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201. Direct-to-Consumer Recruitment Methods via Traditional and Social Media to Aid in Research Accrual for Clinical Trials for Rare Diseases: Comparative Analysis Study.

Author

Applequist, Janelle, Burroughs, Cristina, Merkel, Peter A, Rothenberg, Marc, Trapnell, Bruce, Desnick, Robert, Sahin, Mustafa, and Krischer, Jeffrey

Subjects
SOCIAL media, PATIENT selection, PATIENT advocacy, MASS media, INFORMED consent (Medical law)
Abstract

Background: Recruitment into clinical trials is a challenging process, with as many as 40% of studies failing to meet their target sample sizes. The principles of direct-to-consumer (DTC) advertising rely upon novel marketing strategies. The ability to reach expansive audiences in the web-based realm presents a unique opportunity for researchers to overcome various barriers to enrollment in clinical trials. Research has investigated the use of individual web-based platforms to aid in recruitment and accrual into trials; however, a gap in the literature exists, whereby multiple mass communication platforms have yet to be investigated across a range of clinical trials. Objective: There is a need to better understand how individual factors combine to collectively influence trial recruitment. We aimed to test whether DTC recruitment of potentially eligible study participants via social media platforms (eg, Facebook [Meta Platforms Inc] and Twitter [Twitter Inc]) was an effective strategy or whether this acted as an enhancement to traditional (eg, email via contact registries) recruitment strategies through established clinical research sites. Methods: This study tested multiple DTC web-based recruitment efforts (Facebook, Twitter, email, and patient advocacy group [PAG] involvement) across 6 national and international research studies from 5 rare disease consortia. Targeted social media messaging, social media management software, and individual study websites with prescreening questions were used in the Protocol for Increasing Accrual Using Social Media (PRISM). Results: In total, 1465 PRISM website referrals occurred across all 6 studies. Organic (unpaid) Facebook posts (676/1465, 46.14%) and Rare Diseases Clinical Research Network patient contact registry emails (461/1465, 31.47%) represented the most successful forms of engagement. PRISM was successful in accumulating a 40.1% (136/339) lead generation (those who screened positive and consented to share their contact information to be contacted by a clinical site coordinator). Despite the large number of leads generated from PRISM recruitment efforts, the number of patients who were subsequently enrolled in studies was low. Across 6 studies, 3 participants were ultimately enrolled, meaning that 97.8% (133/136) of leads dropped off. Conclusions: The results indicate that although accrual results were low, this is consistent with previously documented challenges of studying populations with rare diseases. Targeted messaging integrated throughout the recruitment process (eg, referral, lead, and accrual) remains an area for further research. Key elements to consider include structuring the communicative workflow in such a way that PAG involvement is central to the process, with clinical site coordinators actively involved after an individual consents to share their contact information. Customized approaches are needed for each population and research study, with observational studies best suited for social media recruitment. As evidenced by lead generation, results suggest that web-based recruitment efforts, coupled with targeted messaging and PAG partnerships, have the potential to supplement clinical trial accrual. [ABSTRACT FROM AUTHOR]

Published
2023
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203. Vitamin D status in ANCA-associated vasculitis.

Author

Doubelt, Irena, Cuthbertson, David, Carette, Simon, Khalidi, Nader A, Koening, Curry L, Langford, Carol, McAlear, Carol A, Moreland, Larry W, Monach, Paul, Seo, Philip, Specks, Ulrich, Warrington, Kenneth J, Merkel, Peter A, and Pagnoux, Christian

Abstract

Objective Vitamin D might participate in the pathogenesis of several immune-mediated diseases, but few related data are available for ANCA-associated vasculitis (AAV). In this study, we analysed the association between vitamin D status and disease in patients with AAV. Methods Serum levels of 25(OH)D2/3 were measured in 125 randomly selected patients with AAV [granulomatosis with polyangiitis (n  = 50), eosinophilic granulomatosis with polyangiitis (n  = 50) or microscopic polyangiitis (n  = 25)] enrolled in the Vasculitis Clinical Research Consortium Longitudinal Studies at the time of enrolment and a subsequent relapse visit. Sufficient, insufficient and deficient vitamin D status were defined as 25(OH)D3 levels >30, 20–30 and ˂20 ng/ml, respectively. Results Seventy of 125 patients (56%) were female, with a mean age of 51.5 (16) years at diagnosis; 84 (67%) were ANCA positive. Mean 25(OH)D was 37.6 (16) ng/ml, with vitamin D deficiency in 13 (10.4%) and insufficiency in 26 (20.8%). In univariate analysis, lower vitamin D status was associated with male sex (P  = 0.027) and disease activity (P  = 0.047). In univariate and multivariate analyses, deficient vitamin D status was associated with disease activity (P  = 0.015). Mean 25(OH)D status in the 21 patients with a subsequent relapse did not differ between baseline and relapse visit [37.8 (16) vs 38.0 (10) ng/ml, respectively; P  = 0.92]. Conclusion Most patients with AAV have sufficient 25(OH)D levels, although those with lower vitamin D status were more likely to be male and to have active disease. Whether optimization of vitamin D status alters disease manifestations or activity in AAV remains to be determined. Trial Registration Vasculitis Clinical Research Consortium (VCRC) Longitudinal Study (LS), NCT00315380, https://clinicaltrials.gov/ct2/show/NCT00315380 [ABSTRACT FROM AUTHOR]

Published
2023
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204. Urine eosinophil‐derived neurotoxin: A potential marker of activity in select eosinophilic disorders.

Author

Makiya, Michelle A., Khoury, Paneez, Kuang, Fei Li, Mata, Alexis Dominique, Mahmood, Sana, Bowman, Abbie, Espinoza, David, Kovacs, Nicholas, Brown, Thomas, Holland, Nicole, Wetzler, Lauren, Ware, JeanAnne M., Dyer, Anne‐Marie, Akuthota, Praveen, Bochner, Bruce S., Chinchilli, Vernon M., Gleich, Gerald J., Langford, Carol, Merkel, Peter A., and Specks, Ulrich

Subjects
CHURG-Strauss syndrome, URINE, BASIC proteins, HYPEREOSINOPHILIC syndrome, EOSINOPHILS
Abstract

Background: Biomarkers of eosinophilic disease activity, especially in the context of novel therapies that reduce blood eosinophil counts, are an unmet need. Absolute eosinophil count (AEC) does not accurately reflect tissue eosinophilia or eosinophil activation. Therefore, the aims of this study were to compare the reliability of plasma and urine eosinophil major basic protein 1, eosinophil cationic protein, eosinophil‐derived neurotoxin (EDN), and eosinophil peroxidase measurement and to evaluate the usefulness of eosinophil granule protein (EGP) measurement for the assessment of disease activity in patients with eosinophil‐associated diseases treated with mepolizumab, benralizumab, or dexpramipexole. Methods: Eosinophil granule protein concentrations were measured in serum, plasma, and urine from healthy volunteers and patients with hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA), and eosinophilic asthma using a multiplex assay. Results: Urine EGP concentrations remained stable, whereas serum and plasma EGP concentrations increased significantly with delayed processing. Plasma (p) EDN, but not urine (u) EDN, concentration correlated with AEC and negatively correlated with prednisone dose. Both pEDN and uEDN decreased significantly following treatment of HES patients with benralizumab and EGPA patients with mepolizumab. uEDN appeared to increase with clinical relapse in both patient groups. Conclusions: Measurement of EGP in urine is noninvasive and unaffected by cellular lysis. Although plasma and urine EDN concentrations showed a similar pattern following benralizumab and mepolizumab treatment, the lack of correlation between AEC or prednisone dose and uEDN concentrations suggests that measurement of uEDN may provide a potential biomarker of disease activity in patients with HES and EGPA. [ABSTRACT FROM AUTHOR]

Published
2023
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205. 2022 American College of Rheumatology/EULAR Classification Criteria for Giant Cell Arteritis.

