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1. 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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3. Therapeutic Plasma Exchange for the Symptomatic Treatment of Scleromyxedema: A Case Report and Literature Review.

Author

Lanehart, Matthew H., Johnson, Erika S., and Aqui, Nicole A.

Subjects
PLASMA exchange (Therapeutics), RANGE of motion of joints, INTRAVENOUS immunoglobulins, DEGLUTITION disorders, GLUCOCORTICOIDS
Abstract

Scleromyxedema is a rare skin mucinosis often associated with systemic involvement and monoclonal gammopathy (MG). No formal recommendation for management with therapeutic plasma exchange (TPE) has been published due to rarity. This paper reports a 42‐year‐old male with progressive scleromyxedema. The patient was treated with glucocorticoids, immunosuppressants, and intravenous immunoglobulin (IVIG) therapy, but the disease progressed. Ultimately, the patient was referred for TPE, which resulted in decreased skin stiffness, improved extremity range of motion, and decreased visibility of papules on the hands. The patient's debilitating dysphagia gradually improved. A review of the literature focusing on clinical response identified five cases of scleromyxedema patients treated with TPE. Three of the five cases reported significant improvement in cutaneous symptoms and range of motion for at least 12 months. Overall, we propose that TPE should be considered an effective supportive treatment for symptomatic relief in severe or refractory scleromyxedema. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Red cell exchange for rapid leukoreduction in adults with hyperleukocytosis and leukostasis

Author

Mack, Ethan Andrew, primary, Dougher, Meaghan C., additional, Ginda, Ashley, additional, Cahill, Caitlin Q, additional, Murter, Melissa, additional, Schell, Kevin, additional, Tanhehco, Yvette C, additional, Bhoj, Vijay, additional, Fesnak, Andrew D, additional, Siegel, Don L, additional, Kambayashi, Taku, additional, Aqui, Nicole, additional, and O'Doherty, Una, additional

Published
2023
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5. A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia

Author

Bar, Katharine J., Shaw, Pamela A., Choi, Grace H., Aqui, Nicole, Fesnak, Andrew, Yang, Jasper B., Soto-Calderon, Haideliza, Grajales, Lizette, Starr, Julie, Andronov, Michelle, Mastellone, Miranda, Amonu, Chigozie, Feret, Geoff, DeMarshall, Maureen, Buchanan, Marie, Caturla, Maria, Gordon, James, Wanicur, Alan, Monroy, M. Alexandra, Mampe, Felicity, Lindemuth, Emily, Gouma, Sigrid, Mullin, Anne M., Barilla, Holly, Pronina, Anastasiya, Irwin, Leah, Thomas, Raeann, Eichinger, Risa A., Demuth, Faye, Prak, Eline T. Luning, Pascual, Jose L., Short, William R., Elovitz, Michal A., Baron, Jillian, Meyer, Nuala J., Degnan, Kathleen O., Frank, Ian, Hensley, Scott E., Siegel, Donald L., and Tebas, Pablo

Subjects
Bacterial pneumonia -- Development and progression -- Care and treatment, Pneumonia -- Development and progression -- Care and treatment, Critically ill -- Care and treatment, Health care industry
Abstract

