben, additional, Chen, Lang, additional, Xie, Fenglong, additional, and Clinton, Cassie, additional

Published
2023
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16. Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Author

Peh, C. Au, Chakera, A., Cooper, B., Kurtkoti, J., Langguth, D., Levidiotis, V., Luxton, G., Mount, P., Mudge, D., Noble, E., Phoon, R., Ranganathan, D., Ritchie, A., Ryan, J., Suranyi, M., Rosenkranz, A., Lhotta, K., Kronbichler, A., Demoulin, N., Bovy, C., Hellemans, R., Hougardy, J., Sprangers, B., Wissing, K., Pagnoux, C., Barbour, S., Brachemi, S., Cournoyer, S., Girard, L., Laurin, L., Liang, P., Philibert, D., Walsh, M., Tesar, V., Becvar, R., Horak, P., Rychlik, I., Szpirt, W., Dieperink, H., Gregersen, J., Ivarsen, P., Krarup, E., Lyngsoe, C., Rigothier, C., Augusto, J., Belot, A., Chauveau, D., Cornec, D., Jourde-Chiche, N., Ficheux, M., Karras, A., Klein, A., Maurier, F., Mesbah, R., Moranne, O., Neel, A., Quemeneur, T., Saadoun, D., Terrier, B., Zaoui, P., Schaier, M., Benck, U., Bergner, R., Busch, M., Floege, J., Grundmann, F., Haller, H., Haubitz, M., Hellmich, B., Henes, J., Hohenstein, B., Hugo, C., Iking-Konert, C., Arndt, F., Kubacki, T., Kotter, I., Lamprecht, P., Lindner, T., Halbritter, J., Mehling, H., Schönermarck, U., Venhoff, N., Vielhauer, V., Witzke, O., Szombati, I., Szucs, G., Garibotto, G., Alberici, F., Brunetta, E., Dagna, L., De Vita, S., Emmi, G., Gabrielli, A., Manenti, L., Pieruzzi, F., Roccatello, D., Salvarani, C., Dobashi, H., Atsumi, T., Fujimoto, S., Hagino, N., Ihata, A., Kaname, S., Kaneko, Y., Katagiri, A., Katayama, M., Kirino, Y., Kitagawa, K., Komatsuda, A., Kono, H., Kurasawa, T., Matsumura, R., Mimura, T., Morinobu, A., Murakawa, Y., Naniwa, T., Nanki, T., Ogawa, N., Oshima, H., Sada, K., Sugiyama, E., Takeuchi, T., Taki, H., Tamura, N., Tsukamoto, T., Yamagata, K., Yamamura, M., van Daele, P., Rutgers, A., Teng, Y., Walker, R., Chua, I., Collins, M., Rabindranath, K., de Zoysa, J., Svensson, M., Grevbo, B., Kalstad, S., Little, M., Clarkson, M., Molloy, E., Pamplona, I. Agraz, Anton, J., Lucia, V. Barrio, Ciggaran, S., Cid, M. Cinta, Encarnacion, M. Diaz, Oliveras, X. Fulladosa, Soler, M. Jose, Rusinol, H. Marco, Praga, M., Porras, L. Quintana, Segarra, A., Bruchfeld, A., Segelmark, M., Soveri, I., Thomaidi, E., Westman, K., Neumann, T., Burnier, M., Daikeler, T., Dudler, J., Hauser, T., Seeger, H., Vogt, B., Jayne, D., Burton, J., Al Jayyousi, R., Amin, T., Andrews, J., Baines, L., Brogan, P., Dasgupta, B., Doulton, T., Flossmann, O., Griffin, S., Harper, J., Harper, L., Kidder, D., Klocke, R., Lanyon, P., Luqmani, R., McLaren, J., Makanjuola, D., McCann, L., Nandagudi, A., Selvan, S., O'Riordan, E., Patel, M., Patel, R., Pusey, C., Rajakariar, R., Robson, J., Robson, M., Salama, A., Smyth, L., Sznajd, J., Taylor, J., Merkel, P., Sreih, A., Belilos, E., Bomback, A., Carlin, J., Chen Lin, Y. Chang, Derebail, V., Dragoi, S., Dua, A., Forbess, L., Geetha, D., Gipson, P., Gohh, R., Greenwood, G.T., Hugenberg, S., Jimenez, R., Kaskas, M., Kermani, T., Kivitz, A., Koening, C., Langford, C., Marder, G., Mohamed, A., Monach, P., Neyra, N., Niemer, G., Niles, J., Obi, R., Owens, C., Parks, D., Podoll, A., Rovin, B., Sam, R., Shergy, W., Silva, A., Specks, U., Spiera, R., Springer, J., Striebich, C., Swarup, A., Thakar, S., Tiliakos, A., Tsai, Y., Waguespack, D., Wasko, M. Chester, Cortazar, Frank B., Niles, John L., Jayne, David R.W., Merkel, Peter A., Bruchfeld, Annette, Yue, Huibin, Schall, Thomas J., and Bekker, Pirow