Author

Ponte, Cristina, Grayson, Peter C., Robson, Joanna C., Suppiah, Ravi, Gribbons, Katherine Bates, Judge, Andrew, Craven, Anthea, Khalid, Sara, Hutchings, Andrew, Watts, Richard A., Merkel, Peter A., Luqmani, Raashid A., Gatenby, Paul, Hill, Catherine, Ranganathan, Dwarakanathan, Kronbichler, Andreas, Blockmans, Daniel, Barra, Lillian, Carette, Simon, and Pagnoux, Christian

Subjects
TEMPORAL arteries, C-reactive protein, RESEARCH evaluation, BIOPSY, CONFIDENCE intervals, RESEARCH methodology, GIANT cell arteritis, SEVERITY of illness index, BLOOD sedimentation
Abstract

Objective: To develop and validate updated classification criteria for giant cell arteritis (GCA). Methods: Patients with vasculitis or comparator diseases were recruited into an international cohort. The study proceeded in 6 phases: 1) identification of candidate items, 2) prospective collection of candidate items present at the time of diagnosis, 3) expert panel review of cases, 4) data‐driven reduction of candidate items, 5) derivation of a points‐based risk classification score in a development data set, and 6) validation in an independent data set. Results: The development data set consisted of 518 cases of GCA and 536 comparators. The validation data set consisted of 238 cases of GCA and 213 comparators. Age ≥50 years at diagnosis was an absolute requirement for classification. The final criteria items and weights were as follows: positive temporal artery biopsy or temporal artery halo sign on ultrasound (+5); erythrocyte sedimentation rate ≥50 mm/hour or C‐reactive protein ≥10 mg/liter (+3); sudden visual loss (+3); morning stiffness in shoulders or neck, jaw or tongue claudication, new temporal headache, scalp tenderness, temporal artery abnormality on vascular examination, bilateral axillary involvement on imaging, and fluorodeoxyglucose–positron emission tomography activity throughout the aorta (+2 each). A patient could be classified as having GCA with a cumulative score of ≥6 points. When these criteria were tested in the validation data set, the model area under the curve was 0.91 (95% confidence interval [95% CI] 0.88–0.94) with a sensitivity of 87.0% (95% CI 82.0–91.0%) and specificity of 94.8% (95% CI 91.0–97.4%). Conclusion: The 2022 American College of Rheumatology/EULAR GCA classification criteria are now validated for use in clinical research. [ABSTRACT FROM AUTHOR]

Published
2022
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206. 2022 American College of Rheumatology/EULAR Classification Criteria for Takayasu Arteritis.

Author

Grayson, Peter C., Ponte, Cristina, Suppiah, Ravi, Robson, Joanna C., Gribbons, Katherine Bates, Judge, Andrew, Craven, Anthea, Khalid, Sara, Hutchings, Andrew, Danda, Debashish, Luqmani, Raashid A., Watts, Richard A., Merkel, Peter A., Gatenby, Paul, Hill, Catherine, Ranganathan, Dwarakanathan, Kronbichler, Andreas, Blockmans, Daniel, Barra, Lillian, and Carette, Simon

Subjects
BLOOD pressure, CONFIDENCE intervals, RHEUMATOLOGY, AGE distribution, ANGINA pectoris, TAKAYASU arteritis, DIAGNOSTIC imaging, SEX distribution, DESCRIPTIVE statistics, SENSITIVITY & specificity (Statistics), VASCULITIS, INTERMITTENT claudication, PULSE (Heart beat)
Abstract

Objective: To develop and validate new classification criteria for Takayasu arteritis (TAK). Methods: Patients with vasculitis or comparator diseases were recruited into an international cohort. The study proceeded in 6 phases: 1) identification of candidate criteria items, 2) collection of candidate items present at diagnosis, 3) expert panel review of cases, 4) data‐driven reduction of candidate items, 5) derivation of a points‐based classification score in a development data set, and 6) validation in an independent data set. Results: The development data set consisted of 316 cases of TAK and 323 comparators. The validation data set consisted of an additional 146 cases of TAK and 127 comparators. Age ≤60 years at diagnosis and imaging evidence of large‐vessel vasculitis were absolute requirements to classify a patient as having TAK. The final criteria items and weights were as follows: female sex (+1), angina (+2), limb claudication (+2), arterial bruit (+2), reduced upper extremity pulse (+2), reduced pulse or tenderness of a carotid artery (+2), blood pressure difference between arms of ≥20 mm Hg (+1), number of affected arterial territories (+1 to +3), paired artery involvement (+1), and abdominal aorta plus renal or mesenteric involvement (+3). A patient could be classified as having TAK with a cumulative score of ≥5 points. When these criteria were tested in the validation data set, the model area under the curve was 0.97 (95% confidence interval [95% CI] 0.94–0.99) with a sensitivity of 93.8% (95% CI 88.6–97.1%) and specificity of 99.2% (95% CI 96.7–100.0%). Conclusion: The 2022 American College of Rheumatology/EULAR classification criteria for TAK are now validated for use in research. [ABSTRACT FROM AUTHOR]

Published
2022
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207. Contributors