BACKGROUND. Antibody-based strategies for COVID-19 have shown promise in prevention and treatment of early disease. COVID-19 convalescent plasma (CCP) has been widely used but results from randomized trials supporting its benefit in hospitalized patients with pneumonia are limited. Here, we assess the efficacy of CCP in severely ill, hospitalized adults with COVID-19 pneumonia. METHODS. We performed a randomized control trial (PennCCP2), with 80 adults hospitalized with COVID-19 pneumonia, comparing up to 2 units of locally sourced CCP plus standard care versus standard care alone. The primary efficacy endpoint was comparison of a clinical severity score. Key secondary outcomes include 14- and 28-day mortality, 14- and 28-day maximum 8-point WHO ordinal score (WHO8) score, duration of supplemental oxygenation or mechanical ventilation, respiratory SARS-CoV-2 RNA, and anti-SARS-CoV-2 antibodies. RESULTS. Eighty hospitalized adults with confirmed COVID-19 pneumonia were enrolled at median day 6 of symptoms and day 1 of hospitalization; 60% were anti-SARS-CoV-2 antibody seronegative. Participants had a median of 3 comorbidities, including risk factors for severe COVID-19 and immunosuppression. CCP treatment was safe and conferred significant benefit by clinical severity score (median [MED] and interquartile range [IQR] 10 [5.5-30] vs. 7 [2.75-12.25], P = 0.037) and 28-day mortality (n = 10, 26% vs. n = 2, 5%; P = 0.013). All other prespecified outcome measures showed weak evidence toward benefit of CCP. CONCLUSION. Two units of locally sourced CCP administered early in hospitalization to majority seronegative participants conferred a significant benefit in clinical severity score and 28-day mortality. Results suggest CCP may benefit select populations, especially those with comorbidities who are treated early. TRIAL REGISTRATION. ClinicalTrials.gov NCT04397757. FUNDING. University of Pennsylvania., Introduction Since the identification of the first SARS-CoV-2 infections in late 2019, the COVID-19 pandemic has caused more than 200 million cases and 4.5 million deaths worldwide (1). Prevention strategies [...]

Published
2021
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16. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence‐Based Approach from the Writing Committee of the American Society for Apheresis: The Ninth Special Issue

Author

Connelly‐Smith, Laura, primary, Alquist, Caroline R., additional, Aqui, Nicole A., additional, Hofmann, Jan C., additional, Klingel, Reinhard, additional, Onwuemene, Oluwatoyosi A., additional, Patriquin, Christopher J., additional, Pham, Huy P., additional, Sanchez, Amber P., additional, Schneiderman, Jennifer, additional, Witt, Volker, additional, Zantek, Nicole D., additional, and Dunbar, Nancy M., additional

Published
2023
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17. Data from Rapid Immune Recovery and Graft-versus-Host Disease–like Engraftment Syndrome following Adoptive Transfer of Costimulated Autologous T Cells

Author

Rapoport, Aaron P., primary, Stadtmauer, Edward A., primary, Aqui, Nicole, primary, Vogl, Dan, primary, Chew, Anne, primary, Fang, Hong-Bin, primary, Janofsky, Stephen, primary, Yager, Kelly, primary, Veloso, Elizabeth, primary, Zheng, Zhaohui, primary, Milliron, Todd, primary, Westphal, Sandra, primary, Cotte, Julio, primary, Huynh, Hong, primary, Cannon, Andrea, primary, Yanovich, Saul, primary, Akpek, Gorgun, primary, Tan, Ming, primary, Virts, Kristen, primary, Ruehle, Kathleen, primary, Harris, Carolynn, primary, Philip, Sunita, primary, Vonderheide, Robert H., primary, Levine, Bruce L., primary, and June, Carl H., primary

Published
2023
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18. Supplementary Table 1 from Combination Immunotherapy after ASCT for Multiple Myeloma Using MAGE-A3/Poly-ICLC Immunizations Followed by Adoptive Transfer of Vaccine-Primed and Costimulated Autologous T Cells

Author

Rapoport, Aaron P., primary, Aqui, Nicole A., primary, Stadtmauer, Edward A., primary, Vogl, Dan T., primary, Xu, Yin Yan, primary, Kalos, Michael, primary, Cai, Ling, primary, Fang, Hong-Bin, primary, Weiss, Brendan M., primary, Badros, Ashraf, primary, Yanovich, Saul, primary, Akpek, Gorgun, primary, Tsao, Patricia, primary, Cross, Alan, primary, Mann, Dean, primary, Philip, Sunita, primary, Kerr, Naseem, primary, Brennan, Andrea, primary, Zheng, Zhaohui, primary, Ruehle, Kathleen, primary, Milliron, Todd, primary, Strome, Scott E., primary, Salazar, Andres M., primary, Levine, Bruce L., primary, and June, Carl H., primary