Published
2023
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19. Vasculitis

Author

Micheletti, Robert G., Merkel, Peter A., Garg, Amit, editor, Merola, Joseph F., editor, and Fitzpatrick, Laura, editor

Published
2022
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21. Arterial lesions in giant cell arteritis: A longitudinal study.

Author

Kermani, Tanaz, Diab, Sehriban, Sreih, Antoine, Cuthbertson, David, Borchin, Renée, Carette, Simon, Forbess, Lindsy, Koening, Curry, McAlear, Carol, Monach, Paul, Moreland, Larry, Pagnoux, Christian, Seo, Philip, Spiera, Robert, Warrington, Kenneth, Ytterberg, Steven, Langford, Carol, Merkel, Peter, and Khalidi, Nader

Subjects
Aortic aneurysm, Computed tomography angiography, Disease activity, Giant cell arteritis, Large-artery stenosis, Magnetic resonance angiography, Aged, Aorta, Thoracic, Axillary Artery, Computed Tomography Angiography, Female, Giant Cell Arteritis, Humans, Longitudinal Studies, Magnetic Resonance Angiography, Male, Middle Aged, Subclavian Artery
Abstract

OBJECTIVES: To evaluate large-vessel (LV) abnormalities on serial imaging in patients with giant cell arteritis (GCA) and discern predictors of new lesions. METHODS: Clinical and imaging data from patients with GCA (including subjects diagnosed by LV imaging) enrolled in a prospective, multicenter, longitudinal study and/or a randomized clinical trial were included. New arterial lesions were defined as a lesion in a previously unaffected artery. RESULTS: The study included 187 patients with GCA, 146 (78%) female, mean (±SD) age at diagnosis 68.5 ± 8.5 years; 39% diagnosed by LV imaging. At least one arterial lesion was present in 123 (66%) on the first study. The most frequently affected arteries were subclavian (42%), axillary (32%), and thoracic aorta (20%). In 106 patients (57%) with serial imaging, new arterial lesions were noted in 41 patients (39%), all of whom had a baseline abnormality, over a mean (±SD) follow-up of 4.39 (2.22) years. New abnormalities were observed in 33% patients by year 2; clinical features of active disease were present at only 50% of these cases. There were no differences in age, sex, temporal artery biopsy positivity, or disease activity in patients with or without new lesions. CONCLUSIONS: In this cohort of patients with GCA, LV abnormalities on first imaging were common. Development of new arterial lesions occurred in patients with arterial abnormalities at first imaging, often in the absence of symptoms of active disease. Arterial imaging should be considered in all patients with GCA at diagnosis and serial imaging at least in patients with baseline abnormalities.

Published
2019

23. Neutrophil activation in patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis and large-vessel vasculitis

Author

Michailidou, Despina, Duvvuri, Bhargavi, Kuley, Runa, Cuthbertson, David, Grayson, Peter C., Khalidi, Nader A., Koening, Curry L., Langford, Carol A., McAlear, Carol A., Moreland, Larry W., Pagnoux, Christian, Seo, Philip, Specks, Ulrich, Sreih, Antoine G., Warrington, Kenneth J., Mustelin, Tomas, Monach, Paul A., Merkel, Peter A., and Lood, Christian

Published
2022
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27. Signal Regulatory Protein α Expression in Systemic Vasculitis.