Author

Abdellatif, Engy, primary, Abeles, Aryeh M., additional, Abelson, Abby G., additional, Abhishek, Abhishek, additional, Abramson, Steven B., additional, Adachi, Jonathan D., additional, Adams, Michael A., additional, Aigner, Thomas, additional, Akira, Shizuo, additional, Aletaha, Daniel, additional, Aliprantis, Antonios O., additional, Almeida de Jesus, Adriana, additional, Altman, Roy D., additional, Amigo, Mary-Carmen, additional, Aringer, Martin, additional, Ascherman, Dana P., additional, Assassi, Shervin, additional, Atamas, Sergei P., additional, Azevedo, Pedro Ming, additional, Baer, Alan N., additional, Baeten, Dominique, additional, Baines, Colin, additional, Baker, Nancy A., additional, Balogh, Emese, additional, Balsa, Alejandro, additional, Baraliakos, Xenofon, additional, Bardin, Thomas, additional, Barnsley, Les, additional, Bathon, Joan M., additional, Bauch, Angela, additional, Belch, Jill J.F., additional, Bellamy, Nicholas, additional, Bellido, Teresita, additional, Benjamin, Michael, additional, Beresford, Michael W., additional, Berman, Brian, additional, Bermas, Bonnie Lee, additional, Bertsias, George, additional, Bilezikian, John P., additional, Bilginer, Yelda, additional, Birnbaum, Julius, additional, Bishop, Felicity L., additional, Bleasel, Jane F., additional, Böhm, Markus, additional, Bolster, Marcy B., additional, Bombardieri, Stefano, additional, Bonelli, Michael, additional, Bonnick, Sydney L., additional, Boumpas, Dimitrios T., additional, Bozec, Aline, additional, Brasington, Richard D., additional, Braun, Juergen, additional, Brown, Matthew A., additional, Bruce, Ian N., additional, Bugbee, William D., additional, Bukhari, Marwan A.S., additional, Burgos-Vargas, Rubén, additional, Burmester, Gerd-Rüdiger, additional, Burns, Jane C., additional, Burr, David B., additional, Buttgereit, Frank, additional, Bykerk, Vivian P., additional, Calabrese, Leonard H., additional, Callen, Jeffrey P., additional, Cavallo, Sabrina, additional, Cawston, Tim E., additional, Chandran, Vinod, additional, Chard, Michael Denis, additional, Chaudhary, Prateek, additional, Chen, Lan X., additional, Choi, Hyon K., additional, Choy, Ernest H., additional, Christopher-Stine, Lisa, additional, Chu, Alvina D., additional, Clauw, Daniel J., additional, Clements, Philip J., additional, Clowse, Megan E.B., additional, Coghlan, J. Gerry, additional, Conaghan, Philip G., additional, Cooper, Cyrus, additional, Costenbader, Karen H., additional, Creamer, Paul, additional, Crispín, José C., additional, Cronstein, Bruce N., additional, Cross, Raymond, additional, Cusano, Natalie E., additional, Cutolo, Maurizio, additional, D'Adamo, Chris, additional, D'Agati, Vivette, additional, D'Cruz, David P., additional, Dagfinrud, Hanne, additional, Daikh, David I., additional, Dalbeth, Nicola, additional, Dalton, Seamus E., additional, Dass, Shouvik, additional, Davis, Aileen M., additional, De Ceulaer, Karel, additional, Deal, Chad L., additional, Deane, Kevin D., additional, Della Rossa, Alessandra, additional, Dellaripa, Paul F., additional, Dennison, Elaine, additional, Denton, Christopher P., additional, Dieppe, Paul, additional, Doherty, Michael, additional, Dolan, Patricia, additional, Donn, Rachelle, additional, Dvorkina, Olga, additional, Dyer, George S.M., additional, Eastell, Richard, additional, Edwards, N. Lawrence, additional, Emery, Paul, additional, Erturan, Gurhan, additional, Espinoza, Luis R., additional, Eyre, Steve, additional, Fanouriakis, Antonios C., additional, Farber, Joshua, additional, Farrokhi, Shawn, additional, Fasth, Anders, additional, Feist, Eugen, additional, Feldman, Debbie, additional, Felson, David T., additional, Fisk, John D., additional, Fitzgerald, G. Kelley, additional, Flores, Raymond H., additional, Fox, David A., additional, Francomano, Clair A., additional, Frangos, Jennifer, additional, Freemont, Anthony J., additional, Fricka, Kevin B., additional, Furst, Daniel E., additional, Gabay, Cem, additional, Gadina, Massimo, additional, Gaston, J.S. Hill, additional, Gay, Steffen, additional, Gensler, Lianne S., additional, Geraldino-Pardilla, Laura, additional, Gerlag, Danielle M., additional, Ginzler, Ellen M., additional, Gizinski, Alison M., additional, Gladman, Dafna D., additional, Gold, Garry E., additional, Goldbach-Mansky, Raphaela, additional, Goldingay, Sarah, additional, Gordon, Sharon M., additional, Gorodkin, Rachel, additional, Goronzy, Jörg J., additional, Görtz, Simon, additional, Grahame, Rodney, additional, Grainger, Andrew J., additional, Gravallese, Ellen M., additional, Greenberg, Jeffrey D., additional, Gujar, Bansari, additional, Hagan, Matilda, additional, Hagley, Karlene, additional, Hakim, Alan J., additional, Hall, John C., additional, Hamuryudan, Vedat, additional, Hanly, John G., additional, Hanson, Eric P., additional, Haraoui, Boulos, additional, Harley, John B., additional, Hashkes, Philip J., additional, Hawker, Gillian A., additional, Hawkins, Philip N., additional, Heiberg, Turid, additional, Heinegård, Dick, additional, Helfgott, Simon M., additional, Ho, Pauline Y.P., additional, Hochberg, Marc C., additional, Hochman, Jacqueline, additional, Hodgkiss-Harlow, Chelsea J., additional, Hoffman, Robert W., additional, Hoffmann, Markus, additional, Holers, V. Michael, additional, Holick, Michael F., additional, Holroyd, Christopher, additional, Hübscher, Osvaldo, additional, Hunter, David J., additional, Husni, M. Elaine, additional, Inman, Robert D., additional, Isaac, Zacharia, additional, Iversen, Maura D., additional, Jabs, Douglas A., additional, Jackson, William, additional, Jaimungal, Sarada, additional, James, Judith A., additional, Javier, Rose-Marie, additional, Johnsen, Alyssa K., additional, Jordan, Joanne M., additional, Kaisho, Tsuneyasu, additional, Kallenberg, Cees G.M., additional, Kane, David, additional, Kapoor, Mohit, additional, Karlson, Elizabeth W., additional, Kassimos, Dimitrios G., additional, Kastner, Daniel L., additional, Katz, Jeffrey N., additional, Kay, Jonathan, additional, Kelly, Jennifer A., additional, Keystone, Edward, additional, Khamashta, Munther A., additional, Khanna, Dinesh, additional, Kjeken, Ingvild, additional, Koch, Alisa E., additional, Koff, Matthew F., additional, Kottyan, Leah, additional, Koutsogeorgopoulou, Loukia A., additional, Kraus, Virginia Byers, additional, Kumar, Pradeep, additional, Kvien, Tore K., additional, Lafyatis, Robert, additional, Landewé, Robert B.M., additional, Langford, Carol A., additional, Lau, Arthur N., additional, Laxer, Ronald M., additional, Learch, Thomas J., additional, Lewith, George, additional, Li, Yi, additional, Liao, Katherine P., additional, Littlejohn, Geoffrey, additional, Lorenzo, Pilar, additional, Luger, Thomas A., additional, Lundberg, Ingrid E., additional, Lundberg, Karin, additional, Machold, Klaus P., additional, MacKenzie, C. Ronald, additional, Mahr, Alfred D., additional, Manheimer, Eric, additional, Marini, Joan C., additional, Marquez, Javier, additional, Marsden, Debbie, additional, Martel-Pelletier, Johanne, additional, Martín-Mola, Emilio, additional, Martínez-Lavín, Manuel, additional, Massarotti, Elena M., additional, Matteson, Eric L., additional, Matzat, Stephen J., additional, Mayahi, Reza, additional, Mayes, Maureen Davidica, additional, McAlindon, Timothy, additional, McBain, Hayley, additional, McCarberg, Bill, additional, McCarthy, Edward F., additional, McCarthy, Geraldine, additional, McDermott, Michael F., additional, McGonagle, Dennis, additional, McLean, Lachy, additional, Merkel, Peter A., additional, Mikdashi, Jamal A., additional, Miller, Frederick W., additional, Miller, Paul D., additional, Minden, Kirsten, additional, Monach, Paul A., additional, Mulligan, Kathleen, additional, Namur, Gauthier, additional, Naredo, Esperanza, additional, Naylor, Kim E., additional, Nelson, Amanda E., additional, Newman, Stanton P., additional, Nordal, Ellen, additional, Nöth, Ulrich, additional, Ntatsaki, Eleana, additional, O'Shea, John J., additional, Oddis, Chester V., additional, Olivé, Alejandro, additional, Omair, Mohammed A., additional, Ombrello, Michael J., additional, Omisade, Antonina, additional, Ong, Voon H., additional, Önnerfjord, Patrik, additional, Orcel, Philippe, additional, Ospelt, Caroline, additional, Ozen, Seza, additional, Paget, Stephen A., additional, Patel, Dipak R., additional, Patrono, Carlo, additional, Pelletier, Jean-Pierre, additional, Pereira, Rosa Maria Rodrigues, additional, Pilkington, Clarissa A., additional, Pillinger, Michael H., additional, Pineda, Carlos, additional, Plenge, Robert M., additional, Price, Andrew, additional, Pricop, Luminita, additional, Rackwitz, Lars, additional, Ravelli, Angelo, additional, Redmond, Anthony C., additional, Reeves, Westley H., additional, Remmers, Elaine F., additional, Requena, Luis, additional, Ribbens, Clio, additional, Richardson, Bruce C., additional, Riera Alonso, Elena, additional, Riley, Graham, additional, Ritchlin, Christopher, additional, Ritter, Susan Y., additional, Rosas, Ivan O., additional, Rowan, Drew D., additional, Rudwaleit, Martin, additional, Rull, Marina, additional, Rygg, Marite, additional, Saag, Kenneth G., additional, Salmon, Jane E., additional, Salter, Donald M., additional, Salzberg, Daniel J., additional, Sambrook, Philip N., additional, Saxne, Tore, additional, Schaible, Hans-Georg, additional, Scher, Jose U., additional, Schett, Georg, additional, Schmitz, Nicole, additional, Schreiber, Benjamin, additional, Schumacher, H. Ralph, additional, Schwartz, Daniella Muallem, additional, Scott, David G.I., additional, Seton, Margaret, additional, Shapiro, Lauren M., additional, Sharby, Nancy, additional, Siegel, Jeffrey, additional, Siegel, Richard M., additional, Sieper, Joachim, additional, Silver, Richard M., additional, Silverberg, Shonni J., additional, Simard, Julia F., additional, Simmons, Barry P., additional, Simms, Robert W., additional, Singer, Nora G., additional, Smith, Malcolm D., additional, Smith, Stacy E., additional, Smolen, Josef S., additional, Spector, Tim D., additional, Steen, Virginia D., additional, Steere, Allen C., additional, Steiner, Günter, additional, Steinert, Andre F., additional, Stojan, George, additional, Stone, John H., additional, Strand, Vibeke, additional, Straub, Rainer H., additional, Streeten, Elizabeth A., additional, Superti-Furga, Giulio, additional, Symmons, Deborah P.M., additional, Szekanecz, Zoltan, additional, Tak, Paul P., additional, Tavoni, Antonio, additional, Taylor, Peter C., additional, Terkeltaub, Robert, additional, Thomas, Sarah S., additional, Thorne, Jennifer E., additional, Tobias, Jonathan H., additional, Tremoulet, Adriana H., additional, Tsokos, George C., additional, Tuan, Rocky S., additional, Turesson, Carl, additional, Unizony, Sebastian H., additional, Valdes, Ana M., additional, van den Berg, Wim B., additional, van der Heijde, Désirée, additional, van Vollenhoven, Ronald Frits, additional, Varga, John, additional, Vassilopoulos, Dimitrios, additional, Vital, Edward M., additional, Walker-Bone, Karen, additional, Wallace, Daniel J., additional, Warburton, Gary, additional, Ward, Robert J., additional, Watts, Richard, additional, Wechalekar, Mihir D., additional, Wedderburn, Lucy R., additional, Weinblatt, Michael E., additional, Weir, Matthew R., additional, Wenham, Claire Y.J., additional, West, Sterling G., additional, Weyand, Cornelia M., additional, White, Kenneth E., additional, Winthrop, Kevin L., additional, Wong, John B., additional, Woolf, Anthony D., additional, Worthington, Jane, additional, Xu, Huji, additional, Yazici, Hasan, additional, Young, D.A., additional, Yurdakul, Sebahattin, additional, Zhang, Yuqing, additional, and Zhuang, Haoyang, additional