Published
2023
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19. Supplementary Data from Rapid Immune Recovery and Graft-versus-Host Disease–like Engraftment Syndrome following Adoptive Transfer of Costimulated Autologous T Cells

Author

Rapoport, Aaron P., primary, Stadtmauer, Edward A., primary, Aqui, Nicole, primary, Vogl, Dan, primary, Chew, Anne, primary, Fang, Hong-Bin, primary, Janofsky, Stephen, primary, Yager, Kelly, primary, Veloso, Elizabeth, primary, Zheng, Zhaohui, primary, Milliron, Todd, primary, Westphal, Sandra, primary, Cotte, Julio, primary, Huynh, Hong, primary, Cannon, Andrea, primary, Yanovich, Saul, primary, Akpek, Gorgun, primary, Tan, Ming, primary, Virts, Kristen, primary, Ruehle, Kathleen, primary, Harris, Carolynn, primary, Philip, Sunita, primary, Vonderheide, Robert H., primary, Levine, Bruce L., primary, and June, Carl H., primary

Published
2023
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21. Supplementary Figure 2 from Combination Immunotherapy after ASCT for Multiple Myeloma Using MAGE-A3/Poly-ICLC Immunizations Followed by Adoptive Transfer of Vaccine-Primed and Costimulated Autologous T Cells

Author

Rapoport, Aaron P., primary, Aqui, Nicole A., primary, Stadtmauer, Edward A., primary, Vogl, Dan T., primary, Xu, Yin Yan, primary, Kalos, Michael, primary, Cai, Ling, primary, Fang, Hong-Bin, primary, Weiss, Brendan M., primary, Badros, Ashraf, primary, Yanovich, Saul, primary, Akpek, Gorgun, primary, Tsao, Patricia, primary, Cross, Alan, primary, Mann, Dean, primary, Philip, Sunita, primary, Kerr, Naseem, primary, Brennan, Andrea, primary, Zheng, Zhaohui, primary, Ruehle, Kathleen, primary, Milliron, Todd, primary, Strome, Scott E., primary, Salazar, Andres M., primary, Levine, Bruce L., primary, and June, Carl H., primary

Published
2023
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22. Supplementary Figure Legends from Combination Immunotherapy after ASCT for Multiple Myeloma Using MAGE-A3/Poly-ICLC Immunizations Followed by Adoptive Transfer of Vaccine-Primed and Costimulated Autologous T Cells

Author

Rapoport, Aaron P., primary, Aqui, Nicole A., primary, Stadtmauer, Edward A., primary, Vogl, Dan T., primary, Xu, Yin Yan, primary, Kalos, Michael, primary, Cai, Ling, primary, Fang, Hong-Bin, primary, Weiss, Brendan M., primary, Badros, Ashraf, primary, Yanovich, Saul, primary, Akpek, Gorgun, primary, Tsao, Patricia, primary, Cross, Alan, primary, Mann, Dean, primary, Philip, Sunita, primary, Kerr, Naseem, primary, Brennan, Andrea, primary, Zheng, Zhaohui, primary, Ruehle, Kathleen, primary, Milliron, Todd, primary, Strome, Scott E., primary, Salazar, Andres M., primary, Levine, Bruce L., primary, and June, Carl H., primary

Published
2023
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23. Supplementary Figure 3 from Combination Immunotherapy after ASCT for Multiple Myeloma Using MAGE-A3/Poly-ICLC Immunizations Followed by Adoptive Transfer of Vaccine-Primed and Costimulated Autologous T Cells