Author

Banerjee, Shubhasree, Rose, Eileen, Panicker, Sandip, Dugan, John, Khalidi, Nader, Koening, Curry L., Langford, Carol A., Monach, Paul A., Pagnoux, Christian, McAlear, Carol A., and Merkel, Peter A.

Subjects
VASCULITIS, CELL migration, BIOPSY, MACROPHAGES, MONOCYTES, CROHN'S disease, RESEARCH funding, NEUTROPHILS, CELL proliferation, MICROSCOPIC polyangiitis, KRUSKAL-Wallis Test, MYELOID cells, GIANT cell arteritis, CELLULAR signal transduction, GENE expression, GRANULOMATOSIS with polyangiitis, IMMUNOHISTOCHEMISTRY, MICROBIOLOGICAL assay, STAINS & staining (Microscopy), MEMBRANE proteins, PHAGOCYTOSIS, TEMPORAL arteries, KIDNEYS
Abstract

Objective: Signal regulatory protein α (SIRPα) is found primarily on myeloid cells, including macrophages and neutrophils; binds to CD47; and regulates phagocytosis, antigen presentation, cellular fusion, cell proliferation, and migration. Therefore, SIRPα may be involved in the pathogenesis of autoimmune diseases, including systemic vasculitis. This study aimed to assess SIRPα expression in tissue samples from patients with vasculitis. Methods: Immunohistochemical staining for SIRPα was performed on temporal artery (TA), kidney, and lung biopsy samples from patients with giant cell arteritis (GCA), patients with microscopic polyangiitis (MPA), patients with granulomatosis with polyangiitis (GPA), and patients without vasculitis. A score of SIRPα+ expression was calculated, derived from the percentages of monocytes, macrophages, and dendritic cells and neutrophils with different staining intensities in affected tissues. Results: A total of 46 samples from patients with different vasculitides (GCA, MPA, and GPA) were included in the study. Tissue samples included TA samples from 15 patients with GCA; kidney samples from 11 and 9 patients with GPA and MPA, respectively; and lung samples from 11 patients with GPA. Most tissue samples from patients with active vasculitis (15 of 15 TA samples, 17 of 20 kidney samples, and 9 of 11 lung samples) showed SIRPα staining. SIRPα staining intensity was less in kidney samples compared to TA and lung samples. Conclusion: This study demonstrates high‐level expression of SIRPα in macrophages and monocytes in affected tissue in systemic vasculitis. These findings provide a foundation for further studies exploring the role of the SIRPα–CD47 pathway in the pathogenesis of systemic vasculitis and the potential for the blockade of SIRPα and/or the depletion of SIRPα+ cells as treatment of systemic vasculitis. [ABSTRACT FROM AUTHOR]

Published
2024
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28. Risk of Relapse of Antineutrophil Cytoplasmic Antibody–Associated Vasculitis in a Randomized Controlled Trial of Plasma Exchange and Glucocorticoids.

Author

Junek, Mats L., Merkel, Peter A., Vilayur, Eswari, Wald, Ron, Khalidi, Nader, Jayne, David, Walsh, Michael, Paizis, Kathy, Reidlinger, Donna, Morrish, Alicia, Badve, Sunil V, Pascoe, Elaine, Paul‐Brent, Peta‐Anne, Robison, Laura, Valks, Andrea, Walters, Giles, Jardine, Meg, Milton, Caroline, Ibraham, Abu, and Siva, Brian

Subjects
*VASCULITIS treatment, *AUTOIMMUNE disease treatment, *RISK assessment, *DATA analysis, *ANTINEUTROPHIL cytoplasmic antibodies, *SEVERITY of illness index, *DISEASE remission, *DESCRIPTIVE statistics, *HEMODIALYSIS, *STATISTICS, *DISEASE relapse, *CONFIDENCE intervals, *PLASMA exchange (Therapeutics), *GLUCOCORTICOIDS, *CYCLOPHOSPHAMIDE, *DISEASE risk factors
Abstract

