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1. Evaluating Avacopan in the Treatment of ANCA-Associated Vasculitis: Design, Development and Positioning of Therapy

Author

van Leeuwen JR, Quartuccio L, Draibe JB, Gunnarson I, Sprangers B, and Teng YKO

Subjects
antineutrophil cytoplasmic antibody (anca), pauci-immune glomerulonephritis, complement, c5a inhibition, glucocorticoid toxicity., Therapeutics. Pharmacology, RM1-950
Abstract

Jolijn R van Leeuwen,1 Luca Quartuccio,2 Juliana Bordignon Draibe,3 Iva Gunnarson,4 Ben Sprangers,5 Y K Onno Teng1 1Center of Expertise for Lupus-, Vasculitis- and Complement-Mediated Systemic Diseases (Luvacs), Department of Internal Medicine - Nephrology Section, Leiden University Medical Center, Leiden, the Netherlands; 2Division of Rheumatology, Department of Medicine, University of Udine, Udine, Italy; 3Department of Nephrology, Bellvitge University Hospital, Bellvitge Biomedical Research Institute (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain; 4Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Karolinska University Hospital, Stockholm, Sweden; 5Department of Nephrology, Ziekenhuis Oost Limburg Genk, Genk, BelgiumCorrespondence: Y K Onno Teng, Department of Nephrology, Leiden University Medical Center (LUMC), P.O. Box 9600, Leiden, 2300 RC, the Netherlands, Tel +31-71-5262148, Fax +31-71-5266868, Email Y.K.O.Teng@lumc.nlAbstract: Recently, avacopan has been approved for the treatment of ANCA-associated vasculitis (AAV). Avacopan is an inhibitor of the C5a-receptor, which plays an important role in chemotaxis and the amplification loop of inflammation in AAV. In the most recent, international guidelines avacopan is recommended as steroid-sparing agents for the management of AAV. Here, we review the clinical trials that have led to demonstrate that avacopan is an effective treatment option in the management of AAV, where it can significantly reduce the cumulative dosage of glucocorticoids (GC). Despite the new guideline recommendations, clear guidance on how to employ avacopan in real-world clinical practice is lacking. We therefore also address in this review the data and clinical experience with avacopan obtained from real-world evidence. Combining preclinical studies, clinical trials, and real-world evidence helps to provide a better position of avacopan for the management of AAV in routine clinical practice, taking advantage of the GC-sparing effects of avacopan as a possible solution for the current challenge of reducing GC-toxicity in AAV patients. Furthermore, we delineate current knowledge gaps and future research areas that need to be addressed.Keywords: antineutrophil cytoplasmic antibody, ANCA, pauci-immune glomerulonephritis, complement, C5a inhibition, glucocorticoid toxicity