Author

Rapoport, Aaron P., primary, Aqui, Nicole A., primary, Stadtmauer, Edward A., primary, Vogl, Dan T., primary, Xu, Yin Yan, primary, Kalos, Michael, primary, Cai, Ling, primary, Fang, Hong-Bin, primary, Weiss, Brendan M., primary, Badros, Ashraf, primary, Yanovich, Saul, primary, Akpek, Gorgun, primary, Tsao, Patricia, primary, Cross, Alan, primary, Mann, Dean, primary, Philip, Sunita, primary, Kerr, Naseem, primary, Brennan, Andrea, primary, Zheng, Zhaohui, primary, Ruehle, Kathleen, primary, Milliron, Todd, primary, Strome, Scott E., primary, Salazar, Andres M., primary, Levine, Bruce L., primary, and June, Carl H., primary

Published
2023
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24. Supplementary Figure 1 from Combination Immunotherapy after ASCT for Multiple Myeloma Using MAGE-A3/Poly-ICLC Immunizations Followed by Adoptive Transfer of Vaccine-Primed and Costimulated Autologous T Cells

Author

Rapoport, Aaron P., primary, Aqui, Nicole A., primary, Stadtmauer, Edward A., primary, Vogl, Dan T., primary, Xu, Yin Yan, primary, Kalos, Michael, primary, Cai, Ling, primary, Fang, Hong-Bin, primary, Weiss, Brendan M., primary, Badros, Ashraf, primary, Yanovich, Saul, primary, Akpek, Gorgun, primary, Tsao, Patricia, primary, Cross, Alan, primary, Mann, Dean, primary, Philip, Sunita, primary, Kerr, Naseem, primary, Brennan, Andrea, primary, Zheng, Zhaohui, primary, Ruehle, Kathleen, primary, Milliron, Todd, primary, Strome, Scott E., primary, Salazar, Andres M., primary, Levine, Bruce L., primary, and June, Carl H., primary

Published
2023
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26. Infusion of CD3/CD28 costimulated umbilical cord blood T cells at the time of single umbilical cord blood transplantation may enhance engraftment

Author

Hexner, Elizabeth O., Luger, Selina M., Reshef, Ran, Jeschke, Grace R., Mangan, James K., Frey, Noelle V., Frank, Dale M., Richman, Lee P., Vonderheide, Robert H., Aqui, Nicole A., Rosenbach, Misha, Zhang, Yi, Chew, Anne, Loren, Alison W., Stadtmauer, Edward A., Levine, Bruce L., June, Carl H., Emerson, Stephen G., and Porter, David L.

Published
2016
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28. The effects of plasma exchange and glucocorticoids on early kidney function among patients with ANCA-associated vasculitis in the PEXIVAS trial

Author

Odler, Balazs, Riedl, Regina, Geetha, Duvuru, Szpirt, Wladimir M., Hawley, Carmel, Uchida, Lisa, Wallace, Zachary S., Walters, Giles, Muso, Eri, Tesar, Vladimir, Pusey, Charles D., Little, Mark A., Merkel, Peter A., Walsh, Michael, Jayne, David R.W., Kronbichler, Andreas, 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, Smyth, Lucy, 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, Merkel, Peter A., Sreih, Antoine, Rhee, Rennie, McAlear, Carol, Aqui, Nicole, Moreland, Larry, Kiss, Joseph, Liang, Kimberly, Mohan, Niveditha, Balogun, Rasheed, Li, Tingting, and Brasington, Richard

