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1. Clinical Characteristics of an Internet-Based Cohort of Patient-Reported Diagnosis of Granulomatosis With Polyangiitis and Microscopic Polyangiitis: Observational Study

Author

Springer, Jason Michael, Kermani, Tanaz A, Sreih, Antoine, Shaw, Dianne G, Young, Kalen, Burroughs, Cristina M, and Merkel, Peter A

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
Abstract

BackgroundUtilizing the traditional centers of excellence approach to conduct clinical trials involving rare diseases remains challenging. Patient-based registries have been shown to be both feasible and valid in several other diseases. ObjectiveThis report outlines the clinical characteristics of a large internet registry cohort of participants with a self-reported diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis. MethodsPatients with a self-reported diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis in an internet-based prospective longitudinal cohort (from the Vasculitis Patient-Powered Research Network) were included. Data on symptoms, diagnostic testing, and treatment were collected using standardized questionnaires. ResultsThe study compared patients with granulomatosis with polyangiitis (n=762) and patients with microscopic polyangiitis (n=164). Of the cohort, 97.7% (904/925) reported the diagnosis had been confirmed by a physician. Compared to microscopic polyangiitis, patients with granulomatosis with polyangiitis reported significantly more ear, nose, and throat manifestations (granulomatosis with polyangiitis: 641/723, 88.7%; microscopic polyangiitis: 89/164, 54.3%; z=10.42, P

Published
2020
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2. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody–Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial

Author

Merkel, Peter A, Jayne, David R, Wang, Chao, Hillson, Jan, and Bekker, Pirow

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundAntineutrophil cytoplasmic antibody (ANCA)–associated vasculitis is a serious, often life-threatening disease. In new-onset disease or a relapse, the standard treatment is immunosuppressive therapy with glucocorticoids; these therapies are associated with substantial short- and long-term toxicity. Complement component 5a (C5a) binding to C5a receptor (C5aR) may play a central role in the pathogenesis of ANCA-associated vasculitis. Avacopan is a novel, orally bioavailable, and highly selective antagonist of human C5aR. Avacopan does not interfere with the production of C5b or the membrane attack complex (ie, terminal complement complex) and does not block C5a binding to a second receptor, C5L2 (also called C5aR2), shown to be protective in antimyeloperoxidase glomerulonephritis. This trial will evaluate if avacopan replaces the need for chronic glucocorticoids in the treatment of ANCA-associated vasculitis. ObjectiveThe aim of this study is to determine the proportions of patients in remission at week 26 and with sustained remission at week 52, defined as Birmingham Vasculitis Activity Score=0, and not taking glucocorticoids within the 4 weeks before week 26 and week 52, respectively. MethodsThe Avacopan Development in Vasculitis to Obtain Corticosteroid elimination and Therapeutic Efficacy study is a randomized, double-blind, active-comparator (prednisone), 2-arm study evaluating the safety and efficacy of avacopan versus prednisone, administered in combination with other immunosuppressive therapy. Eligible subjects will have active disease requiring induction of remission. Subjects are stratified based on the type of immunosuppressive therapy, ANCA subtype, and new or relapsing disease. Target sample size is 300 patients, enrolled at over 200 sites globally. All authors and local ethics committees approved the study design. All patients will provide informed consent. ResultsEnrollment of patients was completed in Q4 2018. Topline results are anticipated to be published by Q3 2020. ConclusionsResults will be released irrespective of whether the findings are positive or negative. Trial RegistrationClinicalTrials.gov NCT02994927; https://clinicaltrials.gov/ct2/show/NCT02994927 International Registered Report Identifier (IRRID)DERR1-10.2196/16664

Published
2020
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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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5. 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

6. 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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9. 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

10. 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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11. 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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12. The effects of plasma exchange and glucocorticoids on early kidney function among patients with ANCA-associated vasculitis in the PEXIVAS trial