Published
2025

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

Author

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

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

Author

Cortazar, F, Niles, J, Jayne, D, Merkel, P, Bruchfeld, A, Yue, H, Schall, T, Bekker, P, Peh, C, 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, Schonermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, De Vita, S, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, van Daele, P, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, de Zoysa, J, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, Pamplona, I, Anton, J, Lucia, V, Ciggaran, S, Cid, M, Encarnacion, M, Oliveras, X, Soler, M, Rusinol, H, Praga, M, Porras, L, Segarra, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Burton, J, Al Jayyousi, R, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Chen Lin, Y, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, 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, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, Wasko, M, Cortazar F. B., Niles J. L., Jayne D. R. W., Merkel P. A., Bruchfeld A., Yue H., Schall T. J., Bekker P., Peh C. A., 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., Schonermarck U., Venhoff N., Vielhauer V., Witzke O., Szombati I., Szucs G., Garibotto G., Alberici F., Brunetta E., Dagna L., De Vita S., Emmi G., Gabrielli A., Manenti L., Pieruzzi F., Roccatello D., Salvarani C., Dobashi H., Atsumi T., Fujimoto S., Hagino N., Ihata A., Kaname S., Kaneko Y., Katagiri A., Katayama M., Kirino Y., Kitagawa K., Komatsuda A., Kono H., Kurasawa T., Matsumura R., Mimura T., Morinobu A., Murakawa Y., Naniwa T., Nanki T., Ogawa N., Oshima H., Sada K., Sugiyama E., Takeuchi T., Taki H., Tamura N., Tsukamoto T., Yamagata K., Yamamura M., van Daele P., Rutgers A., Teng Y., Walker R., Chua I., Collins M., Rabindranath K., de Zoysa J., Svensson M., Grevbo B., Kalstad S., Little M., Clarkson M., Molloy E., Pamplona I. A., Anton J., Lucia V. B., Ciggaran S., Cid M. C., Encarnacion M. D., Oliveras X. F., Soler M. J., Rusinol H. M., Praga M., Porras L. Q., Segarra A., Segelmark M., Soveri I., Thomaidi E., Westman K., Neumann T., Burnier M., Daikeler T., Dudler J., Hauser T., Seeger H., Vogt B., Jayne D., Burton J., Al Jayyousi R., Amin T., Andrews J., Baines L., Brogan P., Dasgupta B., Doulton T., Flossmann O., Griffin S., Harper J., Harper L., Kidder D., Klocke R., Lanyon P., Luqmani R., McLaren J., Makanjuola D., McCann L., Nandagudi A., Selvan S., O'Riordan E., Patel M., Patel R., Pusey C., Rajakariar R., Robson J., Robson M., Salama A., Smyth L., Sznajd J., Taylor J., Merkel P., Sreih A., Belilos E., Bomback A., Carlin J., Chen Lin Y. C., Derebail V., Dragoi S., Dua A., Forbess L., Geetha D., Gipson P., Gohh R., Greenwood G. T., Hugenberg S., Jimenez R., Kaskas M., Kermani T., Kivitz A., Koening C., Langford C., Marder G., Mohamed A., Monach P., Neyra N., Niemer G., Niles J., Obi R., Owens C., Parks D., Podoll A., Rovin B., Sam R., Shergy W., Silva A., Specks U., Spiera R., Springer J., Striebich C., Swarup A., Thakar S., Tiliakos A., Tsai Y., Waguespack D., Wasko M. C., Cortazar, F, Niles, J, Jayne, D, Merkel, P, Bruchfeld, A, Yue, H, Schall, T, Bekker, P, Peh, C, 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, Schonermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, De Vita, S, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, van Daele, P, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, de Zoysa, J, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, Pamplona, I, Anton, J, Lucia, V, Ciggaran, S, Cid, M, Encarnacion, M, Oliveras, X, Soler, M, Rusinol, H, Praga, M, Porras, L, Segarra, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Burton, J, Al Jayyousi, R, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Chen Lin, Y, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, 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, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, Wasko, M, Cortazar F. B., Niles J. L., Jayne D. R. W., Merkel P. A., Bruchfeld A., Yue H., Schall T. J., Bekker P., Peh C. A., 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., Schonermarck U., Venhoff N., Vielhauer V., Witzke O., Szombati I., Szucs G., Garibotto G., Alberici F., Brunetta E., Dagna L., De Vita S., Emmi G., Gabrielli A., Manenti L., Pieruzzi F., Roccatello D., Salvarani C., Dobashi H., Atsumi T., Fujimoto S., Hagino N., Ihata A., Kaname S., Kaneko Y., Katagiri A., Katayama M., Kirino Y., Kitagawa K., Komatsuda A., Kono H., Kurasawa T., Matsumura R., Mimura T., Morinobu A., Murakawa Y., Naniwa T., Nanki T., Ogawa N., Oshima H., Sada K., Sugiyama E., Takeuchi T., Taki H., Tamura N., Tsukamoto T., Yamagata K., Yamamura M., van Daele P., Rutgers A., Teng Y., Walker R., Chua I., Collins M., Rabindranath K., de Zoysa J., Svensson M., Grevbo B., Kalstad S., Little M., Clarkson M., Molloy E., Pamplona I. A., Anton J., Lucia V. B., Ciggaran S., Cid M. C., Encarnacion M. D., Oliveras X. F., Soler M. J., Rusinol H. M., Praga M., Porras L. Q., Segarra A., Segelmark M., Soveri I., Thomaidi E., Westman K., Neumann T., Burnier M., Daikeler T., Dudler J., Hauser T., Seeger H., Vogt B., Jayne D., Burton J., Al Jayyousi R., Amin T., Andrews J., Baines L., Brogan P., Dasgupta B., Doulton T., Flossmann O., Griffin S., Harper J., Harper L., Kidder D., Klocke R., Lanyon P., Luqmani R., McLaren J., Makanjuola D., McCann L., Nandagudi A., Selvan S., O'Riordan E., Patel M., Patel R., Pusey C., Rajakariar R., Robson J., Robson M., Salama A., Smyth L., Sznajd J., Taylor J., Merkel P., Sreih A., Belilos E., Bomback A., Carlin J., Chen Lin Y. C., Derebail V., Dragoi S., Dua A., Forbess L., Geetha D., Gipson P., Gohh R., Greenwood G. T., Hugenberg S., Jimenez R., Kaskas M., Kermani T., Kivitz A., Koening C., Langford C., Marder G., Mohamed A., Monach P., Neyra N., Niemer G., Niles J., Obi R., Owens C., Parks D., Podoll A., Rovin B., Sam R., Shergy W., Silva A., Specks U., Spiera R., Springer J., Striebich C., Swarup A., Thakar S., Tiliakos A., Tsai Y., Waguespack D., and Wasko M. C.