Published
2015
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210. Circulating autoreactive proteinase 3+ B cells and tolerance checkpoints in ANCA-associated vasculitis

Author

Berti, Alvise, primary, Hillion, Sophie, additional, Hummel, Amber M., additional, Son, Young Min, additional, Chriti, Nedra, additional, Peikert, Tobias, additional, Carmona, Eva M., additional, Abdulahad, Wayel H., additional, Heeringa, Peter, additional, Harris, Kristina M., additional, St. Clair, E. William, additional, Brunetta, Paul, additional, Fervenza, Fernando C., additional, Langford, Carol A., additional, Kallenberg, Cees G.M., additional, Merkel, Peter A., additional, Monach, Paul A., additional, Seo, Philip, additional, Spiera, Robert F., additional, Stone, John H., additional, Grandi, Guido, additional, Sun, Jie, additional, Pers, Jacques-Olivier, additional, Specks, Ulrich, additional, and Cornec, Divi, additional

Published
2021
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211. Serum Biomarkers of Disease Activity in Longitudinal Assessment of Patients with ANCA‐Associated Vasculitis

Author

Monach, Paul A., primary, Warner, Roscoe L., additional, Lew, Robert, additional, Tómasson, Gunnar, additional, Specks, Ulrich, additional, Stone, John H., additional, Fervenza, Fernando C., additional, Hoffman, Gary S., additional, Kallenberg, Cees G. M., additional, Langford, Carol A., additional, Seo, Philip, additional, St. Clair, E. William, additional, Spiera, Robert, additional, Johnson, Kent J., additional, and Merkel, Peter A., additional

Published
2021
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214. Rituximab versus cyclophosphamide for ANCA-associated vasculitis

Author

Stone, John H., Merkel, Peter A., Spiera, Robert, Langford, Carol A., Hoffman, Gary S., Kallenberg, Cees G.M., Seo, Philip, Clair, E. William St., Tchao, Nadia K., Webber, Lisa, Ding, Linna, Sejismundo, Lourdes P., Turkiewicz, Anthony, Mieras, Kathleen, Ikle, David, Weitzenkamp, David, Margolis, Vicki Seyfert, Mueller, Mark, Brunetta, Paul, Allen, Nancy B., Geetha, Duvuru, Fervenza, Fernando C., Keogh, Karina A., Kissin, Eugene Y., Monach, Paul A., Stegeman, Coen, Ytterberg, Steven R., Specks, Ulrich, and Peikert, Tobias

Subjects
Autoantibodies -- Comparative analysis, Autoantibodies -- Patient outcomes, Autoantibodies -- Research, Vasculitis -- Drug therapy, Vasculitis -- Research
Abstract

A multicenter, randomized, double-blind, double-dummy, noninferiority trial of rituximab was conducted to compare rituximab with standard cytotoxic therapy for the induction of complete remission by 6 months in patients with severe ANCA-associated vasculitis. Rituximab therapy was not found to be inferior to daily cyclophosphamide treatment for induction of remission in severe ANCA-associated vasculitis and might be superior in relapsing disease.

Published
2010

217. Patient-powered research networks: building capacity for conducting patient-centered clinical outcomes research

Author

Daugherty, Sarah E, Wahba, Sarita, Fleurence, Rachael, Avillach, Paul, Buelow, Janice, Colletti, Richard, Eichler, Florian, Ginsberg, Seth, Dewitt, Esi Morgan, McBurney, Robert, Merkel, Peter A., Mularski, Richard, Natter, Marc, Nierenberg, Andrew A., Horn, Liz, OʼBoyle, Megan, Peay, Holly, Pletcher, Mark, Redline, Susan, Robinson, Bruce, Kappleman, Michael D, Sullivan, Kathleen E., Friedman, Sue, Sutphen, Rebecca, and Walsh, John

Published
2014
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219. Reply

Author

Farrer, Lindsay A., Sherva, Richard, Merkel, Peter A., and Siminovitch, Katherine A.