Author

Paizis, Kathy, Walters, Giles, Jardine, Meg, Milton, Caroline, Ibraham, Abu, Siva, Brian, Desmond, Michael, Perkovic, Vlado, Kurtkoti, Jadadeesh, Vilayur, Eswari, Cass, Alan, Summers, Shaun, Brown, Fiona, Ryan, Jessica, Kerr, Peter, Noble, Euan, Luxton, Grant, Mudge, David W., Hawley, Carmel, Johnson, David W., Peh, Chen Au, Faull, Randall J., Ranganathan, Dwarakanathan, Jeffs, Lisa, Nicholls, Kathy, Hughes, Peter, Cooper, Bruce, Boudville, Neil, Ford, Sharon, Langham, Robyn, Reidlinger, Donna, AliciaMorrish, Badve, Sunil V., Pascoe, Elaine, Paul-Brent, Peta-Anne, Robison, Laura, Valks, Andrea, Blockmans, Daniel, Henckaerts, Liesbet, Sprangers, Ben, Suri, Rita, Brachemi, Soumeya, Clark, William, Garg, Amit, Carette, Simon, Pagnoux, Christian, Reich, Heather, Barth, David, Walsh, Michael, Khalidi, Nader, Cox, Gerry, Mazzetti, Andrea, Robins, Diane, Wald, Ron, Perl, Jeffrey, Pavenski, Katerina, Dacouris, Niki, Levin, Adeera, Copland, Michael, Fairhead, Todd, Pannu, Neesh, Qarni, Muhammad Uwais, Habib, Syed, Girard, Louis, Manns, Braden, Tesar, Vladimir, Hruskova, Zdenka, Chocova, Zdenka, Povlsen, Johan, Gregersen, Jon, Ivarsen, Per, Birn, Henrik, Krarup, Elizabeth, Pedersen, Erling B., Thomsen, Ingrid, Bech, Jesper Nørgaard, Szpirt, Wladmir, Egfjord, Martin, Mesbah, Rafik, Bataille, Pierre, Rey, Isabelle, Chantrel, François, Vanhille, Philipe, Quémeneur, Thomas, Carron, Pierre-Louis, Zaoui, Philippe, de Moreuil, Claire, Gosselin, Morgane, Delluc, Aurélien, Hanrotel-Saliou, Catherine, Le Jeune, Mathilde, Ficheux, Maxence, Aniort, Julien, Lavigne, Christian, Augusto, Jean Francois, Chauveau, Dominique, Guitard, Joëlle, Huart, Antoine, Ribes, David, Gatault, Philippe, Becmeur, Camille, Muller, Sandrine, Betz, Valérie, Klein, Alexandre, Blaison, Gilles, Seror, Raphaele, Francois, Hélène, Mariette, Xavier, Aubrun, Aurore, Coustet, Baptiste, Palazzo, Elisabeth, Ottaviani, Sébastien, Goulenok, Tiphaine, Daugas, Eric, Dieudé, Philipe, Papo, Thomas, Lebas, Céline, Lionet, Arnaud, Guillevin, Loïc, Mouthon, Luc, Puéchal, Xavier, Jourde-Chiche, Noémie, Ruivard, Marc, Karras, Alexandre, Limal, Nicolas, Kofman, Thomas, Le Quellec, Alain, Maurier, François, Gibelin, Aude, Parrot, Antoine, Bachmeyer, Claude, Gombert, Bruno, Nouvier, Mathilde, Lega, Jean-Christophe, Fain, Olivier, Andrès, Emmanuel, Cottet, Rachel, Gregorini, Gina, Jeannin, Guido, Possenti, Stefano, Buzio, Carlo, Vaglio, Augusto, Oliva, Elena, Makino, Hirofumi, Muso, Eri, Endo, Tomomi, Kakita, Hiroko, Suzuki, Hiroyuki, Handa, Takaya, Kang, Youngna, Ariyasu, Yuki, Tsukamoto, Tatsuo, Endo, Shuichiro, Miyata, Hitomi, Yamada, Hiroyuki, Ito-Ihara, Toshiko, Uchida, Shunya, Kono, Hajime, Fujigaki, Yoshihide, Kikuchi, Hirotoshi, Nanki, Toshihiro, Kato, Hideki, Okamoto, Akiko, Asako, Kurumi, Suzuki, Kazuo, Hamano, Yoshitomo, Yamagata, Kunihiro, Usui, Joichi, Fujimoto, Shouichi, Sato, Yuji, Kikuchi, Masao, Flores-Suárez, Luis