Abstract

Introduction: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m2 in the avacopan group and 4.1 ml/min per 1.73 m2 in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m2. Methods: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups. Results: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m2. At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m2 in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m2, respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group. Conclusion: Among patients with baseline eGFR ≤20 ml/min per 1.73 m2 in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.

Published
2023

10. Kidney Transplantation in Patients With Monoclonal Gammopathy of Renal Significance.

Author

Sprangers, B., Hegenbart, U., Wetzels, J.F.M., Sprangers, B., Hegenbart, U., and Wetzels, J.F.M.

Abstract

Item does not contain fulltext, Monoclonal gammopathy of renal significance (MGRS) defines disorders characterized by direct or indirect kidney injury caused by a monoclonal immunoglobulin produced by a B-cell or plasma-cell clone that does not meet current hematologic criteria for therapy. MGRS-associated kidney diseases are diverse and can result in the development of end-stage kidney disease. The current paradigm states that the underlying hematologic condition should be treated and in deep remission before kidney transplantation can be performed because recurrence has been reported for all MGRS-associated kidney diseases. However, we suggest that decisions regarding kidney transplantation in MGRS patients should be individualized considering many factors such as the subtype of MGRS-associated kidney disease, patient age and comorbidity, presence and risk of extrarenal complications, estimated waiting time, the availability of a living kidney donor, and previous hematological treatment and response. Thus, kidney transplantation should be considered even in treatment-naive patients, with hematological treatment initiated after successful kidney transplantation.

Published
2023

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

Author

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

Published
2023
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14. WCN23-0412 EFFECT OF IPTACOPAN ON PROTEINURIA AND COMPLEMENT BIOMARKERS OVER TIME IN IgA NEPHROPATHY

Author

Barratt, J., primary, Rovin, B.H., additional, Zhang, H., additional, Rizk, D.V., additional, Kashihara, N., additional, Maes, B.D., additional, Trimarchi, H., additional, Sprangers, B., additional, Meier, M., additional, Kollins, D., additional, Junge, G., additional, Milojevic, J., additional, Papachristofi, O., additional, and Perkovic, V., additional

Published
2023
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15. Corrigendum: Cemiplimab for advanced cutaneous squamous cell carcinoma in kidney transplant recipients

Author

Van Meerhaeghe, T., primary, Baurain, J.F., additional, Bechter, O., additional, Orte Cano, C., additional, Del Marmol, V., additional, Devresse, A., additional, Doubel, P., additional, Hanssens, M., additional, Hellemans, R., additional, Lienard, D., additional, Rutten, A., additional, Sprangers, B., additional, Le Moine, A., additional, and Aspeslagh, S., additional

Published
2023
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17. Cemiplimab for advanced cutaneous squamous cell carcinoma in kidney transplant recipients

Author

Van Meerhaeghe, T., Baurain, J.F., Bechter, O., Orte Cano, C., Del Marmol, V., Devresse, A., Doubel, P., Hanssens, M., Hellemans, Rachel, Lienard, D., Rutten, A., Sprangers, B., Le Moine, A., and Aspeslagh, S.

Subjects
Human medicine
Abstract

BackgroundKidney transplant recipients (KTR) are at increased risk of cancer due to chronic immunosuppression. Non-melanoma skin cancer has an excess risk of approximately 250 times higher than the general population. Moreover, in solid organ transplant recipients (SOTR) these cancers have a more aggressive behavior, with an increased risk of metastasis and death. Cemiplimab, a human monoclonal IgG4 antibody against programmed cell death (PD-1) has shown considerable clinical activity in metastatic and locally advanced cutaneous squamous cell carcinoma (cSCC) in patients for whom no widely accepted standard of care exists. Cemiplimab has therefore been approved since 2018 for the treatment of advanced cSCC. However, data regarding the use of cemiplimab in SOTR and particularly in KTR are scarce and based on published case reports and small case series. In this study, we report on the real-life outcome of cemiplimab use in a Belgian cohort of seven KTR suffering from advanced cSCC.ObjectiveTo report on the overall response rate (ORR) and safety of cemiplimab in KTR in Belgium.ResultsSeven patients suffering from advanced cSCC, treated with cemiplimab, between 2018 and 2022, in Belgium were identified. Three patients were on corticosteroid monotherapy, one patient on tacrolimus monotherapy and three patients were on at least 2 immunosuppressants at start of cemiplimab. The ORR was 42.8%, stable disease was seen in 14.3% and progressive disease was found in 42.8% of the patients, respectively. The median administered number of cycles was 12, interquartile range (IQR) 25-75 [3.5 – 13.5]. All patients were treated with surgery before administration of cemiplimab, 71.4% received additional radiotherapy and only 1 patient was treated with chemotherapy prior to receiving cemiplimab. Biopsy-proven acute renal allograft rejection was observed in one patient, who eventually lost his graft function but showed a complete tumor response to treatment. Low grade skin toxicity was seen in one patient of the cohort.ConclusionThe present case series shows that the use of cemiplimab in KTR with advanced cSCC who failed to respond to previous surgery, chemo – and/or radiotherapy treatment is associated with an ORR of 42.8% with minimal risk of graft rejection (14.3%) and good tolerance.