Objective: Relapses of antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis are important events that can cause organ dysfunction and reduce quality of life. Understanding the effects of the initial treatments for ANCA‐associated vasculitis on the subsequent risk of relapse may help guide monitoring and treatment. Methods: We performed a post hoc analysis of participants with severe ANCA‐associated vasculitis enrolled in an international two‐by‐two factorial randomized controlled trial comparing the effects of plasma exchange (PLEX) to no PLEX and a regimen of reduced glucocorticoid exposure to a standard regimen. We estimated the effects of treatments on relapses of any severity using three competing risk time‐to‐event models adjusted for patient and disease characteristics and other treatments. Each model was adjusted for disease manifestations in different ways. Results: Of 704 participants, 649 (92.2%) achieved remission and 147 (22.7%) experienced 204 relapses. The relapse rate was 10.3 (95% confidence interval [CI] 8.4–12.1) relapses per 100 patient‐years. Neither the use of PLEX (subhazard ratio 0.91–0.94; 95% CIs range from 0.66 to 1.31) nor a glucocorticoid regimen (subhazard ratio 0.93–0.94; 95% CIs range from 0.67 to 1.35) appreciably changed the risk of relapse. Proteinase 3–ANCA and the presence of nonhemorrhagic respiratory manifestations of the disease at trial entry were associated with increased risks of relapse. Receiving dialysis at baseline and administration of oral cyclophosphamide as induction therapy were associated with lower risks of relapse. Conclusion: In patients with severe ANCA‐associated vasculitis, relapses remain common; neither the use of PLEX nor an initial glucocorticoid tapering regimen impacted relapse risk. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Evaluation of damage in giant cell arteritis.

Author

Kermani, Tanaz, Sreih, Antoine, Cuthbertson, David, Carette, Simon, Hoffman, Gary, Khalidi, Nader, Koening, Curry, Langford, Carol, McAlear, Carol, Monach, Paul, Moreland, Larry, Pagnoux, Christian, Seo, Philip, Warrington, Kenneth, Ytterberg, Steven, and Merkel, Peter

Subjects
damage, giant cell arteritis, large-artery manifestations, large-vessel vasculitis, vasculitis, Aged, Eye Diseases, Female, Follow-Up Studies, Giant Cell Arteritis, Humans, Intermittent Claudication, Longitudinal Studies, Male, Middle Aged, Odds Ratio, Prospective Studies, Recurrence, Risk Factors, Severity of Illness Index, Time Factors
Abstract

OBJECTIVES: To evaluate damage and variables associated with damage in GCA. METHODS: Patients with GCA enrolled in a prospective, multicentre, longitudinal study were included. Per-protocol assessments were made with the Vasculitis Damage Index and the Large-Vessel Vasculitis Index of Damage. RESULTS: The study included 204 patients: 156 women (76%), mean age at diagnosis 71.3 years (s.d. 8.3), mean follow-up of 3.5 years (s.d. 1.9). One or more damage item was present in 54% at baseline and 79% at the last follow-up on the Vasculitis Damage Index, and 60% at baseline and 82% at the last follow-up on the Large-Vessel Vasculitis Index of Damage. The most frequently observed damage items were large-artery complications (29% cohort) and ocular (22%). Among 117 patients with new damage, most new items were ocular (63 patients), cardiac/vascular (48) and musculoskeletal (34). Of these, treatment-associated items were frequently observed, including cataracts (46 patients), osteoporosis (22) and weight gain (22). Disease-associated new damage included ischaemic optic neuropathy (3 patients), limb claudication (13), arterial occlusions (10) and damage requiring vascular intervention (10). In univariate analysis, the risk of damage increased 22% for every additional year of disease duration [odds ratio (OR) 1.22 (95% CI 1.04, 1.45)]. In 94 patients enrolled within ⩽90 days of diagnosis of GCA, the risk of new damage at the last follow-up decreased 30% for each additional relapse [OR 0.70 (95% CI 0.51, 0.97)]. CONCLUSIONS: Large-artery complications and ocular manifestations are the most commonly occurring items of damage in GCA. Most new damage is associated with treatment. These findings emphasize the cumulative burden of disease in GCA.