Abstract

Therapeutic plasma exchange (PLEX) is an adjunctive treatment for patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis and kidney involvement. Little is known about the effect of PLEX on early changes in kidney function. This post-hocanalysis of the PEXIVAS trial investigated the effects of PLEX on changes in kidney function within 12 months. PEXIVAS was a randomized controlled trial recruiting 691 patients with ANCA-associated glomerulonephritis, of whom 349 underwent PLEX and 342 received no-PLEX. The primary outcomes of this post hocstudy of PEXIVAS were change in estimated glomerular filtration rate (eGFR) from baseline and recovery of kidney function (defined as eGFR increase of 15ml/min/1.73m2or more). Baseline eGFR was 21.7 ± 20.3 and 20.6 ± 18.7 ml/min/1.73m2in the PLEX and no-PLEX groups, respectively. Mean improvements in eGFR at weeks two, four, and eight after initiation of therapy were greater for the PLEX vs. the no-PLEX groups. The greatest significant difference in recovery of kidney function in the PLEX compared to the no-PLEX groups was at week four (relative risk (RR): 1.41; 95% confidence interval:1.09-1.82). Increased eGFR or recovery of kidney function at week four were significantly associated with lower risk for end-stage kidney disease at week 52 (RR: 0.96: 0.95-0.97, and RR: 0.29: 0.16-0.52; respectively). Neither changes in eGFR nor recovery of kidney function differed by reduced- compared to standard-dose glucocorticoid group. Overall, our study indicates that PLEX improves early kidney function in patients with ANCA-associated glomerulonephritis.

Published
2025
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29. Lack of defined apheresis collection criteria in publicly available CAR‐T cell clinical trial descriptions: Comprehensive review of over 600 studies.

Author

Thibodeaux, Suzanne R., Aqui, Nicole A., Park, Yara A., Schneiderman, Jennifer, Su, Leon L., Winters, Jeffrey L., Zubair, Abba C., Schwartz, Joseph, and Liu, Hien D.

Subjects
LEUCOCYTES, CHIMERIC antigen receptors, CLINICAL trials, LYMPHOCYTE count
Abstract

Background: Chimeric antigen receptor T (CAR‐T) cell successes have encouraged continued clinical study. Apheresis collection of starting material for CAR‐T cell therapy product manufacturing is critical but described approaches suggest variability and clinical guidelines are currently lacking. The goal of this study was to gather and assess variability in apheresis collection descriptions in publicly available CAR T‐cell therapy clinical trials. Study design: We searched clinicaltrials.gov (a publicly available clinical trial database) for "chimeric antigen receptor T cells" on July 01, 2020 and studies accessed July 30, 2020‐August 15, 2020. Data collected included date posted, study characteristics, apheresis mentions (number, location, and context), laboratory parameters and transfusion allowances. Apheresis context was analyzed using a qualitative inductive approach of grounded theory method with open coding. Text was classified into 37 context codes, grouped into 12 categories, and then consolidated into patient, procedure, product, and miscellaneous themes. Results: Apheresis was mentioned 1044 times in 322 (51.9%) of 621 total studies. Laboratory parameters mentioned included white blood cells (100 studies), absolute neutrophil count (220 studies), absolute lymphocyte count (102 studies), CD3+ cell (38 studies), hemoglobin (233 studies, 54 studies specified transfusion allowance), and platelet (269 studies, 48 studies specified transfusion allowance). Conclusions: Apheresis collection of CAR‐T cell products is not well‐defined in clinical study descriptions and the context is inconsistent. Laboratory parameters useful for apheresis collection are variably present and do not consistently align with current practices. Further exploration, and clinical guideline development will encourage alignment of apheresis collections for CAR‐T cell products. [ABSTRACT FROM AUTHOR]

Published
2022
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30. Update to the ASFA guidelines on the use of therapeutic apheresis in ANCA‐associated vasculitis

Author

Balogun, Rasheed A., primary, Sanchez, Amber P., additional, Klingel, Reinhard, additional, Witt, Volker, additional, Aqui, Nicole, additional, Meyer, Erin, additional, Padmanabhan, Anand, additional, Pham, Huy P., additional, Schneiderman, Jennifer, additional, Schwartz, Joseph, additional, Wu, Yanyun, additional, Zantek, Nicole D., additional, Connelly‐Smith, Laura, additional, and Dunbar, Nancy M., additional

Published
2020
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33. The report from ASFA COVID‐19 taskforce: Considerations and prioritization on apheresis procedures during the SARS‐CoV‐2 coronavirus disease (COVID‐19) pandemic.