Published
2022
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20. POS-546 EFFICACY AND SAFETY OF IPTACOPAN IN IgA NEPHROPATHY: RESULTS OF A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 2 STUDY AT 6 MONTHS

Author

Barratt, J., primary, Rovin, B., additional, Zhang, H., additional, Kashihara, N., additional, Maes, B., additional, Rizk, D., additional, Trimarchi, H., additional, Sprangers, B., additional, Meier, M., additional, Kollins, D., additional, Wang, W., additional, Magirr, A., additional, and Perkovic, V., additional

Published
2022
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21. Acute kidney injury in patients treated with immune checkpoint inhibitors

Author

Gupta, S., Short, S.A.P., Sise, M.E., Prosek, J.M., Madhavan, S.M., Soler, M.J., Ostermann, M., Herrmann, S.M., Abudayyeh, A., Anand, S., Glezerman, I., Motwani, S.S., Murakami, N., Wanchoo, R., Ortiz-Melo, D.I., Rashidi, A., Sprangers, B., Aggarwal, V., Malik, A.B., Loew, S., Carlos, C.A., Chang, W.T., Beckerman, P., Mithani, Z., Shah, C.V., Renaghan, A.D., Seigneux, S.D., Campedel, L., Kitchlu, A., Shin, D.S., Rangarajan, S., Deshpande, P., Coppock, G., Eijgelsheim, M., Seethapathy, H., Lee, M.D., Strohbehn, I.A., Owen, D.H., Husain, M., Garcia-Carro, C., Bermejo, S., Lumlertgul, N., Seylanova, N., Flanders, L., Isik, B., Mamlouk, O., Lin, J.S., Garcia, P., Kaghazchi, A., Khanin, Y., Kansal, S.K., Wauters, E., Chandra, S., Schmidt-Ott, K.M., Hsu, R.K., Tio, M.C., Sarvode Mothi, S., Singh, H., Schrag, D., Jhaveri, K.D., Reynolds, K.L., Cortazar, F.B., and Leaf, D.E.

Subjects
urogenital system, Cardiovascular and Metabolic Diseases, urologic and male genital diseases, female genital diseases and pregnancy complications
Abstract

BACKGROUND: Immune checkpoint inhibitor-associated acute kidney injury (ICPi-AKI) has emerged as an important toxicity among patients with cancer. METHODS: We collected data on 429 patients with ICPi-AKI and 429 control patients who received ICPis contemporaneously but who did not develop ICPi-AKI from 30 sites in 10 countries. Multivariable logistic regression was used to identify predictors of ICPi-AKI and its recovery. A multivariable Cox model was used to estimate the effect of ICPi rechallenge versus no rechallenge on survival following ICPi-AKI. RESULTS: ICPi-AKI occurred at a median of 16 weeks (IQR 8-32) following ICPi initiation. Lower baseline estimated glomerular filtration rate, proton pump inhibitor (PPI) use, and extrarenal immune-related adverse events (irAEs) were each associated with a higher risk of ICPi-AKI. Acute tubulointerstitial nephritis was the most common lesion on kidney biopsy (125/151 biopsied patients [82.7%]). Renal recovery occurred in 276 patients (64.3%) at a median of 7 weeks (IQR 3-10) following ICPi-AKI. Treatment with corticosteroids within 14 days following ICPi-AKI diagnosis was associated with higher odds of renal recovery (adjusted OR 2.64; 95% CI 1.58 to 4.41). Among patients treated with corticosteroids, early initiation of corticosteroids (within 3 days of ICPi-AKI) was associated with a higher odds of renal recovery compared with later initiation (more than 3 days following ICPi-AKI) (adjusted OR 2.09; 95% CI 1.16 to 3.79). Of 121 patients rechallenged, 20 (16.5%) developed recurrent ICPi-AKI. There was no difference in survival among patients rechallenged versus those not rechallenged following ICPi-AKI. CONCLUSIONS: Patients who developed ICPi-AKI were more likely to have impaired renal function at baseline, use a PPI, and have extrarenal irAEs. Two-thirds of patients had renal recovery following ICPi-AKI. Treatment with corticosteroids was associated with improved renal recovery.