Published
2018

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

Author

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

Published
2024
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34. Computable phenotype for real-world, data-driven retrospective identification of relapse in ANCA-associated vasculitis

Author

Scott, Jennifer, primary, White, Arthur, additional, Walsh, Cathal, additional, Aslett, Louis, additional, Rutherford, Matthew A, additional, Ng, James, additional, Judge, Conor, additional, Sebastian, Kuruvilla, additional, O’Brien, Sorcha, additional, Kelleher, John, additional, Power, Julie, additional, Conlon, Niall, additional, Moran, Sarah M, additional, Luqmani, Raashid Ahmed, additional, Merkel, Peter A, additional, Tesar, Vladimir, additional, Hruskova, Zdenka, additional, and Little, Mark A, additional

Published
2024
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36. OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody-associated Vasculitis.

Author

Robson, Joanna, Tomasson, Gunnar, Milman, Nataliya, Ashdown, Sue, Boonen, Annelies, Casey, George, Cronholm, Peter, Cuthbertson, David, Dawson, Jill, Direskeneli, Haner, Easley, Ebony, Kermani, Tanaz, Farrar, John, Gebhart, Don, Lanier, Georgia, Luqmani, Raashid, Mahr, Alfred, McAlear, Carol, Peck, Jacqueline, Shea, Beverley, Shea, Judy, Sreih, Antoine, Tugwell, Peter, and Merkel, Peter

Subjects
ANCA-ASSOCIATED VASCULITIS, ICF, OMERACT, PATIENT-REPORTED OUTCOMES, PROMIS, Algorithms, Anti-Inflammatory Agents, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Health Status, Humans, Patient Reported Outcome Measures, Quality of Life, Treatment Outcome
Abstract

OBJECTIVE: The antineutrophil cytoplasmic antibody-associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016. METHODS: A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented. RESULTS: OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement). CONCLUSION: The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial.

Published
2017

37. The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica.

Author

Mackie, Sarah, Twohig, Helen, Neill, Lorna, Harrison, Eileen, Shea, Beverley, Black, Rachel, Kermani, Tanaz, Merkel, Peter, Mallen, Christian, Buttgereit, Frank, Mukhtyar, Chetan, Simon, Lee, and Hill, Catherine

Subjects
OMERACT, OUTCOMES, POLYMYALGIA RHEUMATICA, Antirheumatic Agents, Clinical Trials as Topic, Delphi Technique, Humans, Outcome Assessment, Health Care, Polymyalgia Rheumatica, Quality of Life, Research Design
Abstract

OBJECTIVE: To inform development of a core domain set for outcome measures for clinical trials in polymyalgia rheumatica (PMR), we conducted patient consultations, a systematic review, a Delphi study, and 2 qualitative studies. METHODS: Domains identified by 70% or more of physicians and/or patients in the Delphi study were selected. The conceptual framework derived from the 2 qualitative research studies helped inform the meaning of each domain and its relationship to the others. The draft core domain set was refined by further discussion with patients and physicians who had participated in the Delphi study. At the Outcome Measures in Rheumatology (OMERACT) 2016, the domains were discussed and prioritized by 8 breakout groups. Formal voting took place at the end of the workshop and in the final plenary. RESULTS: Ninety-three percent of voters in the final plenary agreed that the inner core of domains considered mandatory for clinical trials of PMR should consist the following: laboratory markers of systemic inflammation, pain, stiffness, and physical function. Patients global and fatigue were considered important but not mandatory (outer core). The research agenda included psychological impact, weakness, physical activity, participation, sleep, imaging, and health-related quality of life. CONCLUSION: This core domain set was considered sufficiently well-defined that the next step will be to apply the OMERACT Filter 2.0 Instrument Selection Algorithm to select candidate instruments for a subsequent deeper dive into the data. This will allow instruments to be mapped onto each of our core domains to derive a core outcome set for PMR.