Published
2014
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220. Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study

Author

Jayne, David, Blockmans, Daniel, Luqmani, Raashid, Moiseev, Sergey, Ji, Beulah, Green, Yulia, Hall, Leanne, Roth, David, Henderson, Robert B, Merkel, Peter A, BREVAS Study Collaborators, Blockmans, Daniel [0000-0001-9783-1780], Merkel, Peter A [0000-0001-9284-7345], and Apollo - University of Cambridge Repository

Subjects
Adult, Male, B-Lymphocytes, Remission Induction, Immunoglobulins, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Middle Aged, Antibodies, Monoclonal, Humanized, Infections, Antibodies, Antineutrophil Cytoplasmic, Maintenance Chemotherapy, Treatment Outcome, Double-Blind Method, Azathioprine, Humans, Drug Therapy, Combination, Female, Rituximab, Cyclophosphamide, Glucocorticoids, Immunosuppressive Agents, Aged
Abstract

OBJECTIVE: To evaluate the safety and efficacy of belimumab as adjunctive therapy to maintain remission in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). METHODS: In this multicenter, double-blind, placebo-controlled study, patients with AAV (ages ≥18 years) were randomized 1:1 to receive azathioprine (2 mg/kg/day), low-dose oral glucocorticoids (≤10 mg/day), and either intravenous belimumab (10 mg/kg) or placebo, following remission induction with rituximab or cyclophosphamide along with glucocorticoids. The primary end point was time to first protocol-specified event (PSE), with first PSE defined as a Birmingham Vasculitis Activity Score (BVAS) of ≥6, presence of ≥1 major BVAS item, or receipt of prohibited medications for any reason, resulting in treatment failure (adjusted for ANCA type [proteinase 3 (PR3) or myeloperoxidase (MPO)], disease stage at induction, and induction regimen). Vasculitis relapse was defined as the PSE of either a BVAS activity score of ≥6 or receipt of prohibited medications for vasculitis. Changes in treatment practice led to truncation of the study population from ~300 patients to ~100 patients. RESULTS: The intent-to-treat population totaled 105 patients with AAV, of whom 52 (40 with PR3-ANCAs, 12 with MPO-ANCAs) received placebo and 53 (41 with PR3-ANCAs, 12 with MPO-ANCAs) received belimumab; 27 of the patients were in rituximab-induced disease remission, while 78 were in cyclophosphamide-induced disease remission at baseline. Compared with placebo, treatment with belimumab did not reduce the risk of a PSE (adjusted hazard ratio [HR] 1.07, 95% confidence interval [95% CI] 0.44-2.59; P = 0.884) or vasculitis relapse (adjusted HR 0.88, 95% CI 0.29-2.65; P = 0.821). The overall rate of PSEs was low (11 [21.2%] of 52 patients receiving placebo, 10 [18.9%] of 53 patients receiving belimumab). Vasculitis relapse in the placebo group (n = 8) occurred independent of the induction regimen, disease stage, or ANCA type. All vasculitis relapses in the belimumab group (n = 6) occurred in patients who had PR3-ANCA-associated vasculitis with cyclophosphamide-induced disease remission. Adverse events occurred in 49 (92.5%) of 53 patients receiving belimumab and 43 (82.7%) of 52 patients receiving placebo, with no new safety concerns. CONCLUSION: Belimumab plus azathioprine and glucocorticoids for the maintenance of remission in AAV did not reduce the risk of relapse.

Published
2019

221. Avacopan for the Treatment of ANCA-Associated Vasculitis

Author

Jayne, David R W, Merkel, Peter A, Schall, Thomas J, Bekker, Pirow, ADVOCATE Study Group:, C Au Peh, 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, S De Vita, 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, P van Daele, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, J de Zoysa, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, I Agraz Pamplona, Anton, J, V Barrio Lucia, Ciggaran, S, M Cinta Cid, M Diaz Encarnacion, X Fulladosa Oliveras, M Soler, J, H Rusinol, M, Praga, M, L Quintana Porras, 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, R Al Jayyousi, 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, Y Chang Chen Lin, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, T Greenwood, G, 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, M Chester Wasko, Internal Medicine, Immunology, Jayne, D, Merkel, P, Schall, T, Bekker, P, Pieruzzi, F, Jayne, David RW [0000-0002-1712-0637], Apollo - University of Cambridge Repository, and Translational Immunology Groningen (TRIGR)

Subjects
Male, Receptor, Anaphylatoxin C5a/antagonists & inhibitors, Anaphylatoxin C5a, Anaphylatoxin C5a/antagonists & inhibitors, Nipecotic Acids, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculiti, Administration, Oral, Azathioprine, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, urologic and male genital diseases, Gastroenterology, C5a receptor, Cyclophosphamide/administration & dosage, Rituximab/administration & dosage, Immunosuppressive Agent, renal vasculitis, Prednisone/administration & dosage, 0302 clinical medicine, Glucocorticoid, immune system diseases, Prednisone, Recurrence, Medicine, 030212 general & internal medicine, skin and connective tissue diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy, Aniline Compounds, Remission Induction, General Medicine, Aniline Compound, Middle Aged, Administration, Combination, Rituximab, Drug Therapy, Combination, Female, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Cyclophosphamide, Double-Blind Method, Glucocorticoids, Humans, Immunosuppressive Agents, Receptor, Anaphylatoxin C5a, Vasculitis, Receptor, medicine.drug, Human, Azathioprine/administration & dosage, Oral, medicine.medical_specialty, Nipecotic Acid, ANCA-Associated Vasculitis, 03 medical and health sciences, Drug Therapy, Internal medicine, Aniline Compounds/adverse effects, cardiovascular diseases, Immunosuppressive Agents/administration & dosage, Anti-neutrophil cytoplasmic antibody, business.industry, Glucocorticoids/administration & dosage, medicine.disease, Nipecotic Acids/adverse effects, respiratory tract diseases, business
Abstract

BACKGROUND: The C5a receptor inhibitor avacopan is being studied for the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.METHODS: In this randomized, controlled trial, we assigned patients with ANCA-associated vasculitis in a 1:1 ratio to receive oral avacopan at a dose of 30 mg twice daily or oral prednisone on a tapering schedule. All the patients received either cyclophosphamide (followed by azathioprine) or rituximab. The first primary end point was remission, defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 (on a scale from 0 to 63, with higher scores indicating greater disease activity) at week 26 and no glucocorticoid use in the previous 4 weeks. The second primary end point was sustained remission, defined as remission at both weeks 26 and 52. Both end points were tested for noninferiority (by a margin of 20 percentage points) and for superiority.RESULTS: A total of 331 patients underwent randomization; 166 were assigned to receive avacopan, and 165 were assigned to receive prednisone. The mean BVAS at baseline was 16 in both groups. Remission at week 26 (the first primary end point) was observed in 120 of 166 patients (72.3%) receiving avacopan and in 115 of 164 patients (70.1%) receiving prednisone (estimated common difference, 3.4 percentage points; 95% confidence interval [CI], -6.0 to 12.8; PCONCLUSIONS: In this trial involving patients with ANCA-associated vasculitis, avacopan was noninferior but not superior to prednisone taper with respect to remission at week 26 and was superior to prednisone taper with respect to sustained remission at week 52. All the patients received cyclophosphamide or rituximab. The safety and clinical effects of avacopan beyond 52 weeks were not addressed in the trial. (Funded by ChemoCentryx; ADVOCATE ClinicalTrials.gov number, NCT02994927.).