Published
2021

33. 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

34. Initiation and termination of dialysis in older patients with advanced cancer: providing guidance in a complicated situation

Author

Sprangers, B, Van der Veen, A, Hamaker, ME, Rostoft, S, Latcha, S, Lichtman, SM, DE MOOR, Bart, and Wildiers, H

Abstract

Cancer and chronic kidney disease prevalence both increase with age. As a consequence, physicians are more frequently encountering older people with cancer who need dialysis, or patients on dialysis diagnosed with cancer. Decisions in this context are particularly complex and multifaceted. In this Review, we aim to provide an overview of the key points to address when making a treatment strategy in these patients. We provide information on what happens if dialysis is not started or is stopped, and how physicians should deal with such patients. Informed decisions about dialysis require a personalised care plan that considers the prognosis and treatment options for each condition while also respecting patient preferences. The concept of prognosis should include quality-of-life considerations, functional status, and burden of care. Close collaboration between oncologists, nephrologists, and geriatricians is crucial to making optimal treatment decisions, and several tools are available for estimating cancer prognosis, prognosis of renal disease, and general age-related prognosis. Emerging evidence shows that these geriatric assessment tools, which measure degrees of frailty, are useful in patients with chronic kidney disease. In this Review, we try to hand tools to practising physicians, to guide decision making regarding the initiation and termination of dialysis in patients with advanced cancer. SML is supported by the US National Cancer Institute Cancer Center Support Grant (award number: P30CA008748). BS and HW are senior clinical investigators of the Research Foundation Flanders (BS: FWO 1842919N. HW: FWO G067014N).

Published
2021

37. Contributors

Author

Allen, Richard D.M., primary, Barry, John M., additional, Basu, Amit, additional, Becker, Bryan N., additional, Billiau, A.D., additional, Bordea, Cristina, additional, Bradley, J. Andrew, additional, Brook, Nicholas R., additional, Campbell, Michael, additional, Chapman, Jeremy R., additional, Colvin, Robert B., additional, Cosimi, A. Benedict, additional, Cranston, David, additional, Daar, Abdallah S., additional, Dallman, Margaret J., additional, Davis, John A., additional, Delmonico, Francis L., additional, Dyar, Oliver J., additional, Ettenger, Robert B., additional, Fishman, Jay A., additional, Ford, Andria L., additional, Franc-Guimond, Julie, additional, Franklin, Patricia M., additional, Fuggle, Susan V., additional, Gloor, James M., additional, González, Ricardo, additional, Gruessner, Angelika C., additional, Gruessner, Rainer W.G., additional, Hamilton, David, additional, Israni, Ajay K., additional, Kahan, Barry D., additional, Kasiske, Bertram L., additional, Kirk, Allan D., additional, Knechtle, Stuart J., additional, Knight, Simon R., additional, Ko, Dicken S.C., additional, Kobayashi, Takashi, additional, Lally, Aoife, additional, Lee, Jin-Moo, additional, Leuvenink, Henri G.D., additional, Lucey, Michael R., additional, Mathieu, C., additional, Mauiyyedi, Shamila, additional, Mohacsi, Paula J., additional, Montgomery, Robert A., additional, Moosa, M. Rafique, additional, Morris, Peter J., additional, Nadig, Satish N., additional, Nankivell, Brian J., additional, Nanovic, Lisa, additional, Nicholson, Michael L., additional, Pirenne, J., additional, Pirsch, John D., additional, Ploeg, Rutger J., additional, Rianthavorn, Pornpimol, additional, Russell, Neil K.I., additional, Safdar, Nasia, additional, Said, Adnan, additional, Sarwal, Minnie M., additional, Sear, John W., additional, Shapiro, Ron, additional, Shoskes, Daniel, additional, Simpkins, Christopher E., additional, Sprangers, B., additional, Stegall, Mark D., additional, Sutherland, David E.R., additional, Taylor, Craig J., additional, Thompson, John F., additional, van Etten, E., additional, Venning, Vanessa, additional, Vo, Katie D., additional, Waer, Mark, additional, Warnecke, Gregor, additional, Watson, Christopher J.E., additional, Wells, Jennifer T., additional, Wojnarowska, Fenella, additional, Wood, Kathryn J., additional, Wood, Kenneth E., additional, and Wright, Linda, additional

Published
2008
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40. KDIGO Controversies Conference on onco-nephrology: kidney disease in hematological malignancies and the burden of cancer after kidney transplantation