Felipe, Sánchez-Guerrero, Sergio A., Collins, Michael, Schollum, John, de Zoysa, Janak, Quincy, Vicki, Sizeland, Peter, Aasarod, Knut, Solbu, Marit, Bruun, Trude Jannecke, Koldingsnes, Wenche, Wludarczyk, Anna, Nowak, Ilona, Gorka, Jacek, Sznajd, Jan, Padjas, Agnieszka, Jankowski, Milosz, Widawska, Agnieszka, Szczeklik, Wojciech, Ballarin, Jose, Bruchfeld, Annette, Efvergren, Mats, Eriksson, Per, Westman, Kerstin, Selga, Daina, Heijl, Caroline, Ohlsson, Sophie, Segelmark, Marten, Basu, Neil, Kidder, Dana, Fluck, Nicholas, Jayne, David R.W., Smith, Rona, Wilcocks, Lisa, McClure, Mark, Jones, Rachel, Trivedi, Sapna, Gopaluni, Seerapani, Brettell, Elizabeth, Crump, Paul, Feilbach, Annika, Hewitt, Catherine, Hilken, Nick, Howman, Andrew, Hughes, Terry, Ives, Natalie, Jarrett, Hugh, Mehta, Samir, Record, Rebecca, Ryan, Gemma, Sidile, Chaka, Wheatley, Keith, Sheerin, Brown, Alison, Baines, Laura Anne, Lordan, Jim, Pusey, Charles, Tanna, Anisha, McAdoo, Stephen, Levy, Jeremy, Griffith, Megan, Klebe, Bernhard, Doulton, Timothy, Warwick, Graham, Burton, James, Barratt, Jonathon, Topham, Peter, Baines, Richard, Brunskill, Nigel, Al-Jayyousi, Reem, Hamilton, Patrick, Patel, Mumtaz, Mitra, Sandip, Brown, Nina, Sharples, Edward, Luqmani, Raashid, Harper, Lorraine, Rhodes, Benjamin, Chanouzas, Dimitrios, Morgan, Matthew, Hewins, Peter, Floßmann, Oliver, Bhandary, Nitin, Foxton, Julie, Jones, Linda, King, Jenny, Smyth, Lucy, D’Souza, Richard, Haigh, Richard, Hough, Maxine, Salama, Alan, Burns, Aine, Little, Mark, Dhaun, Neeraj, Dhaygude, Ajay, Basnayake, Kolitha, Iggo, Neil, Jones, Daniel, Oliveira, David, MacPhee, Iain A.M., Dunn, Emma, Lewington, Andrew J.P., Fan, Stanley Linsun, Rajakariar, Ravindra, Yaqoob, Magdi, Short, Andrew, Geddes, Colin, Mackinnon, Bruce, Jardine, Alan G., Monach, Paul, Merkel, Peter A., Amudala, Naomi, Quillen, Karen, Weisman, Michael, Wallace, Daniel, Forbess, Lindsy, Venuturupalli, Swamy, Langford, Carol, Hajj-Ali, Rula, Koo, Anna, Hoffman, Gary, Specks, Ulrich, Keogh, Karina, Ytterberg, Steven, Winters, Jeff, Warrington, Kenneth, Cartin-Ceba, Rodrigo, Peikert, Tobias, Fervenza, Fernando, Baqir, Misbah, Nachman, Patrick, Detwiler, Randy, Mottl, Amy, Derebail, Vimal, McGregor, JulieAnne, Sreih, Antoine, Rhee, Rennie, McAlear, Carol, Aqui, Nicole, Moreland, Larry, Kiss, Joseph, Liang, Kimberly, Mohan, Niveditha, Balogun, Rasheed, Li, Tingting, Brasington, Richard, Odler, Balazs, Riedl, Regina, Geetha, Duvuru, Szpirt, Wladimir M., Uchida, Lisa, Wallace, Zachary S., Pusey, Charles D., Little, Mark A., and Kronbichler, Andreas