Published
2021

222. Long‐Term Safety of Rituximab in Granulomatosis With Polyangiitis and in Microscopic Polyangiitis

Author

Merkel, Peter A., primary, Niles, John L., additional, Mertz, Lester E., additional, Lehane, Patricia B., additional, Pordeli, Pooneh, additional, Erblang, Félix, additional, Allen, Nancy, additional, Block, Joel A., additional, Cartin‐Ceba, Rodrigo, additional, Koening, Curry, additional, Langford, Carol, additional, Monach, Paul, additional, Moreland, Larry W., additional, Nachman, Patrick, additional, and Wallace, Daniel, additional

Published
2021
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223. Dynamic Changes in the Nasal Microbiome Associated With Disease Activity in Patients With Granulomatosis With Polyangiitis

Author

Rhee, Rennie L., primary, Lu, Jiarui, additional, Bittinger, Kyle, additional, Lee, Jung‐Jin, additional, Mattei, Lisa M., additional, Sreih, Antoine G., additional, Chou, Sherry, additional, Miner, Jonathan J., additional, Cohen, Noam A., additional, Kelly, Brendan J., additional, Lee, Hongzhe, additional, Grayson, Peter C., additional, Collman, Ronald G., additional, and Merkel, Peter A., additional

Published
2021
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224. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis

Author

Maz, Mehrdad, primary, Chung, Sharon A., additional, Abril, Andy, additional, Langford, Carol A., additional, Gorelik, Mark, additional, Guyatt, Gordon, additional, Archer, Amy M., additional, Conn, Doyt L., additional, Full, Kathy A., additional, Grayson, Peter C., additional, Ibarra, Maria F., additional, Imundo, Lisa F., additional, Kim, Susan, additional, Merkel, Peter A., additional, Rhee, Rennie L., additional, Seo, Philip, additional, Stone, John H., additional, Sule, Sangeeta, additional, Sundel, Robert P., additional, Vitobaldi, Omar I., additional, Warner, Ann, additional, Byram, Kevin, additional, Dua, Anisha B., additional, Husainat, Nedaa, additional, James, Karen E., additional, Kalot, Mohamad A., additional, Lin, Yih Chang, additional, Springer, Jason M., additional, Turgunbaev, Marat, additional, Villa‐Forte, Alexandra, additional, Turner, Amy S., additional, and Mustafa, Reem A., additional

Published
2021
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225. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

Author

Chung, Sharon A., primary, Langford, Carol A., additional, Maz, Mehrdad, additional, Abril, Andy, additional, Gorelik, Mark, additional, Guyatt, Gordon, additional, Archer, Amy M., additional, Conn, Doyt L., additional, Full, Kathy A., additional, Grayson, Peter C., additional, Ibarra, Maria F., additional, Imundo, Lisa F., additional, Kim, Susan, additional, Merkel, Peter A., additional, Rhee, Rennie L., additional, Seo, Philip, additional, Stone, John H., additional, Sule, Sangeeta, additional, Sundel, Robert P., additional, Vitobaldi, Omar I., additional, Warner, Ann, additional, Byram, Kevin, additional, Dua, Anisha B., additional, Husainat, Nedaa, additional, James, Karen E., additional, Kalot, Mohamad A., additional, Lin, Yih Chang, additional, Springer, Jason M., additional, Turgunbaev, Marat, additional, Villa‐Forte, Alexandra, additional, Turner, Amy S., additional, and Mustafa, Reem A., additional

Published
2021
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226. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Polyarteritis Nodosa

Author

Chung, Sharon A., primary, Gorelik, Mark, additional, Langford, Carol A., additional, Maz, Mehrdad, additional, Abril, Andy, additional, Guyatt, Gordon, additional, Archer, Amy M., additional, Conn, Doyt L., additional, Full, Kathy A., additional, Grayson, Peter C., additional, Ibarra, Maria F., additional, Imundo, Lisa F., additional, Kim, Susan, additional, Merkel, Peter A., additional, Rhee, Rennie L., additional, Seo, Philip, additional, Stone, John H., additional, Sule, Sangeeta, additional, Sundel, Robert P., additional, Vitobaldi, Omar I., additional, Warner, Ann, additional, Byram, Kevin, additional, Dua, Anisha B., additional, Husainat, Nedaa, additional, James, Karen E., additional, Kalot, Mohamad, additional, Lin, Yih Chang, additional, Springer, Jason M., additional, Turgunbaev, Marat, additional, Villa‐Forte, Alexandra, additional, Turner, Amy S., additional, and Mustafa, Reem A., additional

Published
2021
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227. Obinutuzumab as treatment for ANCA-associated vasculitis.

Author

Amudala, Naomi A, Boukhlal, Sara, Sheridan, Brittany, Langford, Carol A, Geara, Abdallah, Merkel, Peter A, and Cornec, Divi

Subjects
THERAPEUTIC use of monoclonal antibodies, THERAPEUTIC use of antineoplastic agents, ANAPHYLAXIS, RITUXIMAB, ANTINEUTROPHIL cytoplasmic antibodies, INTERSTITIAL lung diseases, TREATMENT effectiveness, CHURG-Strauss syndrome, CASE studies, IMMUNOLOGIC diseases, VASCULITIS, MICROSCOPIC polyangiitis, DISEASE remission
Abstract

Objectives Rituximab is a standard of care therapy for patients with ANCA-associated vasculitis. When rituximab is contraindicated, or in the case of refractory disease, other treatments are needed. Obinutuzumab is another anti-CD20 antibody for the treatment of haematological malignancies that may induce a deeper B cell depletion compared with rituximab. This article reviews three cases of patients with ANCA-associated vasculitis who were treated with obinutuzumab due to their history of anaphylactic reactions to rituximab. Methods Case series of three patients with ANCA-associated vasculitis treated with obinutuzumab. Results One female patient with microscopic polyangiitis and two male patients with granulomatosis with polyangiitis received obinutuzumab. The treatment was well-tolerated in all patients despite previous anaphylactic reaction to rituximab. Treatment with obinutuzumab was effective in (i) inducing disease remission, (ii) inducing total B cell depletion, and (iii) resulting in undetectable serum titres of ANCA. All three patients were re-treated with obinutuzumab for maintenance of remission. Conclusion Obinutuzumab appears to be a safe and efficacious therapy for patients with ANCA-associated vasculitis who have had refractory disease or a history of anaphylaxis to rituximab. Prospective studies comparing rituximab to obinutuzumab in ANCA-associated vasculitis patients are warranted. [ABSTRACT FROM AUTHOR]

Published
2022
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228. Case 31-2008: a 39-year-old man with chest pain, arthralgias, and a mediastinal mass

Author

Merkel, Peter A., McCarthy, David, Sharma, Amita, and Stone, James R.

Subjects
Arthritis -- Diagnosis, Arthritis -- Case studies, Wegener's granulomatosis -- Case studies, Wegener's granulomatosis -- Diagnosis
Abstract

A case study of a 39-year-old man with chest pain and other complications is discussed to better understand the growth of mediastinal mass which affects the pulmonary arteries and cardiac conduction system, onset of arthritis, etc. The only way to explain the disease from the symptoms is Wegener's granulomatosis.

Published
2008

230. Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis

Author

Smith, Rona M, Jones, Rachel Bronwen, Specks, Ulrich, Bond, Simon, Nodale, Marianna, Aljayyousi, Reem, Andrews, Jacqueline, Bruchfeld, Annette, Camilleri, Brian, Carette, Simon, Cheung, Chee Kay, Derebail, Vimal, Doulton, Tim, Forbess, Lindsy, Fujimoto, Shouichi, Furuta, Shunsuke, Gewurz-Singer, Ora, Harper, Lorraine, Ito-Ihara, Toshiko, Khalidi, Nader, Klocke, Rainer, Koening, Curry, Komagata, Yoshinori, Langford, Carol, Lanyon, Peter, Luqmani, Raashid Ahmed, Makino, Hirofumi, McAlear, Carole, Monach, Paul, Moreland, Larry W, Mynard, Kim, Nachman, Patrick, Pagnoux, Christian, Pearce, Fiona, Peh, Chen Au, Pusey, Charles, Ranganathan, Dwarakanathan, Rhee, Rennie L, Spiera, Robert, Sreih, Antoine G, Tesar, Vladimir, Walters, Giles, Weisman, Michael H, Wroe, Caroline, Merkel, Peter, Jayne, David, RITAZAREM Co-Investigators, Arimura, Y, Clarkson, M, De Zoysa, J, Endo, T, Hamano, Y, Kono, H, Lawman, S, Muso, E, Sada, K, Smith, R, Suzuki, K, Tsukamoto, T, Uchida, S, Vaglio, A, Watts, R, Smith, Rona M [0000-0002-7438-5156], Jones, Rachel Bronwen [0000-0003-4790-283X], Nodale, Marianna [0000-0002-0333-8918], Harper, Lorraine [0000-0003-1343-9234], Rhee, Rennie L [0000-0002-4907-0304], Walters, Giles [0000-0003-4854-9353], and Apollo - University of Cambridge Repository

Subjects
Vasculitis, B cells, granulomatosis with polyangiitis, treatment, systemic vasculitis
Abstract

Funder: Research Committee on Intractable Vasculitides; The Ministry of Health, Labour and Welfare of Japan., Objectives: Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial. Methods: Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m2) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse. Results: 188 patients were studied: 95/188 (51%) men, median age 59 years (range 19–89), prior disease duration 5.0 years (range 0.4–34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections. Conclusions: This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.