Author

Małyszko, J. Bamias, A. Danesh, F.R. Dębska-Ślizień, A. Gallieni, M. Gertz, M.A. Kielstein, J.T. Tesarova, P. Wong, G. Cheung, M. Wheeler, D.C. Winkelmayer, W.C. Porta, C. Abu-Alfa, A.K. Amer, H. Beutel, G. Chapman, J. Chen, X. Chudek, J. Cosmai, L. Danesi, R. De Stefano, F. Iseki, K. Jaimes, E.A. Jhaveri, K.D. Jurczyszyn, A. Kazancioğlu, R. Kitchlu, A. Kollmannsberger, C. Lahoti, A. Li, Y. Macía, M. Matsubara, T. Mitropoulos, D. Noiri, E. Perazella, M.A. Ronco, P. Rosner, M.H. Soler Romeo, M.J. Sprangers, B. Stadler, W.M. Stevens, P.E. Tesař, V. Torres da Costa e Silva, V. Vesole, D.H. Vijayan, A. Viklický, O. Workeneh, B.T. Yanagita, M. Zakharova, E. Conference Participants

Abstract

The bidirectional relationship between cancer and chronic kidney disease (CKD) is complex. Patients with cancer, particularly those with hematological malignancies such as multiple myeloma and lymphoma, are at increased risk of developing acute kidney injury and CKD. On the other hand, emerging evidence from large observational registry analyses have consistently shown that cancer risk is increased by at least 2- to 3-fold in kidney transplant recipients, and the observed increased risk occurs not only in those who have received kidney transplants but also in those on dialysis and with mild- to moderate-stage CKD. The interactions between cancer and CKD have raised major therapeutic and clinical challenges in the management of these patients. Given the magnitude of the problem and uncertainties, and current controversies within the existing evidence, Kidney Disease: Improving Global Outcomes (KDIGO) assembled a global panel of multidisciplinary clinical and scientific expertise for a controversies conference on onco-nephrology to identify key management issues in nephrology relevant to patients with malignancy. This report covers the discussed controversies in kidney disease in hematological malignancies, as well as cancer after kidney transplantation. An overview of future research priorities is also discussed. © 2020 Kidney Disease: Improving Global Outcomes (KDIGO)

Published
2020

41. KDIGO Controversies Conference on onco-nephrology: understanding kidney impairment and solid-organ malignancies, and managing kidney cancer

Author

Porta, C. Bamias, A. Danesh, F.R. Dębska-Ślizień, A. Gallieni, M. Gertz, M.A. Kielstein, J.T. Tesarova, P. Wong, G. Cheung, M. Wheeler, D.C. Winkelmayer, W.C. Małyszko, J. Abu-Alfa, A.K. Amer, H. Beutel, G. Chapman, J. Chen, X. Chudek, J. Cosmai, L. Danesi, R. De Stefano, F. Iseki, K. Jaimes, E.A. Jhaveri, K.D. Jurczyszyn, A. Kazancioğlu, R. Kitchlu, A. Kollmannsberger, C. Lahoti, A. Li, Y. Macía, M. Matsubara, T. Mitropoulos, D. Noiri, E. Perazella, M.A. Ronco, P. Rosner, M.H. Soler Romeo, M.J. Sprangers, B. Stadler, W.M. Stevens, P.E. ladimír Tesař Torres da Costa e Silva, V. Vesole, D.H. Vijayan, A. Viklický, O. Workeneh, B.T. Yanagita, M. Zakharova, E.

Abstract

The association between kidney disease and cancer is multifaceted and complex. Persons with chronic kidney disease (CKD) have an increased incidence of cancer, and both cancer and cancer treatments can cause impaired kidney function. Renal issues in the setting of malignancy can worsen patient outcomes and diminish the adequacy of anticancer treatments. In addition, the oncology treatment landscape is changing rapidly, and data on tolerability of novel therapies in patients with CKD are often lacking. Caring for oncology patients has become more specialized and interdisciplinary, currently requiring collaboration among specialists in nephrology, medical oncology, critical care, clinical pharmacology/pharmacy, and palliative care, in addition to surgeons and urologists. To identify key management issues in nephrology relevant to patients with malignancy, KDIGO (Kidney Disease: Improving Global Outcomes) assembled a global panel of multidisciplinary clinical and scientific expertise for a controversies conference on onco-nephrology in December 2018. This report covers issues related to kidney impairment and solid organ malignancies as well as management and treatment of kidney cancer. Knowledge gaps, areas of controversy, and research priorities are described. © 2020 Kidney Disease:Improving Global Outcomes (KDIGO)