Published
2017

39. Pulmonary Eosinophilic Granulomatosis with Polyangiitis Has IgG4 Plasma Cells and Immunoregulatory Features

Author

Dong, Zachary M., Lin, Edwin, Wechsler, Michael E., Weller, Peter F., Klion, Amy D., Bochner, Bruce S., Delker, Don A., Hazel, Mark W., Fairfax, Keke, Khoury, Paneez, Akuthota, Praveen, Merkel, Peter A., Dyer, Anne-Marie, Langford, Carol, Specks, Ulrich, Gleich, Gerald J., Chinchilli, Vernon M., Raby, Benjamin, Yandell, Mark, and Clayton, Frederic

Published
2020
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44. Efficacy and Safety of Benralizumab Compared with Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Patients Receiving Standard of Care Therapy: Phase 3 MANDARA Study

Author

Wechsler, Michael, primary, Nair, Parameswaran, additional, Terrier, Benjamin, additional, Walz, Bastian, additional, Bourdin, Arnaud, additional, Jayne, David, additional, Jackson, David, additional, Roufosse, Florence, additional, Sjö, Lena Börjesson, additional, Fan, Ying, additional, Jison, Maria, additional, McCrae, Christopher, additional, Necander, Sofia, additional, Shavit, Anat, additional, Walton, Claire, additional, and Merkel, Peter, additional

Published
2024
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45. Combined Orbital and Cranial Vessel Wall Magnetic Resonance Imaging for the Assessment of Disease Activity in Giant Cell Arteritis

Author

Rhee, Rennie L., primary, Rebello, Ryan, additional, Tamhankar, Madhura A., additional, Banerjee, Shubhasree, additional, Liu, Fang, additional, Cao, Quy, additional, Kurtz, Robert, additional, Baker, Joshua F., additional, Fan, Zhaoyang, additional, Bhatt, Vatsal, additional, Amudala, Naomi, additional, Chou, Sherry, additional, Liang, Rui, additional, Sanchez, Marisa, additional, Burke, Morgan, additional, Desiderio, Lisa, additional, Loevner, Laurie A., additional, Morris, Jeffrey S., additional, Merkel, Peter A., additional, and Song, Jae W., additional

Published
2024
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46. The Birmingham Vasculitis Activity Score as a Measure of Disease Activity in Patients with Giant Cell Arteritis.

Author

Kermani, Tanaz, Cuthbertson, David, Carette, Simon, Hoffman, Gary, Khalidi, Nader, Koening, Curry, Langford, Carol, McKinnon-Maksimowicz, Kathleen, McAlear, Carol, Monach, Paul, Seo, Philip, Warrington, Kenneth, Ytterberg, Steven, Merkel, Peter, and Matteson, Eric

Subjects
BIRMINGHAM VASCULITIS ACTIVITY SCORE, COHORT STUDY, DISEASE ACTIVITY, GIANT CELL ARTERITIS, Aged, Aged, 80 and over, Female, Giant Cell Arteritis, Humans, Longitudinal Studies, Male, Middle Aged, Prospective Studies, Severity of Illness Index, Symptom Assessment
Abstract

OBJECTIVE: To evaluate the performance of the Birmingham Vasculitis Activity Score (BVAS) in the assessment of disease activity in giant cell arteritis (GCA). METHODS: Patients with GCA enrolled in a prospective, multicenter, longitudinal study with symptoms of active vasculitis during any visit were included. Spearmans rank correlation was used to explore the association of the BVAS with other measures of disease activity. RESULTS: During a mean (SD) followup of 2.3 (1.6) years, symptoms of active GCA were present in 236 visits in 136 subjects (100 female, 74%). Median (range) BVAS1 (new/worse symptoms) was 1 (0-10) and median (range) BVAS2 (persistent symptoms) was 0 (0-5). Median (range) physicians global assessment (PGA) was 4 (0-9) for disease activity in the past 28 days and 2 (0-9) for activity on the day of the visit. Important ischemic manifestations of active vasculitis not recorded by the BVAS included tongue/jaw claudication (27%), upper extremity claudication (15%), lower extremity claudication (5%), carotidynia (7%), and ischemic retinopathy (5%). During 25 visits (11%) with active disease, all symptoms of active vasculitis were placed in the Other category yet still resulted in a BVAS1 and BVAS2 of 0. BVAS1 moderately correlated with PGA for the past 28 days (Spearmans correlation 0.50) and physician-rated disease activity for the past 28 days (Spearmans correlation 0.46). CONCLUSION: The BVAS has limited utility in GCA. Patients with active GCA can have a BVAS of 0. Many important ischemic symptoms attributable to active vasculitis are not included in the composite score.

