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

2023; Elsevier BV; Volume: 8; Issue: 4 Linguagem: Inglês

10.1016/j.ekir.2023.01.039

2468-0249

Frank B. Cortazar, John L. Niles, David Jayne, Peter A. Merkel, Annette Bruchfeld, Huibin Yue, Thomas J. Schall, Pirow Bekker, Chen Au Peh, Aron Chakera, Bruce A. Cooper, Jadadeesh Kurtkoti, Daman Langguth, Vicki Levidiotis, G. Luxton, Peter F. Mount, David W. Mudge, Euan Noble, R. Phoon, Dwarakanathan Ranganathan, A. Ritchie, Jessica Ryan, M. Suranyi, Alexander R. Rosenkranz, K. Lhotta, Andreas Kronbichler, Nathalie Demoulin, C. Bovy, R. Hellemans, Jean‐Michel Hougardy, Ben Sprangers, Katherine D. Wissing, Christian Pagnoux, S. Barbour, Soumeya Brachemi, S. Cournoyer, Louis Girard, Louis‐Philippe Laurin, Patrick Liang, David Philibert, Michael Walsh, Vladimı́r Tesař, Radim Bečvář, P. Horak, Ivan Rychlík, Wladimir Szpirt, Hans Dieperink, Jon Waarst Gregersen, Per Ivarsen, Elizabeth Krarup, Cecilie Lyngsoe, Claire Rigothier, Jean‐François Augusto, Alexandre Bélot, Dominique Chauveau, Divi Cornec, Noémie Jourde‐Chiche, M. Ficheux, Alexandre Karras, Armelle Klein, F. Maurier, Rafik Mesbah, Olivier Moranne, A. Néel, T. Quéméneur, David Saadoun, Benjamin Terrier, Philippe Zaoui, Matthias Schaier, Urs Benck, Raoul Bergner, Matthias H. Busch, Jürgen Floege, Franziska Grundmann, Hermann Haller, Marion Haubitz, B. Hellmich, Jörg Henes, Bernd Hohenstein, C. Hugo, Christof Iking‐Konert, Fabian Arndt, Torsten Kubacki, Ina Kötter, Peter Lamprecht, Tom H. Lindner, Jan Halbritter, H. Mehling, Ulf Schönermarck, Nils Venhoff, Volker Vielhauer, Oliver Witzke, István Szombati, G Szücs, Giacomo Garibotto, Federico Alberici, Enrico Brunetta, Lorenzo Dagna, Salvatore De Vita, Giacomo Emmi, Armando Gabrielli, Lucio Manenti, Federico Pieruzzi, Dario Roccatello, Carlo Salvarani, Hiroaki Dobashi, Tatsuya Atsumi, Shouichi Fujimoto, Noboru Hagino, Atsushi Ihata, Shinya Kaname, Yoriaki Kaneko, A. Katagiri, Michihito Katayama, Yohei Kirino, Kiyoki Kitagawa, Atsushi Komatsuda, Hajime Kono, Takahiko Kurasawa, Ryutaro Matsumura, T. Mimura, Akio Morinobu, Yohko Murakawa, Taio Naniwa, Toshihiro Nanki, N. Ogawa, H. Oshima, Ken‐ei Sada, Eiji Sugiyama, Tohru Takeuchi, H. Taki, Naoto Tamura, Tatsuo Tsukamoto, Kunihiro Yamagata, Masayuki Yamamura, P. van Daele, Abraham Rutgers, Y.K. Onno Teng, Robert Walker, I. Chua, Michael P. Collins, K. Rabindranath, Janak de Zoysa, Maria Svensson, Bård Waldum - Grevbo, Synove Kalstad, Mark A. Little, Michael Clarkson, Eleanor J. Molloy, Irene Agraz Pamplona, Jordi Antón, V. Barrio Lucia, Secundino Ciggaran, M. Cinta Cid, Montserrat Díaz-Encarnación, Xavier Fulladosa, María José Soler, Helena Marco Rusinol, Manuel Praga, Luis Quintana Porras, A. Segarra, Annette Bruchfeld, Mårten Segelmark, Inga Soveri, Eleni Thomaidi, Kerstin Westman, Thomas Neumann, Michel Burnier, Thomas Daikeler, J. Dudler, Thomas Häuser, H. Seeger, Bruno Vogt, David Jayne, James O. Burton, Reem Al Jayyousi, Talha Shahid Amin, Jeanette S. Andrews, J. T. Baines, Paul Brogan, Bhaskar Dasgupta, Timothy William Ronald Doulton, Oliver Floßmann, Simon J. Griffin, Janice Marian Harper, Lorraine Harper, Dana Kidder, Rainer Klocke, Peter Lanyon, Raashid Luqmani, John McLaren, David Makanjuola, L. McCann, A. Nandagudi, S. Selvan, Edmond O’Riordan, Mumtaz Patel, Reysha Patel, CD Pusey, R. Rajakariar, Joanna Robson, M. Robson, Alan D. Salama, Lucy Smyth, J Sznajd, Jocelyn Taylor, Peter A. Merkel, Antoine G. Sreih, E. Belilos, Andrew S. Bomback, J. Carlin, Yih Chang Lin, Vimal K. Derebail, S. Dragoi, Anisha B. Dua, Lindsy Forbess, Duvuru Geetha, Patrick Gipson, R. Gohh, Gregory Todd Greenwood, S. Hugenberg, Richard Jimenez, Marwan Omar Kaskas, Tanaz A. Kermani, A. Kivitz, Curry L. Koening, Carol A. Langford, G. Marder, Abdulfataah A A Mohamed, Paul A. Monach, N. Roxanne Neyra, Gregory W. Niemer, John L. Niles, R. Obi, Charles Owens, D. Parks, Amber S. Podoll, Brad H. Rovin, R. Sam, William Julius Shergy, Alejandra Tellez Silva, Ulrich Specks, Robert Spiera, Jason Springer, Christopher Charles Striebich, A. Swarup, S. Thakar, A. Tiliakos, Yi‐Shan Tsai, Dia Rose Waguespack, M. Chester Wasko,

Amyloidosis: Diagnosis, Treatment, Outcomes

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.eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups.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.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.