Published
2020

43. The genetic architecture of membranous nephropathy and its potential to improve non-invasive diagnosis

Author

Xie, J, Liu, L., Mladkova, N., Li, Yifu, Ren, H., Wang, W., Cui, Z., Lin, L., Hu, X., Yu, X, Xu, J, Liu, G., Caliskan, Y., Sidore, C., Balderes, O., Rosen, R.J., Bodria, M., Zanoni, F., Zhang, J.Y., Krithivasan, P., Mehl, K., Marasa, M., Khan, A., Ozay, F., Canetta, P.A., Bomback, A.S., Appel, G.B., Sanna-Cherchi, S., Sampson, M.G., Mariani, L.H., Perkowska-Ptasinska, A., Durlik, M., Mucha, K., Moszczuk, B., Foroncewicz, B., Paczek, L., Habura, I., Ars, E., Ballarin, J., Mani, L.Y., Vogt, B., Ozturk, S., Yildiz, A., Seyahi, N., Arikan, H., Koc, M., Basturk, T., Karahan, G., Akgul, S.U., Sever, M.S., Zhang, D., Santoro, D., Bonomini, M., Londrino, F., Gesualdo, L., Reiterova, J., Tesar, V., Izzi, C., Savoldi, S., Spotti, D., Marcantoni, C., Messa, P., Galliani, M., Roccatello, D., Granata, S., Zaza, G., Lugani, F., Ghiggeri, G., Pisani, I., Allegri, L., Sprangers, B., Park, J.H., Cho, B., Kim, Y.S., Kim, D.K., Suzuki, H, Amoroso, A., Cattran, D.C., Fervenza, F.C., Pani, A., Hamilton, P., Harris, S., Gupta, S., Cheshire, C., Dufek, S., Issler, N., Pepper, R.J., Connolly, J., Powis, S., Bockenhauer, D., Stanescu, H.C., Ashman, N., Loos, R.J., Kenny, E.E., Wuttke, M., Eckardt, K.U., Kottgen, A., Hofstra, J.M., Coenen, M.J.H., Kiemeney, L.A.L.M., Wetzels, J., Chen, N., Kiryluk, K., Xie, J, Liu, L., Mladkova, N., Li, Yifu, Ren, H., Wang, W., Cui, Z., Lin, L., Hu, X., Yu, X, Xu, J, Liu, G., Caliskan, Y., Sidore, C., Balderes, O., Rosen, R.J., Bodria, M., Zanoni, F., Zhang, J.Y., Krithivasan, P., Mehl, K., Marasa, M., Khan, A., Ozay, F., Canetta, P.A., Bomback, A.S., Appel, G.B., Sanna-Cherchi, S., Sampson, M.G., Mariani, L.H., Perkowska-Ptasinska, A., Durlik, M., Mucha, K., Moszczuk, B., Foroncewicz, B., Paczek, L., Habura, I., Ars, E., Ballarin, J., Mani, L.Y., Vogt, B., Ozturk, S., Yildiz, A., Seyahi, N., Arikan, H., Koc, M., Basturk, T., Karahan, G., Akgul, S.U., Sever, M.S., Zhang, D., Santoro, D., Bonomini, M., Londrino, F., Gesualdo, L., Reiterova, J., Tesar, V., Izzi, C., Savoldi, S., Spotti, D., Marcantoni, C., Messa, P., Galliani, M., Roccatello, D., Granata, S., Zaza, G., Lugani, F., Ghiggeri, G., Pisani, I., Allegri, L., Sprangers, B., Park, J.H., Cho, B., Kim, Y.S., Kim, D.K., Suzuki, H, Amoroso, A., Cattran, D.C., Fervenza, F.C., Pani, A., Hamilton, P., Harris, S., Gupta, S., Cheshire, C., Dufek, S., Issler, N., Pepper, R.J., Connolly, J., Powis, S., Bockenhauer, D., Stanescu, H.C., Ashman, N., Loos, R.J., Kenny, E.E., Wuttke, M., Eckardt, K.U., Kottgen, A., Hofstra, J.M., Coenen, M.J.H., Kiemeney, L.A.L.M., Wetzels, J., Chen, N., and Kiryluk, K.

Abstract

Contains fulltext : 220480.pdf (publisher's version ) (Open Access), Membranous Nephropathy (MN) is a rare autoimmune cause of kidney failure. Here we report a genome-wide association study (GWAS) for primary MN in 3,782 cases and 9,038 controls of East Asian and European ancestries. We discover two previously unreported loci, NFKB1 (rs230540, OR = 1.25, P = 3.4 x 10(-12)) and IRF4 (rs9405192, OR = 1.29, P = 1.4 x 10(-14)), fine-map the PLA2R1 locus (rs17831251, OR = 2.25, P = 4.7 x 10(-103)) and report ancestry-specific effects of three classical HLA alleles: DRB1*1501 in East Asians (OR = 3.81, P = 2.0 x 10(-49)), DQA1*0501 in Europeans (OR = 2.88, P = 5.7 x 10(-93)), and DRB1*0301 in both ethnicities (OR = 3.50, P = 9.2 x 10(-23) and OR = 3.39, P = 5.2 x 10(-82), respectively). GWAS loci explain 32% of disease risk in East Asians and 25% in Europeans, and correctly re-classify 20-37% of the cases in validation cohorts that are antibody-negative by the serum anti-PLA2R ELISA diagnostic test. Our findings highlight an unusual genetic architecture of MN, with four loci and their interactions accounting for nearly one-third of the disease risk.