Published
2016

47. The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis

Author

Khanna, Dinesh, Berrocal, Veronica J, Giannini, Edward H, Seibold, James R, Merkel, Peter A, Mayes, Maureen D, Baron, Murray, Clements, Philip J, Steen, Virginia, Assassi, Shervin, Schiopu, Elena, Phillips, Kristine, Simms, Robert W, Allanore, Yannick, Denton, Christopher P, Distler, Oliver, Johnson, Sindhu R, Matucci-Cerinic, Marco, Pope, Janet E, Proudman, Susanna M, Siegel, Jeffrey, Wong, Weng Kee, Wells, Athol U, and Furst, Daniel E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Scleroderma, Inflammatory and immune system, Adult, Female, Humans, Male, Middle Aged, Psychometrics, Randomized Controlled Trials as Topic, Rheumatology, Scleroderma, Diffuse, Severity of Illness Index, Public Health and Health Services, Psychology, Clinical sciences, Allied health and rehabilitation science
Abstract

ObjectiveEarly diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs).MethodsWe developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not improved over a period of 1 year. Using the profiles for which raters had reached a consensus on whether the patients were improved versus not improved (79% of the profiles examined), we fit logistic regression models in which the binary outcome referred to whether the patient was improved or not, and the changes in the core set items from baseline to followup were entered as covariates. We tested the final index in a previously completed RCT.ResultsSixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. In the logistic regression model in which the included core set items were change over 1 year in the modified Rodnan skin thickness score, the forced vital capacity, the patient and physician global assessments, and the Health Assessment Questionnaire disability index, sensitivity was 0.982 (95% confidence interval 0.982-0.983) and specificity was 0.931 (95% confidence interval 0.930-0.932), and the model with these 5 items had the highest face validity. Subjects with a significant worsening of renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. With use of the index, the effect of methotrexate could be differentiated from the effect of placebo in a 1-year RCT (P = 0.02).ConclusionWe have developed a CRISS that is appropriate for use as an outcome assessment in RCTs of early dcSSc.

Published
2016

48. Comparison of EULAR/PRINTO/PReS Ankara 2008 and 2022 ACR/EULAR Classification Criteria for Granulomatosis with Polyangiitis in Children

Author

Kaya Akca, Ummusen, primary, Batu, Ezgi Deniz, additional, Jelusic, Marija, additional, Calatroni, Marta, additional, Bakry, Reima, additional, Frkovic, Marijan, additional, Vinšová, Nikol, additional, Campos, Reinan T, additional, Horne, AnnaCarin, additional, Caglayan, Sengul, additional, Vaglio, Augusto, additional, Moroni, Gabriella, additional, Emmi, Giacomo, additional, Ghiggeri, Gian Marco, additional, Koker, Oya, additional, Sinico, Renato Alberto, additional, Kim, Susan, additional, Gagro, Alenka, additional, Matucci-Cerinic, Caterina, additional, Çomak, Elif, additional, Ekici Tekin, Zahide, additional, Arslanoglu Aydin, Elif, additional, Heshin-Bekenstein, Merav, additional, Acar, Banu Celikel, additional, Gattorno, Marco, additional, Akman, Sema, additional, Sozeri, Betul, additional, Palmblad, Karin, additional, Al-Mayouf, Sulaiman M, additional, Silva, Clovis Artur, additional, Doležalová, Pavla, additional, Merkel, Peter A, additional, and Ozen, Seza, additional

Published
2023
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