Published
2020
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231. British Society for Rheumatology guideline on diagnosis and treatment of giant cell arteritis

Author

Mackie, Sarah L, Dejaco, Christian, Appenzeller, Simone, Camellino, Dario, Duftner, Christina, Gonzalez-Chiappe, Solange, Mahr, Alfred, Mukhtyar, Chetan, de Souza, Alexandre Wagner S, Brouwer, Elisabeth, Bukhari, Marwan, Buttgereit, Frank, Byrne, Dorothy, Cid, Maria C, Cimmino, Marco, Direskeneli, Haner, Gilbert, Kate, Kermani, Tanaz A, Khan, Asad, Lanyon, Peter, Luqmani, Raashid, Mallen, Christian, Mason, Justin C, Matteson, Eric L, Merkel, Peter A, Mollan, Susan, Neill, Lorna, O'Sullivan, Eoin, Sandovici, Maria, Schmidt, Wolfgang A, Watts, Richard, Whitlock, Madeline, Yacyshyn, Elaine, Ytterberg, Steven, and Dasgupta, Bhaskar

Published
2020

232. Reporting items for capillaroscopy in clinical research on musculoskeletal diseases: A systematic review and international Delphi consensus

Author

Immuno/reuma patientenzorg, Infection & Immunity, MS Reumatologie/Immunologie/Infectie, Ingegnoli, Francesca, Herrick, Ariane L., Schioppo, Tommaso, Bartoli, Francesca, Ughi, Nicola, Pauling, John D., Sulli, Alberto, Cutolo, Maurizio, Smith, Vanessa, Akil, Mohammed, Ancuta, Codrina, Baines, Colin, Bernard, Imbert, Bhojani, Kaushik, Blaise, Sophie, Moscovici, Yolanda Braun, Caporali, Roberto, Chatelus, Emmanuel, Chatterjee, Soumya, Cracowski, Jean Luc, Csuka, Mary Ellen, Angelis, Rossella De, Vries-Bouwstra, Jeska De, Derk, Chris, Distler, Oliver, Duba, Ayyappa, Fernandez-Codina, Andreu, Foeldvari, Ivan, Frech, Tracy, Guerra, Miguel, Guiducci, Serena, Gyger, Geneviève, Hernandez-Molina, Gabriela, Hesselstrand, Roger, Hinze, Alicia, Hsu, Vivien, Hughes, Michael, Inanc, Murat, Irace, Rosaria, Jacobsen, Soren, Koenig, Martial, Lenaerts, Jan, Lwin, Cho Mar, Makol, Ashima, Martin, Thierry, Lopez, Maria Martin, Medina, Yimy F., Merkel, Peter A., Mesa Navas, Miguel Antonio, Messiniti, Valentina, Mihai, Carina, Nadashkevich, Oleg, Narain, Sonali, Lambova, Sevdalina Nikolova, Pelechas, Eleftherios, Pizzorni, Carmen, Riccardi, Antonella, Riccieri, Valeria, Rimar, Doron, Rudnicka, Lidia, Sabelli, Mirtha, Sarafrazi, Mojgan, Schonenberg-Meinema, Dieneke, Scolnik, Marina, Senécal, Jean Luc, Shenavandeh, Saeedeh, Sifuentes-Giraldo, Walter Alberto, Spierings, Julia, Stevens, Wendy, Valenzuela, Antonia, Velásquez-Franco, Carlos Jaime, Vila, Josephine, Vilela, Verônica, Vonk, Madelon, Voskuyl, Alexandre, Immuno/reuma patientenzorg, Infection & Immunity, MS Reumatologie/Immunologie/Infectie, Ingegnoli, Francesca, Herrick, Ariane L., Schioppo, Tommaso, Bartoli, Francesca, Ughi, Nicola, Pauling, John D., Sulli, Alberto, Cutolo, Maurizio, Smith, Vanessa, Akil, Mohammed, Ancuta, Codrina, Baines, Colin, Bernard, Imbert, Bhojani, Kaushik, Blaise, Sophie, Moscovici, Yolanda Braun, Caporali, Roberto, Chatelus, Emmanuel, Chatterjee, Soumya, Cracowski, Jean Luc, Csuka, Mary Ellen, Angelis, Rossella De, Vries-Bouwstra, Jeska De, Derk, Chris, Distler, Oliver, Duba, Ayyappa, Fernandez-Codina, Andreu, Foeldvari, Ivan, Frech, Tracy, Guerra, Miguel, Guiducci, Serena, Gyger, Geneviève, Hernandez-Molina, Gabriela, Hesselstrand, Roger, Hinze, Alicia, Hsu, Vivien, Hughes, Michael, Inanc, Murat, Irace, Rosaria, Jacobsen, Soren, Koenig, Martial, Lenaerts, Jan, Lwin, Cho Mar, Makol, Ashima, Martin, Thierry, Lopez, Maria Martin, Medina, Yimy F., Merkel, Peter A., Mesa Navas, Miguel Antonio, Messiniti, Valentina, Mihai, Carina, Nadashkevich, Oleg, Narain, Sonali, Lambova, Sevdalina Nikolova, Pelechas, Eleftherios, Pizzorni, Carmen, Riccardi, Antonella, Riccieri, Valeria, Rimar, Doron, Rudnicka, Lidia, Sabelli, Mirtha, Sarafrazi, Mojgan, Schonenberg-Meinema, Dieneke, Scolnik, Marina, Senécal, Jean Luc, Shenavandeh, Saeedeh, Sifuentes-Giraldo, Walter Alberto, Spierings, Julia, Stevens, Wendy, Valenzuela, Antonia, Velásquez-Franco, Carlos Jaime, Vila, Josephine, Vilela, Verônica, Vonk, Madelon, and Voskuyl, Alexandre

Published
2021

234. Nutrient status of adults with cystic fibrosis

Author

Gordon, Catherine M., Anderson, Ellen J., Herlyn, Karen, Hubbard, Jane L., Pizzo, Angela, Gelbard, Rondi, Lapey, Allen, and Merkel, Peter A.

Subjects
Cystic fibrosis -- Care and treatment, Cystic fibrosis -- Diet therapy
Abstract

Nutrition is thought to influence disease status in patients with cystic fibrosis (CF). This cross-sectional study sought to evaluate nutrient intake and anthropometric data from 64 adult outpatients with cystic fibrosis. Nutrient intake from food and supplements was compared with the Dietary Reference Intakes for 16 nutrients and outcomes influenced by nutritional status. Attention was given to vitamin D and calcium given potential skeletal implications due to cystic fibrosis. Measurements included weight, height, body composition, pulmonary function, and serum metabolic parameters. Participants were interviewed about dietary intake, supplement use, pulmonary function, sunlight exposure, and pain. The participants' mean body mass index ([+ or -] standard deviation) was 21.8 [+ or -] 4.9 and pulmonary function tests were normal. Seventy-eight percent used pancreatic enzyme replacement for malabsorption. Vitamin D deficiency [25-hydroxyvitamin D (25OHD)<37.5 nmol/L] was common: 25 (39%) were deficient despite adequate vitamin D intake. Lipid profiles were normal in the majority, even though total and saturated fat consumption represented 33.0% and 16.8% of energy intake, respectively. Reported protein intake represented 16.9% of total energy intake (range 10%-25%). For several nutrients, including vitamin D and calcium, intake from food and supplements in many participants exceeded recommended Tolerable Up per Intake Levels. Among adults with cystic fibrosis, vitamin D deficiency was common despite reported adequate intake, and lipid profiles were normal despite a relatively high tat intake. Mean protein consumption was adequate, but the range of intake was concerning, as both inadequate or excessive intake may have deleterious skeletal effects. These findings call into question the applicability of established nutrient thresholds for patients with cystic fibrosis.