Author

Yamada, Chisa, Hofmann, Jan C., Witt, Volker, Gupta, Gaurav K., Winters, Jeffrey L., Aqui, Nicole A., Wu, YanYun, Banez‐Sese, Grace, Doggett, Betty, Eichbaum, Quentin G., Hagen‐Coonradt, Antonia, Hannan, Margaret, Ipe, Tina S., Joshi, Sarita, Knight, Susan, Raval, Jay S., Sachais, Bruce S., Schwartz, Joseph, Tanhehco, Yvette C., and Zantek, Nicole D.

Subjects
COVID-19, SARS-CoV-2, COVID-19 pandemic, VACCINATION, CORONAVIRUSES, HEMAPHERESIS
Abstract

Since vaccination for SARS‐CoV‐2 coronavirus started, the trajectory of patient numbers infected with the virus has improved once; however, variants of SARS‐CoV‐2 have emerged and more people have been infected; therefore, pandemic status is still far from resolution. Government and social efforts to prevent coronavirus infection continue in most states in the US and globally even after the Centers for Disease Control and Prevention declared some restriction relief for fully vaccinated people in March 2021. Healthcare institutions and various professional organizations have developed guidelines or policies to prevent the spread of these coronaviruses in the setting of apheresis. In this report, the issues that apheresis services may encounter under the current COVID‐19 (SARS‐CoV‐2 coronavirus disease) pandemic will be discussed with potential strategies that can be adapted for efficient and optimum use of apheresis resources. [ABSTRACT FROM AUTHOR]

Published
2021
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34. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence‐Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue

Author

Padmanabhan, Anand, primary, Connelly‐Smith, Laura, additional, Aqui, Nicole, additional, Balogun, Rasheed A., additional, Klingel, Reinhard, additional, Meyer, Erin, additional, Pham, Huy P., additional, Schneiderman, Jennifer, additional, Witt, Volker, additional, Wu, Yanyun, additional, Zantek, Nicole D., additional, Dunbar, Nancy M., additional, and Schwartz, Guest Editor: Joseph, additional

Published
2019
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35. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice–Evidence‐Based Approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue

Author

Schwartz, Joseph, primary, Padmanabhan, Anand, additional, Aqui, Nicole, additional, Balogun, Rasheed A., additional, Connelly‐Smith, Laura, additional, Delaney, Meghan, additional, Dunbar, Nancy M., additional, Witt, Volker, additional, Wu, Yanyun, additional, and Shaz, Beth H., additional

Published
2016
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41. The thrombotic microangiopathy Registry of North America: A United States multi-institutional TMA network.

Author

Metjian, Ara, Tanhehco, Yvette C., Aqui, Nicole, Bhoj, Vijay G., Jamensky, Lita, Marques, Marisa B., Onwuemene, Oluwatoyosi, Pham, Huy P., and Arepally, Gowthami M.

Abstract

The thrombotic microangiopathy (TMA) Registry Network of North America (TRNA) is a collaborative network organized for the purpose of developing a multi-institutional registry and network to conduct clinical studies in a rare patient population. The TRNA was founded in 2013 by four academic medical centers (Columbia University Medical Center, Duke University Medical Center, University of Alabama at Birmingham, and University of Pennsylvania) to develop a national and demographically diverse dataset of patients with TMA. A clinical database was developed by network members using REDCap (Research Electronic Data Capture), a web-based database developed for clinical research. To facilitate rapid Institutional Review Board (IRB) approval at multiple sites, the TRNA utilized IRBshare, a streamlined IRB process to allow patient recruitment and enrollment into the TMA registry. This article reviews the process used to establish the TRNA network and discusses the significance of the first multi-institutional clinical apheresis network developed in the United States. J. Clin. Apheresis 31:448-453, 2016. © 2015 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Published
2016
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