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.
Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan / 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.; 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. 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.. - In: KIDNEY INTERNATIONAL REPORTS. - ISSN 2468-0249. - 8:4(2023), pp. 860-870. [10.1016/j.ekir.2023.01.039]
Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan
Dagna L.;Mohamed A.;
2023-01-01
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