Published
2020

45. Monoclonal gammopathy of renal significance (mgrs): Histopathologic classification, diagnostic workup, and therapeutic options

Author

Amaador, K., Peeters, H., Minnema, M. C., Tri Q Nguyen, Dendooven, A., Vos, J. M. I., Croockewit, A. J., Donk, N. W. C. J., Jacobs, J. F. M., Wetzels, J. F. M., Sprangers, B., Abrahams, A. C., General Internal Medicine, Clinical Haematology, Graduate School, AII - Inflammatory diseases, and Hematology

Subjects
Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2], Journal Article, Human medicine, Renal disorders Radboud Institute for Health Sciences [Radboudumc 11], Rare cancers Radboud Institute for Health Sciences [Radboudumc 9]
Abstract

Monoclonal gammopathy of renal significance (MGRS) includes all kidney disorders caused by a monoclonal protein (M-protein) secreted by a small plasma cell clone or other B-cell clones in patients who do not meet the diagnostic criteria for multiple myeloma or other B-cell malignancies. The underlying disorder in patients with MGRS is generally consistent with monoclonal gammopathy of undetermined significance (MGUS). MGRS-associated kidney disorders are various and the list is still expanding. The kidney disorders can manifest as glomerular diseases, tubulopathies, and vascular involvement with varying clinical presentations. Diagnosis is often challenging because of the wide spectrum of MGRS, and it is difficult to establish a pathogenic link between the presence of the M-protein or serum free light chains and kidney diseases; further complicating accurate diagnosis is the high incidence of MGUS and/or kidney disorders, independent of MGRS, in elderly patients. However, MGRS can significantly impair kidney function. Because treatment can stop and also reverse kidney disease, early recognition is of great importance. A combined haematologic and nephrologic approach is crucial to establish the causative role of the M-protein in the pathogenesis of kidney disease. Clone-directed therapy, which may include autologous stem cell transplantation in eligible patients, often results in improved outcomes. In this review, we discuss the histopathologic classification of MGRS lesions, provide a renal and haematologic diagnostic workup, discuss treatment options for MGRS, and introduce a Benelux MGRS Working Group.

Published
2019

47. Monoclonal gammopathy of renal significance (MGRS) histopathologic classification, diagnostic workup, and therapeutic options

Author

Amaador, K, Peeters, H, Minnema, M C, Nguyen, T Q, Dendooven, A, Vos, J M I, Croockewit, A J, van de Donk, N W C J, Jacobs, J F M, Wetzels, J F M, Sprangers, B, Abrahams, A C, Amaador, K, Peeters, H, Minnema, M C, Nguyen, T Q, Dendooven, A, Vos, J M I, Croockewit, A J, van de Donk, N W C J, Jacobs, J F M, Wetzels, J F M, Sprangers, B, and Abrahams, A C

Published
2019

48. Monoclonal gammopathy of renal significance (MGRS) histopathologic classification, diagnostic workup, and therapeutic options

Author

MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Pathologie Pathologen staf, Circulatory Health, Pathologie Opleiding, Externen Hematologie, MKA/BT Onderzoek, MS Nefrologie, Amaador, K, Peeters, H, Minnema, M C, Nguyen, T Q, Dendooven, A, Vos, J M I, Croockewit, A J, van de Donk, N W C J, Jacobs, J F M, Wetzels, J F M, Sprangers, B, Abrahams, A C, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Pathologie Pathologen staf, Circulatory Health, Pathologie Opleiding, Externen Hematologie, MKA/BT Onderzoek, MS Nefrologie, Amaador, K, Peeters, H, Minnema, M C, Nguyen, T Q, Dendooven, A, Vos, J M I, Croockewit, A J, van de Donk, N W C J, Jacobs, J F M, Wetzels, J F M, Sprangers, B, and Abrahams, A C

Published
2019

49. Other Forms of Immunosuppression

Author

Sprangers, B., Pirenne, J., van Etten, E., Waer, Mark, Mathieu, C., and Billiau, A.D.

Subjects
Article
Published
2009

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