Published
2007

238. Efficacy of leflunomide in the treatment of vasculitis

Author

Mustapha, Noura, primary, Barra, Lillian, additional, Carette, Simon, additional, Cuthbertson, David, additional, Khalidi, Nader A., additional, Koening, Curry L., additional, Langford, Carol A., additional, McAlear, Carol A., additional, Milman, Nataliya, additional, Moreland, Larry W., additional, Monach, Paul A., additional, Seo, Philip, additional, Specks, Ulrich, additional, Sreih, Antoine G., additional, Ytterberg, Steve Y., additional, Merkel, Peter A., additional, and Pagnoux, Christian, additional

Published
2021
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240. Social Distancing, Health Care Disruptions, Telemedicine Use, and Treatment Interruption During the COVID‐19 Pandemic in Patients With or Without Autoimmune Rheumatic Disease

Author

George, Michael D., primary, Baker, Joshua F., additional, Banerjee, Shubhasree, additional, Busch, Howard, additional, Curtis, David, additional, Danila, Maria I., additional, Gavigan, Kelly, additional, Kirby, Daniel, additional, Merkel, Peter A., additional, Munoz, George, additional, Nowell, William Benjamin, additional, Stewart, Patrick, additional, Sunshine, William, additional, Venkatachalam, Shilpa, additional, Xie, Fenglong, additional, and Curtis, Jeffrey R., additional

Published
2021
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245. Contributors

Author

Alberts, Mark J., primary, Battinelli, Elisabeth M., additional, Beckman, Joshua A., additional, Belkin, Michael, additional, Blei, Francine, additional, Blume, Peter, additional, Brass, Eric P., additional, Brennan, Christina, additional, Carter-Monroe, Naima, additional, Chacko, Billy G., additional, Chadachan, Veerendra, additional, Chan, Stephen Y., additional, Cid, Maria C., additional, Coselli, Joseph S., additional, Creager, Mark A., additional, Criqui, Michael H., additional, Cronenwett, Jack L., additional, Dake, Michael D., additional, Danczyk, Rachel C., additional, Davis, Mark D.P., additional, Duran, Cihan, additional, Eagleton, Matthew J., additional, Eberhardt, Robert T., additional, Eikelboom, John W., additional, Fisher, Marc, additional, Freedman, Jane E., additional, Freischlag, Julie Ann, additional, Fulton, David R., additional, Garg, Nitin, additional, Gerhard-Herman, Marie, additional, Gloviczki, Peter, additional, Goldhaber, Samuel Z., additional, Goldstein, Larry B., additional, Gornik, Heather L., additional, Greif, Daniel M., additional, Griendling, Kathy K., additional, Habersberger, Jonathon, additional, Halperin, Jonathan L., additional, Hansen, Kimberley J., additional, Haqqani, Omar P., additional, Harrison, David G., additional, Harthun, Nancy, additional, Hiatt, William R., additional, Hilenski, Lula L., additional, Hoffman, Gary S., additional, Huh, Joseph, additional, Iafrati, Mark D., additional, Iyer, Sriram S., additional, Keegan, Kirk A., additional, Kwolek, Christopher J., additional, Landry, Gregory J., additional, Lau, Joe F., additional, LeMaire, Scott A., additional, Leopold, Jane A., additional, Libby, Peter, additional, Lichtman, Judith H., additional, Long, Chandler A., additional, Loscalzo, Joseph, additional, Luther, James M., additional, Machleder, Herbert I., additional, Madder, Ryan D., additional, Mahameed, Amjad Al, additional, Maksimowicz-McKinnon, Kathleen, additional, Maron, Bradley A., additional, McPhee, James T., additional, Menard, Matthew T., additional, Merkel, Peter A., additional, Moneta, Gregory L., additional, Moore, Wesley S., additional, Newburger, Jane W., additional, Newton, William B., additional, O'Gara, Patrick T., additional, Olin, Jeffrey W., additional, Önal, Mehmet Zülküf, additional, Pande, Reena L., additional, Penson, David F., additional, Perlstein, Todd S., additional, Piazza, Gregory, additional, Plummer, Mitchell M., additional, Raghow, Rajendra, additional, Rajagopalan, Sanjay, additional, Rathbun, Suman, additional, Rockson, Stanley G., additional, Rooke, Thom W., additional, Roubin, Gary, additional, Rybicki, Frank J., additional, Safian, Robert D., additional, Shepherd, Roger F.J., additional, Sobieszczyk, Piotr S., additional, Stone, David H., additional, Sumpio, Bauer E., additional, Tafur, Alfonso J., additional, Taylor, Allen J., additional, Textor, Stephen C., additional, Upchurch, Gilbert R., additional, Valentine, R. James, additional, Virmani, Renu, additional, Vitek, Jiri, additional, Walls, Michael C., additional, Watkins, Michael T., additional, Weitz, Jeffrey I., additional, White, Christopher J., additional, and Williams, Timothy K., additional

Published
2013
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249. Expert consensus for performing right heart catheterisation for suspected pulmonary arterial hypertension in systemic sclerosis: a Delphi consensus study with cluster analysis

Author

Avouac, Jérôme, Huscher, Dörte, Furst, Daniel E, Opitz, Christian F, Distler, Oliver, Allanore, Yannick, Ahmadi-Simab, Keihan, Albera, Carlo, Behrens, Frank, Bolster, Marcy B., Burger, Charles, Chatterjee, Soumya, Clements, Philip, Confalonieri, Marco, Ellen Csuka, Mary, Denton, Christopher P., Farber, Harrison, Fessler, Barri, Foeldvari, Ivan, Foley, Raymond, Frantz, Robert, Tore Gran, Jan, Highland, Kristin, Hsu, Vivien, Humbert, Marc, Inanc, Murat, Johnson, Sindhu, Kahaleh, Bashar, Kawut, Steven M, Khanna, Dinesh, Köhler, Christian M., Kowal-Bielecka, Otylia, Lang, Irene, Mahmud, Tafazzul H., Mandel, Jess, Cerinic, Marco Matucci, Mayes, Maureen, McHugh, Neil, McLaughlin, Vallerie, Medsger, Thomas A., Mehta, Sanjay, Merkel, Peter A., Mubarak, Kamal, Nash, Peter, Nathan, Steven, Oudiz, Ronald, Palevsky, Harold, Park, Myung, Pittrow, David, Pope, Janet, Ralph, David, Rothfield, Naomi, Rubenfire, Melvyn, Rubin, Lewis J., Saketkoo, Lesley Ann, Scorza, Sak Raffaella, Seibold, James R., Senecal, Jean-Luc, Silver, Richard, Staehler, Gerd, Steen, Virginia, strand, Vibeke, Strange, Charlie, Sweiss, Nadera, Taichman, Darren, Voskuyl, Alexandre, Wigley, Fredrick, Williamson, Tim, and Wollheim, Frank

Published
2014
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