Published
2024
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13. 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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14. 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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18. 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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21. 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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22. 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. 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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28. 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

29. 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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32. 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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36. Eosinophils in Health and Disease: A State-of-the-Art Review

Author

Wechsler, Michael E., Munitz, Ariel, Ackerman, Steven J., Drake, Matthew G., Jackson, David J., Wardlaw, Andrew J., Dougan, Stephanie K., Berdnikovs, Sergejs, Schleich, Florence, Matucci, Andrea, Chanez, Pascal, Prazma, Charlene M., Howarth, Peter, Weller, Peter F., and Merkel, Peter A.

Published
2021
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38. 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

39. 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

41. Identification of susceptibility loci for Takayasu arteritis through a large multi-ancestral genome-wide association study

Author

Ortiz-Fernández, Lourdes, Saruhan-Direskeneli, Güher, Alibaz-Oner, Fatma, Kaymaz-Tahra, Sema, Coit, Patrick, Kong, Xiufang, Kiprianos, Allan P., Maughan, Robert T., Aydin, Sibel Z., Aksu, Kenan, Keser, Gokhan, Kamali, Sevil, Inanc, Murat, Springer, Jason, Akar, Servet, Onen, Fatos, Akkoc, Nurullah, Khalidi, Nader A., Koening, Curry, Karadag, Omer, Kiraz, Sedat, Forbess, Lindsy, Langford, Carol A., McAlear, Carol A., Ozbalkan, Zeynep, Yavuz, Sule, Çetin, Gozde Yildirim, Alpay-Kanitez, Nilufer, Chung, Sharon, Ates, Askin, Karaaslan, Yasar, McKinnon-Maksimowicz, Kathleen, Monach, Paul A., Ozer, Hüseyin T.E., Seyahi, Emire, Fresko, Izzet, Cefle, Ayse, Seo, Philip, Warrington, Kenneth J., Ozturk, Mehmet A., Ytterberg, Steven R., Cobankara, Veli, Onat, Ahmet Mesut, Duzgun, Nurşen, Bıcakcıgil, Muge, Yentür, Sibel P., Lally, Lindsay, Manfredi, Angelo A., Baldissera, Elena, Erken, Eren, Yazici, Ayten, Kısacık, Bünyamin, Kaşifoğlu, Timuçin, Dalkilic, Ediz, Cuthbertson, David, Pagnoux, Christian, Sreih, Antoine, Reales, Guillermo, Wallace, Chris, Wren, Jonathan D., Cunninghame-Graham, Deborah S., Vyse, Timothy J., Sun, Ying, Chen, Huiyong, Grayson, Peter C., Tombetti, Enrico, Jiang, Lindi, Mason, Justin C., Merkel, Peter A., Direskeneli, Haner, and Sawalha, Amr H.

Published
2021
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44. 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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45. 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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46. Patient‐Reported Sinonasal Symptoms and Risk of Relapse in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis.

Author

Romich, Ellen, Banerjee, Shubhasree, Amudala, Naomi, Chou, Sherry, Li, Ruolan, Lee, Hongzhe, Cohen, Noam, Merkel, Peter A., and Rhee, Rennie L.

Subjects
PROPORTIONAL hazards models, GRANULOMATOSIS with polyangiitis, GENERALIZED estimating equations, DISEASE remission, PARANASAL sinuses
Abstract

Objective: Relapses are frequent and difficult to predict in antineutrophil cytoplasmic antibody–associated vasculitis (AAV), resulting in long‐term use of immunosuppression. Although sinonasal disease is associated with relapse of AAV, detailed characterization of sinonasal symptoms is lacking. Using a patient‐reported outcome, the 22‐item SinoNasal Outcome Test (SNOT‐22), we investigated the relationship between sinonasal symptoms and disease activity in AAV. Methods: This was a prospective, longitudinal study of individual with AAV and healthy individuals. Relapse was defined as a Birmingham Vasculitis Activity Score for Wegner's Granulomatosis score >0. Higher SNOT‐22 scores indicate worse symptoms. Generalized estimating equation and Cox proportional hazard models evaluated the association between SNOT‐22 and relapse. Results: There were 773 visits (106 active disease visits) from 168 patients with AAV and 51 controls. Median SNOT‐22 at remission was higher in AAV versus controls (20 vs 5; P < 0.001) and higher during active disease versus remission (P < 0.001). In all AAV, and particularly within granulomatosis with polyangiitis, higher SNOT‐22 scores were observed months to years before relapse and were associated with increased risk of relapse (hazard ratio 2.7, 95% confidence interval 1.2–6.2; P = 0.02). Similar findings were seen when examining patients with versus without sinonasal disease and after removing relapses limited to the ear, nose, and throat. Conclusion: A patient‐reported outcome measure of sinonasal disease, the SNOT‐22, not only changes with disease activity in AAV, but also is associated with a higher risk of relapse within two years. These findings support the possibility that the SNOT‐22 score may enhance prediction of relapse and that persistent sinonasal disease may be important in the pathophysiology of relapse. [ABSTRACT FROM AUTHOR]

Published
2024
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49. Patterns of clinical presentation in Takayasu's arteritis

Author

Quinn, Kaitlin A., Gribbons, K. Bates, Carette, Simon, Cuthbertson, David, Khalidi, Nader A., Koening, Curry L., Langford, Carol A., McAlear, Carol A., Monach, Paul A., Moreland, Larry W., Pagnoux, Christian, Seo, Philip, Sreih, Antoine G., Warrington, Kenneth J., Ytterberg, Steven R., Novakovich, Elaine, Merkel, Peter A., and Grayson, Peter C.

Published
2020
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50. 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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